From Discovery to Clinic: Creating a Comprehensive and Efficient Development Operation

Thursday 22 November 2018 08:30 – 14:00


This event is free to attend* 

Please contact Alicia for any further information and registration.

Building on the success of last year’s “Getting Ready for Phase 1” event, this event will delve into the challenges facing the pharmaceutical industry to achieve clinical success. The pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. Inflation of molecule physicochemical properties and complexities in clinical trial protocols stand among the main reasons for these trends. The most successful companies can leverage different expertise, manage risks, and follow logical sequences of operations in an integrated manner.

This event will focus on key considerations for transitioning a molecule from discovery through clinical studies including molecule developability assessment, phase appropriate formulation selection, integration of product development and clinical supply, and creating an appropriate clinical study design.

Programme:
08:30 - Registration and Coffee

09:00 - Welcome from the Hosts
Peter Haughton, Catalent

09:10 Introduction to the challenges and context 
David Elder, David P Elder Consultancy

- Reasons for attrition in early and late phases
- Trends in medicinal chemistry
- Biopharmaceutics considerations
- Design quality into NCEs

09:55Assessing molecule developability using pharmacokinetic modeling
Jan Neelissen, Catalent

- Assess developability of NCEs
- Understand ADME deficiencies that can be improved through drug design or formulation
- Set target PK profile and starting dose
- DMPK modeling to guide formulation selection
- Case studies

10:40 - Coffee Break

10:55 - Integrated Drug Product and Clinical Supplies
Julien Meissonnier, Catalent

- Selecting an optimal formulation: when advanced technologies (solubility enhancing) are required versus simplified approaches (i.e. powder-in-capsule)
- Efficiently coordinating all components of clinical supplies: clinical manufacturing, packaging, storage and distribution (manufacture at the clinics + integrated services)

11:55 - Clinical
Malcolm Boyce, Hammersmith Medicines Research

- Overview of Phase 1 study protocol designs and goals
- How to initiate Phase 1 study
- Importance of pharmacokinetics, achieving max tolerated dose and establishing therapeutic index
- Case studies

12:40 Lunch 
1:1 Private Consultancy Appointments

14:00 - Close

Following the meeting, all presenters and Catalent’s Science and Technology leaders will be available for private, no-obligation discussions on specific programmes and challenges. 

*Catalent reserve the right to refuse any registration.

Hosted by

When
November 22nd, 2018 from  8:30 AM to  2:00 PM
Location
The Nucleus
Chesterford Research Park
Little Chesterford
Saffron Walden
Cambridge, Cambridgeshire CB10 1XL
United Kingdom
Contact
Phone: 01223 896450
Phone: 01223 896456