Register for our first live in-person meeting today!
In collaboration with
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!
Date and time
Mon, Sep 19, 2022, 9:00 AM –
Wed, Sep 21, 2022, 4:00 PM EDT
Location
Meeting Agenda
Sep 19: Development of quality drug products, Predictive Dissolution to guide formulation development
| 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 | |
Sep 20: Understanding of Dissolution Mechanism to guide robust formulation development, Role of Dissolution in regulatory submission
| 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. | |
Sep 21: Dissolution of Special Dosage Forms
| 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 | |
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.
Patrick serves as Vice President and Deputy of the CEO of the Aesch, BL, Switzerland headquartered SOTAX Group. Raised in Switzerland and educated at ETH Zurich, he moved to Pennsylvania in 2005 and Massachusetts in 2009 to develop the presence of SOTAX in the United States. Today he oversees all activities of SOTAX in North- and South America, including Production, Product Development and Application Laboratories at SOTAX in Westborough, MA. A Chemist by training, his research interests prior to joying SOTAX were in the areas of Medicinal and Computational Chemistry.
Dr. Shah is a founding President of Society of Pharmaceutical Dissolution Science (SPDS) US Chapter. He is a Pharmaceutical Consultant, a member of Steering Committee of Non-Biological Complex Drugs (NBCD) hosted at Lygature in The Netherlands (2011-Present), and expert consultant with NDA Partners (2016 – Present).
