OVERVIEW

Making the right choices is important in today’s R&D environment, especially considering the various pressures on developers such as time, resources, and funding. Short term thinking can lead to long term problems leading to missed timelines, escalating costs, and even regulatory issues in later phases. These factors can unfortunately contribute to non-optimal drug products unless they are addressed upfront by incorporating patient focused design principles to promote better drug performance and patient outcomes.

This event will focus on a number of key considerations for developing the best small or large molecule drug product for patients:

• Avoiding the biggest pitfalls in drug development
• Addressing biopharmaceutical challenges such as low solubility
• Incorporating patient considerations in designing a drug product
• Latest trends and technologies for small and large molecule therapeutics

Agenda:

8:00 AM | REGISTRATION & BREAKFAST               

8:30 AM | WELCOME & INTRODUCTION

               Dr. Kara Bortone, JLABS, Director of Venture Sourcing & Development

               Dr. Cornell Stamoran, Catalent Institute, Founder

SMALL MOLECULE DRUG DEVELOPMENT CONSIDERATIONS

08:45 AM | Presentation:

Delivering the “Promise of R&D”     

Speaker: Dr. Jim Spavins, SVP, Pharm Sci (Ret.),Pfizer, Founder, Spavins Consulting LLC

09:30 AM | Presentation:

Parallel formulation screening to quickly and efficiently complete preclinical studies                  

Speaker: Mr. Stephan Tindal, Catalent Pharma Solutions, Director of Science & Technology

10:15 AM |  BREAK

10:30 AM | Presentation:        

Strategic formulation and dose form selection for clinical studies

Speaker: Nathan Barksdale, Catalent Pharma Solutions, Senior Scientist, Pharmaceutics

11:15 AM | Presentation:        

Patient focused dose form design     
Speaker: Dr. Cornell Stamoran, Catalent Institute, Founder

12:00 PM | NETWORKING LUNCH 

LARGE MOLECULE DEVELOPMENT & DELIVERY

01:30 PM | WELCOME & INTRODUCTION

01:30 PM | Presentation:

Efficient expression of complex proteins in mammlian cells        

Speaker: Dr. Greg Bleck, Catalent Pharma Solutions, Global Head of R&D, Biologics

02:15 PM | Presentation:

The Patient-Focus Imperative: Insights from Non-Invasive Delivery of Macromolecules Conference

Speaker: Dr. Ronak Savla, Catalent Pharma Solutions, Scientific Affairs Manager

03:00 PM | Presentation:

Enhancing Patient Outcomes by Optimizing Drug Delivery Systems  
Speaker: Dr. Carl Dabruzzi, Senior Manager, Product Management, West Pharmaceutical Services

03:45 PM | BREAK

04:00 PM | PANEL DISCUSSION

04:30 PM | CLOSING REMARKS