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Event info
Date:07 Mar
Time:9:30 - 15:00
Venue:Medicon Valley Alliance, Copenhagen S

From Discovery to Clinic: Creating a Comprehensive and Efficient Development Operation

The pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. Inflation of molecule physicochemical properties and complexities in clinical trial protocols stand among the main reasons for these trends. The most successful companies can leverage different expertise, manage risks, and follow logical sequences of operations in an integrated manner.

This event will focus on key considerations for transitioning a molecule from discovery through clinical studies including molecule developability assessment, phase appropriate formulation selection, integration of product development and clinical supply, and creating an appropriate clinical study design.

Date: March 7, 2019
Time: 9:30 – 15:00
Venue: Medicon Valley Alliance, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor

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Agenda

9:30

Registration & Coffee

10:00

Welcome

Will Downie, Senior Vice-President, Catalent Pharma Solutions &
David Zepernick, Head of Communication and Public Affairs, Medicon Valley Alliance

10:10

Assessing Molecule Developability Using Pharmacokinetic Modeling

  • Assess developability of NCEs
  • Understand ADME deficiencies that can be improved through drug design or formulation
  • Set target PK profile and starting dose
  • DMPK modeling to guide formulation selection
  • Case studies

Jan Neelissen, Scientifc Adviser, Science & Technology, Catalent

10:55

Drug Product

  • Selection of an optimal formulation: when advanced technologies (solubility enhancing) are required versus simplified approaches (i.e. powder-in-capsule)
  • Formulation and dose form considerations for clinical studies

Rob Harris, Chief Technical Officer, Catalent

11:40

Lunch and Networking

12:30

Efficient Coordination of Clinical Supplies

  • Best practices to efficiently coordinate clinical supplies: clinical manufacturing, packaging, storage and distribution

Susie Jelsbak Christensen, Clinical Supply Manager, Symphogen

13:15

Clinical Studies

  • Different models of clinical studies and their goals
  • Challenges of executing complex clinical studies

Gunnar Danielsson, Senior Regulatory Advisor, LINK Medical Research AS

14:00

Closing Remarks

Andy Maitland, Account Director, Catalent

14:10

Coffee and Networking

15:00

End of seminar

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

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In collaboration with: