From Discovery to Clinic: Creating a Comprehensive and Efficient Development Operation
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
09:55 - Assessing 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
Chesterford Research Park
Little Chesterford
Saffron Walden
Cambridge, Cambridgeshire CB10 1XL
United Kingdom