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




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Date: May 7, 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 Institutes 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. Chris Towler, Senior Fellow, Novartis Institutes for Biomedical Research

9:05 am – 9:40 am - MODELING THE PHARMACOKINETIC CHALLENGES OF ORAL SMALL MOLECULE DRUGS 
Dr. Katarina Vulic, Senior Scientist, Novartis Institutes for BioMedical Research

9:40 am – 10:15 am - FORMULATION STRATEGIES TO OVERCOME ORAL BIOAVAILABILITY CHALLENGES OF SMALL MOLECULE DRUGS
 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 pm - INTEGRATING QUALITY AND CMC INTO EARLY DEVELOPMENT 
 Mr. Jim Spavins, SVP, Pharm Sci (Ret.), Pfizer; Principal, ‎Spavins Consulting LLC

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 - STRATEGIC FORMULATION AND DOSAGE FORM SELECTION FOR EARLY PHASE CLINICAL TRIAL 
Dr. Manuel Sanchez-Felix, Senior Fellow, Novartis Institutes for BioMedical Research

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.