WEDNESDAY, OCTOBER 28
10:30 am - 11:00 am
Opportunities & Challenges for Using Real-World Data in Oncology Trials
Ann Collins -
Vice President, Clinical Development,
Syneos Health
David Thompson - Senior Vice President, Real World Research, Syneos Health
Real-world data (RWD) is increasingly being used to facilitate and enhance clinical research in oncology. Opportunities for using RWD in oncology trials include assessing protocol feasibility by overlaying trial eligibility criteria onto a RWD source, identifying patients from RWD sources for inclusion in external control arms, and using RWD to augment data collection in long-term follow-up studies following gene therapy trials. However, it is easy to underestimate the challenges that arise in implementation.
This session will discuss the opportunities and challenges for RWD in oncology trials. Attendees will:
- Hear an overview of use of RWD sources in oncology trials
- What are the challenges related to use of RWD in any given trial
- Gain insight into opportunities to expand use of this approach with FDA, EMA and regulatory bodies around the world
The session will end with a live open question and answer discussion.
11:15 am - 11:45 am
Early Development & Regulatory Strategy in Oncology :What’s Important to Get New Products Approved?
Gracie Lieberman -
Senior Director Regulatory Policy,
Genentech
Marcel Rozencweig - CMO, NeoTX Therapeutics
Laurie Smaldone MD - CMO/CSO, NDA Group
What do you need to think about early in development to get new products approve? In a very condensed time frame for oncology products, understand why you need think “end game” early on.
12:00 pm - 12:30 pm
Post-trial Access to Treatment: The Opportunity Presented By Managed Access Programs
Kieron Lewis -
Business Development Director,
Clinigen
Sandra Vingerhoedt - Clinical Project Manager, Bayer AG, Belgium
The rising cost of clinical development, coupled with the ethical obligation to ensure that patients exiting a clinical trial are able to remain on active treatment if necessary, has led some pharmaceutical and bio-pharmaceutical companies to review their trial protocols and consider alternative options. This session looks at some of the key considerations and how many companies are adopting different supply models.
12:30 pm - 1:00 pm
Improving Diversity, Inclusion & Health Equity in Cancer Clinical Trials
Lola Fashoyin-Aje -
Deputy Division Director (acting) & Assoc. Dir, Science & Policy to Address Disp,
Food and Drug Administration
Marvella E. Ford, PhD - Associate Director, Population Sciences and Cancer Disparities; SmartState Endow, Hollings Cancer Center; University of South Carolina and South Carolina State University
Melissa Gonzales - Inclusion Principal, External Partnering, Genentech
Dr. Kevin Knopf MD - Division Chief Hematology/Oncology, Highland Hospital/ Alameda Health System
Disparate rates of enrollment of racial and ethnic minorities and medically underserved populations in cancer clinical trials is well documented. Understand how this factor not only impacts the validity of trial results and increases health disparities for under-served communities and patients. Explore how trials might engage novel strategies to diversify their studies and also the wider social and economic factors affecting health equity that need to be addressed to truly overcome barriers for cancer patients from underrepresented populations.
Lola Fashoyin-Aje
Deputy Division Director (acting) & Assoc. Dir, Science & Policy to Address DispFood and Drug Administration
Marvella E. Ford, PhD
Associate Director, Population Sciences and Cancer Disparities; SmartState EndowHollings Cancer Center; University of South Carolina and South Carolina State University
Dr. Kevin Knopf MD
Division Chief Hematology/OncologyHighland Hospital/ Alameda Health System
1:15 pm - 1:45 pm
Designing Trials in the Age of Rapidly Developing Innovation
Michel Azoulay MD -
Senior Medical Director Oncology,
Kyowa Kirin
Caroline Germa - Vice President, Head Clinical Development, Early Portfolio, Oncology R&D, AstraZeneca
David S. Hong MD - Associate Vice President of Clinical Research, M.D. Anderson Cancer Center
Kenneth G. Faulkner PhD - Vice President of eCOA Scientific Services, ERT
We have adaptive design, but what else can be considered in diverse approaches to treat cancer? What have we learned about what else might be considered to augment with real world evidence and other data sets that could be valuable to understand the safety and effectiveness of a new molecule? How can industry be “better” at designing trials to utilize resources in the best way possible?
Caroline Germa
Vice President, Head Clinical Development, Early Portfolio, Oncology R&DAstraZeneca
2:00 pm - 2:30 pm
Keynote Fireside Chat: The Impact of “Big Data” and Data Analytics on Trial Design and Execution
Amy Abernethy MD, PhD -
Principal Deputy Commissioner, Acting CIO,
US Food & Drug Administration (FDA)
Craig Lipset - Assistant Professor of Health Informatics, Rutgers University
Discuss the importance of developing more efficient ways to collect and utilize data to enhance the development of new treatments and cures. Hear an agency perspective on efforts to not only modernize its technological infrastructure but also invest in expertise and build initiatives that support and evaluate the work being done on the forefront of science and technology to improve clinical outcomes for cancer patients.
Amy Abernethy MD, PhD
Principal Deputy Commissioner, Acting CIOUS Food & Drug Administration (FDA)
