WEBINAR RECORDING AVAILABLE - WATCH ON DEMAND

Can sponsors collect data in Expanded Access (EAPs) and Named Patient Programs (NPPs)?

Expanded Access (EAPs) and Named Patient Programs (NPPs) provide sponsors with a unique opportunity to collect Real World Data that can be used to support clinical trials or provide further insight into a promising new drug.

In this webinar, WEP Clinical, a service provider in this space, will explore why, when and how to collect data that provides long-term benefits throughout a drug’s lifecycle. WEP Clinical’s VP of Business Development will be joined by both a sponsor and physician representative, to promote a cohesive and well-rounded discussion for audience members.

During this presentation we will discuss:

The difference between Expanded Access and Named Patient Programs
What is Real World Data and Evidence?
Why should sponsors collect data in EAPs or NPPs?
What kinds of data can be collected and how is it used?
How should data be collected – what are the tools used?

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Lee Sutton

VP Business Development – WEP Clinical

Lee has been in the pharmaceutical & logistics industry for over 10 years. He joined WEP Clinical in 2020, after spending 7 years with Thermo Fisher Scientific where he led global commercial operations within a supply chain business unit. In his current role, Lee is responsible for driving the strategy & growth of WEP’s Expanded Access and Named Patient Programs across the pharmaceutical industry. Lee is a highly experienced, results-oriented global business development leader who possesses strong strategic capabilities and knowledge of managing clinical and commercial supply chains. His innovative thinking and straightforward business approach drive value and exceptional service to our clients and their patients.

Raymond Mankoski, MD, PhD

Consultant – The NemetzGroup LLC

Ray is an enthusiastic and strategic medical affairs leader with a 13-year career spanning big pharma and small biotech in US- and Global-focused roles. He has led the development of strategic medical affairs plans and activities for launches of multiple therapies to treat both rare and common conditions, utilizing his therapeutic area expertise in oncology, rare disease, pediatrics, and neuropsychiatry. Most recently, as a VP of Global Medical Affairs, Ray has built two medical affairs organizations from the ground up, establishing and overseeing multiple critical functions including medical/scientific communications, key opinion leader engagement and field medical science liaisons (MSLs), health economics and outcomes research, pre-approval access programs, investigator-initiated studies, and medical information. Ray received his MD from Tufts University School of Medicine and his PhD in Genetics from the Tufts School of Graduate Biomedical Sciences.

Kevin J Weatherwax

Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan; Co-Chair, Expanded Access Oversight Committee, Michigan Medicine; Adjunct Associate Clinical Professor, College of Pharmacy

Kevin is the Managing Director of the Michigan Institute for Clinical & Health Research (MICHR) and Adjunct Associate Clinical Professor in the College of Pharmacy. He also serves as co-chair of the Michigan Medicine Expanded Access Oversight Committee to develop and enhance processes and infrastructure to support treating clinicians interested in providing access to investigational therapies/agents to patients with no alternatives. Kevin is co-principal investigator with Dr. George Mashour on a NIH U01 award promoting a national network for the FDA’s Expanded Access program.

moderator

arsalan arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.