CADDI Workshop | Smart Drug Development & Design From Candidate To Phase I




Click here to register for this event.

Date: February 1, 2018

Location: Cambridge, MA

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.

AGENDA SPEAKERS
8:00 am – 8:30 am - WELCOME & INTRODUCTION
Dr. Chris Towler, Senior Fellow, Novartis Institute for Biomedical Research
Dr. Cornell Stamoran, Founder, Catalent Institute

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
Dr. Katarina Vulic, Senior Scientist, Novartis Institute for Biomedical Research

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
Speaker 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
Dr. Sudhakar Garad, Global Head, Chemical and Pharmaceutical Profiling, Novartis
Dr. Ronak Savla, Scientific Affairs Manager, Catalent Pharma Solutions

Click here to register for this event.