From Discovery To Clinic: Getting Ready For Phase 1




 

To register for this free event, please email Aline@onenucleus.com 

Date: April 27, 2017

Time: 09:30 - 14:00

Location: Chesterford Research Park, Little Chesterford, Saffron Walden, CB10 1XL
Free onsite car parking available 

From Discovery to Clinic: Getting Ready for Phase 1

Today’s scientists are under significant time pressure to accelerate their compound from discovery to the clinic. Such pressure can often lead research organizations 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.

Time

Agenda Item

Presenter

08:30

Registration/Coffee

09:00

Introductions

Aline Charpentier of One Nucleus

Phil Berry of Catalent

09:15

Chairperson –

  • Overview of the proceedings

David Elder

09:30

API Design –

  • Reasons for attrition in early phase and late phase
  • Profiling drug candidate physicochemical 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

Paul Leeson

10:15

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 of Catalent

11:00

Coffee and Networking

11:30

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 of Catalent

12:15

Regulatory

  • Best practices for preparing the IMPD chemistry, quality, manufacture, and control section

Andrew Willis of A Willis Consulting

13:00

Networking Lunch

1:1 Private Consultancy Appointments

 Following the meeting, Catalent’s Science and Technology leaders will be available for private, no-obligation discussions on specific programmes and challenges.