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.
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.
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 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.
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.