New technologies and biomarkers: The way ahead
11-12th May 2006, Washington DC, USA
Overview
Once again, the CMR International Institute for Regulatory Science assembled an impressive team of regulatory, industry and academic speakers to address the topical issue of integrating new technologies, especially biomarkers, into new drug development in a scientific and practical way, within the bounds of economic reality.
In the first Session, chaired by Dr Murray Lumpkin, Deputy Commissioner, FDA, the business case for investing in the development of new technologies and biomarkers was reviewed by the President of Pfizer Global R&D, Dr John L. LaMattina. A panel of speakers, Dr Marisa Papaluca Amati, EMEA, Shigeki Tsuda, PMDA and Dr Chris Webster, Millennium Pharmaceuticals, USA, gave regulatory and industry perspectives on the new methodologies for the development and registration of new medicines.
Under the Session heading ‘Promises, practices and pitfalls’, Dr Johannes Tauscher, Eli Lilly & Co., USA and Prof Klaus Lindpaintner, Roche, Switzerland, looked (respectively) at the potential biomarker role of imaging and genomics, whilst Dr Joe Hackett, CDRH, FDA, USA discussed the regulatory implications for the drug-device interface.
In the second half of the Session, chaired by Omer Boudreau, Director General, TPD, Health Canada, the regulatory framework for validation of biomarkers was discussed by Dr Larry Lesko, FDA, whilst Dr David Jefferys, Vice President, Eisai, looked at the feasibility of harmonisation within and across the ICH regions. Joint research consortia and the integration of the new technologies into development were examined from a legal viewpoint by Gregory Levine, Partner, Arnold & Porter LLP, USA, and from a pharmacoeconomic viewpoint by Professor Louis Garrison, University of Washington.
Syndicate discussions
The Syndicates, that convened in the second half of the meeting were charged with the task of identifying key factors and making recommendations on ‘the way forward’ to optimise the development and utilisation of new technologies and biomarkers.