WORKSHOPS

Accelerating the Development of Molecules through Early Clinical Development
Dates: Location: Cost:
November 13, 2008

Hyatt Regency, Cambridge MA, USA

Free Seminar
Register
Included Meals: Contact Information:
Continental Breakfast
Lunch



 ICON
Development Solutions
215-616-3064
Timothy.OBrien@iconplc.com
Course Description
Workshop Agenda:
Day 1:
9:00 am Registration Opens

9:30 am Chairman - Introduction
Dr. Cyril Clarke
ICON Development Solutions, Marlow

9:40 am Robert Jevon
Boston Millennia Partners
Early Clinical Development: Venture Capitalists View
  • Current funding outlook

  • What are a VC company looking for in a development package

  • What do they expect to see from the first few studies


    • 10:20 am Dr. Ajay Verma
    Merck
    Role of Translational Pharmacology
  • Why do we need a translational medicine approach

  • Do animal models predict efficacy

  • Rethinking preclinical approaches with clinical data

  • Current status of translational medicine in pain research


    • 11:00 am Morning Coffee Break

    11:15 am Dr. John Connell
    ICON Development Solutions, Manchester
    Human Models of Disease State
  • Selection, Validation and Benchmarking a Model

  • Therapeutic targets for pharmacodynamic models

  • Can volunteer models make a molecule a medicine?


    • 11:30 am Practical Workshop (1)
    Demostrations of Pharmacodynamic Biomarkers in Pain, Cognition, Sedation and Appetite Control
  • Hands on demonstrations

  • Focus on validation and benchmarking

  • Incorporation of techniques in FIM studies


    • 12:45 pm Lunch

    13:45 pm Dr. J. Patrick Kesslak
    Allergan
    Reprofiling a Drug into a New Therapeutic Area
  • Identification of putative analgesics

  • Validation of therapeutic activity in preclinical and clinical models of pain

  • Demonstration of efficacy in patient populations


    • 14:25 pm Jim Conklin
    ICON Medical Imaging
    Maximising the benefit or imaging techniques in Early Clinical Development
  • What can imaging add to the development plan

  • Peripheral v central imaging

  • Limitations and Pitfalls to be avoided


    • 15:00 pm Panel Discussion

    15:30 pm Meeting Close