Solicitation Opening Soon!
Harnessing AI and real-world evidence to accelerate drug repurposing for national health security threats
PICD Program Workshop | September 2
Join fellow stakeholders for an opportunity to shape the future of the PICD Program
Drug repurposing is one of the fastest and most cost-effective pathways for developing therapeutic medical countermeasures (MCMs). Since FDA-approved drugs and therapies already in clinical development have well characterized safety and pharmacokinetic profiles as well as established manufacturing processes, they can often be advanced for new indications with reduced time, cost and risks compared to de novo drug development.
The Problem
Despite substantial advances in biomedical research, significant gaps remain in the availability of therapeutic MCMs for national health security threats. Traditional drug development is too slow, costly and risky to meet the urgent demands of national emergencies. Developing a new therapeutic can require more than a decade, cost hundreds of millions to billions of dollars and still face a likelihood of failure in clinical development.
These challenges are compounded for emerging threats where uncertain or limited commercial markets provide little financial incentive for industry investment and as a result, create a dependency on government funding and delays in drug development during critical response windows.
Our Solution
Drug repurposing offers a compelling path forward by leveraging the established safety and pharmacology of existing medicines. Combined with recent advances in artificial intelligence (AI) and the growing availability of real-world data (RWD)—including electronic health records, insurance claims, and other clinical datasets—we have an unprecedented opportunity to transform how promising drug candidates are identified and prioritized.
Integrating capabilities in AI, computational biology, disease biology, RWD, and MCM development into a systematic, scalable, AI-enabled pipeline will accelerate the identification and prioritization of safe, effective repurposed therapies for emerging health threats. This will enable the timely delivery of evidence-based MCMs and strengthen national health security.
Goal
Systematically identify, evaluate, and prioritize existing therapeutics for new indications through an AI-enabled drug repurposing pipeline.
Potential Initial Use Cases
PICD establishes a coordinated public-private effort to integrate complementary capabilities and platforms that rapidly identify and evaluate promising therapeutic repurposed or repositioned candidates for emerging national health security threats.
The program will establish a sustainable, evidence-driven drug repurposing platform capability that systematically identifies, evaluates and prioritizes existing therapeutics for new indications. Initially, this includes the generation of an evidence-based, rank-ordered list of repurposed drug candidates for up to four BARDA designated use cases, in alignment with national health security threats.
Source databases and other resources, especially those that may be relevant to BARDA use cases. This includes large, diverse real world data sets, and ideally access to real-time data.
Leverage existing AI based models or build new multi-modal models that can produce a ranked list of candidates, backed by scientific rationale.
Confirm biological plausibility of candidates. Methods may include but are not limited to: use of real world evidence; in silico mechanistic predictions (e.g., optimal dose exposure, PK, safety); in silico simulation (e.g., disease modeling, treatment response).
Determine which candidates may be best for advanced development based on feasibility (e.g. manufacturing, IP, drug sponsor, commercialization). Potential future program phases will depend on access to the candidate drug(s) and feasibility assessment.
Obtain Relevant Data
Source databases and other resources, especially those that may be relevant to BARDA use cases. This includes large, diverse real world data sets, and ideally access to real-time data.
Identify Candidates
Leverage existing AI based models or build new multi-modal models that can produce a ranked list of candidates, backed by scientific rationale.
Validate Findings
Confirm biological plausibility of candidates. Methods may include but are not limited to: use of real world evidence; in silico mechanistic predictions (e.g., optimal dose exposure, PK, safety); in silico simulation (e.g., disease modeling, treatment response).
Prioritize Final Candidates
Determine which candidates may be best for advanced development based on feasibility (e.g. manufacturing, IP, drug sponsor, commercialization). Potential future program phases will depend on access to the candidate drug(s) and feasibility assessment.
01
Viral Hemorrhagic Fever (Focus on Ebola)
02
Botulinum Toxin (Focus on Intracellular Intoxication)
03
04
The program will establish a framework for therapeutic repurposing, reducing the cost, time and risk associated with drug development. Designed for long-term impact, the platform will be adaptable, with the ability to scale with additional data inputs, enabling the ability to quickly pivot to other national health security threats.
BARDA and VITAL are hosting an in-person workshop to help shape the PICD program — or sign up to stay connected on future updates.
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