OVERVIEW

The Catalent Applied Drug Delivery Institute, Columbia Lab-to-Market Accelerator Network and the Translational Therapeutics Accelerator (TRx) will be organizing an upcoming event focused on key considerations for transitioning a molecule from discovery to phase 1 readiness.

AGENDA

8:45am – 9:00am | WELCOME & INTRODUCTION

Speaker TBC, BioRN
               -Columbia Tech Ventures, Dr.Cornell Stamoran, Founder, Catalent Institute

9:00am – 9:45am | IN SILICO PHYSICOCHEMICAL PROFILING DURING DISCOVERY AND EARLY DEVELOPMENT
               -Dr. Alex Avdeef, Founder In-ADME Research

9:45am – 10:30am | MODELING THE PHARMACOKINETIC CHALLENGES OF ORAL SMALL MOLECULE DRUGS
               -Dr. Richard Tschirret-Guth Ex-Merck, Living   Water DMPK Consulting

10:30am – 10:45am | BREAK

10:45am – 11:30am | FORMULATION STRATEGIES TO OVERCOME ORAL BIOAVAILABILITY CHALLENGES OF SMALL MOLECULE DRUGS
               -Mr. Brent Moody, Principal Scientist, Catalent Pharma Solutions

11:30am – 12:00pm | AUDIENCE APPLIED LEARNING CHALLENGE
               -AM Speakers

12:00pm – 1:00pm | NETWORKING LUNCH & MEET THE EXPERTS

1:00pm – 1:45pm | INSIGHTS ANDSTRATEGIES TO INCORPORATE PATIENT FOCUSED DESIGN
               -Dr.Cornell Stamoran, Founder, Catalent Institute

1:45pm – 2:15pm | WHY PATIENT-FOCUSED PRODUCTS MAKE GOOD BUSINESS SENSE
               -Mr. Mike Rea, CEO, IDEA Pharma

2:15pm – 2:30pm | BREAK

2:30pm – 3:15pm | PARTNERING, OUTSOURCING, WORKING WITH EXTERNAL PARTNERS
               -Dr. Irach Taraporewala, President & Managing Member, Sitara Pharmaceutical Consulting, LLC

3:15pm – 4:00pm | INTEGRATED EARLY DEVELOPMENT: TECHNICAL, QUALITY, REGULATORY, AND STRATEGIC CONSIDERATIONS
               -Mr. Jim Spavins, SVP, Pharm Sci (Ret.), Pfizer Principal, Spavins Consulting LLC

3:15pm – 4:00pm | CONCLUDING REMARKS
               -Dr. Ronak Savla, Scientific Affairs Manager, Catalent Pharma Solutions