Risk Assessment: Traditional and Novel Approaches to Assess and Manage Risks

Risk assessment is a complex process intended to protect human health by identifying drug-related hazards, determining dose-response relations for a product within relevant biological systems, and assessing exposure levels to characterize potential risks. These assessments may be conducted via traditional frameworks using data from in vitro and in vivo studies, as well as novel frameworks using pharmacokinetic and pharmacodynamic model-based prediction. Data used to assess risks are typically collected under conditions that mimic, as closely as possible, the clinical context in which a given product is intended for use. Across the mentioned frameworks, risk assessment must be based on clinically relevant information and include exposure data.

Risks may be characterized by evaluating the mechanism/mode of action, onset and offset, and incidence of clinically relevant hazards. Traditional frameworks put risks into perspective based on the target organs of toxicity identified and the exposure levels at which hazards occurred. The exposure levels at which hazards occurred are used to identify the most sensitive species, which is typically deemed the most relevant species unless proved otherwise.

Modeling approaches enable the extrapolation of data from preclinical species to humans using established physiological differences. These approaches also allow the prediction of hazard and exposure in scenarios not explicitly measured in preclinical studies. Modeling frameworks can be incorporated at a very early stage in the development pipeline and can also assist in determining which set of preclinical studies would be most clinically relevant.

Although these frameworks are intended for characterizing and putting potential risks into perspective, each is critical in managing potential clinical risks within relevant contexts to ensure patient safety.

Join the discussion on traditional and novel risk assessment frameworks, the advantages and disadvantages of these frameworks, and explore case studies and perspectives on current and future challenges related to them.


About the Speaker

Marcus Delatte, Ph.D.
Vice President, Regulatory Strategy and Consulting

Dr. Marcus S. Delatte, PhD, completed a fellowship at the Harvard Medical School/McLean Hospital prior to working over 11 years at the US Food and Drug Administration (FDA) as a Senior Pharmacology/Toxicology Reviewer. In that role, Marcus gained expertise in regulatory affairs, as well as risk assessment and management of small and large molecule products. His FDA experience involved managing over 264 IND and 30 NDA applications; advising sponsors on the adequacy of the design and results of pharmacology, safety pharmacology, general toxicology, genetic toxicology, reproductive and developmental and carcinogenicity studies; in addition to training and supporting regulatory staff. These experiences prepared him to transition into consulting, where he continues to serve customers across the world and to grow his expertise via engagement with client projects and thought leadership projects. As a Vice President of Regulatory Strategy, he serves in multiple roles that include project lead, nonclinical expert and regulatory strategist.

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