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From Discovery to Clinic: Getting Ready for Phase 1

08:30 - 14:00

Location:
Chesterford Research Park, Little Chesterford, Saffron Walden CB10 1XL
Date:
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 

09.10API 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
Paul Leeson

09.55DMPK/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

11.10Drug 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

11.55Regulatory 
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
Speaker tbc

13.25 - Networking lunch and 1:1 private consultancy appointments 


*Organisers reserve the right to refuse any registration.



Title: From Discovery to Clinic: Getting Ready for Phase 1
Start: 2017-04-27 08:30:00Z
End: 2017-04-27 14:00:00Z