There is a growing interest in pre-approval collection of real-world data (RWD) in early access programs, which manufacturers often set up for the provision of an investigational medicinal product to patients who are ineligible or otherwise cannot participate in the drug’s clinical trials.
Early access programs are not research studies in the conventional sense, but regulatory bodies require adverse event reporting from these programs, and it is permissible to collect treatment outcomes, patient experience data and other real-world measures.
This webinar will provide an overview of early access programs including regulatory context, types of real-world measures of interest and lessons learned from a recent case study.
Speakers
David Thompson, Senior Vice President Real World and Late Phase, Syneos Health
David Thompson, PhD is Senior Vice President, Real World Research for Syneos Health.
Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector.
Dave is Editor-in-Chief of ISPOR’s publication, Value & Outcomes Spotlight, a position he has held since 2008, and serves on the advisory board of the Duke-Margolis Real-World Evidence Consortium.
Message Presenter
Maryna Kolochavina, PharmD, PMP, Executive Director, Syneos One
Maryna Kolochavina has 14+ years of experience in post-marketing research, asset management, early access and market launch across multiple rare and orphan indications. Maryna is an author of the Syneos Health EAP policy and is also a member of the Syneos Health Rare Disease Consortium, Pediatric Consortium and European Forum for GCP, ACRP, BARQA, ASQ, PMI.
Message Presenter
Noolie Gregory, Executive Director, Client Engagement Real World Evidence, Syneos Health
Noolie has over 14 years of experience working in large pharmaceutical companies with expertise in real world and late phase projects, working closely with medical affairs teams to identify and build solutions to fulfill medical evidence gaps to ensure successful product launch. She has written and operationalized several EAP policies and SOPs with a strong focus in Oncology. Noolie has also supported development of several major medicines across therapy areas from Phase I-launch.
Message PresenterWho Should Attend?
This webinar will appeal to senior professionals with an interest in Market Access and Real World Evidence:
- Market Access
- Medical Affairs
- Payer Strategy
- Real World Evidence
- HEOR
What You Will Learn
- Overview of early access programs
- Benefits and challenges of collecting real-world data and other real-world measures
- Regulatory requirements of early access programs
- Lessons learned from a case study
Xtalks Partner
Syneos Health
Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com.
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