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Disso America 2022

Dissolution Science: Principles and Applications

Over the course of three days, we’ll cover dissolution topics covering a range current topics with industry and academia’ leading experts!

Download Agenda (PDF)

Speakers

Date and time

Mon, Sep 19, 2022, 9:00 AM –

Wed, Sep 21, 2022, 4:00 PM EDT

Location

DoubleTree by Hilton Hotel Boston – Westborough

5400 Computer Drive

Westborough, MA 01581

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Meeting Agenda

Welcome – Session Chair: Patrick Ballmer, Vice President, SOTAX Group
Time Title Speaker
09:00 am – 09:05 am Introduction Patrick Ballmer, Board Member, SPDS US Chapter and Vice President, SOTAX Group
09:05 am – 09:10 am Welcome Dr. Ramaswamy Lakshmanan, General Secretary, SPDS-India
09:10 am – 09:15 am Welcome Dr. Vinod P. Shah, President, SPDS US Chapter
09:15 am – 09:25 am Welcome Dr. Tina Morris, CEO, AAPS
09:25 am – 09:40 am Keynote Address Dr. Navnit Shah, SVP and Scientific Advisor, Amneal Pharmaceuticals
09:40 am – 09:55 am Keynote Address Pankajbhai Patel, Chairman, Zydus Life Sciences Ltd., India
Session I: Development of quality drug products – Session Chair: Samir Haddouchi, Managing Director, SPS Pharma Services
Time Title Speaker
10:00 am – 10:30 am Evolution of Dissolution in Pharmaceutical Science Dr. Vinod P Shah, President, SPDS US Chapter
10:30 am – 11:00 am Coffee break
11:00 am – 11:30 am Challenges Dissolution Science is facing in the Brand Name Pharmaceutical Industry Dr. Xujin Lu, Research Fellow, BMS
11:30 am – 12:00 am Challenges Dissolution Science is facing in the Generics Industry Dr. Prasad Panzade, Head, Analytical Operations and Laboratory Platforms. Protagene
12:00 pm – 12:30 pm Panel Discussion. Questions & Answers.
12:30 pm – 02:00 pm Lunch break
Session II: Predictive Dissolution to Guide Formulation Development – Session Chair: Dr. David Sperry, Senior Research Advisor, Eli Lily
Time Title Speaker
02:00 pm – 02:30 pm Biorelevant dissolution media Dr. Deanna Mudie, Principal Scientist, Lonza
02:30 pm – 03:00 pm Linking predictive dissolution data in early development and pre-clinical studies Dr. Steve Stamatis, Sr. Consultant Engineer, Eli Lily
03:00 pm – 03:30 pm Coffee Break
03:30 pm – 04:00 pm In vitro predictive tools to understand biopharmaceutics risk assessment- Precipitation risk Sanjay Patel, Principal Scientist, Merck
04:00 pm – 04:30 pm Prediction of oral drug absorption using a hollow fiber membrane (HFM) module Dr. James Polli, Professor, University of Maryland
04:30 pm – 05:00 pm Panel Discussion. Questions & Answers.
05:00 pm – 06:00 pm Wine & Cheese
Session III: Understanding of Dissolution Mechanism to Guide Robust Formulation Development – Session Chair: Dr. Deanna Mudie, Principal Scientist, Lonza
Time Title Speaker
09:00 am – 09:30 am Factors influencing dissolution Dr. Arvind Bansal, Dean, NIPER, India
09:30 am – 10:00 am Understanding dissolution mechanism Dr. David Sperry, Senior Research Advisor, Eli Lilly
10:00 am – 10:30 am Modeling and Simulations (driving towards RTRT) Dr. Tessa Carducci, Assoc. Principal Scientist, Merck
10:30 pm – 11:00 am Coffee Break
11:00 pm – 11:30 pm Dissolution safe space Dr. Tyco Heimbach, Principal Scientist, Merck
11:30 pm – 12:00 pm Use of dissolution testing to support clinical bridging studies Dr. Vivek Purohit, Sr. Director Clinical Pharmacology,  Pfizer
12:00 pm – 12:30 pm Panel Discussion. Questions & Answers.
12:30 pm – 02:00 pm Lunch break
Session IV: Role of Dissolution in Regulatory Submission – Session Chair: Dr. Xujin Lu, Research Fellow, BMS
Time Title Speaker
02:00 pm – 02:30 pm Dissolution Data Integrity: Who did what, when and where? Ajay Pydah, Lead Software and Data Management, SOTAX Group
02:30 pm – 03:00 pm M9 and Beyond Talia Flannagan, Head of Product Design and Performance, UCB, Belgium
03:00 pm – 03:30 pm Coffee Break
03:30 pm – 04:00 pm Establishing clinically relevant dissolution specifications Dr. Andre Hermans, Director, Merck
04:00 pm – 04:30 pm Agency perspective on evaluating dissolution data in product development and in product life cycle Dr. Mei Ou, Biopharmaceutics Reviewer, FDA
04:30 pm – 05:00 pm Panel Discussion. Questions & Answers.
Session V: Dissolution of Special Dosage Forms – Session Chair: Sanjay Patel, Principal Scientist, Merck
Time Title Speaker
09:00 am – 09:30 am Advanced Third Generation Solid Dispersion Films – Facile Innovative Technology Dr. Padma Devrajan, Professor, Institute of Chemical Technology, India
09:30 am – 10:00 am Characterization and Quality Comparison of Liposome Formulations Dr. Anna Schwendeman, William I. Higuchi Collegiate Professor, University of Michigan
10:00 am – 10:30 am IV, IVC Dr. Diane Burgess, Board of Trustees and Distinguished Professor of Pharmaceutics, University of Connecticut
10:30 pm – 11:00 am Coffee Break
11:00 pm – 11:30 pm Biodegadable polymers. Dr. John Middleton, Vice President of Polymer Development, Tolmar
11:30 pm – 12:00 pm Global implementation for automated dissolution testing for commercial Release Testing Dr. Zachery Custer, Sr. Scientist, Merck
12:00 pm – 12:30 pm Panel Discussion. Questions & Answers.
12:30 pm – 02:00 pm Lunch break
2:00 pm – 04:00 pm Tour of SOTAX Westborough Facilities
Members: click here to get a $100 discount

​The Society for Pharmaceutical Dissolution Science, US Chapter

Our mission is to support progress in and disseminate information pertaining to the on-going advancement of pharmaceutical dissolution science across industry and academia worldwide.

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