The pharmaceutical industry has experienced a trend in the number of accelerated approval designations for drugs (e.g. orphan drugs, breakthrough therapies, accelerated approvals, and FDA priority reviews) being developed.  These designations are given shortened timelines for product development, product assessment and commercial scale-up (typically between 3-5 years) and come with several development and manufacturing challenges. 

In this webinar you will hear from industry experts on:

  • How to manage stability challenges for accelerated approval programs
  • Fit-for-purpose manufacturing strategies
  • Overcoming scale-up challenges
  • Developing a comprehensive solution for unexpected challenges
  • Avoiding typical pitfalls in accelerated programs

Featured Speakers

Joe Dukich

Director, Operations
Catalent Pharma Solutions

Joe Dukich, Director of Operations at Catalent Pharma Solutions, joined Catalent in 2016.  He leads the operations team in the development and clinical supply of new molecular entities and commercial manufacturing and supply for marketed drug products.  Joe’s area of expertise includes operational aspects of commercial drug product manufacturing and manufacturing technologies, technical transfers and the launches of new small molecules. 

Siegfried Schmitt, PhD

Parenteral Drug Association, UK Chapter

Dr. Siegfried Schmitt, President, PDA UK Chapter and Vice President, Technical at Parexel Consulting, joined Parexel Consulting in 2007.  He provides consulting services to the healthcare industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems.  The services cover the entire product lifecycle, from clinical to commercial phase. Dr. Schmitt’s area of expertise includes all aspects of quality and compliance for systems, processes, facilities, and operations for drug substances and drug products. 


Register now for this webinar