In this episode of The Chain, Richard Bonneau, PhD, and Marcel Hop, PhD, of Genentech interview Tala Fakhouri, PhD, of the FDA on her thoughts on the discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biologic Products” and the evolving role of AI/ML to create models and inform decisions in biopharmaceutical development and regulatory submissions. Dr. Fakhouri also discusses the impact AI/ML models could have on clinical trial conduct, patient enrollment, patient selection, and data interpretation. She also talks about the next steps to get the right processes in place and why transparency is important to establish trust with patients about AI/ML tools.

GUEST BIO

Tala Fakhouri, PhD, MPH, Associate Director for Policy Analysis, CDER, Office of Medical Policy, FDA
Tala H. Fakhouri PhD MPH is the Associate Director for Policy Analysis in the Office of Medical Policy Initiatives (OMPI), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing medical policy with a focus on the use of Artificial Intelligence (AI) and Machine Learning (ML) in drug development. These efforts include overseeing an AI policy group, as well as engaging external stakeholders and advancing the development of regulatory science around the use of AI in drug development. Recently, she led the development and publication of a Discussion Paper; titled: “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products”. She also contributes to the development of medical policy related to real-world evidence (RWE) and the use of digital health technologies for medical product development. In 2023, Dr. Fakhouri was selected by the Office of Management and Budget (OMB) to serve on the Federal Committee for Statistical Methodology (FCSM) for her expertise in statistical methods.

Prior to joining FDA, Dr. Fakhouri served as a Senior Health Scientist and Chief Statistician for the CDC’s flagship population survey, the National Health and Nutrition Examination Survey (NHANES). The NHANES program, which is conducted by the CDC’s National Center for Health Statistics (NCHS), is recognized as the premier source of nationally representative data on the health of the nation. In her role at NHANES, Dr. Fakhouri advised and provided guidance on all epidemiologic, statistical, and methodological issues related to NHANES within CDC and with external stakeholders, with special emphasis on issues related to selection bias, data linkage, and data quality. She was also responsible for designing strategies to increase survey cooperation rates including changes to recruitment protocol and procedures, changes to survey sampling and design, and developing targeted outreach materials to increase survey representativeness. In addition, Dr. Fakhouri served on the NCHS Disclosure Review Board, the Cancer Moonshot Data Science Workgroup, and co-led the FCSM Nonresponse Bias Subcommittee, which was tasked with identifying gaps in issues related to survey nonresponse and selection bias, and with providing recommendations to OMB on Federal survey standards and guidelines. Prior to joining NHANES, she served as an Epidemic Intelligence Service Officer with the CDC, and deputy lead for health surveys at ICF-Macro International. Dr. Fakhouri published over 30 government reports, peer-reviewed papers, and book chapters on chronic disease epidemiology and on methodological issues related to nonresponse bias and data quality.

Dr. Fakhouri earned a Ph.D. in Oncological Sciences from The Huntsman Cancer Institute at the University of Utah, an MPH in Epidemiologic and Biostatistical Methods from the Johns Hopkins University School of Public Health, and a postdoctoral fellowship in molecular biology and genetics from Harvard University, and holds a BSc Medical Technology form the Jordan University of Science and Technology

MODERATOR BIO

Richard A. Bonneau, PhD, Vice President, Drug Discovery, Prescient Design, Genentech
Richard Bonneau is a computational biologist and data scientist who now leads Computational Drug Discovery in the Computational Sciences division at Genentech. This effort centers on pioneering new methods for combining machine learning and molecular modeling to power drug discovery. His past research spans multiple levels of biological structure and includes learning biological networks, designing protein, biomimetic chemical biology and exploring social networks.  He received his PhD at the University of Washington, Seattle, studying under Dr. David Baker, where he pioneered new methods to predict biomolecular structures. His postdoctoral training was completed at the Institute for Systems Biology, working with Leroy Hood. Dr. Bonneau has been a professor at NYU jointly appointed in the Computer Science and Biology departments.  He was a founding member or co-founder of the RosettaCommons, The Center for Data Science at NYU, the Simons Center for Data Analysis (which evolved into the Flatiron institute) and recently co-founded Prescient Design (acquired by Genentech). Dr. Bonneau is excited to be part of Genentech’s effort to revolutionize molecular design and drug discovery with computational advances.

Marcel Hop, PhD, Vice President, Drug Metabolism & Pharmacokinetics, Genentech
Dr. Cornelis “Marcel” Hop is Vice-President at Genentech and manages the Drug Metabolism and Pharmacokinetics department.  He leads a team of about 90 scientists involved in acquisition and interpretation of ADME data in support of drug discovery and development ranging from early stage research to NDA and beyond.  He is also a member of various strategic decision-making bodies at Genentech.  Before that, he was a Senior Director at Pfizer and a Senior Research Fellow at Merck.  He has extensive experience in ADME sciences with a particular focus on PK optimization, human PK and dose prediction, biotransformation, bioanalysis and the use of artificial intelligence and machine learning in drug discovery.  He has authored more than 190 publications and made more than 90 external oral presentations.  In addition, he co-authored two of the best-selling books in the ADME field: Drug Metabolism and Pharmacokinetics Quick Guide and Discovery DMPK Quick Guide.  He has served on various committees for ISSX, the IQ Consortium, academic industrial advisory boards and the Tuberculosis Drug Accelerator.