Setting Up Your Drug For Clinical Success: Strategies And Considerations From Discovery To Clinic




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Date: September 10, 2019
 Time: 09:30-15:00
 Location: MalmöMässan, Exhibition & Congress Center, Malmö, Sweden

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 to speed development.

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.

Agenda:

9:30 | REGISTRATION & COFFEE

10:00 | WELCOME FROM THE HOSTS
Jonas Ekstrand, CEO, SwedenBio
Andy Clyburn, Senior Account Director, Catalent

10:10 | PART 1: DEVELOPMENT FROM DISCOVERY TO PHASE 1
DRUG SUBSTANCE – FROM BENCH TO REACTORS
Alan Harris, Partner at Alacrity Pharma Associates

  • Attrition rates and impact on development strategy 
  • Developability assessment of the API
    • When is a route of synthesis not a route of synthesis? Evaluation of COGS, availability of starting material...
    • Importance of early evaluation of physicochemical characteristics
    • Initial potential genotoxic impurities (PGI) assessment

PHARMACOKINETICS
Jan Neelissen, Scientific Advisor, Catalent 

  • Understand ADME deficiencies that can be improved through drug design or formulation
  • Set target PK profile and starting dose
  • Case studies

FORMULATION AND DRUG PRODUCT
Rob Harris, Director, Science & Technology, Catalent 

  • Selecting an optimal formulation:
    • When advanced (solubility enhancing) technologies are required versus simplified approaches (i.e., powder-in-capsule)
    • Parallel formulation screening

CLINICAL
Gunnar Danielsson, Senior Regulatory Advisor, LINK Medical Research AS

  • Overview of Phase 1 study protocol designs and goals
  • How to initiate a Phase 1 study
  • Importance of pharmacokinetics, achieving max tolerated dose and establishing therapeutic index

11:40 | LUNCH AND NETWORKING

12:30 | PART 2: MOVING THROUGH CLINICAL STUDIES TO COMMERCIALIZATION 

DRUG SUBSTANCE – LONGER TERM NEEDS 
Alan Harris, Partner at Alacrity Pharma Associates 

  • Scale-up of API synthesis – non-cGMP to cGMP
  • Establishing control of critical quality attributes
  • Preparing for Process Performance Qualification (Validation)

FORMULATION AND DRUG PRODUCT AND CLINICAL SUPPLIES
Rob Harris, Director, Science & Technology, Catalent

  • Phase-appropriate formulation
  • Selection of the optimal dosage form for commercialization 
  • Efficient coordination of clinical supplies: clinical manufacturing, packaging, storage and distribution (manufacture at the clinics + integrated services)

CLINICAL
Gunnar Danielsson, Senior Regulatory Advisor, LINK Medical Research AS  

  • CRO coordination
  • Running complex trials
  • Guidance with regulatory submissions

14:00 | 1:1 Private Consultancy Appointments