Online-Anmeldung

Anmeldungen für

Setting up your drug for clinical success: strategies and considerations from discovery to clinic

1. Oktober 2019, 10:00 bis 14:00 Uhr

Actelion Business Center, Hegenheimermattweg 95, 4123 Allschwil, Switzerland

sind leider nicht mehr möglich.


Die Anmeldefrist für die Veranstaltung ist leider abgelaufen.

Time

Agenda Item

Presenter

9:30

Registration & Coffee

10:00

Welcome from the Hosts

TBD BaseLaunch

Andy Maitland, Account Director, Catalent

10:10-11:40

PART 1: PRECLINICAL STARTEGIES TO DERISK DEVELOPMENT

 

DRUG SUBSTANCE – FROM BENCH TO REACTORS

To be confirmed

  • Attrition rates and impact on development strategy
  • Long term 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

 

PHARMACOKINETICS

Jan Neelissen, Scientific Advisor, Catalent Pharma Solutions

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

 

FORMULATION AND DRUG PRODUCT

Julien Meissonnier, Vice President, Science & Technology, Catalent Pharma Solutions

  • Selecting an optimal formulation:
    • When advanced (solubility enhancing) technologies are required versus simplified approaches
    • Parallel formulation screening

11:40-12:30

Lunch & Networking

12:30-

14:00

PART 2: ACHIEVING CLINICAL INFLECTION MILESTONES

 

DRUG SUBSTANCE

To be confirmed

  • 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

Julien Meissonnier, Vice President, Science & Technology, Catalent Pharma Solutions

  • 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)

 

PARTNERING, OUTSOURCING, WORKING WITH EXTERNAL PARTNERS

Katja Wosikowski, Nonclinical Drug Development Consultant, Wosikowski Consulting

  • Coordinate working with consultants, API manufacturers, CDMOs, CROs

14:00

Networking and 1:1 Private Consultancy Appointments