Webinar

From Ethics to Evidence: Applying Real-World Data in Oncology Trials

Available on-demand

60 Minutes

Real-world data (RWD) is a powerful asset for pharmaceutical sponsors looking to enhance oncology trial design, support regulatory submissions, and demonstrate real-world value. From generating external control arms to identifying patient cohorts and uncovering long-term safety signals, RWD offers strategic advantages across the development lifecycle. But as the stakes grow, so does the ethical responsibility to use RWD with transparency, fairness, and patient-centered rigor.

This webinar will explore how to ethically and effectively incorporate RWD into oncology clinical research. Industry leaders and experts will share insights on navigating consent, bias, and data provenance—while aligning with regulatory expectations and building confidence in research practices.

Key Takeaways:

How RWD can be used to improve oncology clinical trial design and operations
Ethical considerations around patient privacy, informed consent, and data provenance—and strategies to align scientific, ethical, and reputational goals in trial design
FDA, EMA, and global guidance on the responsible use of RWD

Designed for R&D, clinical strategy, and regulatory leaders, this session offers a practical framework for building responsible, high-impact RWD programs in oncology research.

Speakers

Ashita Batavia, MD, MS

Head of Hematology & Oncology Data Sciences, R&D

Johnson & Johnson

Ashita S. Batavia, MD, MS is Head of Hematology & Oncology Data Sciences for Johnson & Johnson Innovative Medicine. She is an industry leader in using Data Sciences to accelerate drug development. She was previously at McKinsey & Co. where she counseled Fortune 50 executives on precision medicine and using advanced analytics to drive impact. Dr. Batavia is an Assistant Professor at Weill Cornell Medicine and has been a practicing physician for over 15 years. She has received numerous research awards and has multiple peer-reviewed publications. Dr. Batavia is passionate about using data and technology to improve the health of patients.

Amit Raval, PhD

Global Director- Real-World Evidence Oncology

Bayer

Dr. Amit Raval is a strategic leader with over 15 years of experience in the field of real-world evidence and health outcomes research. As the Global Director- Real-World Evidence Oncology, he leads the design and implementation of evidence-generation strategies to support regulatory and reimbursement approvals of in-line and marketed oncology products across the life cycle at Bayer. Before Bayer, he held positions at Merck and HealthCore (now Carelon) to research scientists to generate timely and meaningful research to support regulatory commitments and payor engagement. Dr. Raval holds a Ph.D. in Health Outcomes Research from West Virginia University and an MPharm in Pharmacy Practice from the National Institute of Pharmaceutical Education and Research, SAS Nagar. He enjoys knowledge dissemination to future leaders and currently also holds an adjunct faculty position at the University of North Texas College of Pharmacy. He has co-authored over 58 peer-reviewed publications and over 90 scientific presentations at congresses.

André Mansinho, MD

Director, Clinical Research

The START Center for Cancer Care

Dr. André Mansinho has a diverse range of work experience in the medical field. André started his career as a General Resident at Centro Hospitalar Lisboa Ocidental in 2012. André then went on to complete an Oncology Residency at Centro Hospitalar Lisboa Norte, EPE from 2013 to 2017. During this time, he also served as a Clinical Trials Unit Coordinator in Oncology and later became a Medical Oncologist. In 2017, he completed a Fellowship at The START Center for Cancer Care. In 2019, he became an Assistant Professor at Faculdade de Medicina da Universidade de Lisboa. In 2020, he worked as a Research Consultant at the Institute for Evidence-Based Health (ISBE). Currently, Dr. Mansinho holds the position of Director – Clinical Research at The START Center for Cancer Care since 2023.

Dr. Mansinho completed his education from 2005 to 2011 at NOVA Medical School – Faculdade de Ciências Médicas. He pursued a Mestrado Integrado em Medicina (Integrated Master’s in Medicine) and focused on the field of study in Medicine.

James Riddle, MCSE, CIP, CPIA, CRQM

Senior Vice President, Global Review Operations

Advarra

James Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational responsibility for Advarra’s global review services including IRB, IBC, DMC, EAC. In this role, he helps sponsors, CROs, and research sites advance clinical research with a mission to improve human health. Prior to Advarra, Riddle served as a senior leader within the research oversight and compliance office at the world-leading Fred Hutch / University of Washington Cancer Research Center. He also launched and led the consulting division of a major central IRB that became part of Advarra. He also served as Vice President of Operations and Director of Technology at another large central IRB organization. His expertise includes developing and operationalizing processes for maximum efficiency, client satisfaction, and participant protection; development and implementation of technology solutions; and efficient, compliant operation of large clinical research review programs. He has also supported leading pharma companies in building clinical trial processes in the most efficient, effective, and regulatorily compliant ways possible. Riddle is a regular speaker at industry events and has written abundantly on research compliance and efficiency topics. He is also a member of CTTI, NWABR, SASI, and PRIM&R.

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