SCOPE Summit 2025, held at the Rosen Shingle Creek, is focused on collaborating to advance medical knowledge, improve patient care and develop new treatments and therapies for patients. Join TransCelerate CEO Janice Chang along with Mark McClellan from Duke Margolis for a keynote panel discussing the future of clinical research and care on the first day of the conference. TransCelerate contributors will present at many other SCOPE sessions throughout the week on topics including amplifying the patient voice, diversity in clinical research, risk-based strategies… and much more! View the full list of sessions below:
Keynote:
- Fast Forward to 2035: What Success Could Look Like in Converging Clinical Research and Care—And How to Get There
- Date and time: February 3rd at 4 pm (EST)
- Speaker: Janice Chang, CEO, TransCelerate and Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA
Sessions:
- Can You Hear Me Now? Amplifying the Patient Voice in Trial Design
- Date and time: February 4 at 11:05 AM
- Speaker: Peter Schaeffer, Digital & Process Optimization Leader, Digital Analytics & Performance, GSK
- In Pursuit of Adoption: Risk-Based Quality Management and ICH E6 R3
- Date and time: February 4 at 11:30 AM
- Speaker: Vimi A Shukkoor, Advisor, Medical Quality Systems, Eli Lilly & Co, and Nicole Stansbury, SVP, Premier Research; Co-Lead, Risk-Based Monitoring Working Group, ACRO
- Panel – Data, Data Everywhere, and Not a Byte to Use
- Date and time: February 4 at 11:50 AM
- Moderator: Robert DiCicco, Vice President, Portfolio Management, TransCelerate
- Panelists: Su Chen, MD, Clinical Science Principal, MITRE; Jesper Kjaer, Global Director, Novo Nordisk; Trevan Locke, PhD, Assistant Research Director, Duke-Margolis Institute for Health Policy; Chris Decker, President & CEO, CDISC
- Help Is Here: Interpreting the New ICH E6 R3 Data Governance Requirements
- Date and time: February 4 at 11:55 AM
- Speakers: Arlene Lee, Director, Medidata, and Tashan K. Mistree, MS, Senior Director, GSK; in partnership with TransCelerate
- It’s Been a While—10 Years of Data Sharing and Reuse: Highs, Lows, and What’s Next
- Date and time: February 4 at 3:45 PM
- Speaker: Medha Patel, Clinical Design Analytics Director, Amgen
- Going with the (Digital Data) Flow: Reduce Time & Effort on Study Start-Up
- Date and time: February 5 at 8:55 AM
- Speaker: Donald Jennings, Senior Advisor of Systems, Tech@Lilly Clinical Design and Operations, Eli Lilly & Co
- This, Not That: Data Collection, Optimized
- Date and time: February 5 at 9:15 AM
- Speaker: Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck
- Decreasing Site Burden to Adopt DCT Methods
- Date and time: February 5 at 12:20 PM
- Moderator: Jane Myles, Co-Lead, Priority Initiative 3B, DCT Playbook, Decentralized Trials & Research Alliance (DTRA)
- Panelists: Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS); Joe Dustin, Founder & Managing Partner, eClinical Consulting; Sylvie Kruyner, Director, DCT Operations, Bayer Pharmaceuticals; Caroline Redeker, Senior Vice President, Corporate Development, Advanced Clinical
- Actionable Strategies to Promote Diversity in Clinical Research Participation
- Date and time: February 6 at 8:25 AM
- Moderator: Katie Shaw, Senior Director Patient Recruitment & Enablement, Global Patient and Site Services, IQVIA
- Panelists: Brittany Gerald-Lewis, Associate Director, Clinical Trial Health Equity, Moderna, Inc.; Neha Shah Londono, Director, Global Clinical Trial Diversity, Equity, and Inclusion, Pfizer; Casey Orvin, CCO, Alcanza Clinical Research
- Transforming the Clinical Trial Protocol—Moving from a Document-Centric to a Data-Centric World
- Date and time: February 6 at 12:25 PM
- Moderator: Chris Decker, President & CEO, CDISC
- Panelists: Amy Cramer, Founder and Director, Vulcan; Data Acquisition, eSource, Johnson & Johnson Innovative Medicine; Stacy Tegan, Program Director, TransCelerate; Mary Lynn Mercado, PhD, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis Pharmaceuticals; Donald Jennings, Senior Advisor of Systems, Tech@Lilly Clinical Design and Operations, Eli Lilly and Company