How Pharma Is Adopting Generative AI Across Clinical Development

David Apfel is the Head of External Innovation, Janssen R&D Data Science. In this role, Mr Apfel and his team focus on identifying and building Data Science partnerships across Discovery & Development and all of Janssen’s therapeutic areas, enabling the application of the world’s best innovation, data, and technology to Janssen R&D’s mission of developing innovative medicines. These partnerships deploy AI/ML, Digital Health, and regulatory-grade RWE to high-impact areas across the Janssen pipeline with applications ranging from discovering new targets, accelerating the development of new molecules, enhanced clinical trial design, patient stratification, external control arms, and clinical operations. Prior to his current role, Mr Apfel built and led the Janssen R&D Data Science Immunology Portfolio Management team, working to identify and deliver high impact use-cases to advance Janssen’s Immunology portfolio. Under his leadership, the team developed regulatory-grade real-world evidence, accelerated trials utilizing novel datasets and AI/ML patient finding approaches, and developed algorithms based on real-world data and medical image data. Mr Apfel joined Janssen in February 2019 as a member of the Janssen R&D Strategy and Operations team. Prior to joining Janssen, Mr Apfel worked at The Boston Consulting Group, a management consulting firm, in the healthcare practice as well as the Clinton Health Access Initiative, partnering with the Eswatini Ministry of Health to improve their public health laboratory infrastructure and strengthen access to life-saving diagnostics. Mr Apfel received his BA in mathematical-economics from Pomona College and an MBA from NYU Stern.

Dr Shameer Khader is an Executive Director of Precision Medicine and Computational Biology at Sanofi. He leads a global team dedicated to utilizing trans-disciplinary big data and machine intelligence in drug target discovery, clinical development, and indication positioning. Before joining Sanofi, Dr Khader played a vital role in establishing the Data Science and Artificial Intelligence function at AstraZeneca. He has extensive experience working with leading organizations like Mayo Clinic, Philips Healthcare, Northwell Health, and Mount Sinai Health System, focusing on precision medicine projects.Dr Khader holds a PhD in computational biology from the National Center for Biological Sciences in India and completed his post-doctoral training in computational genomics and precision medicine at the Mayo Clinic in Rochester, MN. With over 125 peer-reviewed research papers, patents, and conference proceedings, his scholarly contributions have made a significant impact in domains like healthcare data science, bioinformatics, drug discovery, and precision medicine. His groundbreaking work has gained widespread recognition, receiving attention from reputable media outlets such as Forbes, Fast Company and Bloomberg News.Acknowledged for his exceptional achievements, Dr Khader has received multiple awards and has been recognized as one of the 100 Artificial Intelligence Leaders in Drug Discovery & Healthcare by DKI Global in 2019. Recently, he was honored as one of the Most Influential AI & Analytics Leaders in the United States by AIM in 2023. Dr Khader’s dedication to advancing precision medicine and artificial intelligence has solidified his position as a prominent figure in the precision medicine and drug development communities.

Sujata Shah, a seasoned professional with over 30 years of experience in medical writing and clinical operations is known for her innovative approach and expertise in leveraging cutting-edge technologies. As a Senior Director at Moderna, she has been instrumental in envisioning and building the infrastructure for the Medical Writing Delivery and Excellence division. Her leadership has driven the adoption of generative AI and other emerging technologies to enhance performance, streamline processes, and boost productivity within her teams. Sujata's career is marked by a strong commitment to innovation and excellence. She has consistently championed the use of technology to transform traditional practices, ensuring that her teams stay ahead in a rapidly evolving industry. Her role at Moderna includes overseeing centralized systems for resource management, vendor oversight, and the integration of new technologies, which has significantly improved the efficiency and quality of medical writing services. With a background that spans leadership roles at Synchrogenix (Certara), Worldwide Clinical Trials, and UCB Pharma, Sujata has a proven track record of building and optimizing organizational processes. Her ability to inspire and retain high-performing teams, combined with her deep understanding of the clinical and regulatory landscape, has made her a key player in the industry. Sujata holds an MBA in Healthcare Management and a BS in Biology, further solidifying her foundation in both the technical and managerial aspects of her field. Her passion for innovation and her expertise in generative AI continue to drive her success in shaping the future of medical writing.

Henry Wei, MD, is Executive Director, Development Innovation at Regeneron, aimed at accelerating clinical research. Dr Wei previously worked at Google, the White House, Aetna, and McKinsey. Dr Wei has co-authored several patents on applied artificial intelligence in healthcare and on real-world data, outcomes and drug safety. He earned his MD at Cornell, his graduate and undergraduate degrees at Harvard University, and did additional informatics training at Stanford and Harvard.Dr Wei is an adjunct faculty member at Weill-Cornell Medicine in Health Policy and Research. He currently leads TransCelerate’s pragmatic trials workstream within the Real-World Data initiative.

Syed Waseem Haider has over 17 years of experience in AI healthcare and commercial innovation with a track record of leading AI strategy and delivering enterprise AI solutions. Dr Haider currently leads AI and Life Data Sciences at Merck. A believer in promoting AI and Data Science education and literacy, he is an Adjunct Associate Professor at Columbia University’s Data Science Institute. Dr Haider has authored in leading business publications, co-authored articles for international peer-reviewed journals and conferences and has filed patents and inventions. He holds a PhD from the University of Texas at Dallas.