Role of Dissolution in Continuous Manufacturing

Speakers

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  Sanjaykumar Patel
  

  Sanjaykumar Patel

  Sanjaykumar Patel is Sr. Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has more than 22 years of experience in the pharmaceutical industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastroretentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand the in-vivo performance of oral and parental formulations. He has co-authored 18 scientific papers. He is an active member of AAPS and an immediate past Chair of the IVRDT (In Vitro Release and Dissolution Testing) community. He is a board member of the Society of Pharmaceutical Sciences-US Chapter in the area focusing on dissolution.

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  David Sperry
  

  David Sperry

  Dr. Sperry is a Sr. Research Advisor in Small Molecule Drug Development at Lilly Research Laboratories. He obtained a B.S. degree in chemistry from Indiana University, Bloomington, IN and a Ph.D. degree in chemistry from the University of Rochester, Rochester, NY. After receiving his degree, he took a postdoctoral research scientist position at Pharmacia & Upjohn where he developed an Artificial Stomach Duodenum model and studied its utility in drug development. Shortly thereafter, he accepted a research scientist position at Pharmacia (later Pfizer), working in the area of in vitro methods and biopharmaceutics. He then moved to Bausch and Lomb where he developed commercial ophthalmic formulations for late stage molecules. In 2007, Dr. Sperry joined Lilly Research Laboratories, where he created a group focusing on in vitro drug product performance techniques and predictions of in vivo performance. In 2013, Dr. Sperry joined a computational modeling group at Lilly. He now supports product development by using existing and creating new models to predict product performance and oral absorption of small molecule drug formulations.

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  Carrie Coutant Research Advisor and analytical chemist
  

  Carrie Coutant

  Research Advisor and analytical chemist

  Carrie Coutant, Ph.D., Research Advisor, is an analytical chemist with over 20 years of experience in drug product development spanning from first human dose to commercial launch. She has expertise in product performance of oral dosage forms, including dissolution and disintegration method development, analytical control strategy, biowaivers, and applied in silico modeling of in vitro dissolution. She received a doctorate in analytical chemistry from University of Michigan.

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  Justin Pritchard Senior Director in Analytical Development at Vertex Pharmaceuticals Inc.
  

  Justin Pritchard

  Senior Director in Analytical Development at Vertex Pharmaceuticals Inc.

  Justin Pritchard is a Senior Director in Analytical Development at Vertex Pharmaceuticals Incorporated working on the Analytical Development Leadership Team and leading two groups in the department, the Process Analytics & Control Team and the Dissolution Team. Vertex has the first automated continuous drug product manufacturing process with three approved products manufactured continuously. Justin and the PAC team are responsible for the development, implementation, and validation of PAT methods and for the implementation of an automated control strategy for continuous drug product manufacturing at Vertex. The dissolution team is also responsible for dissolution method development and justification for all clinical products and initial submissions. Justin has spent his career innovating in Analytical Development, the last 14 years at Vertex and, prior to that, working at Alkermes and Aphios. Justin also currently serves on the IFPAC Scientific Board.

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  Andreas Abend Senior Project Chemist, Merck & Co.
  

  Andreas Abend

  Senior Project Chemist, Merck & Co.

  Andreas Abend received his PhD degree in Organic Chemistry from the University of Karlsruhe in Germany. Prior to joining Merck & Co. as a Senior Project Chemist, Andreas spent 3 years as a Post-Doctoral Fellow at the University of Wisconsin’s Enzyme Institute. He is currently a Senior Principal Scientist in the Pharmaceutical Sciences Department supporting a range of different formulations under development at Merck. During his career, he supported small molecule API and drug product development spanning all clinical phases an Analytical Scientist and manager. Andreas is a member of Merck’s Biopharmaceutical Advisory Team, co-chair of PQRI’s Biopharmaceutics Technical Committee, and a member of IQ’s Analytical Leadership Group. He presented at many national and international meetings, published several manuscripts on Clinically Relevant Dissolution Specifications and he recently served as co-organizer of two workshops at the Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).