Speaker Profile
MD, PhD, Senior Vice President, Immunology, Eli Lilly
Biography
Ajay Nirula is Sr. Vice President, Immunology for Lilly Research Laboratories based at the Lilly Biotechnology Center in San Diego. Ajay joined Lilly in 2015 and is responsible for discovery research and early phase clinical development in immunology for the company. He also served as the medical leader for Lilly’s work during the COVID pandemic that led to emergency authorization for multiple therapeutic neutralizing antibodies. Prior to joining Lilly, Ajay held leadership positions at Amgen and Biogen Idec and was involved in several research programs and regulatory filings spanning diseases such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, psoriasis, and vasculitis. Ajay earned his undergraduate degree in molecular biology from UC Berkeley, his MD from UCLA School of Medicine, and his PhD from the University of Texas Southwestern Medical School. He subsequently joined the faculty in the Division of Rheumatology at UCSF Medical Center. He has published extensively in the scientific literature in journals such as New England Journal of Medicine, JAMA, and Nature Immunology.
Session Abstract – PMWC 2024 Silicon Valley
Track Chair:
- William Oh, Mount Sinai
Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support.
Sessions:
- PMWC 2024 Award Ceremony
Pioneer Honoree: Atul Butte, UCSF
- Opening Talk: Pioneering the Next Decade: The Transformative Potential of Real-World Evidence/Data
- William Oh, Mount Sinai
- Strategies to Enhance Data Sharing in Medical Research (PANEL)
Chair: Amar Das, Guardant Health
- Paul Boutros, UCLA
- Ziad Obermeyer, UC Berkeley
- George Sledge, Caris Life Sciences
- Erica Galvez, Manifest MedEx - Data Privacy and Security in RWE/D (PANEL)
Chair: Deven McGraw, Invitae
- Christopher Boone, Oracle
- John Kalafut, Asher Orion Group
- Susan Stayn, Stanford
- Jessica Santos, Oracle - Using RWD to Accelerate Precision Medicine Product Development
- Mark Watson, Guardian Research Network
- Multi-Modal Datasets & RWE/D: Pioneering Tools for Accelerated Biomedical Research (PANEL)
Chair: Ilyana Rosenberg, Microsoft
- Charlene Son Rigby, STXBP1 Foundation
- John Wilbanks, Broad Institute
- Tristan Naumann, Microsoft - Leveraging RWE/D in Lupus: Using RNA Data and Predictive AI to Enhance Patient Care Decisions (PANEL)
Chair: Amrie Grammer, Ampel Biosolutions
- Ajay Nirula, Eli Lilly
- Pete Schafer, Bristol Myers Squibb - Accelerating Drug Development Approvals Using RWE/D (PANEL)
Chair: Mika Newton, xCures
- Leo Russo, Pfizer
- Eric Schadt, Pathos AI
- Ashley Brenton, Optum
- Nasha Fitter, Invitae - CVS Health Real World Evidence – Updates and New Directions in RWE
Chair: Alexandra Berk, CVS Health
- Kate Rosenbluth, Cala Health - Regulatory Challenges in RWE (PANEL)
Chair: Susan Winkler, Reagan-Udall Center
- Mei Sheng Duh, Analysis Group
- Rachael Fones, IQVIA
