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.
David Thompson, Senior Vice President Real World and Late Phase, Syneos Health
David is a health economist with 30+ years of experience in the health economics arena. Prior to joining Syneos Health, he held leadership positions at Quintiles (2012-2016), i3 Innovus/OptumInsight (2000-2012) and PAI (1988-2000). He is also a current committee member of the Clinical Trials Transformation Initiative (CTTI) in real-world evidence (RWE). His areas of expertise include work in economic modeling, retrospective database analysis, trial-based economic evaluations and patient-reported outcomes.Message Presenter
Maryna Kolochavina, PharmD, PMP, Executive Director, Syneos One
Maryna Kolochavina has 14+ years of experience in post-marketing research, asset management and remediation, early access and market launch, quality assurance, accelerated pathways and expedited approvals, line extensions in multiple rare and orphan indications. Her most recent experience was to oversee lifecycle of rare and orphan assets varying in study/project phases (I, IIA/IIB, IIIA/IIIB, IV) and designs (such as disease and product observational registries with prospective and retrospective data collection, pregnancy registries, observational FUP, retro chart review studies; compassionate use programs (including Named Patient Program, Expanded Access Programs, ATU, Special Access, IND); safety surveillance studies (including active and passive surveillance studies, descriptive drug utilization studies, PASS, PAES); non-interventional studies (NIS)) with ePRO, GHEOR and EPI modules. Maryna is the author of the Syneos Health EAP SOP and policy. She 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 Presenter
Who 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
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
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.