Expanding Patient Pools while Navigating Regulatory Landscapes in the European Market
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Head of the Bio Deutschland Regulatory Working Group
The European clinical research landscape is quickly transforming. New regulatory initiatives, new technology, and new approaches to conducting research are all paving the way for a new era of clinical trials.
Yet one thing hasn't changed: the integrity of studies relies on the capacity to identify and enroll patients with a specific profile at dedicated clinical trial sites. As a sponsor, how do you adapt while ensuring you meet your bottom line?
Join Morgan Sellars and Steve Novak who will take a closer look at delivering impactful patient recruitment strategies.
Their discussion will highlight a study struggling to recruit rare disease patients in Germany during the height of the COVID-19 pandemic and the tactics used to:
- Enhance trial awareness among 57,000+ Health Care Providers (HCPs)
- Reach and enroll 3 of the less than 20 known patients diagnosed with the rare genetic disease in Germany at the time of recruitment
- ...and more!
Register today!
Speakers:
Morgan Sellars
Morgan is the EMEA Patient Engagement & Recruitment Lead for Citeline Engage. He has been supporting sponsors to drive excellence in clinical trials for 5+ years. As the EMEA patient engagement and recruitment lead, Morgan works with clinical project teams, to find innovative solutions for Sponsors patient recruitment and retention challenges.
Steve Novak
Steve is the Senior Director, Global Clinical Operations for Citeline Engage. Previously, as the Managing Director for CBR Biotech Strategies GmbH in Berlin, Germany, Steve provided US and EU strategic and regulatory services and support to European biotech and pharmaceutical companies. He provided oversight for an FDA required Bioresearch Monitoring Program (BIMO) Inspection for a sponsor conducting clinical trials in Europe resulting in the dual FDA/EMA approvals for a medical procedure targeting the early diagnosis of Alzheimer’s disease. In addition, Steve led a specialized team of clinical, regulatory, and scientific consultants supporting the unprecedented first-in-human compassionate use of a monoclonal antibody to stem the West African Ebola outbreak. As an expert in building collaborative partnerships and driving strategic programs across a broad spectrum of commercial companies, Steve led the business development efforts for a global CRO in the United States, Europe, and Japan. He spent a significant period of his early career successfully leading numerous military units throughout the United States and Europe as a Lieutenant Colonel in the US Army Military Intelligence Corps.