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Keynote Speakers

Keynote 1 - Thursday, April 4, 2024

Chair: Shein-Chung Chow (Duke University) 
Vice Chair: Xiaofei Wang (Duke University)       

Opening Remarks and Welcome: Dr. David Page (Duke University)

Title: Changes in the Drug Development and Regulatory Landscape: Evolutions and Revolutions
Speaker:  
Peter Stein, M.D (FDA)
Director of CDER’s Office of New Drugs

Peter Stein, M.D.

Keynote Abstract: 

Over the past decades, there have been notable changes in the types and targets of drugs being developed, the tools available for supporting development, and in the regulatory review process and even in the statutory framework for drug regulation. Some of these changes have been incremental, others, dramatic. Some examples are the marked increase in drugs targeting rare diseases or rare subtypes of common diseases; new drug platforms such as antibody drug conjugates, siRNA and antisense oligonucleotide drugs and molecularly targeted drugs with “individualized medicine”; new development tools such as the use of real world evidence, digital health technology endpoints, decentralized trials, synthetic control groups, and platform trials; new analytic approaches such as the use of Bayesian statistics; and the introduction, increased application, and recent statutory  modifications, of accelerated approval. The talk will discuss the impact of these and other changes on drug development and drug regulation and consider the “accelerant” of the COVID pandemic.

Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. 

A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as Vice President, head of metabolism development at Janssen. He has more than 30 years of academic, clinical, and industry experience. 

Dr. Stein holds a bachelor’s degree in history from the University of Rochester in New York and a medical degree from University of Pennsylvania. He trained at Yale University and Yale-New Haven Hospital in internal medicine and in endocrinology and metabolism. 

Keynote 2 - Friday, April 5, 2024

Chair: Xiaofei Wang (Duke
Vice Chair: Shein-Chung Chow (Duke)

Title:  The Power of AI, Data Sciences, and Technology in Drug Development 
Speaker:  
Venkat Sethuraman, PhD, MBA (Bristol Myers Squibb)
Sr Vice President
Global Biometrics and Data Sciences

Venkat Sethuraman, PhD MBA

Keynote Abstract: 
Pharmaceutical drug development is a complex and costly process that involves extensive research and development, clinical trials, and regulatory approval. In recent years, the power of AI, data sciences, and cutting-edge technology has revolutionized this process and opened up new possibilities for the pharmaceutical industry. 

AI algorithms and machine learning have enabled researchers to analyze vast amounts of data and identify new drug targets and biomarkers. By using machine learning to analyze data from clinical trials, researchers can identify patient subgroups that are more likely to respond positively to a particular drug. This can help optimize clinical trial design, leading to faster and more efficient drug development. In addition to machine learning, natural language processing (NLP) has also been used in drug development. NLP algorithms can extract valuable insights from scientific literature and clinical trial data, helping researchers to accelerate clinical development process. 

Radiomics imaging is a field of medical imaging that uses advanced algorithms to analyze images and extract quantitative features. These features can provide valuable insights into the underlying biology of diseases and help drug developers identify disease progression. By analyzing radiomics data from clinical trials, researchers can identify patient subgroups that are more likely to respond positively to a particular drug, allowing for faster and more efficient drug development.  

The power of AI and other cutting-edge technologies in drug development is not limited to the laboratory. Digital health technologies are also being used to monitor patients in real-time and collect valuable data on drug efficacy and safety. This data can be used to optimize drug dosages and improve patient outcomes. Overall, the power of AI, data sciences, and cutting-edge technology is transforming the pharmaceutical industry and accelerating the pace of drug development. As these technologies continue to evolve and become more sophisticated, we can expect to see even more groundbreaking discoveries in the years ahead. 

Venkat Sethuraman is currently the Global Head of Biometrics and Data Sciences at Bristol Myers Squibb, where he is accountable for the biostatistics/quantitative support to R&D Global Development and Medical organization. In addition, Venkat leads the Innovation Pillar for the Global Drug Development. 

Prior to BMS, Venkat was a partner at a management consulting firm, where he led the R&D clinical development and operations. While there, he worked closely with R&D leaders of top 10 pharma companies in driving data-driven clinical decision-making, leveraging advanced analytics and data science. Venkat has held various leadership roles at BMS, Novartis Oncology and GSK leading quantitative and biometrics organization. Venkat has diverse research interests and consulting experience in industry that includes clinical trials design, innovative trial models, data science, and most recently, digital efforts in clinical research. 

Venkat received a PhD in statistics from Temple University and an MBA from the Wharton School of the University of Pennsylvania. He currently serves on the Board of Association for Women in Science (AWIS) and has served on the board of the Biopharmaceutical Section of the American Statistical Association.