From Discovery To Clinic: Creating A Comprehensive And Efficient Development Operation

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Date: March 7, 2019

Time: 9:30am - 3:00pm

Location: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2., DK-2300, Copenhagen

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.


9:30 | Registration and Coffee

10:00 | Welcome from the Hosts
Will Downie, Senior Vice President, Global Sales and Marketing, Catalent
David Zepernick, Head of Communication and PublicAffairs, 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, Scientific 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 | Close

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.