Bringing new drugs to the market is becoming increasingly challenging and complex with multiple perspectives to be considered such as non-clinical, regulatory, clinical, CMC, Market access, statistics and operations among many others. In this webinar, we will discuss key elements needed to design and execute a bench to bedside integrated development strategy to help navigate these challenges in an optimized manner that increases the probability of regulatory approval and commercial success while managing costs and critical timelines. Case studies and client experience will be presented.
Vice President, Principal Consultant
Development Consulting & Scientific Affairs
An expert in global drug development Mark has over 30 years of experience in life sciences. His product development experience spans small molecules, biologics, biosimilars and medical devices across multiple therapy areas. Understanding what it takes to deliver new drugs to the market his expertise includes clinical and regulatory strategy, regulatory agency meetings, and program, project and portfolio management.
Senior Director, Head Integrated Product Development & Consulting
Head Swiss Operations & Qualified Person
Frederic brings to the role more than 16 years’ experience in the pharmaceutical industry, together with 10+ years’ experience as a Consultant, which has given him extensive experience of what is expected from Agencies from pre-filing dialogue to the granting and maintenance of Marketing Authorizations. During this time, Frederic has gained an in-depth knowledge of development and regulatory requirements and he has prepared and driven numerous meetings with Health Authorities/bodies, including for National and European Scientific Advice.