DissoAmerica 2022 - Welcome - Vinod Shah

Welcome Vinod P. Shah, Ph.D., FAAPS. FFIP President, Board of Directors of SPDS-US Chapter Disso America 2022 Dissolution Science: Principles and Applications September 19, 2022

Society for Pharmaceutical Dissolution Science (SPDS) • SPDS was formed on 16th July 2012 in Mumbai, India with the objective of promoting the science and technological development in the field of dissolution among pharmaceutical professionals, academia, students, regulatory bodies, etc., • Vision: To be one of the most prominent professional body focusing on Dissolution Science among the pharmaceutical industry and academia.

• Mission: To dissipate the science and advancement taking place in the field of dissolution related to clinical application and methods.

Only professional body dedicated to Dissolution and its applications worldwide.

SPDS – US Chapter, Board of Directors • SPDS-US chapter is an extension of the organization, established in 2019, registered in the state of Massachusetts as a non-profit organization. Its vision is to advance the knowledge of dissolution science and technology and to organize dissolution science conferences among professionals in the pharmaceutical industry and academia worldwide.

• President : Dr. Vinod P. Shah, Pharmaceutical Consultant, VPS Consulting, LLC. • Director : Patrick Ballmer, Vice President of SOTAX Group • Director : Sanjaykumar Patel, Principal Scientist, Merck, USA • Director : Ajay Pydah Application Engineer, Product lead software and Data management, Sotax • Director : Jerome Morris Sales Director, Sotax USA Region

Scientific Advisory Committee • Vinod P. Shah, Ph.D., FAAPS, FFIP. Pharmaceutical Consultant, USA • Patrick Ballmer Vice President of Sotax Group, USA • Sanjaykumar Patel, Principal Scientist, Merck, USA • James E. Polli, Ph.D., FAAPS Professor, University of Maryland, USA • Xujin Lu, Ph.D., Research Fellow, Bristol-Myers Squibb, USA

• Deanna Mudie, Ph.D. Principal Scientist, Lonza, USA • David Sperry, Ph.D. Sr. Research Advisor, Lilly Research Laboratories, USA • Arvind Bansal, Ph.D. Professor and Head, department of Pharmaceutics, NIPER, India

Disso America 2020 (Virtual) Sept 10, 2020: Dissolution of Amorphous Dispersion.

Vinod Shah, Joseph Polli, David Sperry, James Polli, Lynne Taylor, Deanne Mudie.

Sept 11, 2020: In Vivo Predictive Dissolution.

Patrick Ballmer, Vivek Shah, Sanjay Patel, Greg Amidon, Vatsala Naageshwaran, Xujin Lu.

Webinars (2021 – 2022) • May 14, 2021:Trends in USP 4 flow through Dissolution Science: Complex and long-acting parenteral dosage forms.

Vinod P Shah, Patrick Ballmer, Samir Haddouchi, Dian Burgess, David Curran • June 11, 2021: The role of material properties in dissolution Science.

Vinod Shah, Arvind Bansal, Patrick Augustijns, Ashwini Nangia.

• Sept 17, 2021: Application of modeling to support drug product development and assessment.

Vinod Shah, James Polli, Sandra Suerez-Sharp, Rodrigo Cristofoletti.

• Oct 15, 2021: Trends in pediatric drug development and age-related biopharmaceutics and dissolution.

Sanjay Patel, Xujin Lu, Nikoletta Fotaki, Terry Ernest, Fang Wu. • Oct 29, 2021: Trends in dissolution science: In vitro and in silico methods for assessing food and PPI effects.

Sanjay Patel, Deanna Mudie, Christos Reppas, Filippos Kesisoglou., • Feb 11, 2022: The role of dissolution in Continuous manufacturing.

Sanjay Patel, David Sperry, Carrie Coutant, Justin Pritchard, Andreas Abend.

Disso America 2022 Dissolution Science: Principles and Applications Sept 19, 2022.

- Welcome: Patrick Ballmer, Ramaswamy, Vinod Shah, Tina Morris, Navnit Shah, Pankajbhai Patel.

- Development of Quality Drug Products: Vinod Shah, Xujin Lu, Prasad Panzade.

- Predictive Dissolution to Guide Formulation Development: Deanna Mudie, Steve Stamatis, Sanjay Patel, James Polli Sept 20, 2022.

- Understanding of Dissolution Mechanism to Guide Robust Formulation Development: Arvind Bansal, David Sperry, Tessa Carducci, Tycho Heimbach.

- Role of Dissolution in Regulatory Submission: Ajay Pydah, Talia Flannagan, Andre Hermans, Mei Ou. Sept 21, 2022.

- Dissolution of Special Dosage Forms: Padma Devarajan, Anna Schwendeman, Diane Burgess, John Middleton, Erin Heim.

Thank You for Your attention