PharmaLex Presents, Ask An Expert
Let’s get smarter! Get the answers to the questions from industry experts on topics that are impacting your drug/ device lifecycle management. No slides, no lectures. Just ANSWERS.
Pain points
• Program delays or additional overruns when clients don’t engage or don’t engage early enough with Regulatory Agencies to gain alignment on their programs
• Failure to recognize the benefits that special regulatory designations may bring such as rolling review, more frequent Agency input on the development program and possible financial incentives, among others.
An expert in global drug development Mark has over 30 years of experience at some of the worlds leading institutions and companies including the US National Institutes of Health, Merck, Wyeth, MedImmune and GE Healthcare, among others. His drug development experience includes both biologics and small molecules across multiple therapy areas. Possessing an understanding of what it takes to deliver new drugs to the market he has progressed several assets through development from preclinical through Phase 3 including supporting key regulatory agency meetings and submissions.
Adair joined PharmaLex in April 2017 as Principal Consultant, Director Regulatory Operations, where she is responsible for electronic submission activities, regulatory information management and related topics in the US. She has a wealth of experience in managing hundreds of Regulatory submissions throughout the product lifecycle, leading cross-functional project teams, and implementing innovative technologies.
Patrick has significant experience in the development of biologics (monoclonal antibodies, recombinant protein), therapeutic and prophylactic vaccines and IVDs/Companion Diagnostic (CDx) tests, specifically in the areas of Oncology, Auto-Immune Disorders and Infectious Diseases."