BARDA seeks to partner with diverse organization with both national and global reach. The purpose of the Teaming Partner List is to facilitate teaming among organizations interested in joining additional organizations to form a proposed BARDA Accelerator Hub. The list does not represent final selections and does not include all interested organizations.
By enabling and publishing the Teaming Partner List, BARDA is not endorsing, sponsoring, or otherwise evaluating the qualifications of the individuals and organizations that are self-identifying themselves for placement on this Teaming Partner List. BARDA plans to update this webpage periodically at BARDA's discretion based on the frequency and volume of submissions. BARDA reserves the right to edit or decline to post any information submitted by an organization if BARDA determines that the information submitted is not within the scope of the questionnaire and/or within the scope of the BARDA Accelerator Network 2.0 program, is determined to be an otherwise irrelevant submission, is deemed unfit for public consumption, or for any reason at BARDA's discretion.
| Organization Name | Point of Contact | Location | Hubs of Interest | Role | Organizational Background and Teaming Potential | Organization's Strenghts and Experiences Regarding Selected Role(s) | Reasons for Partnering | |
|---|---|---|---|---|---|---|---|---|
| Access to Advanced Health Institute | Casey Benadof | casey.benadof@aahi.org | Seattle, Washington | Vaccines and Therapeutics | Development, Evaluation, and Validation Services | AAHI is a non-profit biotech research institute that develops equitably accessible vaccines and immunotherapies based on its formulations (immune-enhancing adjuvants and delivery vehicles) and self-amplifying RNA (saRNA) platforms. AAHI's special expertise in formulating adjuvants from its robust portfolio to be combined with specific protein antigens, targeted to specific pathogens, optimizes the impact of vaccines, improving breadth and durability of immune responses to provide enhanced protection, including for vulnerable populations (children, the elderly, the immunocompromised). AAHI scientists apply pragmatic creativity to innovate effective vaccines that are also temperature stable, easy to manufacture, sustainably sourced, and cost-efficient. By evaluating different formulations, presentations, routes of administration, and regimens (including the combination of two different vaccine technologies -- adjuvanted protein and RNA), AAHI supports development of vaccines that provide broad protection against endemic and pandemic threats, while maintaining stability at ambient temperatures, so they can be made available around the world. AAHI innovates, develops, and manufactures its adjuvant formulations and vaccines based on its formulations and saRNA platforms, from preclinical studies to IND-enablement to Phase 1 and 2 clinical trials, transfers technology to support scale-up for Phase 3 and commercial manufacture, and leads or supports applications for regulatory approval. | AAHI's three decades of scientific discovery and formulations expertise support development of novel vaccines and immunotherapies. AAHI collaborates with public and private partners to develop innovative immune-enhancing products and methods of making and using those products. To ensure the products are made globally accessible, AAHI transfers manufacturing technology and know-how to international partners, enabling local self-reliance. Decades of GMP manufacturing experience and a state-of-the-art cGMP manufacturing suite have equipped AAHI to supply its novel adjuvant formulations for 37 completed Phase 1 and Phase 2 clinical trials, and to supply such formulations and/or saRNA vaccines for 14 currently active clinical trials (with numerous additional Phase 1 and Phase 2 clinical trials planned to begin in 2023-2024) . Preclinical and clinical testing against multiple difference pathogens has demonstrated that AAHI's formulations are a critical vaccine component, important to eliciting the desired immune response and demonstrate excellent safety profiles. AAHI's platform approach to vaccine development enables the latest advancements in formulation technology to be applied and optimized to any endemic or pandemic target. | AAHI's ground-breaking work in formulation of adjuvants and delivery vehicles and its saRNA expertise are a natural fit for a network of teaming partners with complementary technologies -- for example, cutting-edge protein technology, specialized animal models for advanced preclinical testing, or technology to enable novel routes of vaccine administration. While AAHI itself has established relationships with private sector partners with capability and capacity rapidly to produce and distribute adjuvant formulations and/or vaccines at commercial scale, AAHI would welcome teaming partners who also have established such relationships, to flesh out a network that can not only innovate and develop next-generation vaccines, but can also quickly pivot to produce vaccines rapidly to support late-phase clinical trials and commercial-scale manufacture, to meet an emerging health threat. |
| Advanced Technology International (ATI) | Elaine Sumera | elaine.sumera@ati.org | Summerville, SC | Vaccines and Therapeutics | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Advanced Technology International (ATI) is a public service 501(c)(3) non-profit that offers 25 years of experience as the nation’s preeminent Consortium Management Firm (CMF). We manage 17 Other Transaction/Other Arrangement consortia focused on the missions of the Department of Health and Human Services, Department of Defense, Department of Homeland Security and the National Science Foundation. ATI is the only experienced CMF with a federally funded life science consortia, executing nearly $7B of prototyping efforts during COVID response. With ATI, Biomedical Advanced Research and Development Authority (BARDA) and potential teaming partners gain full advantage of our existing health innovation network that includes large and small businesses, traditional and nontraditional innovators, non-profit organizations, and academia. | ATI's strengths and experiences in health innovation are what set us apart from our competitors. These strengths include: 1) Battle-Tested Practices – We offer a proven suite of business tools and a deep reservoir of best practices proven during the global crisis of the COVID-19 pandemic, 2) Flexibility – We bring a flexible and responsive team capable of surging during a national health emergency while sustaining high quality customer service and operations support, 3) Speed – We provide a connected, diverse national innovation network that is supported/trained to rapidly respond at scale and speed, and 4) Reach – We have access to a global network of industry health leaders and emerging solution providers as well as academic innovators across multiple technology areas. Our experience and expertise in consortium management along with our efficient business processes uniquely positioned us to assist the Government in Operation Warp Speed. The three ATI-managed medical consortia executed 44 COVID-19 projects with several large-scale vaccine and therapeutic developments as well as diagnostics, awarding one in just 8 days from solicitation to award. In FY22, ATI, across its individual Government sponsor-focused program teams (25 funded programs), managed 1300 Government funded projects, totaling $3.7B in funding. | ATI is open to partnering with all US-based companies, innovators, research institutions and academic institutions who want to support BARDA in promoting the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats. More specifically, we are looking for partners who have proven experience in the vaccine/therapeutics technology areas referenced in the BARDA's Accelerator Network (BAN) 2.0 RFI. |
| ASELL | Michael Ehret | mehret@asell.com | Owings Mills, MD | Diagnostics and Medical Devices | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | ASELL is a medical device company with a mission to translate technologies from early-stage concepts to FDA-authorized in vitro diagnostics. We partner with developers to provide solutions that enhance health-related security and preparedness, with a particular emphasis on development programs under US government funding. ASELL provides services in quality assurance, regulatory affairs, clinical research, product development, and project management. Our cross disciplinary team brings experience from a wide range of companies including venture-funded startups, multinational diagnostic companies, and government-backed technology developers. ASELL operates under an FDA QSR compliant Quality Management System and has a government audited and FAR-compliant accounting system. ASELL has deep experience and robust systems to support establishing and managing subcontracts with key partners, including contract manufacturers, clinical research partners, specialized testing and development providers, and other capabilities to support advanced development and commercialization of products. ASELL has years of experience leading large, complex systems development efforts, performing clinical and non-clinical studies, working closely with biotechnology partners, and collaborating with BARDA and FDA to develop regulatory strategies and validation approaches for complex in vitro diagnostics. From small advisory projects through integrated partnerships, ASELL leverages this expertise to turn science into solutions. | ASELL brings proven experience in providing the integrated capabilities needed to successfully develop medical devices under US- government funding and in providing key development services to commercial partners. ASELL is led by an executive team with over 100 years of combined experience managing the successful development, validation, deployment and support of complex medical devices and analytical systems for US Government customers. This has included execution of two BARDA funded prime contracts for the advanced development, validation, FDA authorization and deployment of radiation biodosimetry diagnostics, as well as support for other technology developers with BARDA DRIVe projects. In addition, over the last 3 years, we have supported more than 30 diagnostics developers ranging from startups through industry leaders. Projects have included determining regulatory strategy and FDA engagement, establishing quality management systems, performing independent audits, supporting technical product development, designing and performing clinical studies, and engaging with funding agencies. ASELL’s ability to respond to emerging needs was exemplified by our COVID-19 response. Soon after the pandemic began, ASELL began providing product development support to multiple diagnostic developers. This support ranged from regulatory affairs and clinical study advisory services through management and execution of non-clinical and clinical studies culminating in Emergency Use Authorization for an at-home test. | We are seeking to partner with a prime contractor that shares ASELL’s commitment to advance technologies to increase health security and emergency preparedness. Specifically, we are interested in providing Wraparound Services and Development, Evaluation, And Validation (DEV) Services for the Diagnostics/Medical Devices Accelerator hub. Wraparound services could include regulatory affairs, quality management, clinical research, and program management. DEV services could include independent usability, feasibility, and validation testing services and the associate program management. In addition, we can provide expertise on securing non-dilutive capital through federal funding. We welcome the opportunity to work across an integrated team with other experts that can complement and leverage ASELL’s capabilities. |
| ATCC | Rebecca Bradford | rbradford@atcc.org | Manassas, VA | Diagnostics and Medical Devices, Enabling Technologies | Development, Evaluation, and Validation Services, Rapid Response Capability | Founded in 1925, ATCC (American Type Culture Collection) is a non-profit organization whose mission is to provide the biological and Life science research and scientific community with authenticated biomaterials and reference standards. The ATCC Federal Solutions (AFS) business unit supports federal agencies and programs focused on global health and infectious diseases, biodefense, clinical studies, and biological material resource support. ATCC can support BARDA and teaming partners with the following capabilities and technologies: 1) Rapid and surge biomanufacturing support to the US government’s pandemic response for developing, manufacturing, testing, storing, and distributing biological materials 2) Acquisition, production, authentication, and characterization of biological pathogens, threat agent panels, and associated reagents under a certified Quality Management System 3) Establishment and management of biorepositories of organisms, standards, reagents, and clinical specimens providing critical materials for development studies 4) Production and distribution of biological diagnostic/detection kits and medical countermeasures under the appropriate quality guidelines, including GMP 5) Rapid product and process development studies in response to global health emergencies. | Development, Evaluation, Validation Services: ATCC, through managing the BEI (Biodefense & Emerging Infections) Resources program, collaborated with NIAID to develop and produce SARS-CoV-2 well-characterized challenge material (WCCM). This process provides the gold standard for viral WCCM production and an essential standard for vaccine development. In addition, ATCC supports both CDC (Centers for Disease Control) and FDA (Food and Drug Administration) in assay development (RUO (Research Use Only) and IVD) for multiple pathogens. ATCC is also the manufacturer of record for a yellow fever surveillance kit, which the World Health Organization has provisionally recommended. Rapid Response Capability: ATCC supports rapid response for diagnostics, serum/plasma repository, detection/diagnostic, 510K support, and global distribution/logistics. ATCC, through the BEI Resources program, was selected as one of two repositories to receive the first U.S. isolate of SARS-CoV-2 and produced, characterized, and began distributing the first US-identified SARS-CoV-2 strain within 48 hours (about two days) of receipt. ATCC has responded to the COVID-19 pandemic by shipping 167,762 vials of SARS-CoV-2 material since February 2020. These critical response biomaterials were shipped to 77 unique countries, including the U.S., 1,955 institutions, and over 3,800 researchers to accelerate medical countermeasures. | ATCC seeks partners in the Enabling Tech category of the BARDA Accelerator Program who require well-characterized biological challenge material (WCCM) as standards for their diagnostic or therapeutic development studies or as QC testing standards. ATCC can rapidly provide WCCM up to liter quantities for pathogens up to risk group 3. ATCC can produce several biological standards, including inactivated pathogens, nucleic acids, and antibodies. Using biological standards from ATCC will reduce variability across studies to increase the speed of development work. A rapid response is critical to a health emergency, and ATCC has responded quickly to support the government through multiple epidemics and pandemics with high-quality biological standards. ATCC offers development, evaluation, validation services, assay development, production of diagnostic and surveillance kits, repository services, global shipping, and rapid response capabilities. What sets ATCC apart from other partners is our ability to produce and manage a vast inventory of biologics, reagents, and research and clinical samples that will aid in this Accelerator Program. |
| Athari BioSciences, Inc. | Susan Mitchell | smitchell@athari.bio | Sterling, Virginia | Vaccines and Therapeutics, Diagnostics and Medical Devices, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | Athari BioSciences Inc. is an emerging biotechnology company that owns and operates a CLIA-certified diagnostic testing laboratory as well as a life sciences incubator and training center in Loudoun County, Northern Virginia. Our company is a woman-owned and minority-owned small business creating an ecosysystem to foster innovation and diversity in our scalable BSL-2 laboratory. Our company can offer BARDA and potential teaming partners CLIA laboratory resources for product evaluation, BSL-2 level laboratory and accompanying office space for incubating life science companies, partnering on projects, and access to our network of scientific and technical experts in the areas of infections disease, medical pathology, product development, commercialization, federal contracting, and STEMM education, training, and outreach for populations, comprised primarily of socially and economically disadvantaged individuals (SEDI), on the benefits of participating in genomic related studies. In addition, we are actively developing several products relevant to vaccines and rapid molecular diagnostics for infectious diseases such as pandemic influenza and SARS-CoV2 that are relevant to BARDA's mission. | Athari BioSciences Inc. has deep domain experience in infectious disease research, genomics research, medical pathology, and clinical laboratory operations that can be of high value to BARDA and its partners seeking to develop new products and medical countermeasures against current and future infectious disease threats. Our team also has relevant experience growing and mentoring small businesses in the life sciences and government services sectors and our leadership has decades of experience in the academic and federal government research funding sectors. | Athari Bioscience Inc. is looking for potential teaming partners to enhance the innovation ecosystem, partner on key projects and add value to our life science company incubator activities in areas such as legal support, finance support, and regulatory strategy support. We are also seeking teaming partners that can add value to our product commercialization activities in the area of infectious diseases, including those with deep experience in GMP manufacturing and gaining regulatory approval for vaccines and molecular diagnostics. |
| Canopy Healthtech | Rachel Lane | rachel@canopyhealth.tech | Tulsa, OK | Digital Health Tools | Wraparound Accelerator Support Services | Canopy Healthtech (www.canopyhealth.tech) was established in 2022 to fast-track university virtual healthtechnologies to market. We have experience connecting emerging technologies with business support to validate need and scalability on an expedited timeline. | We have established best practices and are agile to respond to identified industry needs. We have connected with leaders across the digital health industry to support accelerated product development. | We seeks partners that will expand our capabilities in connecting emerging companies with wrap around services, industry partners, and KOLs. |
| Children's Hospital Los Angeles | Deepa Shah | dshah@chla.usc.edu | Los Angeles, CA | Special Populations | Wraparound Accelerator Support Services | As part of CHLA's Office of Transformation, the CHLA Innovation Studio launched KidsX in 2020 – a global ecosystem of pediatric innovators that facilitates collaboration between multisector partners, including children’s hospitals, providers, payors, investors, entrepreneurs, and corporate partners, to solve the most pressing problems in pediatric care delivery. KidsX delivers accelerators and innovation programs, to support digital health companies achieve product/business model validation in the pediatric market. KidsX is anchored by a consortium of 30+ leading children’s hospitals in the US and globally. KidsX will provide BARDA access to the KidsX network and deliver accelerator program(s) and innovation challenges that cover pre-approved healthcare specific curriculum/workshops, including, but not limited to, whitepapers and lectures on topics such as Building a Digital Health Business Model Strategy, FDA Regulations in Digital Health, Public Payers 101 for Digital Health Companies, Private Payer Partnerships with Digital Health companies, and Value-Based Care Models 101. Additionally, reports of program metrics will be provided including: application statistics, program attendance figures, marketing/engagement, diversity statistics etc. Post programming, KidsX will organize, host and invite participating startups to a Virtual Demo Day to present demonstrations of their proofs of concept to KidsX's network organizations, BARDA stakeholders, and external registrants. | Startups selected to be part KidsX BARDA programs will receive (1) Mentorship and learning curated to their business and growth needs, (2) Networking opportunities with investors, payors, hospital leaders and other subject matter experts (3) Pitch practice and feedback with potential partners and customers (4) Product market fit feedback and validation (5) KidsX support in navigating through hospital operational and administrative hurdles (6) Digital health adoption support. KidsX has graduated five classes of digital health companies since 2020 through the flagship KidsX accelerator programs and two corporate partnership accelerator programs, with Amazon Web Services and Press Ganey. In total, 57 startups have graduated the accelerators. Over 62 pilots are in progess and/or have been completed between the graduated startups and KidsX Hospital Consortium. In addition to executing accelerator programs, KidsX executes innovation challenges focused on public health issues like pediatric obesity, mental/behavioral health, food shortages/insecurities and vaccinations. Previous innovation challenge partners include Elevance Health, Microsoft, City of Glendale, and Los Angeles County Department of Health. | CHLA is looking to develop a shared vision to launch accelerators and other programs with potential partners in order to accelerate pediatric innovation. We've had tremendous success with integrating innovative digital health startups into patient care at our KidsX member hospitals. This partnership would allow us to leverage our network and expand our ability to positively pediatric healthcare outcomes. With this opportunity, CHLA and partners would collaborate to develop success metrics to ensure goals and expectations for the programs are being met. For programming purposes, CHLA is hoping partners can enhance healthcare specific curriculum/workshops; open their networks to provide mentors for startups (in addition to the mentors KidsX would provide from their network). During programs, CHLA is hoping BARDA and potential partners can provide support in Go-to-Market expertise for the companies, including introducing startups to their partner teams, network members, outside businesses, end-customer, and potential investment partners. After programming, CHLA hopes for BARDA and partners to support Program alumni Startups to help continue progressing to achieve their goals. CHLA will offer continued support and mentorship, as reasonably requested by BARDA. |
| CIMIT | Steven C. Schachter, M.D. | sschacht@bidmc.harvard.edu | Boston, MA | Diagnostics and Medical Devices | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | CIMIT seeks to work with BARDA to build on CIMIT's proven track record of success in healthcare innovation. Led for the past 25 years by experts with decades of clinical and medtech development experience, CIMIT has pioneered and established a unique model to identify unmet medical needs; find, fund, and facilitate technology-based projects to solve those needs; and rapidly move these innovations from concept to manufacturing to commercialization to the end-user. During its first 16 years, CIMIT's total funding of over 650 innovative projects at a proof-of-concept stage was approximately $70 million, generating more than $1 billion in follow-on funding from government agencies, companies or private investors with over 60 companies formed. For the past 5 years, CIMIT has served as the national coordinating center for POCTRN, proving our model is scalable and adaptable to different solicitations. Since April 2020, CIMIT stood up and led the extramural aspects of the $1.5 billion RADx Tech program, which after 15 months had generated 27 FDA EUAs for COVID-19 diagnostic tests, including the first over-the-counter test, and had produced 500 million tests. CIMIT scaled and improved its processes for RADx Tech by implementing new processes that blend best academic and business practices (https://www.embs.org/ojemb/special-issue-radx-tech/). | CIMIT will leverage its extensive past experience with solicitations, proposal review (https://ieeexplore.ieee.org/document/9418527), due diligence (https://ieeexplore.ieee.org/document/9418531), subproject support, and entrepreneurship education. CIMIT has designed and managed over 30 medtech solicitations and will apply this experience to identify the most promising technologies and provide milestone-driven funding, resources, and relevant expertise to assist innovators in rapidly moving technologies to clinical stage and beyond through FDA approval and commercialization. To support these roles, CIMIT created, and has continuously improved, a secure, web-based infrastructure to enable efficient and effective operations consisting of 1) the CoLab platform, which is used to manage solicitations, and specifically the flow of applications through CIMIT's unique multi-stage, interactive selection process and 2) the GAITS platform, based on CIMIT's over two decades of experience in managing innovation in healthcare, which helps project teams successfully navigate and accelerate the challenging commercialization journey and which facilitates tracking the progress of funded subprojects (https://ieeexplore.ieee.org/document/9418529). CIMIT enhanced GAITS and CoLab to operate at the required scale of RADx Tech and to address many unique needs and challenges of managing workflows and facilitating the collaborative contributions of over 600 people from different organizations under Dr. Schachter's leadership. | CIMIT has engaged with innumerable partners to advance medical technologies from the laboratory benchtop through FDA approval and commercialization to clinical use. In managing a BARDA 2.0 Accelerator Hub, CIMIT would seek Teaming Partners with expertise in chemical, biological, radiological, and nuclear threats; pandemic influenza and other developing infectious diseases; known and emerging bioterror threats; medical countermeasures; the global health security innovation ecosystem; benchtop validation capabilities; biobanks; regulatory processes; and FDA-informed evaluation of medical countermeasures. CIMIT would also pursue relationships with partners that have developed a curriculum for entrepreneurs in the BARDA mission space; and that have access to facilities and incubator spaces with the required security clearances. CIMIT will preferentially team with partners that have the ability to scale up from regular operations to levels of effort needed to rapidly respond during public health emergencies to find, fund, facilitate, and accelerate product development and validation of medical countermeasures that can be deployed as quickly as possible. Based on RADx Tech, Dr. Schachter worked with a colleague to produce a book called "Accelerating Diagnostics in a Time of Crisis: The Response to COVID-19 and a Roadmap for Future Pandemics", to be published in early 2024 by Cambridge University Press (https://www.cambridge.org/core/books/accelerating-diagnostics-in-a-time-of-crisis/3A608BCA2886A166B3969B61408DCF80). |
| EverGlade Consulting | Stephen Morris, PhD | smorris@everglade.com | Charleston, SC | Diagnostics and Medical Devices, Enabling Technologies | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | EverGlade Consulting is a SDB (Asia/Pacific) offering deep experience in the Federal procurement process, MCM development including the FDA Animal Rule, device/diagnostic clearance, portfolio management, proposal preparation (both technical and cost volumes), and post-award contract administration- allowing the awardee to focus on technical development. | EverGlade staff includes ex-USG employees and prime contractors with experience in HHS and DoD source selection. Staff includes scientists, engineers, project managers, finance managers. Product experience includes vaccines and therapeutics development from tech base to FDA licensure or approval (including Animal Rule), and device clearance. Administration experience includes project management, budget management for many HHS/DoD awards. | EverGlade wants to provide some or all advisory and management sevices to partners including tech developers and sponsors, program managers, and acceperator managers. EverGlade also wishes to partner with academic labs having technolofy solutions of interest to the USG but lacking the experience or resources to manage a Federal award. EverGlade will enter into agreements with these labs which protect their IP and allow them to work as a subK to EverGlade as prime. EverGLade will also license technology and pursue FDA licensure/approval. |
| Ferocity Capital, LLC | Kris Vulgan | kris.vulgan@ferocitycap.com | Palo Alto, CA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services | Rapid validation and product market fit. | We partner with corporations and top VCs to validate technology and product market fit. Our network brings together feedback from a variety of potential clients and investors in less than a week. | We invest in pre-seed and seed research spin-offs and in cybersecurity. We are bullish on research spin-offs funding and hope to have access to deal flow by providing - volunteering with our support. |
| FIND (Foundation for Innovative New Diagnostics) | Willo Brock | willo.brock@finddx.org | Geneva, Switzerland | Diagnostics and Medical Devices, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | FIND is a global non-profit connecting countries and communities, funders, decisionmakers, healthcare providers and developers to spur diagnostic innovation and make testing an integral part of sustainable, resilient health systems. FIND led the diagnostic pillar of the ACT-Accelerator alongside the Global Fund, with strong support from WHO. We are an official WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation. Since 2003, FIND has been working with partners to support development and uptake of 28 diagnostics in LMIC markets. | FIND works with developers and manufacturers to accelerate development of quality diagnostics aligned with global Target Product Profiles to meet needs of LMICs. Through a strong clinical trials capability, we build the evidence needed to support roll out of diagnostic innovations worldwide. Our clinical trials teams in experienced in conducting trials to meet both local and global (WHO PQ) regulatory needs. We have over 300 partners globally which ensures have a global reach and extensive networks including with ministries of health to facilitate uptake. | FIND is global non-profit but we will greatly benefit working with a partner who has deeper experience taking devlopers through private investment pathways. Also, a partner who has experience working with BARDA to manage the administrative side will be super helpful. Any partners looking to complement their work with LMICs focus and a truly global approach will be a good fit. |
| First Flight Venture Center | Krista Covey | kcovey@ffvcnc.org | Research Triangle Park, NC | Vaccines and Therapeutics, Enabling Technologiess | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Extensive experience for 5 years as a BARDA DRIVe Accelerator providing Wrap Around Accelerator Services including--Outreach/Networking and Sourcing: provided international outreach to BARDA through networking and partnering with entities like NC Biotech to identify prospects including identifying relevant companies, opinion leaders/expert panels, sharing funding opportunities, and via market research /strategic input through our partnership with NC Biotech; Entrepreneurship Training/Education: provide programs geared to meet companies where they are in their developmental cycle including 2 different accelerator programs, pitch practices and non-dilutive funding support. We also are an incubator with lab space that has served BARDA-relevant companies. We provide a full suite of wraparound and commercialization services through our mentors, programs and partners; DEV: Experience running a health security-focused accelerator that provided prize awards with commercialization support and access to experts and mentors that was aligned with BARDA Ventures Investment priorities and Identified potential partners/experts/mentors to provide usability, feasibility and testing services; Rapid Response Capabilities: Identifying likely partners to rapidly scale hub operations and function in the event of a Public Health Emergency and providing thought leadership in developing initiatives to better prepare for a PHE. | We have a 5-year track record of providing Wrap Around Accelerator service for BARDA. In addition to the activities outlined in the Organization's Background and Teaming Potential section, we have improved the pipeline of technologies for earlier Technology Readiness Levels including: 1) Designing 6-part Bench to BARDA Series & collaboratively implemented with approx. 10 accelerators. We also identified companies to present in 5 of the sessions and helped identify program directors to participate. 2) Working with BARDA & academic groups to create a transparent pipeline to BARDA. 3) Designed and collaboratively implemented 4-part BARDA Reverse Pitch Series (Sept/Oct 2021) with all of the accelerators 4) Medical, Biomedical, Biodefense Symposium -- included BARDA leadership & FFVC helped organize Infectious Disease panel (moderated by Krista Covey) in 2021 and Public-Private Partnership Panel (moderated by Krista Covey) that included Jurata Thin Film's (winner of FFVC BARDA WheelsUP Accelerator grand prize) Megan Livingston on 6/14/23. 5)BARDA Industry Day: Covey served as panelist; Runge in Lightning Talk discussions. In DEV, we have also successfully run a health security-focused accelerator that provided prize awards with commercialization support and access to experts and mentors. We have collaborated with BARDA on these topics and look forward to doing so again. | We have worked hard for 5 years to find ways to collaborate within our region, within the Southeastern US, across the nation and globally both through the BAN and other partners (e.g.: having RADx present to BAN regarding funding opportunities, participating in National Academy of Engineering events around COVID for prospecting and volunteering for review committees on national and international accelerators). We are also partnering to increase our global footprint with innovation hubs, initially in Europe. We have identified potential partners to provide usability, feasibility and testing services in DEV however we are open to other collaborations. We are also fortunate to have a diverse group of mentors/Navigators in our ecosystem who can be leveraged to help accelerate science and technology innovations into commercial markets. We are also open to connections for scaling up in Rapid Response Capabilities. We will continue to expand our collaboration with universities including Duke, UNC, NC State, Wake Forest as well as NC Biotech to build capacity for new efforts to anticipate a PHE. |
| Fujifilm Diosynth Biotechnologies USA, LLC and Fujifilm Diosynth Biotechnologies Texas, LLC | Andy Fenny | andy.fenny@fujifilm.com | Morrisville, North Carolina and College Station, Texas | Vaccines and Therapeutics | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | FUJIFILM Diosynth Biotechnologies (FDB) is an industry leading biopharmaceutical contract development and manufacturing organization (CDMO) which provides full-service drug substance development and manufacturing support from pre-clinical through commercialization for biologics, viral vectors, and vaccines in addition to DP fill/finish and AL&P services. We have several development and GMP manufacturing sites located across the US (NC and Texas), with assets capable of delivering small to large production volumes. FDB sites in North Carolina and Texas have many years of experience working with USG and USG funded partners. The two sites have completed numerous physical security, IT security, CDC assessments, and many other audits/visits from USG agencies as part of the pandemic response. FDB has maintained its reputation and relationship with the USG as a reliable partner which has delivered upon its commitments while remaining responsive to input, maintaining a mindset of continuous improvement, and maintaining a balance between speed and compliance. More recently in July 2020 under Operation Warp Speed, FDB received a Task Order Award to reserve manufacturing capacity for the USG to produce COVID-19 vaccines. | Collectively our global sites are licensed for the commercial manufacturing of 18 biologics, have supported well over 500 unique development/manufacturing programs for over 450 unique biologics, have successfully manufactured thousands of cGMP drug substance batches, and have over 30 years of experience in the CDMO space with a strong regulatory history. This experience includes a variety of both simple as well as complex and difficult to process proteins, and encompasses molecules such as ADCs, cytokines, enzymes, antibodies (including bi and tri specific), antibody conjugates, antibody fragments, toxins, vaccines, anticoagulants, fusion proteins, PEGylated proteins, protein haptens, etc. With over $5 billion USD in capability and capacity expansions planned and underway, across all sites and business units, FDB continues to be capable of offering large amounts of capacity when the industry needs it most. All existing and new cGMP facilities are built and operated to be flexible, adaptable, and scalable with state-of-the-art segregation and operational workflows. | We are looking for partners who have innovative product technology with whom we can support CMC services for IND-enabling studies to Phase III trials and Commercialization. We are also looking for partners who can help us simplify critical supply chain steps. |
| gener8tor Management, LLC | Lauren Usher | lauren@gener8tor.com | National | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services | gener8tor’s mission is to be the best partner for a community to invest in its best and brightest. The gener8tor platform includes more than 75 programs spanning startup accelerators, corporate programming, speaker series, conferences, skills accelerators and fellowships. gener8tor has exhibited great success in its ability to recruit and support diverse, underrepresented founders across different cities and states in a variety of secondary and tertiary markets worldwide. | gener8tor’s accelerator programs and funds have supported over 1225 companies to raise over $1.6 billion in follow-on financing and created over 10,500 jobs to date. gener8tor credits this, in part, to gener8tor’s nationally recognized curriculum and concierge approach. This concierge approach manifests in smaller cohort sizes and a significantly higher ratio of staff to program participants. Tactically, this allows gener8tor to conduct components of our program like Mentor Swarm and Investor Swarm giving startups in the programs more 1:1 attention from the stakeholders they desire. To date, 40% of gener8tor alumni (companies that gener8tor has invested in) have raised more than $1M in follow-on financing or have been acquired. 69% of gener8tor alumni (companies that gener8tor has invested in) have raised more than $250K in follow-on financing or have been acquired. In addition, we have a gener8tor MedTech accelerator which is a 7-week accelerator for early-stage healthcare startups in partnership with University Enterprise Labs (UEL) and supported by Boston Scientific (founding sponsor), BARDA, Mayo Clinic, University of Minnesota and the Medical Alley Association. We were also a partner in BARDA 1.0. | gener8tor is looking for potential teaming partners who have experience with development, evaluation, and validation services, as well as rapid response capability. |
| German Entrepreneurship, Inc. | Marc Filerman | filerman@german-entrepreneurship.com | Cambridge, MA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools | Wraparound Accelerator Support Services | We are a global startup platform that has supported hundreds of startups in their journey to success. Our global Life Sciences Competence Center (LSCC) is based in Cambridge, MA and works with healthtech and life sciences startups from all over the world to provide them with access to the tools, expertise, and funding they need to bring the next generation of diagnostics, devices, and therapies to the market. We can offer our deep expertise in de-risking startups, validating their products, and accelerating their time to market. Due to our global footprint with offices in Germany / Europe, Asia, LatAm, and the US, we are able to source innovations from all around the world. | We have a track record of providing wrap-around accelerator support services for 8+ years supporting more than 100 startups. We bring a deep bench of very senior expert mentors, an experienced in-house team, and a truly global footprint to the table. | |
| Grand River Aseptic Manufacturing | David Powell | dpowell@grandriverasepticmfg.com | Grand Rapids, MI | Enabling Technologies | Wraparound Accelerator Support Services | Grand River Aseptic Manufacturing, Inc. (GRAM) is a leading aseptic contract development and manufacturing organization (CDMO), located in Grand Rapids, Michigan. GRAM specializes in Current Good Manufacturing Practice (cGMP) manufacturing, analytical testing, and regulatory filing, with capabilities for small molecules, biologics, and controlled substances. GRAM brings more than ten years' of knowledge in the development and scale-up of injectable products and successful cGMP manufacturing experience and over one year providing COVID-19 compatible aseptic fill/finish manufacturing capacity, including labor, facilities, equipment, and line time, resulting in an uninterrupted supply throughout the COVID-19 campaign essential to national defense. From technology transfer to critical product delivery, and development to commercialization, GRAM's GRAM has over 220,000 ft2 of sophisticated cGMP space, all located in Michigan, meeting a full range of fill and finish needs, from early clinical trials through commercialization. In 2020, GRAM completed a new 60,000 ft2 large-scale aseptic fill-finish facility, "Butterworth", on-time and within budget. The facility provides secure access to top-quality parenteral drug manufacturing for all batch sizes and accommodates industry-wide demand for cGMP parenteral drug manufacturing, analytical testing, and regulatory filing services. | GRAM was selected by the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) office and the U.S. Department of Defense as an industry partner in Operation Warp Speed (OWS) to provide the critical components and technology to expand and accelerate the U.S. domestic capacity for manufacturing and distributing vaccines in response to the COVID-19 pandemic. GRAM provided COVID-19 compatible aseptic fill/finish manufacturing capacity, including labor, facilities, equipment, and line time, resulting in an uninterrupted supply throughout the COVID-19 campaign essential to national defense. GRAM concluded its support of OWS on August 3, 2021, and achieved the following notable milestones in performance of its contract with the USG: Accelerated Line Qualification two months ahead of planned schedule; completed technical transfer of J&J COVID-19 Vaccine in 70 days; produced first vaccine commercial lot in less than 4 months; submitted J&J COVID-19 Vaccine EUA in less 7 months; delivered very first J&J COVID-19 Vaccine lot to the USG, and; produced more than 5.5 million vaccine doses during the contract period. More recently GRAM supported BARDA's rapid response to the Mpox outbreak by fill/finishing Bavarian Nordic A/S's JYNNEOS� vaccine on budget and on schedule. | GRAM seeks to establish partnerships with product developers, product integrators, manufacturers of drug products and other entities who are developing solutions to the US Government, in particular (but not limited to) BARDA. GRAM's world-class fill/finish facilities, capabilities, and record of on-time/on-budget delivery of services to BARDA makes us an ideal teaming partner. |
| Harmony Consulting, Inc. | Chris Stanley | harmonyconsulting@live.com | San Clemente, CA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Harmony Consulting, Inc. has extensive and proven experience in Government program administration and over 30 years of technical experience in the pharmaceutical, biotech, and medical device industries. Since 2010, we have been connecting life sciences companies with specialized funding resources including BARDA, DoD and Operation Warp Speed (OWS). providing long term project management and strategic consulting to ensure success. We provide Technology Evaluation/Selection, Strategic Advice and Assessment, Due Diligence Support, Funding Proposal Writing and Preparation, Submission and Follow Up, Pre-Award Negotiations, Post-Award Document Preparation, Project Management, and training program preparation and delivery. We have broad experience in Operations, QA/QC, Regulatory, Validation, and Analytical Methods including biologics, sterile injectable, oral solid dosage, medical device and combination products, and experience with both US and foreign-based companies. Additionally, we offer QA/Regulatory and CMC Development expertise and commercialization guidance and connect our clients with our network of industry experts and scale up resources to take products from idea to commercialization. | Harmony Consulting has had extensive experience with BARDA and DoD contracts, and other government programs. We have provided project selection, project management, proposal preparation, contract management, administration and other consulting services to participants in government contracts over the last 12 years including critical project management throughout the COVID-19 pandemic to Operation Warp Speed (OWS) awardees. Harmony Consulting has extensive experience and insight into US Government requirements for biomedical development projects, including contract structure (FAR, OTA, etc.) as well as contract deliverables and reporting requirements. We have the technical experience to identify gaps and trouble spots in product ideas and plans, and can provide efficent solutions to remedy those gaps, bringing projects to success. We are experienced in providing Rapid Response solutions. We have the knowledge and experience to work with US and foreign companies as well as academic institutions. | Harmony Consulting is interested in teaming with partners needing administration, management, advice and training expertise including candidate selection, proposal/funding request preparation services, project administration, training program preparation and delivery, contract management, rapid response capability development and technical QA/Regulatory and CMC support. Harmony Consulting would like to team with participants in the accelerator network at each level to provide these services. |
| HealthVerity | Daniel Glazier | dglazier@healthverity.com | Philadelphia, PA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services | HealthVerity is a technology-enabled data solutions company. Our modular Software-as-a-Service (SaaS) and modular Data-as-a-Service (DaaS) combine to to power the creation of new frontiers of fully interoperable, HIPAA-compliant, and research ready data to power previously unattainable outcomes and fundamentally advance the science. | Through our privacy-preserving record linkage (PPRL) technology we are able to activate and synchronize data from client and third party data sources with the nation’s largest healthcare and consumer real world data (RWD) ecosystem. | We are open to collaboration with parties pursuing evaluation and validation use cases for which HealthVerity technology and real-world data (RWD) can advance the science. |
| Hyperion Technologies (dba FedTech) | Thomas Martin | Thomas.Martin@FedTech.io | Arlington, VA | Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | FedTech, an Arlington, VA (HQ) based for-profit company currently employs 40+ professionals in HQ and regional programs locations in TX, NM and CA, with plans to continue US and international expansion. Our team is composed of PhDs, scientists, researchers, marketers, entrepreneurs, and SMB experts possessing broad knowledge across digital health, medical devices, diagnostics and special population care in addition to a broad range of deep tech expertise. We support innovations from a seed idea to scaling companies. Our inventor training, startup studio/incubator and accelerator programs are used by DOE, NSIN, DoD, NASA, DOI, DOC, BARDA, VA, NIH and DHS plus FFRDCs and universities. We have a proven track record of spinning up and accelerating breakthrough technology companies through our education, advisory, network, assessment and consulting services. | FedTech supports each aspect of the innovation and TRL lifecycle (idea, concept, new venture startup, acceleration, scale, etc.) and ecosystem through education, expert advice, assessments, and connections (e.g. SMEs, VCs). Our startup studio and accelerator programs combine expansive education with intensive coaching/mentoring/advising to launch and accelerate technology driven startups/companies. In addition, we offer a broad mix of approaches including innovation challenges, themed based cohorts and custom designed Entrepreneur in Residence and cohort programs. We have trained over 2,000 R&D personnel in intraprenuership skills, built 200+ entrepreneur teams around federal IP (with ~40% of entrepreneurs coming from underrepresented backgrounds), launched 125+ new ventures around federal R&D (across 20+ states) and accelerated over 250 companies which raised +$1B from private investors and ~$75m in public grants. We have health and medtech benchstrength to provide tailored, relevant and timely support to inventors, startups and companies. Recently we led a BARDA diagnostics/medical device Startup Studio pairing entrepreneurs with government and university lab IP to spin up new ventures. We currently support NIH Maternal Health Challenge tackling population health improvements for underserved communities. | FedTech can support partners with our unique and proven startup studio and accelerator programs. While we have solid experience in health and medtech, we are seeking additional expertise/capability in rapid response and additional expertise/networks in med tech deployment, testing/trials facilities/programs and regulatory advisory. |
| IIT Research Institute | Robert Baker, Ph.D. | rbaker@iitri.org | Chicago, IL | Vaccines and Therapeutics, Enabling Technologies | Development, Evaluation, and Validation Services, Rapid Response Capability | IITRI is a not-for-profit contract research organization with extensive experience in the testing of MCMs for in vitro and in vivo efficacy as well as drug, biologics and vaccine IND-enabling toxicology. IITRI is GLP-certified and Tier 1 Select Agent registered up to and including ABSL-3. This includes facilities for all standard laboratory species up to and including NHPs. IITRI has the capability to deliver infectious challenge agents and MCMs by any route and has extensive experience in bioaerosol challenges, aerosol drug delivery and inhalational toxicology. IITRI has experience supporting clinical trials with analytical chemistry and immunology assays, including assay development and validation for use under GLP. IITRI supported BARDA at the beginning of the COVID pandemic, winning one of three contracts for virus production and quality control, assay development and validation, and clinical trial support, so we are adept at rapid response and can dedicate thousands of square feet of laboratory facilities in a public health emergency. | IITRI prides itself on rapid initiation of studies as well as timely and thorough communications with sponsors. IITRI has experience as both a government prime contractor, sub-contractor and sponsor to other sub-contractors. We possess all systems, procedures, expertise, SOPs and instrumentation necessary for high-quality studies on-site. IITRIs division managers each hold Ph.D.s with 30+ years of scientific experience. IITRI has a contracts group dedicated to establishing and supporting both government and commercial contracts, a US Government-approved accounting system and an independent Quality Assurance Unit for study auditing. | While IITRI possess world-class testing and evaluation capabilities, IITRI does not independently develop novel MCMs or platforms. Thus IITRI is looking to partner with MCM or device developers, MCM manufacturing partners, and entities capable of providing the wraparound accelerator services to multiple partners. |
| INCubator for Antibiotic Therapies Europe | Douglas Haggstrom | douglas.haggstrom@unibas.ch, douglas.haggstrom@incate.net, info@incate.net | Basel, Switzerland | Vaccines and Therapeutics, Enabling Technologies | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | INCubator for Antibiotic Therapies Europe (INCATE) is a partnership that sources, selects and supports early stage ventures in Antibiotic therapies and vaccines. The partnership consists of academic members (German Center for Infection Research (DZIF), Leibniz-Institute, NCCR AntiResist, University of Basel) and leading industry partners (Roche, Boehringer Ingelheim, MSD Deutschland and Shionogi) supported by other institutions such as GARDP, Global AMR R&D Hub, BEAM Alliance. INCATE focuses on the gap identified between academic research and ventures ready for investment or Non-Dilutive Funding from organisations such as CARB-X. Projects often lack a quality data package and a team that can take the work forward. INCATE supports by providing Advice, connections to Network and a small amount of non-dilutive funding. This work helps take projects from concept validation to lead optimization. INCATE focuses work on Europe but is open to requests from support globally. More info at www.incate.net | INCATE was launched in 2021. Since then we have had contact with over 150 ventures from more than 30 countries. We have received 80 formal applications and approved 25 ventures as INCATE companies. These companies receive 10k euros but importantly advice and support. One company has been given Stage II support and 250k euros. This work has been done in six rounds of a selection committee of diverse experts. There are now 5 FTEs in INCATE with access to a network of experts. In addition to the formal selection process we have hosted events including online webinars on topics of interest to entrepreneurs and hosted two pitch events at the European AMR COnference. https://amr-conference.com/ This work was recognised as one of the key push support mechanisms in the HERA report on Medical Countermeasures published in Dec 2022. Ventures support value the robust questioning, guidance, connection to further experts and suppporters as well as in same cases funding for crucial data collection or expert opinions. | We are looking for teaming partners that can connect us further into the US and global market. We would like to work with organisations with a similar goal and focus in the development pipeline for experience sharing and to collaboratively support ventures. We can also work with partners who have ventures that are "too early" or perhaps in some cases "too late" in development for them and develop these ventures further. |
| Innovation Hub Enterprises, LLC (dba 11TEN Innovation Partners) | James Lewis | james@11ten.com | Atlanta, Georgia | Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | 11TEN is an innovation company that takes a unique approach to de-risking the innovation process and catalyzing the speed to value of new solutions through the creation of a dynamic healthcare innovation ecosystem that brings together healthcare systems, pharmaceutical and life science companies, medical device companies, payers, and public health organizations to work together on the most pressing health needs and problem areas facing the industry. This approach allows us to generate novel insights across multiple stakeholder and end-user groups, co-develop new ideas, rapidly test and validate solutions, and create additional momentum through the scaling and commercialization process. 11TEN has extensive experience standing up and operating Accelerator Hubs (we call them Innovation Ecosystems), leveraging our Innovation Launchpad Process to support entrepreneurs through the problem discovery and ideation generation phase as well as solution design, development, and validation, and a suite of commercialization support offerings. | 11TEN has in place the full suite of accelerator support and DEV services requested for these roles and currently operates numerous innovation ecosystems that can be used as blueprints for and partners to this program. We rely on our collaborative mindset and Innovation Launchpad process to rapidly scale solutions and realize value. 11TEN currently supports both startups and corporates throughout this end-to-end process with countless success stories. Additionally, 11TEN's Trusted Insights capability offers instant access to over five hundred thousand key opinion leaders in relevant healthcare / life sciences industries and roles that will mentor entrepreneurs and startups through their journey. Not only does 11TEN offer the full suite of services, but we ourselves have incubated a digital health solution (AngioCloud), so we truly understand the needs of entrepreneurs and startups as they go through launch and scaling. Lastly, 11TEN has a network of existing validation sites / testbeds, anchored by Emory Healthcare, that will be leveraged to rapidly test and validate meaningful solutions. Having this network in place removes one of the greatest barriers that exists for healthcare / life sciences startups today. | Based on the size of our organization, 11TEN is looking for a teaming partner that can help us with the required surge capacity in a rapid response scenario. 11TEN is well suited to develop the Rapid Response strategy and have the needed process / tools in place, but could use a partner for the actual support execution in case of a large-scale response need. |
| Integrum Scientific LLC | Wendy Boone | wendy.boone@integrumsci.com | Greensboro, North Carolina | Vaccines and Therapeutics, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Rapid Response Capability | Integrum is an Outbreak Readiness and Response Company born out of the international response to the 2014-2015 Ebola outbreak in West Africa. During that crisis, we gathered a team of scientists, engineers, and infrastructure experts from organizations across the Infectious Disease (ID) research community and launched the first clinical trial in West Africa. Our mission is to improve the effectiveness of global and local clinical research by promoting prevention, preparation and awareness. Our vision is to reduce the impact of ID threats. Our strategy is to build partnerships with local, national, and international partners who are experts in their fields, develop long-term relationships, and facilitate long-lasting solutions that benefit our local partners and eradicate or alleviate ID outbreaks. We provide BARDA with ID leaders used to working under short timelines to provide solutions for a rapid response in low resourced and special populations. | Wrap Around Support Services: The Integrum team is experienced leading groups/consortium with multiple stakeholders including team members from the NIH, universities, private clinics and pharmaceutical sponsors. We have experience navigating conflict resolution across team members, leading risk identification and mitigation strategies to ensure timelines and goals are met. Our Infectious Disease Scientific Advisory Board provides access and outreach to experts across specialties including pre-clinical testing, drug development and clinical development. Rapid Response: Integrum team members launched the first clinical trial in West Africa during the 2014-2015 Ebola outbreak. We have expanded on that success by building mobile labs to provide field diagnostics, set up research programs which included training and measures of sustainability in international low resourced areas. Integrum has experience providing assessment of project and location requirements and develops action plans which are agile and sustainable meeting the needs of our stakeholders. | Integrum is looking for teaming partners who are willing to be out of the box thinkers to develop solutions. Integrum values integrity and the relationships of not only our partners but those in the communities we serve and would expect a reciprocal approach. We are looking for companies who share our commitment to providing infectious disease solutions through drug development, clinical research, training and sustainability. |
| IntuitiveX | Emeka Alozie | ealozie@intuitivex.com | Seattle, Washington | Diagnostics and Medical Devices | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | IntuitiveX (IX) is a specialized medical IP incubator and consultancy, with a focus on medical devices and diagnostic startups. We have a proven track record in fast-tracking & co-inventing new IP, supporting international commercialization within the U.S., scaling portfolio companies by oversubscribing on seed and Series A rounds across digital health, medtech, pharma, & biotech, opening access into a pipeline of early-stage companies, spearheading FDA servicing, IP commercialization, IP acquisition, business development, joint venture development, mergers, and staffing, and hosting exclusive life sciences events, leading to significant increases in the valuation of healthcare companies. Our team, which combines over 100+ years of medical device experience, includes IP experts, physicians, investors, scientists, and technologists, and have executives with experience working with Microsoft, Medtronic, Nuvasive, Stryker, Intuitive, and more. Utilizing a closed incubation model and a one-stop shop consultancy model, startups are able to get holistic support in the validation, strategy, and execution needed to bring life sciences products to market. We offer our deep expertise, robust network, and proven methodology to potential partners like BARDA, with a commitment to accelerating healthcare innovation and supporting startups globally. | Building upon its rich history within IP and high technology, the company marries the worlds of high technology and healthcare to produce breakthroughs within medicine. To date, IX has introduced 3 FDA Breakthrough Designated Device Startups. IX's unique ideation to commercialization capabilities have allowed it to significantly improve the valuation of healthcare companies such as Amplify Surgical from $1M to $85M, to Altpep (biotech) from $1M to $200M+, to Navlab (IP Holdings) from $150K to $2.8M more. IX is Chaired by World Famous IP Guru, John Cronin, who ran and created IBM's patent factory, and led by Dr. Jeffrey Roh, Orthopedic Surgeon & serial entrepreneur, Mark Han, who managed one of the largest IP portfolios with over 30,000 assets and $6B+ in investors capital, and Simon Robinson, who has completed over 150+ IP transactions, and supported by advisors consisting of world renowned surgeons, Desney Tan, VP of Microsoft Healthcare, and Gary Locke, a former Washington Governor. We have a proven track record in developing, patenting, spinning out, and monetizing startups. This has lead us to: Launched 12+ portfolio companies. Portfolio companies have raised $120M+ in additional funding, Generated $300M in shareholder value created for portfolio companies, and building a network of 300+ clinicians. | In potential teaming partners, IntuitiveX is looking for organizations that share our commitment to accelerating healthcare innovation and transforming ideas into commercial realities. We value partners who bring complementary skills and expertise to the table, particularly in areas that can enhance our existing capabilities. This could include deep domain knowledge in specific healthcare sectors, advanced technological capabilities, or extensive market access and distribution networks. We appreciate partners who are open to collaborative problem-solving and who are willing to share risks and rewards. A strong track record of successful partnerships and a reputation for integrity and transparency are also important. We believe that diversity of thought and experience can drive innovation, so we welcome partners from different sectors and backgrounds. Ultimately, we are looking for partners who share our vision of advancing healthcare through innovation, and who are ready to join us in navigating the complex journey from idea to commercialization. We believe that through strategic and synergistic partnerships, we can collectively make a greater impact on healthcare outcomes. Working with BARDA allows us to operate at the frontlines of rapid resposne and support and technological innovation that can help advance development of medical countermeasures to protect Americans and respond to 21st centure health security threats, which we were on top of during COVID. |
| IoT Tribe | Tanya Suarez | tsuarez@iottribe.org | London, United Kingdom | Digital Health Tools | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | IoT Tribe is a global tech ecosystem builder that accelerates the growth and adoption of disruptive technologies. We have a proven track record of running accelerator programmes and open innovation initiatives, supporting over 500 startups, scaleups, and SMEs from over 30 countries commercialise, access the market, prove their value, fundraise and scale. This includes healthcare-focused initiatives and other programmes which involved healthcare companies. | We have delivered a number of programmes and initiatives in the healthcare domain such as: (1) Supporting Centre for Healthcare Innovation in Singapore with running the CHISEL Healthcare InnoMatch Challenge aimed at sourcing for the best in class preventative healthcare solutions from startups & SMEs to be deployed in various healthcare clusters in Singapore, (2) Supporting the growth of healthtech startups/scaleups in our previous accelerators such as Deeptech Accelerator, Startup Scaleup and more, (3) Through our sister company, BluSpecs, providing technical support to 5 EU regions to in Finland, France, Spain, Sweden and the UK to develop strategies to adopt digital technologies in their Health systems as part of the EU Commission's READI for Health Programme, (4) BluSpecs is also coordinating INSTAR, a European Commission initiative, that will work to develop global common standards for advanced technologies (AI, IoT and Quantum amongst others) across multiple domains including Health by coordinating inputs and approaches with aligned countries such as the US and Canada. | We're looking for collaborative teaming partners with deep expertise in the healthcare scene in the US, who are complementary to our strengths in providing wrap-around acceleration programmes, support in open innovation and corporate venturing, expertise in scaling technologies, and our ecosystems across Europe and Asia Pacific. |
| Jubilant HollisterStier CMO | Vincent Villegas | vincent.villegas@jubl.com | Spokane, Washington | Vaccines and Therapeutics, Enabling Technologies | Rapid Response Capability | Jubilant HollisterStier CMO is funded by BARDA via a cooperative agreement with HHS to double the capacity of the fill/finish site in Spokane Washington, and continue to be reviewed by our govt partners for potential collaborations. Based in Spokane, Washington, JHS has a unique set of capabilities, with fill finish and lyophilization from clinical through commercial drug product. JHS has an extremely strong track record with USG programs and is an integrated pharmaceutical contract manufacturer, able to manufacture sterile and non-sterile dosage forms. Our facilities across North America provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries offering a full range of other support, from process qualification through commercial release. We are experienced in writing USG program proposals that have a high success rate and as a CMO, we are a flexible and responsive teaming partner. We provide a high state of compliance, flexibility, and expertise in expediting tech transfer to produce safe and effective product domestically. | We are experienced in writing USG program proposals that have a high success rate and as a CMO, we are a flexible and responsive teaming partner. We provide a high state of compliance, flexibility, and expertise in expediting tech transfer to produce safe and effective product domestically. | Companies to subcontract BSL2 capabilities, vaccine innovators for large scale fill / finish, companies looking to subcontract fill / finish |
| JGS Group LLC | Jen Murray | jmurray@jgsgroup.com | Baltimore, Maryland | Vaccines andTherapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | JGS is a strategic reimbursement, regulatory and clinical evidence development consulting group for medical device, diagnostics, digital health and biotech start-ups, early and mid-sized companies. We take a holistic approach to development and commercialization for new and innovative products and technology. Reimbursement, regulatory and clinical evidence are all consecutively moving parts that influence the end result outcome of one another and JGS's holistic approach takes into consideration the three facets of the commercialization process at once. | JGS was founded in 2001. We have worked with companies in all different disease areas, modalities, settings of care and product type. Our staff sit on several accelerator boards and mentor for several different group and associations. We believe in getting new technology into the hands of providers and patients as fast and efficiently as possible in order to have a better health outcome for patients. Commercialization is a complex and challenging process and it's important to have the best strategy for the best outcome. JGS has a great deal of experience working with several accelerator programs and are currently working with NIH TABA, NHLBI/Catalyze, The Praxis Institude and MedTech Innovators. | We look for partners with new and innovative products that need help throughout the commercialization process. We know how to work with start-ups, to be flexible, work with lean budgets, and to work efficiantly with our partners. We like to be considered part of the team, not just a consulting group doing a project and then moving on. We build long-term relationships with our partners. We would love to be a part of the BARDA team. |
| Life Science Washington Institute | Aylin Kim | aylin@lswinstitute.org | Seattle, WA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services | Washington State has a thriving healthcare and life sciences ecosystem, with over 1,200 life sciences companies operating in the region. These companies span a wide range of sectors, from medical devices and diagnostics to biotech and pharmaceuticals. The state's strong research infrastructure, coupled with access to capital and a talented workforce, has made it a hub for innovation in the sector. According to the Washington State Department of Commerce, the state's life sciences industry generated over $17 billion in economic activity in 2020, with a total employment of over 92,000. The region is also home to major healthcare and research institutions, including the University of Washington and the Fred Hutchinson Cancer Research Center, which further strengthens its position as a hub for healthcare and life sciences innovation. In terms of funding, the region has seen significant investment in recent years. We work hand-in-hand with Life Science Washington, the life science trade association for WA State, giving us a larger platform and broader outreach of over 500 member organizations and 6000 subscribers. We partner with research organizations across the state and work closely with all the higher education systems to support their innovators. Furthermore, we are agnostic as far as IP, affiliation, and specific area of focus within biotech, medtech or digital health. Our reach expands beyond WA to Vancouver, BC, Oregon, Wyoming, Alaska and Idaho as the largest life science hub of the Pacific NW; therefore, we are able to support potential teaming partners by providing connections and support to ventures throughout the Pacific NW. | Life Science Washington Institute was part of the BARDA Drive Accelerator network 1.0 from 2018-2023; therefore, we are familiar with working with BARDA and supporting their areas of interest and have experience in pivoting when a rapid response was required (COVID-19). During this work we were able to engage with dozens of companies from around the Pacific NW to prepare to meet with BARDA and secure funding and we feel very confident in the wrap around services that we offer. Our flagship program is our mentoring program which has a strong track record of success and was a strength among the 13 original accelerators in how we support early-stage entrepreneurs. We currently have 31 companies in this program and previous participants have gone on to raise over $1.14B since 2014. Venture Investment and Partnering forums are another program that we organize in order to facilite the connection of life science ventures with industry's specific areas of interest or for partners such as BARDA. Our role for these is to coordinate 1:1 meetings through a highly curated process where we uncover technologies that fit an area of interest and have the venture apply for a meeting. LSWI is similarly grant funded by WA State Commerce to support minority and underrepresented life science entrepreneurs to help them commercialize their life science technologies. At LSWI we believe that meaningful support requires boots on the ground at least regionally and integration of the ecosystem from angel investors to mentors to industry partners. | Our scope covers wrap around services focused on Washington yet spanning the Pacific NW; therefore, we seek to team with partners who can provide wrap around services to those outside of this region as well as development, evaluation and validation services. We could participate in rapid response capability but within our scope rather than a full 100% effort. We can also connect others in the hub with those who can provide needed DEV services. Our structure allows us flexibility in how we engage partners and we welcome the opportunity to be a part of several hubs looking to have a footprint in the Pacific NW across any of the RFI listed focus areas. |
| Logistics Management Institute (LMI) | Janet Webb | janet.webb@lmi.org | Tysons VA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. LMI's Science and Technology branch has offered and delivered product development solutions for all types of medical countermeasures. This includes vaccines, therapeutics and diagnostics for everything from emerging infectious diseases to pandemic support with COVID19. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. | LMI’s experience within the drug discovery and development domain spans from laboratory development through regulatory approval, manufacturing, and distribution of medical countermeasures (MCMs), as demonstrated by our support of Joint Enterprise-Omnibus Program, Engineering, and Technical Support (JE-OPETS) LOG MED, Joint Program Manager (JPM) Chemical, Biological, Radiological, and Nuclear (CBRN)-Medical, Joint Project Leads (JPL)-CBRN-Enabling Biotechnologies (EB), and One Network of Excellence for Regulatory Affairs and Quality Assurance (ONE-RAQA). Additionally, our team was front-facing with the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to drive critical response efforts against COVID-19 and other biological threats. | |
| Longyear Health LLC | Robert Longyear | Robert@longyearhealth.com | Washington, DC | Diagnostics and Medical Devices, Digital Health Tools, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Longyear Health LLC is a boutique healthcare strategy, regulatory, and commercialization digital health, telemedicine, and remote-patient monitoring consulting firm. Our firm also has significant data science capabilities and deep domain experience in Medicaid, rural health solutions, pediatrics, and geriatrics. Our team members come from a wide range of backgrounds in healthcare and provide deep industry, policy, and technical expertise. Our firm has significant expertise in healthcare payment models for digital health and other diagnostic technologies. Longyear Health LLC is a small business and located in a HUD Zone. | Our firm has deep, industry leading expertise in remote patient monitoring, remote therapeutic monitoring, healthcare financial models, algorithmic clinical decision support tools, telemedicine, and other digital health approaches. Our CEO wrote the book on digital health, A Virtual Care Blueprint, published by Taylor and Francis Group and published peer-reviewed academic papers on innovative care models utilizing digital health tools and digital therapeutics. Our deep industry and commercialization expertise has lead to a significant client list of innovative biotechnology, digital health, telemedicine, and healthcare services businesses. Our Head of Data Science is a Fellow at Georgetown University and has extensive background in modeling, algorithm development, machine learning models, and other statistical expertise that will become increasingly relevant as AI and algorithmic-based diagnostic tools, digital health solutions, and clinical decision support tools come through BARDA. We are well qualified to develop educational materials for healthcare commercialization and digital health. We are also very strong at statistical analysis and modeling. | We are looking for teaming partners that are seeking deep commercialization, domain knowledge, and execution expertise in digital health and advanced diagnostics. Our firm has excellent expertise in Medicaid and Medicaid Managed Care, which is a rare area to find in commercialization support firms. Ultimately, we want to be on a team that is a good fit both logically and culturally. Similarly, we like to work with people who have other expertise and manpower to complement ours so we can share knowledge, experience, and develop a relationship built on high performance outcomes, a focus on biodefense and public health, and continued learning. We are a firm that upholds high ethical standards focused on health equity, solving problems to improve quality of life, and ensuring speed to market for impactful innovations. |
| MilliporeSigma | Andrew Tantillo | andrew.tantillo@milliporesigma.com | Burlington, MA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Enabling Technologies | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | MilliporeSigma is a leading supplier of the raw materials, consumables, services, and equipment essential to the development, manufacture, and quality assurance of vaccines, therapeutics, diagnostics, and other finished goods. Our 325,000 life science products and services are used in research, quality control, and production across the life science industry. Researchers and developers leverage our laboratory products, contract development and analytical testing services, and expansive R&D capabilities to deliver breakthroughs in therapies, diagnostics, and preventative solutions. Clients incorporate our market-leading high-quality raw materials to accelerate development, mitigate risk, and enable speed to market. Manufacturers of vaccines, therapeutics, diagnostics, and other finished goods use our products such as filtration devices, chromatography resins, single-use assemblies and systems, processing chemicals, and customized fit for purpose materials. Clients also utilize our services to provide contract biosafety testing and contract manufacturing of diagnostics, excipients, APIs, antibodies, and antibody-drug conjugates. MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, and operates through various legal entities including Sigma-Aldrich Inc., EMD Millipore Corporation, Cerilliant Corporation, and BioReliance Corporation. | MilliporeSigma has expert capabilities across more than 55 manufacturing sites (25 in the U.S.), a footprint of over 100 distribution locations (32 in the U.S.), and a dynamic R&D engine with diverse expertise (24 R&D sites in the U.S.). Our nine M-Lab Collaboration Centers offer customers the opportunity to explore ideas, learn techniques, and work alongside our engineers to solve process development and production challenges. We offer scientist-to-scientist technical support across our portfolio of 325,000 products. We provide custom filling, manufacturing, kitting services, and fit for purpose materials to manufacturers. We are experienced operating in regulated industries and employ an expert team of quality and regulatory professionals. We excel in quality control, packaging, distribution, and logistics. MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, which has a 350-year history. With such an expansive portfolio and reach in the life science industry we have developed thousands of connections from which we draw the latest market intelligence and enable our clients to get their products to market faster. | MilliporeSigma is a leading supplier of the raw materials, consumables, services, and equipment essential to the development, manufacture, and quality assurance of vaccines, therapeutics, diagnostics, and other finished goods. Our 325,000 life science products and services are used in research, quality control, and production across the life science industry. Potential teaming partners would include researchers, developers, and manufacturers who could utilize our ability to design processes and/or take advantage of our broad portfolio to discover, develop, and produce vaccines, therapeutics, diagnostics, and other finished goods. |
| MPR Associates, Inc. | Ryan Downs | rdowns@mpr.com | Alexandria, VA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services, Rapid Response Capability | MPR is a world-class engineering and management company specializing in product development and specialty engineering services. MPR provides a variety of support for innovators and early-stage companies including (1) rapid development and testing of proof-of-concept prototypes, (2) product commercialization planning and road-mapping considering regulatory, marketing, and development strategies, and (3) executive advisory services with mentoring in technology commercialization. We work with our clients as a development partner from conceptualization through technology transfer and commercialization. Engineering, design, and prototyping services are provided through a process that optimizes time to market while reducing risk. Through our extensive industry network, we also provide partners in the fields of manufacturing, financing, legal, marketing, and regulatory compliance which are critical for the success of early-stage firms. For sponsors like BARDA, we can help assess technical risks and development costs/schedules associated with potential investments and advise on development strategies and risk reduction measures that can improve return on investment. | Through our strategic process, MPR applies engineering, science, and design to de-risk development and optimize time to market with comprehensive FDA regulatory compliance. In-house resources cover industrial design, mechanical and electrical design, human factors and usability engineering, engineering analysis and simulation, rapid prototyping, software development, and verification/validation activities. Our teams rapidly prototype proof-of-concept systems, fabricate units for testing and clinical trials in our labs and manage technology transfer to manufacturers for full-scale production. Human factors and usability is integrated with our systems engineering approach to deliver safe and award-winning products. Early-stage clients benefit from leveraging our ISO-13485 quality system to build the device design history file in compliance with FDA’s design control regulations. MPR’s seasoned consultants also advise clients on strategic planning, regulatory and quality compliance, operational improvement, and portfolio risk management, providing a professional and independent perspective that drives results. | MPR’s ideal partners are innovators solving important unmet needs in healthcare who need high-quality technical resources to help hone their vision for the solution and then plan and execute on that vision to realize the desired value proposition. MPR partners with early-stage companies, accelerators (like M2D2), healthcare systems, and established medtech firms to support their missions. |
| Nanovaccine Institute | Balaji Narasimhan, PhD | nbalaji@iastate.edu | Ames, Iowa | Vaccines and Therapeutics | Development, Evaluation, and Validation Services | The Nanovaccine Institute is a consortium of 82 researchers at 27 universities, research institutes, national laboratories, and companies, coordinated by Iowa State University. Our interdisciplinary research merges expertise in immunology, nanotechnology, materials science, microbiology, neuroscience, imaging, bioinformatics, gerontology, clinical science, and social science. We are developing nanovaccines and nanotherapeutics for respiratory infections, biodefense, neural disorders, antimicrobial resistance, cancer, aging, and animal health. We have synthesized: nanovaccines for influenza, SARS-CoV-2, anthrax, plague, RSV, and zoonotic diseases; cancer nanovaccines for immunotherapy; and dose-sparing nanomedicines to deliver antibiotics and chemotherapy drugs. | Our platform technology of biodegradable polyanhydride nanoparticles can encapsulate a wide range of vaccine and therapeutic payloads, including antigens, adjuvants, and drugs. The nanoparticle chemistry can be tuned for extended release, to target specific cells, or to cross the blood-brain barrier. We have developed needle-free intranasal vaccines that can be self-administered with disposable applicators. Our nanovaccines can be stored at room temperature, without a cold chain for long periods of time. We can do BSL-2/BSL-3 animal studies in models ranging from mice to cattle. Our lab and pilot plant capabilities are supplemented by high-end specialized instrumentation in nearby core facilities on campus. | Our focus as academic researchers has been basic research, product development, and IND-enabling animal studies. We are looking for partners with experience scaling up production from laboratory to commercial scale, with GMP manufacturing, regulatory approvals, and clinical studies. We are also interested in partners with drugs or therapeutics that could benefit from room-temperature storage and needle-free delivery via our nanoparticle platform technology. |
| National Center for Therapeutics Manufacturing (NCTM) | Baley Reeves | baley@tamu.edu | College Station, TX | Vaccines and Therapeutics, Enabling Technologies | Development, Evaluation, and Validation Services, Rapid Response Capability | NCTM is a workforce development and contract research facility located on Texas A&M’s campus in College Station, TX. We specialize in hands-on training on industrially-relevant, pilot-scale biomanufacturing equipment, on topics such as upstream processing, downstream processing, and QC in a simulated cGMP facility. We also do contract research projects for clients utilizing our biomanufacturing equipment and staff expertise in order to scale and optimize projects prior to Phase I clinical trials. In terms of equipment, NCTM has a 100L bioreactor on site, with pilot scale centrifugation, chromatography, TFF, and filling capabilities. NCTM staff have experience in vaccines, gene therapy, traditional recombinant proteins (including Mabs), and mRNA therapeutics. Finally, NCTM has an established history working with BARDA on past projects. | NCTM served as part of Operation Warpspeed, on workforce development efforts, to rapidly onboard hundreds of new employees to work on vaccine manufacturing efforts during the COVID-19 crisis. Our team has significant experience running and training people on the unit operations used to manufacture traditional and mRNA vaccines. In addition, we have executed past contract projects successfully. One example of such a project included purifying spike protein to be used as part of diagnostic assays. The existing equipment and staff expertise enabled NCTM to be able to quickly and efficiently execute project deliverables during pandemic times. NCTM would be happy to continue to support BARDA initiatives in other capacities as well. | NCTM looks forward to partnering with companies that may lack equipment or scale-up expertise. We are happy to utilize our existing resources to accelerate discoveries to the clinic, and help to make the transition to clinical manufacturing at a CDMO faster and cheaper. We would also like to partner with companies seeking to rapidly onboard employees, who would like to outsource initial employee training. |
| New Orleans BioInnovation Center | Kris Khalil | kkhalil@neworleansbio.com | New Orleans, Louisiana | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Our organization offers access to two primate research centers, curated programming and we are currently setting up hospital pilot programs. We also offer early stage funding to appropriate startups and commercialization support. We have previously organized reverse pitches and other programming relevant to the BARDA network. We have helped sourced companies relevant to AOIs in the Southeast region (as well as abroad). | We have had two startups In the life sciences see exits. We have helped provide companies support with their strategic endeavors leading in successful SBIR applications. During the pandemic we worked with other BARDA DRIVe members to create reverse pitches and help support pandemic preparedness. | We are looking to take a supporting role in applications who give complementary services to what we offer. |
| Palladium Diagnostics | Jeff Baeur | jbauer@palladiumdx.com | Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services, Rapid Response Capability | Palladium Diagnostics is a unique company in the lateral-flow rapid diagnostics industry. The key members of our scientific team have over 90 years of experience in the development, manufacture, and marketing of point-of-care diagnostic devices with an emphasis on immunoassay and lateral-flow rapid test technology in a range of markets. We are experts in immunoassay development, and we are the ideal partner to assist in the optimization and commercialization of rapid assays. The Palladium team have unrivalled experience in the development of quantitative assays, having developed both fluorescent and colorimetric assays which have been successfully commercialized. Palladium has in house experience in writing trial protocols and running clinical trials, finding trial sites and managing the entire process from site onboarding to closeout and submission of documents to relevant authorities. We have successfully had approvals from the FDA, CE Mark and currently working on submissions the new IVDR system in Europe. From concept and design, initial feasibility, through the product development stage, Validation and Verification Trials, Clinical Trials and commercial launch we aim to use our skills and expertise to support improved access to healthcare in the communities in which Palladium Diagnostics and our customers live and work. | The three principals at Palladium are all highly experienced in the diagnostic space, having worked on the development of over 100 rapid assays over the last 35 years. These assays have covered all application areas for rapid testing, including Medical Diagnostics, Veterinary Assays, Environmental applications, Drugs Testing, Biothreats/Biodefense and Industrial. The range of labels with which Palladium have developed assays include Colloidal gold, fluorescent latex, Paramagnetic particles, Qualitative (yes/no) assays, semi quantitative assays, fully quantitative assays, Quantitative Lateral Flow (involving gold, latex, magnetic, and Fluorescence – both dyes and europium beads.) Palladium regularly perform technology assessment, performing validation and trials on assays as well as having written submissions for approvals. Located in Las Cruces, New Mexico our facility is ISO 9001 and ISO 13485:2003 complaint. In addition, we have established a full-scale contract manufacturing capability with environmentally controlled assembly processes. We utilize a full range of manufacturing equipment capable of handling production volumes ranging into the million+ test per year range. | Palladium is looking to assist researchers, developers, and manufacturers of rapid point-of-care diagnostic devices in bringing their technologies to the marketplace efficiently and effectively. Palladium is used to working with a range of partners at all stages of the development process. The partner can be at an early stage of development or even having a product concept but no additional information. Palladium routinely work with companies looking to validate products that have been developed in their own facilities or at other companies or in need of transferring products to larger scale manufacturing facilities or in need of help performing clinical trials. Palladiums look to partner with organizations and participate in the development of next generation rapid diagnostics and drive the development of better, more cost-efficient diagnostic technologies. | |
| Patricio Enterprises Inc | Dr. Destry Grogan | dgrogan@patricioenterprises.com | Stafford, VA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Patricio Enterprises, Inc. (PE) executive staff includes several former U.S. Government officials with directly relevant experience. These include Mr. Jeff Megargel, a former Contracting Officer and Agreements Officer's Representative, who stood up and managed the Countering Weapons of Mass Destruction Other Transaction (OT) Consortium, and Mr. Nick Stamatakis III, a Senior Executive who led the standup of the Medical CBRN Defense OT Consortium. In their former roles, Mr. Megargel and Mr. Stamatakis developed other transaction agreement training curricula for Government users and industry/academia. The topics included OT authority basics, how to write statements of objectives, how to communicate with industry, how to conduct technical evaluations of white papers, what to consider in protecting data rights, and how to monitor performance post-award, among others. They also worked extensively with consortium management firms to represent the Government in industry outreach events. During these events, they facilitated communication between technology providers and Government buyers and provided detailed instruction on how technology providers could anticipate Government needs and participate in prototyping opportunities. Our team's experience working with contracting activities, program offices, consortium management firms, industry, and academia to explore technology innovation and speed delivery of capability is exceptional, if not unique. | Patricio Enterprises has supported various Federal acquisition programs. We anchor our OTA consortia and acquisition experience with deep technical, innovation environment development, and technology integration experience. Dr. Destry Grogan, the prior Technology Director with the Army Futures Command (AFC) Synthetic Training Environment Cross-Functional Team, is a leader in managing the technical and business integration issues needed to support successful rapid capability development. Dr. Grogan was responsible for defining requirements and incorporating complex training and medical requirements into achievable contracting and OT strategies that ensured the vendor and Government collaborated through development efforts vice forming transactional contractual obligatory relationships. AFC then created the Technology Integration Facility to quickly engage potential solutions and industry partners regarding the current state of technology development, required standardization, and options for accelerating development efforts. These collaborations allowed for more efficient matchmaking of potential vendors within the consortium and the implementation of various strategies at lower costs as executing risks were further defined and managed before making substantial investments in immature or untested technology. Developing a portfolio of industry technical and financial partners will enable the organization to build and finance teams to meet BARDA challenges. | The Patricio Team can support the task's business and technical integration elements. We look to team with partners with technical depth that focus on the development and manufacture of products. In supporting Operation Warp Speed, we saw three crucial aspects that enabled success. First, Scientists were allowed to work the science without getting caught up in the bureaucratic issues plaguing federal development efforts. Second, competent program managers were hand selected to support moving projects forward and breaking down barriers. Finally, technical and business translators between the groups provided understanding to both sides about the technical and business risks. The translators moved the team forward by removing the talking past each other dilemma that drives highly technical low business acumen and high business acumen low technical capability personnel into leadership positions. Our strategy is to use the best parts of the team to accomplish the mission without the need for people to be over-tasked and operate in a space they genuinely don't understand. We bring business acumen and translation to the process. We would seek out highly technical organizations that want to engage the Government to support their efforts and allow their teams to focus on the business of science. |
| PharmStars | Naomi Fried | naomi.fried@pharmstars.com | Boston, MA | Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | PharmStars is the pharma-focused accelerator for digital health startups, dedicated to driving digital health adoption to improve patient outcomes. PharmStars educates and mentors startups so they can optimize their technology innovations through its unique 10-week PharmaU program. PharmaU involves a comprehensive life science curriculum and personalized mentoring performed by life science executives. PharmStars also supports start-ups after they graduate, helping them overcome barriers to success. Similar to BARDA, PharmStars builds its startup cohorts around themes that address the most pressing needs within digital healthcare. We offer BARDA a pipeline of high-quality, digital health start-ups along with direct connections to industry leaders in biotechnology, life science research, and medical innovations. PharmStars can provide BARDA with a robust, successful wrap-around accelerator. Our expert network can assist in the development, evaluation, and validation of emerging technologies. We can also provide advice and services, including rapid responses to advise and/or support government response in a health security crisis. We offer potential teaming partners the same services we offer to BARDA. | PharmStars’ strengths and experiences would make it an excellent BARDA teaming partner. We have built a robust infrastructure and an extensive ecosystem for digital health start-ups, which includes large life science companies, advisors, and investors. Our accelerator infrastructure is tuned to identify startups with cutting-edge digital innovations that have the highest potential to transform healthcare ultimately improving patient’s lives. Since PharmStars launched in 2021, 47 start-ups, selected from over 300 candidates, have graduated from our program. We have facilitated approximately 250 meetings between startups and life science leaders. PharmStars’ “Wrap Around Accelerator Support Services” includes a structured 10-week educational and personalized mentoring program designed to prepare startups for success in the market. Our pharma partners and mentors are experts in the healthcare space with deep industry experience and strong ties to the scientific community across a broad set of disciplines and therapeutic areas. We have a robust startup community and have seen partnerships develop among our startups. After completing PharmaU, we also offer “continuing education” and support to our startups through monthly “graduate” programming and personalized support. | PharmStars has deep expertise in digital health, medical devices, and enabling technologies. PharmStars is seeking potential partners who can assist us in broadening our network of experts or who may have experience in niche areas and/or molecular therapeutics. Additionally, we are seeking partners who are interested in working with our start-up graduates to further validate and develop their technologies. |
| Phlow Corporation | Lee Gearing | lgearing@phlow-usa.com | Richmond, VA | Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Phlow Corp. is a U.S.-based, public benefit corporation that develops and domestically manufactures APIs and finished pharmaceutical products that are critical to the nation's healthcare. In 2019, Phlow set out to solve a problem that our country has faced for decades -- a broken supply chain that has resulted in the shortage of the medicines that our Nation requires to sustain life and conquer disease. Phlow has assembled a world-class team and like-minded strategic partners committed to providing a solution to the broken pharmaceutical supply chain and the over-reliance on foreign manufacturers for our Nation's highest priority medicines. Phlow's capabilities for domestic manufacturing start with our R&D facility offering a range of customized services for small molecule APIs and KSMs to help companies of all sizes reduce production costs, decrease development time, and lower environmental impact serving as an extension of each customer's R&D team. Phlow's cGMP Kilo Facility is a small-scale manufacturing facility equipped with two cGMP suites and 19,200-sq.-ft. dedicated development space for scale-up and continuous flow process refinement to produce API. Our Hybrid Manufacturing Facility is approximately 18,000-sq.-ft. API manufacturing facility that utilizes continuous advanced manufacturing processes and state-of-the-art automation. | Phlow helps the U.S. government protect the health of Americans by bolstering the Strategic National Stockpile with domestically supplied essential medicine APIs needed for lifesaving care. To date, Phlow has delivered more than 2 million doses of essential medicines to the SNS, alongside our manufacturing partners, to support the U.S. government's emergency response capabilities for the health of all Americans. We are also actively developing novel, advanced processes for key APIs of interest through a partnership with BARDA/ASPR. Additionally, leading pharmaceutical and emerging biotech companies collaborate with the industry-defining experts at Phlow to revolutionize the production of their drug candidates in state-of-the-art lab environments. Phlow tests and develops various conditions to find the optimal manufacturing process and quality control measures that ensure molecules are prepared for the rigors of regulatory requirements. Phlow designs stable, reproducible, and cost-effective manufacturing processes in continuous or batch modalities that can rapidly scale up for commercial production while scaling down the impact on the planet. Phlow's deep knowledge and experience creates custom manufacturing solutions that move NCEs (New Chemical Entities) and generics to market quickly and reliably without the risk of global interruptions. | Phlow is focused on partnering with government organizations and biotech and pharmaceutical companies focused on progressing small molecule development and domestic manufacturing. Phlow's goal is to serve as their technical experts in the fields of Chemistry, CMC, Quality and Regulatory. As a team, we can secure our domestic pharmaceutical supply chain. |
| Plug and Play | Jennifer Thomas | jennifer@pnptc.com | Sunnyvale, CA | Digital Health Tools | Wraparound Accelerator Support Services, Rapid Response Capability | Plug and Play's global innovation platform accelerates 2,500 startups annually in 60 global programs in 20 industries, invests in 200+ global startup technologies across industry, and helps 550+ corporate, government and organization members to bring innovation and tech to market faster. We offer BARDA a fast, efficient, and targeted sourcing model to discover the newest technology by topic area, a robust 2x annual accelerator to advance R&D with breakthrough technology startups, and a global platform to elevate BARDA's innovation presence and access to solutions. We hold over 100 annual events, including webinars, innovation showcases and bi-annual Summits that attract industry leaders, VCs and others in the startup ecosystem. | The Plug and Play Health ventures team has deep healthcare industry knowledge, extensive sourcing, vetting and investing experience, and startup trust and access for robust deal flow pipeline to invest in and accelerate the R&D of breakthrough early-stage technologies for PHEs (A). We have facilitated over 100 pilot projects connecting corporations and governments to startup technology. The management and ops team has accelerated 16 startup batches over 8 years with experts, mentors, workshops, and VC and corporate introductions with a goal to commercialize and scale new technologies. We have successfully launched and managed many public open innovation challenges with a 4-week turnaround to address the rapid response needs of national health security, chronic illness, AI and big data developments, and market demands as they arise (C). | Plug and Play is an active investor, with evaluation, due diligence and investment expertise, and has over 30 digital health startups in our portfolio with 3 unicorns. However, Plug and Play does not have the bandwidth to address product development, evaluation, and validation support to innovators and companies that cover a spectrum of technology readiness for its specific technology area of focus. Therefore, we are seeking a partner for these DEV services where we can provide a combination of in-house efforts and collaboration with relevant experts/partners, such as The Global Center for Medical Innovation. https://gcmiatl.com |
| Portal Innovations, LLC | Michael Faulman | mike.faulman@portalinnovations.com | Chicago, IL | Vaccines and Therapeutics, Diagnostics and Medical Devices | Wraparound Accelerator Support Services | At Portal Innovations, we turn breakthroughs into businesses. Portal Innovations is the leading life sciences venture development engine, bridging the gap between scientific exploration and entrepreneurial realization. We equip early-stage life sciences companies with the seed capital, cutting-edge wet lab space, and seasoned management expertise necessary for them to flourish. Our market-based approach identifies the most promising life science startups and supports them throughout the journey. We engage deeply in every aspect of the business, leveraging our network to tackle each company’s specific challenges and lead them to successful Series A investments with world-class VCs and strategic investors. Portal invests in therapeutics, med tech, and bio informatics startups with strong leadership teams. Our differentiated mix of crafted capital drives companies from scientific ideation to business creation, helping entrepreneurs translate cutting-edge technology into sustainable, global businesses. Portal currently has two operational labs in downtown Chicago and South Boston, while developing two additional labs in Atlanta and Houston which will open in early 2024. | Since Portal opened its doors in March 2021, we have 35 companies at Portal Chicago, 200+ employees at Portal member companies, and our member companies have raised over $70M in funding. Portal members have access to world-class biotech and medtech equipment, rarely found in downtown, urban areas. From therapeutics to diagnostics, our member companies can run studies to help benefit the world. As soon as a company joins Portal, they immediately gain access to other founders, researchers, and venture capital firms in the life sciences ecosystem, giving them the tools and relationships, they need to succeed. Portal partners are surrounded by other companies, and employees who are going through similar struggles and breakthroughs. This creates a collaborative atmosphere that allows for a positive work culture. Portal partners are encouraged to discover, network, and relax. Portal offers its members exclusive access to career nights, venture capital networking events, partnering meetings with pharmaceutical companies, and happy hours – we have more than 150 events each year, all dedicated to helping our member companies thrive. Our space comes with access to meeting and board rooms which are perfect for quick catchups, board meetings, or larger pitch events. | Portal would love to partner with teams that want to collaborate with us for DEV and Rapid Response Capability services. We can provide access to technical and business/commercialization expertise and resources. We help advance technical readiness levels by providing NewCos unmetered access to state-of-the-art lab equipment as well as a vibrant community/workplace that ensures that no one develops their technology in isolation. Portal is well-positioned to be a trusted partner to co-develop subawardees who need to conduct preclinical validation studies. Furthermore, Portal has access to over 150K class A lab (BSL2 capable)/office space scattered throughout the country, thus is well-positioned to deliver rapid and scalable operations in different cities simultaneously. Finally, Portal likes to build near specialized resources, like vivarium, that can be readily accessible to derisk technologies in a time and cost-efficient manner. |
| Regis Technologies, Inc. | Louis Glunz | louis.glunz@registech.com | Morton Grove, IL | Vaccines and Therapeutics, Diagnostics and Medical Devices, Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services, Rapid Response Capability | Regis is a US-owned operated business started in 1956 and has been performing CGMP synthesis since the 1980s. Unlike most CDMOs, Regis’ development and manufacturing is co-located at a single site in Morton Grove, IL. This fosters rapid collaborations with our clients and internally within our project teams enabling Regis to collect data and take decisions without shipping samples or waiting for results. This also enables direct oversight by subject matter experts with first-hand experience in the lab during scale-up and manufacturing, helping avoid costly reworks from misinterpretation or translation. The Project Teams, along with the support of our highly experienced project managers, offer the white-glove service needed to manage development risks and ensure timely delivery in full. Our services include route scouting, early process development, analytical development, solid-state chemistry, process optimization, CGMP Scale up, analytical validation, late-stage development (ranging studies, DOE, fate of impurities), impurity characterization, process validation and CGMP manufacturing. | Regis' laboratories are state of the art including sophisticated process development equipment, (ARC reactors, EasyMax, HEL, etc.), glass reactors and isolation equipment modeling the engineering in the plant, and advanced analytical such as 400 MHz NMR, LC-MS, HRMS, HPLC, UHPLC, GC, GC-MS, DSC, TGA, XRPD, ICP-MS etc. Having analytical, process, and solid-state services together on site provides a comprehensive solution to rapid scale up. Regis' offers 13 discrete production suites with equipment ranging from 5L - 2000L capacity, CGMP, with SafeBridge 3a level containment. This facility has delivered over 100 APIs for clinical use and currently supports 5 active commercial drug programs. In this facility, Regis has produced batch sizes from 1-150Kg making Regis an excellent choice for any clinical candidate. For drug programs that don’t require multiple MT annually on market, Regis is the ideal choice being able to take programs from pre-clinical to commercial at one site without any site transfers. Regis also has a Potent Compound Suite to safely synthesize Safebridge 3b projects up to 22 liters in scales. | Regis could team with the therapeutic or diagnostic solution providers to rapidly and compliantly scale-up their candidate molecule. Many projects may 'graduate' out of Regis to larger scale, but you would get attention and support during early to medium scale development. Our largest reactor is 2000 liters, which may produce 100 kilogram batches depending on process intensity. |
| Resilience Government Services (National Resilience) | Donald Ebersole | donald.ebersole@resilience.com | Alachua, Florida | Vaccines and Therapeutics, Enabling Technologies | Development, Evaluation, and Validation Services, Rapid Response Capability | Resilience was founded in 2020 and born out of an identified need to increase domestic biopharmaceutical manufacturing capacity through innovative technology approaches and partner-centric business strategies. Manufacturing technologies to support emerging modalities such as cell and gene therapies have not kept pace with the scientific innovation that fuel them. Our purpose is to create the processes and platforms that allow novel therapies to be manufactured quickly, safely and at scale. Resilience is a proven government and commercial partner, working with scientific innovators across academia, biotechnology, and large pharma. In partnership with the Department of Defense, Resilience manages the DOD Advanced Development and Manufacturing (ADM) in Alachua, Florida as a contractor-owned, contractor-operated end-to-end biomanufacturing facility. Resilience has 13 sites across the United States and Canada, including 7 that offer GMP services, working across six modalities to provide end-to-end services to serve innovator needs at every phase of development. Our model encourages early-stage collaboration and innovation, providing the perfect opportunity right-sized engagement based on program stage to help accelerate product maturation. Resilience enables rapid process and analytical development through technology transfer, cGMP/commercial drug substance and drug product manufacturing, including fill/finish. | Resilience is an innovation partner leading the pursuit of novel medicines by revolutionizing how they’re made, funded, and scaled. We leverage automation and technology to facilitate continuous and advanced manufacturing. Though both established manufacturing systems for vaccines and biologics, novel processes like cell-free protein expression, and disruptive concepts that bring product manufacturing closer to the point of need, Resilience enables critical medicines getting to patients faster, with more than 70 molecules from phase 1 through commercial currently being manufactured for partners across the network. The network is focused on being flexible and adaptive, with purposeful “white space” built into our capacity utilization matrices to ensure we can rapidly pivot to meet emerging customer needs. These capabilities are coupled with testing and evaluation of novel products, technologies, and processes, including regulatory strategies and support services to enable improved access to health solutions. | Resilience has 13 sites across the United States and Canada, including 7 that offer GMP services, working across six modalities (vaccines, biologics, cell therapy, gene therapy, nucleic acids, and drug product) to provide end-to-end services to serve innovator needs at every phase of development. Our model encourages early-stage collaboration and innovation, providing the perfect opportunity right-sized engagement based on program stage to help accelerate product maturation. Resilience enables rapid process and analytical development through technology transfer, cGMP/commercial drug substance and drug product manufacturing, including fill/finish. |
| Rubix LS | Stacy Arrazcaeta | sarrazcaeta@rubixls.com | Lawrence, MA | Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services, Rapid Response Capability | As a leading diverse and culturally competent contract research organization, our company is uniquely positioned to offer unparalleled support to BARDA and potential teaming partners. With an expansive global reach and a profound understanding of diverse populations, we bridge the gap between national and international research initiatives. By partnering with BARDA, we can offer: Diverse Insights: Our cultural competence ensures research that is inclusive and relevant, catering to the multifaceted needs of global populations. National and Global Networks: Our broad network encompasses key stakeholders, making us an ideal partner to facilitate widespread research and implementation. Teaming Synergy: By integrating into the BARDA Accelerator Hub, we can effectively collaborate with other organizations, combining our strengths to drive impactful results. We believe that by joining the Teaming Partner List, we not only expand our collaborative opportunities but also fortify BARDA's mission by providing insights from diverse cultural lenses. We are committed to meeting BARDA's objectives and ensuring that our contributions align with the vision of the BARDA Accelerator Network 2.0 program. As a forward-looking organization, we embrace innovation and partnership, striving to make a difference in global health research. | Within the BARDA Accelerator Network, our company excels in leveraging cutting-edge enabling technologies and offering unparalleled support to special populations. Our core strengths include: Innovative Technologies: With a commitment to fostering innovation, we harness the latest in data analytics, AI, and digital health platforms. This enables precise research, real-time monitoring, and efficient data-driven decision-making, positioning us at the forefront of contemporary health solutions. Special Population Focus: Recognizing the unique needs of various demographics, we've developed tailored solutions for special populations. This includes but isn't limited to pediatric, geriatric, and marginalized communities. Our culturally competent approach ensures that these groups aren't merely included, but their needs are central to our research and interventions. Collaborative Ecosystem: We have cultivated a network that facilitates seamless collaboration with stakeholders in technology, healthcare, and community outreach. This ecosystem ensures that our enabling technologies are always aligned with the specific needs of the populations we serve. Scalability and Reach: Our technologies are designed with scalability in mind. Whether local or global, our solutions can be rapidly deployed and adjusted to suit diverse population needs. In essence, our strengths lie in our ability to integrate advanced technologies with an unwavering focus on the populations that need them the most, ensuring holistic, effective, and inclusive health solutions. | In our pursuit of excellence and impact within the BARDA Accelerator Network, we prioritize the following attributes when considering potential teaming partners: Aligned Vision: Partners who resonate with our commitment to leveraging advanced technologies for the betterment of special populations, ensuring that every initiative is inclusive and culturally competent. Innovative Capability: Organizations that bring novel technologies, methodologies, or perspectives to the table, enriching our collective capacity to address contemporary health challenges. Operational Synergy: Teams with complementary skills, resources, or networks that can enhance our combined operational efficiency and effectiveness, maximizing our collective impact. Ethical Standards: A track record of maintaining the highest ethical standards, ensuring research integrity, transparency, and adherence to global best practices. Adaptability: Organizations that can pivot quickly in response to emerging needs or challenges, highlighting a solution-oriented mindset and flexibility in execution. Diverse Representation: Partners that prioritize or represent under-served or marginalized communities, ensuring that our combined efforts truly reflect the diverse needs of global populations. Open Communication: A culture of open dialogue, knowledge-sharing, and feedback, fostering a collaborative environment where ideas flourish and challenges are addressed collaboratively. In sum, we seek partners who not only augment our technological and operational prowess but also share our dedication to making a meaningful, inclusive impact in global health research and interventions. |
| Sapphiros | Teresa M. Abraham, PhD | t.abraham@sapphiros.com | Boston, MA | Diagnostics and Therapeutics, Special Populations | Development, Evaluation, and Validation Services, Rapid Response Capability | At Sapphiros, we have a suite of capabilities and technologies that we can offer to BARDA and teaming partners that include molecular and lateral flow assay development expertise, device design and development services, high-volume automated manufacturing, and reel to reel flexoprinted electronics (proprietary inks incorporating printed batteries, RFID, Bluetooth, LEDs). We have a 16M per day, 5BN annual unit capacity lateral flow and digital lateral flow manufacturing line with reagent dispense modules that can be swapped out rapidly (within 45min) to produce different tests, accommodating for tests that need to be manufactured in low or high volumes. Our assay development expertise and capabilities are centered around building lateral flow assays that are compatible with our manufacturing line and uses a low-volume test production method, called an LVDO. Here, lateral flow strips are assembled in a manner and with materials that is compatible with our at-scale manufacturing process, this provides a blueprint on how to build LFAs that can be manufactured transferred rapidly on our production line. Our product design and development services provided by our partner, includes end-to-end engineering design, rapid prototyping, computational model testing, and full V&V capabilities for device development under a certified quality system. | The Sapphiros leadership team is composed of seasoned healthcare executives with a proven track record of execution and years of experience as entrepreneurs, operators, and investors. The team has led some of the world largest IVD companies including Alere Inc, worlds largest POC Diagnostic company. The team have collectively been responsible for bringing to market hundreds of diagnostic solutions including Alere I (Abbott ID Now) the first CLIA waived POC molecular respiratory test. We have expertise in developing and commercializing lateral flow and molecular diagnostics platforms, high volume manufacturing, material science, and printed electronics. Sapphiros has a commercial organization and established direct to consumer and point of care sales and distribution channels. Our Leadership has established a global portfolio of patents and trademarks, with all our inventors and founders retained. All our entities are ISO-13485 compliant. | We are looking for partners that can provide wrap-around services, while we provide design and development services, contract manufacturing services, and assay development expertise. Teaming partners can include program management, validation services, reimbursement, market access, clinical and regulatory support. We would also have an interest in providing scientific expertise and advice on a variety of topics including molecular assay development, lateral flow assay development, printed electronics, infectious diseases, design for manufacturing, and other topics as relevant to Accelerator resident companies. Because our reel-to-reel manufacturing platforms can reduce the cost-of-goods of diagnostics and devices, it is uniquely suited for deployment into low-resources settings, including LMICs and other relevant settings. |
| Science Exchange | John Lubin | john.lubin@scienceexchange.com | Palo Alto, CA | Vaccines and Therapeutics | Wraparound Accelerator Support Services | Science Exchange is a purchasing and supplier-orchestration platform for life sciences organizations. We're on a mission to streamline and modernize the way R&D organizations work with suppliers so that scientists can stay focused on what they love doing most--science. Scientists often spend countless hours on administrative tasks associated with outsourcing -- identifying suppliers, contracting and vendor onboarding, project management, invoicing, etc. Science Exchange removes these burdens from scientists and their supporting teams, which gives time back to scientists so they can focus on science. Science Exchange simplifies purchasing, supplier management, and payment processing with one platform and through one digital marketplace. Whether you use our network of 4,000 suppliers with established contracts or sync your existing ones, a simple intake process enables your scientists to purchase the services and goods they need while workflows and integrations guide them through approvals and compliance requirements. | Science Exchange works with 80% of the Top 25 Pharma, as well as dozens of seed-stage to early- and late-stage biotechs. We support our clients in various stages of their growth, as well as with different operating models. For example, we enable companies to easily operate with a 100% outsourced R&D model and eliminate the need for large procurement, finance, or legal functions. Our clients typically see their outsourced projects start 75-90% faster through our platform versus their status quo process. They also save, on average, 15-45% on their projects by competitively sourcing through Science Exchange. | Science Exchange helps companies streamline their processes and put infrastructure in place to work with external suppliers quickly and easily. Science Exchange does not perform, evaluate, or validate scientific research. Therefore, Science Exchange would like to partner with individuals or organizations that can provide the scientific capabilities, expertise, mentorship, and guidance to build a complete Accelerator Hub. |
| Scinai ImmunoPharmaceuticals ltd (formerly BiondVax pharmaceuticals ltd.) | Tamar Ben Yedidia | tammy.benyedidia@scinai.com | Jerusalem, Israel | Vaccines and Therapeutics, Diagnostics and Medical Devices, Enabling Technologies | Development, Evaluation, and Validation Services, Rapid Response Capability | Scinai Immunotherapeutics Ltd. is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products for the treatment of autoimmune and infectious diseases. With a state-of-the-art facility for biopharmaceutical product development and manufacturing, Scinai offers end-to-end boutique CDMO services in parallel to developing our own pipeline of diversified products. Scinai two business units are: R&D: Developing a pipeline of Nanobodies, also known as VHH-antibodies. Our anti-SARS-CoV2 VHH exhibits significant competitive advantages over existing mAbs and oral therapies. Development of our VHH for treatment of plaque psoriasis is currently advancing ahead of schedule, with human clinical testing expected in 2024. Our pipeline currently includes also anti-IL-13 and anti-TSLP for the treatment of asthma; and anti-Ang-2 and anti-VEGF for treatment of age-related wet macular degeneration; Boutique CDMO: Our CDMO service leverages our cGMP biologics manufacturing facility, including bacterial and yeast expression systems, aseptic filling, upstream and downstream process development, process scale-up and optimization, analytical method development, media and buffer preparations, and cGMP batch manufacturing up to pilot scale. We offer BARDA capabilities of developing nanobodies for any use and for any antigen of interest from immunizing Alpacas to clone selection, process development and manufacturing at our CDMO. | Scinai (formerly BiondVax Pharmaceuticals) has previously manufactured recombinant proteins for preclinical and clinical studies and ushered a vaccine candidate through preclinical and clinical development and manufacturing through to a 12,400 participant Phase 3 trial. With a state-of-the-art facility for biopharmaceutical product development and manufacturing and highly experienced pharmaceutical industry leadership, Scinai offers end-to-end boutique CDMO services in parallel to developing its own pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized VHH antibody pipeline targeting diseases with large unmet medical needs. VHHs may serve a broad range of purposes including for the development of diagnostic kits, and the prevention and therapy of infectious diseases. Due to their inherent characteristics, VHHs offer potentially safer and more convenient treatments, such as inhaled treatment of respiratory diseases at a lower cost as compared to mAbs. Scinai’s team includes scientists, technicians, researchers, and administrative staff. Our state-of-the-art GMP facility houses its laboratories, production facilities and offices. | Scinai’s R&D unit seeks to establish partnerships with product developers of diagnostics or therapies that are interested in the development of nanobodies-based technologies or drugs with high affinity to their target. Such Nanobodies have a significant advantage in being highly specific, cost effective and suitable for self-inhalation, which makes them suitable for therapies against any infectious pathogens of the respiratory system. Our CDMO unit seeks a partner looking for professional development of manufacturing processes for recombinant protein in bacteria or yeasts, including support in developing, upscaling, and optimizing upstream, downstream, analytical assays and filling for research and clinical trials. |
| Solvandria Foundation, Inc. | Malvika Verma Miller | malvika@solvandria.org | Boston, MA | Diagnostics and Medical Devices, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | Solvandria, a 501(c)(3) nonprofit, accelerates global health innovations. Under the thesis of BARDA's Enabling Technologies division, we specialize in preclinical testing and coordination. We hope to work with founders and innovators in providing a suite of services including in vivo drug and device testing (especially in large animals), device development/prototyping, and analytical chemistry. Our exceptional team includes subject-matter experts, proven innovators, life sciences consultants, and startup founders. We can provide the DRIVe accelerator 3 key benefits: (1) Our members' track records in transitioning lab and bench innovations to the market, and our wide range of domain expertise, allowing us to work with a wide range of entrepreneurs and innovators while not compromising our understanding of their work and goals. (2) Our nonprofit model that prioritizes impact rather than margins, enabling us to provide tailored support that aligns with DRIVe's mission of addressing our nation's largest health security threats primarily, with the profit-motive being pushed to the side. (3) Our comprehensive E2E support services that can bridge the gap between early-stage R&D and clinical trials, promoting seamless collaboration and efficiency across teams, thus reducing time-to-market and getting DRIVe innovators' ideas realized in a significantly shorter timeline. | Solvandria is a non-profit CRO that provides entrepreneurial education. Our accomplished domain experts validate early-stage technologies. We offer device design/prototyping/testing capabilities for startup founders with limited capital to contract such work out or do it in-house. We can provide BARDA a better understanding of the potential of technologies they are investing in. Our Board of Directors comprises life sciences experts with unparalleled track records in translating technology to humans, founding companies like Moderna and Lyndra Therapeutics. With our combined skillsets and nonprofit model, we help founders validate their products faster, helping them access more capital for growth. We support faster deployment of technologies to market, ensuring that emerging technologies for human health can reach consumers without finances hindering global health. We currently collaborate with academic labs in developing potentially transformative women's health products, and aim to broaden our impact in other focal areas. Our diverse network fosters interdisciplinary collaboration, enhancing our comprehensive approach. With a proven track record and a shared commitment to innovation, Solvandria strengthens BARDA's endeavors in advancing biomanufacturing, drug development, and clinical support and seamlessly integrates with BARDA's mission to advance responsiveness to public health emergencies. | Solvandria's translational expertise is a natural fit with entrepreneurs and early-stage biotech/medtech companies looking to generate preclinical data prior to first-in-human trials. We eagerly seek partnerships with academic lab groups and preclinical-stage companies looking to generate proof of concept data. Solvandria can provide preclinical services (e.g., in vivo testing of drugs and devices in large animals, device design/prototyping, analytical chemistry, and project management). Solvandria is open to partnering with not just domestic, but international companies, innovators, and academic institutions that are interested in advancing product feasibility, navigating regulatory channels to Phase I, and expediting research in innovative global health solutions that ideally have impact and favorable outcomes for traditionally underserved communities. We also invite partnership with investors, incubators, and accelerators who aim to connect an established non-profit CRO with early-stage biotech/medtech startups developed in or targeting overlooked populations, fostering innovation with a societal impact. |
| Southern Research | Lexie Lehmann | alehmann@southernresearch.org | Birmingham, Alabama | Vaccines and Therapeutics | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | Station 41 is a biotechnology commercialization hub powered by Southern Research in Birmingham, Alabama. Whether you have a hypothesis or an established company, Station 41 can help you grow your ideas through funding, expertise, and wet lab space. Station 41 includes three flagship programs, the Accelerator, Incubator, and Venture Studio. These three programs are focused on providing the resources, expertise, and collaborative environment necessary to accelerate innovation and drive the commercialization of next-generation therapeutics and vaccine programs. Additionally, Station 41 is focused on supporting life sciences companies with alignment to Southern Research's focus areas of oncology, infectious disease, and chronic disease and expertise in next-generation therapeutics and vaccines. Southern Research is internationally recognized for its outstanding track record in the discovery and development of antiviral drugs and small-molecule cancer therapeutics. For example, six FDA-approved anticancer drugs (lomustine, carmustine, dacarbazine, fludarabine, clofarabine, and pralatrexate) and one cytoprotective agent (ethyl) were all discovered and developed at SR. SR is also a major contributor to the NCI's Chemical Biological Consortium and was a past member of the Molecular Libraries Probe Production Centers Network, a collaborative research initiative to identify small molecule chemical probes for the biomedical research community. | Southern Research currently employs approximately 250 research scientists, technical staff, and support staff and maintains a campus of more than 450,000 square feet of office and laboratory space. Our campus includes biosafety level 1, BSL 2, and BSL 3 in vivo and in vitro facilities that are completely self-sufficient and conform to all regulatory guidelines and requirements. At the start of 2022, Southern Research launched a new strategic plan focused on translational research in the life sciences. SR intends to invest over $150 million in this new strategy, including the development of new facilities, platforms, and programs like Station 41. We believe in the power of SR and our partners to unlock the immense potential of Alabama's biotech ecosystem to spur economic development, create jobs, and draw investment. Downtown Birmingham sees over $700M in extramural biomedical research every year, including over $300M from the NIH, in large part due to the contributions of SR and the University of Alabama at Birmingham. We are on a mission to translate our R&D volume into investment, high-performance companies, and quality jobs in Alabama and the Deep South. | Southern Research understands the necessity for developing commercialization infrastructure to bring new inventions to market. We are building a lean but mighty team to support Station 41 programs, and are looking for individuals and organizations to partner with us for pipeline development, program development, wrap-around services, and an envisioned mentorship network to support early-stage ventures. Partners we are seeking may include, but are not limited to, university technology transfer offices, entrepreneurship support organizations, venture capital funds, service providers, other commercialization hubs, and consultants in regulatory affairs, technology development, IP/licensing, go-to-market strategy, etc. |
| SRI International | Hannah Mazur | hannah.mazur@sri.com | Menlo Park, California | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services, Rapid Response Capability | SRI International is an independent, non-profit research institute with the mandate to create world-changing solutions that make people safer, healthier, and more productive. Founded in 1946, SRI has a deep legacy of transforming cutting-edge early R&D into mature commercially viable technologies. In support of SRI’s mandate to translate and disseminate emerging technology through commercialization, SRI has several corporate teams supporting innovation activities, as well as innovation platforms that can be used to train and assist external partners and entrepreneurs in deep-tech commercialization. SRI has particular expertise in supporting the development and commercialization of technologies first created in conjunction with federally directed funding and competitive research grants, with some of the most successful SRI-derived startups owing their core technology to long-standing government-funded research work. In addition, SRI has a strong core of technical expertise, unique lab capabilities, and developmental resources that can be used to assist startups and early ventures in bringing new technologies to market. | SRI’s commercialization services accelerate the technical path to commercialization through wrap-around support. This support includes venture guidance, prototype and product development, and commercial licensing. SRI’s innovation services grow an organization’s innovation readiness and help build innovative teams. Our innovation toolbox is built on human-centered design, business and technology-based innovation, and bioscience expertise. Each of our coaches have decades of design thinking experience to assist in developing patient centric solutions. The Biosciences Division at SRI (BSD) is a full-spectrum biological science research and development organization, combining both advanced scientific inquiry and translational efforts, in support of both government and commercial partners. The division offers a wide range of platform and service offerings, and is supported by a strong base of government funded R&D. Commercial clients have ranged from virtual/small companies, to early biotechs, to top global pharma majors. The division has a notable track record of translational success, with over 10 spinouts, 150+ client drugs moved to the clinic, and 15+ client drugs currently on the market. In addition, four SRI developed compounds are currently commercially marketed. | SRI's highly specialized platforms marry the advantages of our cutting-edge research with our flexible biotech business model. Partner with us to leverage our rigorous early discovery and development to customize your specific applications. Our leading-edge R&D is concentrated in the following areas to solve important problems in prevention, diagnosis, and treatment: human sleep, point of care diagnostics, aging and neurodegenerative diseases, neuroimaging and electrophysiological research, blood brain barrier transport, toxicology and safety, homeland security/national defense innovations, immuno-oncology, intracellular biologic therapies, medical countermeasures, formulation design, as well as biomarker discovery, development and validation. SRI Biosciences provides services that span all stages of drug and diagnostics discovery and nonclinical development leading to human clinical trials and, ultimately, to the market. SRI Biosciences partners with clients to seamlessly integrate basic research, drug discovery, and nonclinical and clinical development. Our turnkey and customized services include: models for research and drug discovery, identifying targets and mechanisms of action, efficacy, pharmacology and pharmacokinetics, safety, clinical research studies and a full clinical trials unit. SRI seeks partners who have need of proven commercialization and innovation services at the speed and scale of business. |
| Techstars | Kayla Bernardino | kayla.bernardino@techstars.com | Boulder, Colorado | Diagnostics and Medical Devices, Digital Health Tools | Wraparound Accelerator Support Services | Techstars is the world's most active pre-seed and seed investor, according to Pitchbook and Crunchbase. Founded in 2006, Techstars began with three simple ideas— entrepreneurs create a better future for everyone, collaboration drives innovation and great ideas can come from anywhere. Now Techstars is on a mission to enable every person on the planet to contribute to, and benefit from, the success of entrepreneurs. In addition to operating accelerator programs and venture capital funds, we do this by connecting startups, investors, corporations, and cities to help build thriving startup communities. Our track record includes 3,715 company graduates (with a cumulative market cap of $100B), including 20 $1B+ companies and 439 exited companies. We can help BARDA further build its innovative reputation, discover more disruptive tech (while leveraging a proven methodology that de-risks your innovation/investment dollars), improve deal flow opportunities, and maximize each of the selected startups' long-term performance. | Techstars has a unique approach to building accelerators, using a centralized and decentralized model facilitating 54 programs simultaneously around the world. Each program is assigned a Managing Director (MD) and program team handling local operations, while 250+ people work from HQ to support cross-collaboration within the network to help startups to succeed. One of our biggest strengths is our global network - we ensure cooperation among MDs, 90+ partners (corporate, university, and government), 4,200+ mentors, and 8,500+ founders, and 20,000+ investors through events, outreach, and internal tools. Moreover, we have a team dedicated to supporting our startups after they graduate. Related programs we are currently running include: 1) Techstars Healthcare (Cedars-Sinai, Point32Health, UCI Health and UnitedHealthcare, 2)Techstars Physical Health Fort Worth (University of North Texas Health Science Center, City of Fort Worth, Tarrant County, and Goff Capital), and 3) Techstars Future of Longevity (Pivotal Ventures, a Melinda Gates company). Mentors include: Chief Research Officer @ American College of Radiology, CTO @ GoodRx, Former Senior Managing Director @ Kaiser Permanente Ventures, Vice President, Surgical Services and Orthopedics @ Allina Health, Fellow, Worldwide Innovation @ Pfizer, Chief Medical Information Officer @ InterSystems, Former SVP, Global Market Access & Policy @ Merck, Chief Data Scientist @ Optum, Chief Medical Officer @ Samsung SDS America, etc. | Generally speaking, ideal partners are ones who understand that innovation doesn't happen overnight and are willing to make an investment into the future, whether for strategic or financial reasons. Having experience working with startups is great (though not wholly necessary - Techstars teaches organizations how to work with startups all the time and serves as a middleman to align expectations and ensure successful outcomes). Partners should have a broad idea of what types of technologies they're interested in finding, as it means their thesis is more developed. In terms of teaming partners, those focused on technical development are welcome. Techstars has a plethora of mentors who can guide our founders in this area, but the more the merrier. |
| The Center for Advancing Innovation | Rosemarie Helen Truman | r.truman@caistartups.org | Bethesda, MD | Special Populations | Wraparound Accelerator Support Services | The Center for Advancing Innovation (CAI) is a US-based 501c3 nonprofit that matches entrepreneurs with breakthrough inventions to launch startups and connect them with capital -- a trifecta -- innovation + talent + capital. CAI's mission is to advance technology in the interest of national security. CAI has been coined the "Tinder for Startups" by Nature and "Shark Tank on Steroids" by the Biotechnology Innovation Organization (BIO). CAI earned awards and recognition from Health and Human Services, the White House, and the Federal Laboratory Consortium. CAI was named one of President Obama's "Top 10 Actions to Advance Entrepreneurship" and one of "100 Examples of Obama's Leadership in Science, Technology, & Innovation". CAI received nine White House recognitions, two Government Accountability Office awards, and the Challenge.gov Best in Business Plans/Entrepreneurship award. CAI received funding from the US EDA, Walton Family Foundation, Silicon Valley Community Foundation, Arnold Ventures, AstraZeneca, Avon Foundation, and Heritage Provider Network to orchestrate eleven challenges, including the Global Health Innovation Challenge. CAI built the world's largest virtual accelerator, which directly created 1,560+ new jobs, advanced 300+ inventions, trained 4,000+ entrepreneurs, and launched 380+ startups that have cumulatively raised >$1.35 billion since 2014. >70% of CAI's startups are co-founded by SEDI. | CAI is prepared to leverage its strengths and experience to foster the health security innovation ecosystem as part of the BARDA Accelerator Network 2.0. CAI led innovation strategy (not manufacturing) for Emergent BioSolutions, which develops vaccines and therapeutics for public health threats, during the coronavirus pandemic. CAI also led the personalized medicine strategy for the National Institutes of Allergies and Infectious Diseases (NIAID) and worked with the National Institutes of Health (NIH) to launch multiple challenges and trailblaze the concept of NIH/HHS founder-friendly agreements. CAI has 24 agreements across NIH to advance their inventions. CAI was the catalyst for 380+ startups, including ~40 health security-focused startups, through its challenge-accelerator. CAI also frequently judges business competitions, including for existing BARDA Accelerators; e.g. the MedTech Innovator East Coast Pitch Event and National Capital Consortium for Pediatric Device Innovation "Make Your Medical Device Pitch for Kids!" Competition. Through its proven, turnkey model, CAI conducted 11 challenges, including 5 place-centered challenges, and scaled its model by 10X, receiving 13 awards and significant recognitions for impact. CAI cultivated relationships with ~100,000 stakeholders, including ~10,000 investors who attend CAI's demo days and 150+ industry, academic, and federal labs that offer licenses to inventions through CAI's challenges. | CAI has experience in providing wrap around accelerator support services for all five Technology Areas (Therapeutics/Vaccine, Diagnostics/Medical Device, Digital Health, Enabling Technologies, and Focus on Special Population). For the BARDA Accelerator Network 2.0, CAI is looking for teaming partners with Diagnostics/Medical Devices expertise and the capacity to support 1) Development, Evaluation, Validation Services and 2) Rapid Response Capability. Ideally, teaming partners will have research and development experience in a broad set of health security-related research and development, including, but not limited to, information technology, nanotechnology, artificial intelligence, quantum computing, and biotechnology. Teaming partners will possess personnel and resources integrated in advanced prototyping and manufacturing and possess expertise in areas such as biomaterials, bioinstrumentation, medical imaging, biomechanics, and tissue engineering. Teaming partners will have their own inventions, which can be made available for exclusive licensing to entrepreneurs participating in CAI's accelerator; teaming partners may refer entrepreneurs to CAI. Teaming partners will collaborate with invention licensees from CAI's accelerator and other BARDA health security companies to develop, prototype, and test their products. CAI also seeks teaming partners with experience and capacity to prepare for and respond to public health emergencies via manufacturing; access to a secure BSL-3 facility is a priority. |
| The Idyeas Group | Idong Essiet-Gibson, PhD, MPH | idong@idyeasgroup.com | Silver Spring, MD | Digital Health Tools, Special Populations | Wraparound Accelerator Support Services | The Idyeas Group assist clients with reviewing and drafting proposals and project plans to accomplish key milestones for federally funded projects. We leverage project management tools to help organizations monitor real-time performance while identifying technical hurdles in advance, as they work on deliverables. We perform independent verification and validation of project progress, instituting change management processes to account for the inevitable change that comes with implementing digital health solutions. We provide problem resolution on ongoing projects by liaising with government acquisition and technical staff to get them back on track. We guide the design and implementation of quality and performance improvement activities to get failing projects back on track and optimize opportunities for excellence. We design performance improvement/remediation plans for poor-performing projects and develop quality assurance plans for performance-based projects. By partnering with us, teams gain a strategic ally committed to successfully implementing emerging technologies, from conceptualization to product launch. We have experience in supporting the introduction of digital health solutions in low resource settings in the US and Africa. | With a strong foundation built on over two decades of experience, both in the US and globally, our firm excels in guiding early-stage startups through the intricate landscape of implementing health-related projects. Our unique strength lies in crafting strategies that ensure the precise and successful ramp-up of innovative health projects. Our extensive track record includes managing projects for organizations venturing into collaborations with federal agencies such as NIH, CDC, WRAIR, and the predecessor to BARDA. Our leadership team, boasting hands-on experience, intimately understands the challenges faced by startups navigating their initial biomedical grant opportunities. Our expertise is not only in project management but also in supporting the founding and leadership teams of organizations engaged in building innovative technical solutions, requiring multifaceted stakeholder involvement, leveraging non-dilutive funding opportunities and navigation of Agency-specific requirements. We specialize in addressing the unique implementation challenges posed by such ventures, applying our lived experience from both the government project officer and implementer’s perspective. Our strengths lie in the fusion of strategic insight, deep experience in federal acquisitions, and a keen understanding of the hurdles faced by emerging organizations, positioning us as a reliable partner for those looking to navigate and succeed in federal R&D programs. | We are seeking partners who have commercialization expertise and resources that can leverage our strategic advisory, non-dilutive funding, project management and contract support services, to ensure structured oversight for the steps required to develop the products and technologies that align with BARDA’s strategic priorities. By teaming with us, accelerator network participants will ensure the provision of comprehensive wraparound services for the startups and health security innovators in BARDA’s portfolio. |
| UES, Inc. | Michael Brothers | mbrothers@ues.com | Dayton, Ohio | Diagnostics and Medical Devices | DDevelopment, Evaluation, and Validation Services | UES is an advanced R&D company that has developed and commercialized innovative products and services for over 50 years. Our areas of focus include sensors for cognitive and physiological health and performance monitoring as well as environmental exposure assessment, biotechnology, -omics and analytics. Our scientists specialize in the engineering and design of chem/biosensors and circuits alongside system prototyping, testing, and evaluation. UES has a strong R&D focus with expertise in early- to mid-stage technology development. Notably, our team’s strengths include developing novel biochemical sensors (TRL 4-5) for gas phase (i.e., breath) and liquid phase (i.e., sweat, saliva, urine, interstitial fluid) applications. UES collaborates with and manages subcontracts for many leading academics in the diagnostics field that can help bring disruptive technologies across the "valley of death" and to market. | UES will serve as a center of excellence in test and evaluation (T&E), bringing scientific expertise alongside established design, test, verification and validation methods to this effort. We have a track record of accelerating technologies, including advancing marker discovery in air and biofluids, sensor development, evaluating microbiomes for health and performance, as well as toxicology, industrial hygiene, and high throughput screening for genetic and chemical exposure. UES has experience in biosensor/diagnostics R&D with a focus on real-time diagnostics. Our team of electrochemists and bioengineers both create custom sensor solutions (TRL 4-5) and hold numerous patents and publications demonstrating our ability to create novel solutions to challenging sensor problems. The team’s strengths include the following: 1) well versed in T&E and automating T&E processes for both liquid and gas phase, 2) custom design and fabrication of diagnostic devices leveraging additive manufacturing and other emerging techniques, 3) clinical research coordinators to lead translational studies, and 4) multiple academic partners we can leverage to develop next-generation biochemical sensors and diagnostics. | We seek partners with the following experiences/expertise: 1) Transitioning medical devices and diagnostics through FDA clearance and/or emergency use authorization pathways; 2) Developing user interfaces and algorithms that can translate sensor readouts to actionable data; and 3) Partners who can take batch-level prototyping/low rate initial production efforts and scale them as needed to meet DoD and government needs. |
| United States Pharmacopeia | Gersande Chavez | GBC@usp.org | Rockville, MD | Vaccines and Therapeutics, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | United States Pharmacopeia (USP) is an independent, nonprofit organization focused on advancing science and technologies to build trust in the supply of safe, quality medicines. USP also works to strengthen the global supply chain through our Informatics, Biologics and Advanced Manufacturing programs to ensure medicines are available when needed and work as expected. USP fosters research, leveraging rigorous science to set public standards to help ensure the quality of medicines -- ultimately improving patient care and health outcomes. USP’s analytical laboratories develop process controls and release testing protocols for medical countermeasures, and leverage our expertise to progress advanced manufacturing technologies, such as continuous manufacturing (CM) and distributed manufacturing, to ensure the continued production of quality medicines utilizing new, efficient technologies. USP conducts cutting-edge research, including advanced analytical methods for characterization and testing of pharmaceuticals, excipients, foods, biologics, and dietary supplements, with extensive collaboration experience to drive research and innovation. USP’s standards and analytical capabilities support the production of therapies and vaccines, including emerging modalities such as mRNA, viral vectors, and cell and gene therapies. USP’s predictive analytics platform identifies potential risks that create vulnerabilities in the medicines supply chain, highlighting specific areas to focus mitigation efforts to strengthen resilience. | USP has more than 200 years of experience in setting standards and creating methods, procedures, and processes to help ensure the quality of medicines. With 1,100+ employees in the U.S. and around the world, USP has industry-leading insights into the pharmaceutical supply chain, along with state-of-the-art analytical research and testing laboratories to support pharmaceutical companies in their development and manufacture of drugs in a regulated setting. USP leverages its expertise and extensive capabilities to protect and promote global health. As a subcontractor to Phlow Corporation, USP’s laboratories in Richmond, VA are providing ASPR/BARDA with analytical method development and testing services to produce selected active pharmaceutical ingredients (APIs) using continuous manufacturing. Additionally, USP is leading a project to map essential APIs to their key starting materials to better understand and ensure a more resilient, reliable U.S. pharmaceutical supply chain. USP has extensive analytical capabilities for assessing critical quality attributes across a spectrum of chemical and biological therapeutics, including vaccines, protein therapeutics, cell/ gene therapies, peptides and small molecules. USP also works with stakeholders to drive adoption of new technologies, and was recently awarded a grant under the BSUFA Pilot Research Program for assessment of a Multi-Attribute Method (MAM) for therapeutic proteins. | USP is seeking partners who are developing technologies in the areas of pharmaceutical manufacturing, biomanufacturing and advanced manufacturing where there is a need for characterization, automation, process controls and the identification/assessment of critical quality attributes for regulatory compliance. Characterization includes the use of advanced algorithmic approaches to modeling of reactions or toxicity assessment. Our partners would seek USP’s experience and expertise in moving these technologies to commercial, compliant solutions. Innovations may include the use of digital technologies, automation, sensors, in-line or at-line testing, additive manufacturing, and portable, scalable manufacturing platforms, such as those used in the field or at point of care. In the area of emerging biologics, we would seek partners who can provide samples of new modalities, biotherapeutics, biosimilars and vaccines for analytical characterization development, as well as comparability studies for quality and consistency for on-demand manufacturing. As part of our digital health technology development, USP would seek partners in a clinical informatics setting to co-create structured, interoperable data models, digital integration, data integrity and the development of value sets and standardized nomenclature – all to ensure patient safety. In addition, we seek partners to assist in establishing the need and creation of quality standards in digital therapeutics. |
| University City Science Center | Katie Nash | knash@sciencecenter.org | Philadelphia, PA | Vaccines and Therapeutics, Diagnostics and Medical Devices, Digital Health Tools, Enabling Technologies, Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Servicess | The University City Science Center (UCSC) is a 60-year-old nonprofit 501(c)3 that engages with a broad network of public and private healthcare institutions in Pennsylvania, Delaware, and New Jersey including 31 of the tristate region's leading academic and research institutions. As a nonprofit, UCSC specializes in helping startups grow and convening life sciences connections to inspire action. UCSC has been recognized by The Brookings Institution as a best-in-class investor, mentor, and economic development partner for young technology companies and has supported more than 1,000 early-stage companies alongside industry partners and leading research and academic institutions across the globe. More than $800 million has been leveraged by participants in UCSC's commercialization and accelerator programs to date and more than $10 million has been invested across UCSC programs, leading to more than $94 million in follow-on funding. | UCSC brings access to its deep and broad network in the mid-Atlantic centered on the Greater Philadelphia region in DE, NJ, and PA. Given our 31 academic shareholder institutions, our previous service as a BARDA DRIVe Accelerator, a member of Life Sciences PA, the Greater Philadelphia Chamber of Commerce, SSTI, NIIMBL, UEDA, AURP, and numerous other national organizations we can plug into a rich regional and national life sciences innovation network. UCSC team members bring experience with OTAs, and UCSC programming and support strengths include the following. 1) Capital Readiness Training which equips founders with the know-how to create a capital ready due diligence deal room, helps navigate sophisticated investor and partner capital related inquiry and due diligence processes, and provides direct feedback from industry-relevant investors. 2) Proof Positive for inclusive customer discovery. 3) Venture Due Diligence Courses which better prepare NIA-funded companies to position their scientific ventures for growth through a combination of training, network cultivation, service provider engagement, and skills building over a three-day period. 4) Investor Capability Networks locally and nationally as well as through UCSC's active participation in the Angel Capital Association. | UCSC seeks teaming partners who bring complementary experiences as OTAs, in providing entrepreneurial support to diverse startups across the U.S. and internationally, and those looking to access a deep and broad network that UCSC already has access to across the nation, particularly throughout the Mid-Atlantic region. |
| University of Missouri | Sheila A. Grant | grantsa@missouri.edu | Columbia, MO | Vaccines and Therapeutics, Diagnostics and Medical Devices | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services | The University of Missouri (MU) is a public, land-grant research university and the flagship of the University of Missouri System with MU Extension offices in almost every county in Missouri. It is designated as a Carnegie Very High Research Activity doctoral university and is a member of the Association of American Universities (AAU). Our extensive core research facilities such as the Laboratory for Infectious Disease Research and Center for Influenza and Emerging Infectious Disease, are vibrant collaborative resources. MU has a foundation to support entrepreneurs and small start-up companies through our Missouri Innovation Center (MIC) and local life sciences incubator. We have the capacity and a robust infrastructure for translational research activities that center around training and proof-of-concept funding for biomedical technologies. We are the only university in the country to have received a Coulter Translational Partnership, NIH REACH, and HHS BARDA DRIVe accelerator funding. These three accelerators have allowed us to build an extensive network of innovators, strategic partners, Key Opinion Leaders (KOLs), and mentors as well as establish successful educational programs and wrap around support. We can offer an extensive network of universities and accelerators to team with BARDA to further biomedical technologies. | We have the strength and experience to run a BARDA DRIVe accelerator. Some of our strengths include: 1) A strong network of universities and accelerators. This unique infrastructure allows access to promising technologies in the Midwest, infrastructure for training, funding, and management of proof-of-concept projects, KOLs and subject matter experts, and wraparound services, 2) Educational Bootcamps for skills development and hands-on entrepreneurial experience including de-risking of key product development, 3) Experience in promoting BARDA funding opportunities, 4)Experience in supporting national competitions, e.g., the BARDA Mask Challenge, 5)Experience in soliciting projects, preparing innovators to apply for early-stage deliverable-driven product development funding, managing and working with external experts for project review/selection, managing/mentoring awarded projects including conducting update meetings with program stakeholders, and providing wrap-around support for follow-on opportunities, including funding, identifying strategic partners, CEOs, etc., 6) Experience providing technical and wraparound support and access to network of experts, 7) Experience helping inventors identify strategic partners/accelerators/executives, etc., 8) MU and our partner universities and accelerators have state-of-the-art user facilities. Our university hospitals have the capacity to support preclinical and clinical validation studies, and 9) Membership and leadership roles in PACE: Proof-of-Concept Network Action Committee on Equity, Diversity, and Inclusion, a collaboration with the NIH. | We are a public university in the Midwest and thus we have some limited capabilities. To overcome some of these limitations, our Coulter, REACH, and BARDA DRIVe accelerators established an extensive network of Midwest universities, accelerators, and industries. We are looking to expand and broaden our network and offerings for potential and established entrepreneurs. The following partner expertise would be complementary: 1) Market research expertise, 2) Investor networks -- the Midwest has limited number of investors (angel, VCs), etc. It will be imperative to build an investor network with a teaming partner, 3) Startup executives -- finding experienced company executives (like CEO, etc.) is difficult for new start-ups. We would like to build and/or team with a partner who has a more extensive network of executives on roster, etc. 4) Broadening our ability to connect product developers with a broad array of life science and medical technology experts and resources, viz., entrepreneurs, advisors, manufacturing partners, regulatory and reimbursement experts, contract research organizations, prototyping vendors, etc. |
| University of South Alabama | Jonathan O. Rayner | jrayner@southalabama.edu | Mobile, Alabama | Vaccines and Therapeutics, Enabling Technologies, Special Populations | Development, Evaluation, and Validation Services, Rapid Response Capability | The University of South Alabama includes the Frederick P. Whiddon College of Medicine (COM), the regions premiere medical school. The Department of Microbiology and Immunology is one of 5 basic science departments within the Whiddon COM whose goals include conducting fundamental research in microbial pathogenesis and host defense; and fostering the translation of basic research into clinical applications. In the latter case, faculty in the Microbiology and Immunology department have significant experience with developing animal models for Risk Group 2 and 3 pathogens that fulfill the "animal rule" and have used these models to support preclinical efficacy studies for next generation vaccine platforms and new therapeutic interventions. Additionally, physicians within the University of South Alabama's system of hospitals and clinics, which include underserved populations, are also experienced at conducting clinical studies for new medical interventions. Thus, the University of South Alabama's Whiddon COM has all the required knowledge, skills, and abilities to support BARDA's mission to rapidly develop and test new medical interventions targeting a myriad of infectious diseases of significant consequence to human health. | The Whiddon COM at the University of South Alabama includes faculty, staff and physicians that are experienced with advancing medical interventions for infectious diseases from bench to bedside. For example, Dr. Jonathan Rayner, Associate Professor and Director of the Laboratory of infectious diseases spent 18 years in private industry developing vaccines and therapeutics in collaboration with government, industry, and academic partners. Immediately prior to joining the University, Dr. Rayner was Director of Infectious Disease Research at Southern Research where he served as Principal Investigator for multiple contracts with BARDA and NIAID. Dr. Rayner continues to support drug discovery and development efforts for colleagues at the University as well as for government and industry collaborators. During the COVID-19 pandemic, the University received multiple requests for SARS-CoV-2 virus testing from researchers who were turned away by overwhelmed contract research organizations. In response, Dr. Rayner and his colleagues independently isolated SARS-CoV-2 virus and used these stocks to screen candidate antivirals. The team also established animal models to evaluate several candidate vaccines and therapeutics. These activities demonstrate the ability of university and hospital personnel to respond to emerging infectious diseases threats and highlight the value to any team pursuing the BARDA Accelerator Network. | The University of South Alabama is open to partnering with teams that could benefit from the knowledge, experience, and capabilities of our faculty, staff, and physicians. More specifically, our faculty and physicians could serve as consultants to evaluate the utility of proposed technologies and advise on protocols to advance promising candidates through preclinical studies into clinical trials. Our research faculty would be available to develop and utilize appropriate models for initial proof-of-concept in preclinical efficacy studies. Model development would culminate in a technology transfer package for advanced testing and evaluation under GLP regulations as may be required. On the clinical side, our hospitals and clinics could serve as testing sites for the most promising candidates. These hospitals and clinics currently serve traditionally underrepresented communities, and our physicians are already engaged and experienced with addressing health care disparities in these communities. |
| XLerateHealth | Jacqueline M. Willmot | jackie@xleratehealth.com | Louisville, Kentucky | Special Populations | Wraparound Accelerator Support Services, Development, Evaluation, and Validation Services, Rapid Response Capability | XLerateHealth (XLH) is a nationally recognized accelerator headquartered in Louisville KY. As the recipient of 2 NIH Fast-Track STTR awards, 2 NIH supplements, 6 SBA growth accelerator awards, and a "spoke" on the SBA-funded Community Navigator program we have provided wrap around accelerator services with a track record of building strong partnerships, startup accelerator programs, and resources to benefit innovators/entrepreneur. Our network of over 700 executives, subject matter experts and mentors have provided product development capabilities to source, review, fund, and accelerate innovations to over 1,000+ companies. XLH has the experience and capability to provide rapid emergency response mechanisms to quickly identify and deploy innovative product development initiatives in the event of public health emergencies. XLH's mission is to "cultivate and grow impactful healthcare innovation in areas of the country where great innovation often goes unrecognized and underfunded". Since our inception, XLH has focused on underserved populations and geographies-- both in the entrepreneurs we work with as well as supporting innovators who are solving real world healthcare problems for underserved and vulnerable/special populations (e.g., Medicaid, minority, rural, elderly, neonatal and pediatric). XLH would be an excellent addition to the BARDA Accelerator Network Special Population Technology Area. | The XLH team has an established network of 784 executives, subject matter experts and mentors who work with our companies. Our core team includes entrepreneurs, investors, clinicals and PHDs who have decades of experience working with healthcare/biomedical entrepreneurs and have collectively helped young companies raise over $2 Billion. We operate 3 accelerator programs and 3 DE&I focused startup programs. Our 135+ portfolio companies cover medical devices, diagnostics, therapeutics, digital health, and tech enabled services. Over 52% of the startups we work with are STEM/life science companies and 48% are digital health. XLerateHealth was funded by the National Institutes of Health's (NIH) to create and lead the "XLerator Network" an accelerator hub (2018 -- 2025) covering the NIH Southeast "IDeA States region" (which is designated as a historically underserved region in the United States by both the NIH and NSF). We have a broad and deep network that includes academic institutions, entrepreneurial service providers (ESOs), investors, health systems, payers, pharma, retail, manufacturing, logistics, etc. to support our work; and a pipeline of early stage, commercial ready, and mature startups to draw from. We also operate an "Executives-on-Roster�" program that provides matching talent service to innovators who need to build out their team. | While we have a strong existing network of partners including 25+ academic institutions , research organizations, health systems, payer organizations, etc. we would be interested in teaming with partners who can add to our network: additional (1) Historically Black Universities and Colleges (HBCUs), (2) Hispanic Serving Institutions (HSIs) (3) foundation and professional organizations working with vulnerable/special populations, (4) federal agencies whose mission includes initiatives targeted towards special populations, (5) venture investors, (6) other healthcare focused accelerators, (7) healthcare focused incubators and Venture Labs, and (8) entities that can support XLerateHealth's market research, evaluation, and validation efforts. |
BARDA ACCELERATOR NETWORK 2.0