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From Discovery to Clinic: Getting Ready for Phase 1

This event has now reached its maximum capacity, if you would like to be added to the waiting list, please contact Aline, aline@onenucleus.com

Location:
The Nucleus, Chesterford Research Park, Little Chesterford, Cambridge CB10 1XL
Date:
20 April 2016
 



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 down the line 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 optimize 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.

Programme 

09:00 – Registration and coffee

09:15 - Introductions
Phil Berry, Catalent 

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09:30 - Drug Substance – API development priorities: Positioning for Phase I and beyond
John Knight, JKonsult

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10.15 - Drug Product – Early dose form selection: Selecting and optimizing formulation technologies for clinical success
Pascale Clement, Catalent 

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11.00 – Drug Product – Challenges and Solutions for Non-invasive Macromolecule Delivery
Julien Meissonnier, Catalent 

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11:15 – Coffee and networking

11:30 - Regulatory – Best practices for preparing the IMPD quality section
Judith Jones, Catalent

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12.00
- Clinical – Early clinical studies: What can we achive?
Malcolm Boyce, Hammersmith Medicines Research

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12.45 - Networking Lunch

13:15 - 1:1 Private Consultancy Appointments

Title: From Discovery to Clinic: Getting Ready for Phase 1
Start: 2016-04-20 09:00:00Z
End: 2016-04-20 14:00:00Z