Smart Drug Development & Design from Candidate to Phase I

Monday, May 7, 2018 from 8:00 AM to 4:00 PM (EST)

***Please note the date change. ***

Cambridge, MA

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Since the sequencing of the human genome nearly two decades ago, scientists have made numerous breakthroughs in understanding disease pathophysiology and developing molecules for “undruggable” targets. However, the pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. One reason is that novel small molecule drugs have inflated physicochemical properties, which lead to low bioavailability and poor safety and efficacy profiles. Addressing these issues early and comprehensively can result in fewer problems in later development phases such as escalating timelines, costs, and regulatory issues. Leveraging the skills and experience of experts and integrating competencies can optimize the development pathway and enable drug candidates to reach their true potential.

 

This event will focus on key considerations for transitioning a molecule from discovery to phase 1 readiness including API and formulation development, pharmacokinetics, quality and CMC requirements, and incorporation of patient focus design principles.

 

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AGENDA

8:00 AM – 8:30 AM | WELCOME & INTRODUCTION

8:30 AM – 9:05 AM | IMPORTANCE OF API CHARACTERIZATION FOR IMPROVING DEVELOPABILITY OF SMALL MOLECULES
Dr. Manuel Sanchez-Felix
Senior Fellow
Novartis Institute for Biomedical Research

9:05 am – 9:40 am | MODELING THE PHARMACOKINETIC CHALLENGES OF ORAL SMALL MOLECULE DRUGS
Novartis speaker TBA

9:40 am – 10:15 am | TECHNOLOGY AGNOSTIC FORMULATION SELECTION FOR PRECLINICAL TOXICOLOGY STUDIES
Dr. Ronak Savla
Scientific Affairs Manager
Catalent Pharma Solutions

10:15 am – 10:30 am | BREAK

10:30 am – 11:30 am | AUDIENCE APPLIED LEARNING CHALLENGE- PART 1
ALL SPEAKERS

11:30 am – 1:00 pm | NETWORKING LUNCH & MEET THE EXPERTS

1:00 pm – 1:35 am | CMC AND QUALITY CONSIDERATIONS
TBA

1:35 pm – 2:10 pm | INSIGHTS AND STRATEGIES TO INCORPORATE PATIENT FOCUSED DESIGN

Dr. Cornell Stamoran
Founder
Catalent Institute

2:10 pm – 2:45 pm | STRATEGIES FOR PROGRESSING TO PHASE I FORMULATIONS TO IMPROVE YOUR SPEED TO AND SUCCESS IN CLINIC
Speaker TBA

2:45 pm – 3:00 pm | BREAK

3:00 pm – 4:00 pm | AUDIENCE APPLIED LEARNING CHALLENGE- PART 2
ALL SPEAKERS

CONCLUDING REMARKS