Abstract
Microdosing in Translational Medicine: Pros and Cons evaluates this innovative
approach to investigating candidate molecules.
The CREAM trial and other studies have largely validated the concept of human
microdosing (HMD) as a reliable screen for basing go/no go decisions to Phase
I. CHA predicts human microdosing (HMD) will first be used by smaller drug
developers with limited resources, finding broader acceptance by the industry
as a routine "litmus test" by 2012. Orest Hurko, AVP of Translational Research
at Wyeth, expects 75% of biopharma companies to implement it over the next 5
years.
Microdosing in Translational Medicine: Pros and Cons provides a balanced
evaluation of the pros and cons of HMD, including:
- What the CREAM trial and other HMD studies say about the linearity of PK
results.
- Comparative assessment of EMEA and FDA guidelines governing HMD - which
offers the more hospitable pathway?
- Use of HMD in synergy with in silico and other predictive technologies.
- Assessment of current detection technologies and emerging improvements.
- Use of PET in HMD to study ligand displacement.
- Which sector will adopt HMD first --- big pharma or biotechs?
- Applications of HMD using oral, IV, and other routes of administration.
- Examination of cost-benefit, risk management, regulatory and ethical
aspects of HMD.
Microdosing in Translational Medicine: Pros and Cons is based upon:
- Roundtable interviews with CEOs of the leading CROs specializing in HMD.
- A survey of the views, actions and planned activities of R&D managers at
pharma and biotech companies with responsibility for selecting candidates for
Phase I.
- Forecast of the market for HMD services and timelines to adoption by
pharma and biotech companies.
About the Author
Hermann A.M. Mucke, Ph.D. spent 17 years in academia and industry before he
founded H.M. Pharma Consultancy (www.hmpharmacon.com) in 2000 to become an
independent pharmaceutical consultant, analyst and science author. His last
industry position was Vice President R&D in a European pharmceutical company
which he helped to take public on the Frankfurt Stock Exchange in 1999. Since
then, Dr. Mucke, who holds a Ph.D. in biochemistry from the University of
Vienna (Austria) became a consultant and advisory board member for several
European and U.S. pharmaceutical companies, and a regular reviewer of drugs
and patents for Thomson Current Drugs and Ashley Publications. He has served
as an outside expert author for CHA since 2004. Dr. Mucke is based in Vienna
and can be reached at h.mucke@hmpharmacon.com , or by fax at +43 1 494 9989.
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