From Discovery To Clinic: Getting Ready For Phase 1




 

Date: June 22, 2017

Location: BioM Biotech Cluster Development GmbH, Am Klopferspitz 19a (IZB West II), 82152 Munich, Germany

To register for this free event, please click here

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

09:30

Registration/Coffee

10:00

Introductions

Andreas Berghammer of Bio-M

Stephan Wohlrab, Catalent Pharma Solutions

10:15

European Lead Factory: Early Drug Discovery  

  • ELF a unique pan-European early drug discovery approach 
  • Selection criteria for large screening libraries 
  • Profiling of hit candidates, physicochemical characteristics  
    • How to position molecules for success in early drug discovery

Dmitrios Tzalis of Taros Chemical GmbH & Co. KG

11:00

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

Michael Gassen of Nuvisan Pharma Services

11:45

Coffee and Networking

12:15

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

Uwe Hanenberg of Catalent Pharma Solutions

1:00

Early Regulatory Affairs

  • Regulatory strategy
  • Target product profile and SmPC
  • Documentation and dossiers
  • Scientific advice
  • Good regulatory practice

Josef Hofer of EXDRA GmbH

1:45

Early Development & Clinical Research:

  • Data & Facts
  • Legislation & Quality
  • Early Development
  • The Concert (Translational Medicine/Science)

Gerhard Lorkowski of GL Pharma Consulting R&D

14:30

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.