SC1: BEST PRACTICES FOR BIOTHERAPEUTIC DISCOVERY AND DEVELOPMENT

TUESDAY, JANUARY 21 | 5:45 - 8:45 PM (DINNER PROVIDED)                             

This course provides insights on best practices and the most effective ways of working for biotherapeutics development at each stage from discovery to development. Important decision gates at each stage of development and key parameters for each gate will be described, and you will learn about common work packages that go into the development of biotherapeutics, including but not limited to processes and analytical data from in vivo and in vitro studies. The course will also discuss regulatory expectations and international standards for each of the work packages. The course will be interactive in nature, offering attendees the opportunity to gain insights relevant to issues they encounter during product development in their own operations.

Topics to be Discussed:

  • Discovery and development stages
  • Target-specific considerations
  • Lead and candidate selection during discovery
  • Preclinical evaluations
  • Clinical evaluation, Phase I and II
  • Clinical evaluation, Phase III
  • Filing for regulatory approval
  • Lifecycle management

Instructor:

AlAzzam_WasfiWasfi AlAzzam, PhD, CSO, TechnoPharmaSphere (TPS)

Dr. Wasfi AlAzzam is the Chief Scientific Officer at TechnoPharmaSphere (TPS), and in this role, he provides scientific, research, development and technology development consultations for pharmaceutical and biotechnology products in the early and late stages. He helps technology/method developers develop and promote their technologies. Additionally, he helps intellectual property law firms evaluate data and identify infringement, acts as an expert witness, and drafts patents. He helps review, draft, and address questions on regulatory submissions.

Before this, Dr. AlAzzam was a Fellow in CMC analytical development at GlaxoSmithKline, and formulation and delivery lead at Bayer Healthcare. His experience includes CMC development (cell culture, purification process, formulation, and analytical methods) and interfacing with regulatory and clinical development for multiple marketing and clinical stage biologics. Dr. AlAzzam was also the CMC lead for developing several unique radio labelled products for PET imaging clinical studies. He has done several international collaborations with academic, regulatory, and industrial institutions, and he contributes to the scientific community by serving on organizing committees and forums.

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