In collaboration with
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 Sceinces 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 |