Title: Overview of the biotech drug development pathway
Date: Wednesday, December 05, 2018
Time: 04:00 PM Central European Time
Duration: 1 hour
Biopharmaceuticals consist of some of the top blockbuster medicinal products in the industry. Biotechnology product development for major markets such as US/EU as well as other regions of the world is continuing to increase. Analysis shows that developers who prepare global upfront strategies and utilize risk-based tools benefit from efficiency and save resources leading to faster market entry.
This webinar offers an overview of the multidisciplinary (CMC, non-clinical and clinical) requirements for the development of biotech products, outlines the regulations, highlights critical requirements and summarizes common CMC pitfalls and how to avoid them.
Director, Regulatory Affairs at PharmaLex UK
“At PharmaLex we understand the challenges you face and offer a wide range of support services”
Zeb Younes has over 17 years´ of experience in biopharmaceutical / biosimilar development lifecycle from proof of concept through to, and beyond commercialization with both laboratory and desk based experience in process development, purification, formulation, method development, characterisation, validation, comparability, release and stability testing. Zeb has experience with ATMPs, vaccines, recombinant proteins including monoclonal antibodies and derivatives and over 10 different biosimilar products.
She has also over ten years of management experience and has set up and managed research teams, GMP testing laboratories and operations, developed and implemented lean systems to increase operational efficiency and has participated and led MHRA/FDA and corporate audits. Zeb holds a 1st in Class BSc (Hons) in Medical Biochemistry.