Dr. Sandeep Patel, former Director of BARDA's DRIVe, shares insights from his leadership role during the COVID-19 response. He discusses how BARDA functions like a biotech venture capital firm, bridging the funding gap for crucial biomedical innovations. The conversation dives into the challenges of federal hiring, the importance of attracting top talent, and the innovative funding models developed for health security. Patel also highlights the need for collaboration between public and private sectors to create sustainable solutions for future pandemics.
BARDA effectively bridges the 'valley of death' in biomedical development by funding promising projects that lack commercial viability.
The DRIVE initiative exemplifies BARDA's proactive strategy in advancing technology for preparedness against emerging and unknown biothreats.
By utilizing milestone-based contracts, BARDA fosters innovation and risk-sharing, encouraging industry participation in complex biomedical projects.
Deep dives
Understanding BARDA's Mission and Effectiveness
BARDA, or the Biomedical Advanced Research and Development Authority, has a specific mission focused on developing medical countermeasures for public health emergencies through public-private partnerships. This targeted approach allows BARDA to excel in product development and project execution, making it a vital player in emergency preparedness. The agency operates under the U.S. Department of Health and Human Services and is distinct in its focus, as no other government entity is so narrowly dedicated to this goal. Its effectiveness is attributed to its unwavering commitment to its mission, which has proven successful over its almost two-decade existence.
Navigating the Biomedical Funding Landscape
BARDA operates within a complex federal biomedical funding ecosystem alongside various organizations such as DARPA and NIA, which provide initial research funding and critical data. While these organizations contribute to early-stage research, BARDA’s role is to advance promising products through the development process, particularly for technologies that lack commercial viability. This includes a focus on medical countermeasures for threats such as emerging infectious diseases and other crises that require specialized approaches. The partnership with other entities enables BARDA to strategize effectively while ensuring its products are aimed at the broader U.S. population's health.
The Critical 'Valley of Death' in Drug Development
The term 'valley of death' refers to the crucial stage in drug, vaccine, and medical device development where promising projects often fail due to lack of funding, particularly during the capital-intensive clinical trial phase. BARDA plays a critical role here by providing the necessary funding for these stages, which are often unattractive to private investors since there is no guaranteed profitable market. This support permits BARDA to leverage industry expertise while mitigating financial risks, allowing critical medical solutions to advance that may otherwise languish in development. Additionally, BARDA assists in pivoting existing products for new uses during emergencies, addressing another aspect of this developmental gap.
Innovation through Milestone-Based Contracts
BARDA utilizes milestone-based contracts to incentivize and structure its collaborations with industry partners effectively. These contracts facilitate risk-sharing, enabling strategic decisions at various project stages without committing extensive resources upfront. This approach not only encourages industry participation but also fosters innovation by allowing for adjustments as projects evolve, addressing uncertainties that can deter private investment. By clearly defining deliverables and financial triggers, BARDA successfully navigates the complex landscape of biomedical development while aligning stakeholder goals.
DRIVE's Role in Future Pandemic Preparedness
The DRIVE initiative within BARDA aims to prepare for future biothreats by fostering advancements that are not solely threat-specific but also proactive in anticipating unknown crises. Through its investments in technologies that address common medical challenges, like sepsis, DRIVE seeks to generate diagnostic solutions that can be utilized across various pathogens. Furthermore, it aims to develop agnostic testing methodologies, allowing for quicker responses when new pathogens emerge. This systematic approach to innovation and preparedness underscores the importance of evolving strategies in public health infrastructure to mitigate future pandemic risks.
The Biomedical Advanced Research and Development Authority (BARDA) helped bring Moderna’s mRNA vaccine through clinical trials to market. BARDA’s Division of Research, Innovation, and Ventures (DRIVe) is its in-house biotech venture capital firm, charged with identifying and incubating technologies for U.S. biodefense and preparedness.
Today's interviewee is Dr. Sandeep Patel, the Director of DRIVe from March 2020 to March 2024. Patel helped architect the program’s VC-inspired model and led the organization through its COVID response.
We covered:
(00:00) Introduction
(00:20) How cost-effective is BARDA?
(09:38) Venture-capitalism in government
(26:14) Hiring talent
(34:35) Question grab-bag
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