- Chesterford Research Park, Little Chesterford, Saffron Walden CB10 1XL
- 27 April 2017
This event is free to attend*
Please contact Aline
for any further information.
Today’s scientists are under significant time pressure to accelerate their compound from discovery to the clinic. Such pressure can often lead research organisations to adopt short-term thinking and overlook the downstream realities of drug development.
Addressing issues early and comprehensively in the development life-cycle can result in fewer problems such as escalating timelines, costs and regulatory issues. It is important to leverage the skills and experience of experts and connect the dots between competencies to optimise the development pathway and enable drug candidates to reach their true potential.
This event will focus on a number of key considerations for transitioning a molecule from discovery to phase 1 readiness including API and formulation development, clinical study design, and regulatory requirements.
08.30 – Registration and coffee
08.50 – Welcome from the hosts
Phil Berry, Catalent
Aline Charpentier, One Nucleus
09.00 – Introduction from the Chair
David Elder, Independent
09.10 – API Design
• Reasons for attrition in early phase and late phase
• Profiling drug candidate physicochemical characteristics across industry
• The criteria and process used by different companies to rank compounds and assess risk
• How to position molecule for success in Phase 1 and beyond
09.55 – DMPK/ADME
• Model and predict ADME behavior prior to entering clinical trial
• Understand ADME deficiencies that can be improved through drug design or formulation
• Set target PK profile and starting dose
Jan Neelissen, Catalent
10.40 – Coffee break
11.10 – Drug Product
• Parallel screening for solubility enhancing technologies
• Early dose form: Selection and optimisation
• When is it appropriate to go quickly into clinic (powder-in-capsule) versus when you should better formulate a drug
Julien Meissonnier, Catalent
11.55 – Regulatory
Best practice for preparing the IMPD chemistry, quality, manufacture, and control section
Andrew Willis, A Willis Consulting
12.40 – Clinical
• Overview of Phase 1 study designs and goals
• Proper formulation, dosage form, extemporaneous compounding, and clinical supply for Phase 1 studies
• Importance of good bioavailability to achieve MTD and establish therapeutic index
13.25 - Networking lunch and 1:1 private consultancy appointments
*Organisers reserve the right to refuse any registration.