Dissolution Science: Principles and Applications
Jump To Section:
Date: September 19 – 21, 2022
Location: DoubleTree by Hilton, Westborough, Mass. (Approx. 30 miles from Boston Airport)
September 19, 2022 |
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 and Vice President, Sotax, USA
Patrick.ballmer@sotax.com |
09:05 am – 09:10 am | Welcome | Ramaswamy Lakshmanan, SPDS-India
Lakshmanan.ramaswamy@sotax.com |
09:10 am – 09:15 am | Welcome | Vinod P. Shah, President, SPDS-US
Dr.vpshah@comcast.net |
09:15 am – 09:25 am | Welcome | Tina Morris, CEO AAPS
MorrisT@aaps.org |
09:25 am – 09:40 am | Keynote Address | Navnit Shah, SVP and Scientific Advisor, Amneal Pharmaceuticals
navnit.shah@amneal.com |
09:40 am – 09:55 am | Keynote Address |
Session I: Development of quality drug products – Session Chair: Kevin Whitkanack | ||
Time | Title | Speaker |
10:00 am – 10:30 am | Evolution of Dissolution in Pharmaceutical Science | Vinod P Shah, Pharmaceutical
Consultant, Maryland Dr.vpshah@comcast.net |
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 | Xujin Lu, Research Fellow, BMS, NJ
Xujin.lu@bms.com |
11:30 am – 12:00 am | Challenges Dissolution Science is facing in the Generics Industry | Prasad Panzade
Prasad_panzade1320@yahoo.com |
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: David Sperry | ||
Time | Title | Speaker |
02:00 pm – 02:30 pm | Biorelevant dissolution media | Deanna Mudie, Principal Scientist, Lonza, OR
Deanna.mudie@lonza.com |
02:30 pm – 03:00 pm | Linking predictive dissolution data in early development and pre-clinical studies | Steve Stamatis
Stamatis_stephen_dion@lilly.com |
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, NJ
Sanjaykumar.patel@merck.com |
04:00 pm – 04:30 pm | Prediction of oral drug absorption using a hollow fiber membrane (HFM) module | James Polli, Professor, University of Maryland
jpolli@rx.umaryland.edu |
04:30 pm – 05:00 pm | Panel Discussion. Questions & Answers. | |
05:00 pm – 06:00 pm | Wine & Cheese |
September 20, 2022 |
Session III: Understanding of Dissolution Mechanism to Guide Robust Formulation Development – Session Chair: Deanna | ||
Time | Title | Speaker |
09:00 am – 09:30 am | Factors influencing dissolution | Arvind Bansal, Dean, NIPER, India
bansalarvind@yahoo.com |
09:30 am – 10:00 am | Understanding dissolution mechanism | David Sperry, Senior Research Advisor, Eli Lilly, IN
sperryda@lilly.com |
10:00 am – 10:30 am | Modeling and Simulations (driving towards RTRT) | Tessa Carducci, Assoc. Principal Scientist, Merck, NJ
Tessa.carducci@merck.com |
10:30 pm – 11:00 am | Coffee Break | |
11:00 pm – 11:30 pm | Dissolution safe space | Tyco Heimbach, Principal Scientist, Merck, NJ
Tycho.heimbach@merck.com |
11:30 pm – 12:00 pm | Use of dissolution testing to support clinical bridging studies | Vivek Purohit (Pfizer)
Vivek.s.purohit@pfizer.com |
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: Xujin | ||
Time | Title | Speaker |
02:00 pm – 02:30 pm | Data Integrity | Ajay Pydah, Lead Software and Data Management, SOTAX, MA
Ajay.pydah@sotax.com |
02:30 pm – 03:00 pm | M9 and Beyond | Talia Flannagan, Senior Director, UCB, Belgium
Talia.flanagan@ucb.com |
03:00 pm – 03:30 pm | Coffee Break | |
03:30 pm – 04:00 pm | Establishing clinically relevant dissolution specifications | Andre Hermans, Director, Merck, NJ
Andre_hermans@merck.com |
04:00 pm – 04:30 pm | Agency perspective on evaluating dissolution data in product development and in product life cycle | Mei Ou, Biopharmaceutics Reviewer, FDA
Mei.ou@fda.hhs.gov |
04:30 pm – 05:00 pm | Panel Discussion. Questions & Answers. |
September 21, 2022 |
Session V: Dissolution of Special Dosage Forms – Session Chair: Sanjay | ||
Time | Title | Speaker |
09:00 am – 09:30 am | Advanced Third Generation Solid Dispersion Films – Facile Innovative Technology | Padma Devrajan, ICT, India
pvdevarajan@gmail.com |
09:30 am – 10:00 am | Characterization and Quality Comparison of Liposome Formulations | Anna Schwendeman
annaschw@med.umich.edu |
10:00 am – 10:30 am | IV, IVC | Diane Burgess
d.burgess@uconn.edu |
10:30 pm – 11:00 am | Coffee Break | |
11:00 pm – 11:30 pm | Biodegadable polymers. | John Middleton |
11:30 pm – 12:00 pm | Global implementation for automated dissolution testing for commercial Release Testing | Erin Hein
Erin.hein2@merck.com |
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 |