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From Discovery to Clinic: Getting Ready for Phase 1

08:30 – 14:00

Chesterford Research Park, Little Chesterford, Saffron Walden, CB10 1XL
19 April 2018

This event is free to attend* 

Please contact Aline for any further information.

Since the sequencing of the human genome nearly two decades ago, scientists have made numerous breakthroughs in understanding disease pathophysiology and developing molecules for “undruggable” targets. 

However, the pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. One reason is that novel small molecule drugs have inflated physicochemical properties, which lead to low bioavailability and poor safety and efficacy profiles. Addressing these issues early and comprehensively can result in fewer problems in later development phases such as escalating timelines, costs and regulatory issues. Leveraging the skills and experience of experts and integrating competencies can optimize the development pathway and enable drug candidates to reach their true potential.

This event will focus on 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

09.00: Welcome from the Hosts

09.10: API Design:

- Reasons for attrition in early phase and late phase

- Profiling drug candidate physiochemical characteristics across industry
- Criteria and process used by different companies to rank compounds and assess risk
- How to position molecule for success in Phase 1 and beyond
David Elder

09.55: DMPK / ADME

- Model and predict ADME behaviour 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

10.55: Drug Product

- Parallel screening for solubility enhancing technologies

- Early dose form: Selection and Optimization
- When is it appropriate to go quickly into clinic (powder in-capsule) versus when you should better formulate a drug
Julien Meissonnier, Catalent

11.40: Clinical

Malcom Boyce, HMR London

12.40: Commercial

Speaker tbc

13.00: Lunch 

*Organisers reserve the right to refuse any registration.

Title: From Discovery to Clinic: Getting Ready for Phase 1
Start: 2018-04-19 08:30:00Z
End: 2018-04-19 14:00:00Z