Live Webinar - "Designing Robust Commercial Products Using Computational Predictive Tools"

Join the Process Development Division, June 27th at 02:00 PM CST for our live webinar presentation, "Designing Robust Commercial Products Using Computational Predictive Tools," hosted by Mary am Ende, Vice President of Quality, Product Development & Regulatory CMC at Nalas Engineering Services. Registration is open to all and can be accomplished here as well as via the button below.

Presentation Abstract:

In recent years, computational predictive tools have become instrumental in designing robust commercial products. This new state of the art has been forged predominantly by chemical engineers and members of AIChE.

In this presentation, examples of modeling techniques being applied to drug product processing operations are discussed as support to the design, development, and scale-up for solid oral drug products. These process modeling techniques are discussed and exemplified with case studies ranging from powder flow, segregation, encapsulation, and tableting mapped to process parameter predictions. The major processing to produce capsules/tablets include i) powder processing; ii) dry and wet granulation; iii) encapsulation or tablet compression; and iv) film coating. Specific consideration has been given to transfer and scale-up issues along with general process design related challenges to pharmaceutical process R&D. 

Speaker Bio:

Mary am Ende received her B.S. in chemical engineering from the University of Iowa and her Ph.D. in chemical engineering from Purdue University and has 30 years of pharmaceutical drug product development experience. She is a Vice President of Quality, Product Development & Regulatory CMC at Nalas Engineering Services. Prior to this role, Mary was a Vice President of Process Development at Lyndra Therapeutics, and a Research Fellow at Pfizer for 25 years where she was fortunate to lead the development and commercialization of Ibrance, Duavive, and Chantix drug products. Mary is widely recognized as a leading expert in drug product process development/scale-up, Quality by Design, design space verification, and use of computational predictive tools to streamline commercial development and scale-up through process modeling.

Mary has published 30 papers, 5 patents, 45 presentations, and presented 11 invited talks. She has also addressed a key gap in the pharmaceutical industry by publishing a successful book for chemical engineers in the business of designing and developing API and drug products with her co-editor, David am Ende. The 75 chapters are contained in 2 volumes entitled “Chemical Engineering in the Pharmaceutical Industry”, 2nd Edition by Wiley. She has been active in AIChE since serving as Student President in 1988, recently chairing the Pharmaceutical Discovery, Development and Manufacturing (PD2M) division 2020-2021, and currently serving as a CTOC Director to PDD and PD2M.