Speaker Profile
Biography
Alexa Berk is Chief Scientific Officer for RWE at CVS Health Clinical Trial Services, where she provides scientific leadership and oversees Data Science for CVS Health CTS. Most recently, Alexa was Medical Affairs Director for Digital Health and Data at Invitae, a leading medical genetics company. Alexa has a history of over 20 years in the health research space including roles at Memorial Sloan Kettering Cancer Center, Novartis Oncology, and top consulting and startup companies focused on RWE. Alexa is a frequent speaker and published author on the topic of high quality real world data and best practices in patient centered research methods, particularly in oncology and rare disease.
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