The cost to discover and develop a drug
is increasing dramatically; however, the number of approved new
drug products is on the decline. Drug manufacturers, desperate
for ways to expedite the drug discovery process while decreasing
the expense, are turning to biomarkers as one possible solution.
Biomarkers in Clinical Development: Implications for Personalized Medicine and Streamlining R&D evaluates the following technologies, strategies, and issues in biomarker research:
- Technologies to discover and screen biomarkers, particularly with regard to their impact on both biomarker identification and application in wide-scale clinical use.
- Various approaches to biomarker discovery and development employed by companies such as Pfizer, Bristol-Myers Squibb, Roche, and Novartis. Specialist companies, such as SurroMed, are also profiled.
- The FDA’s
perspective on biomarkers in clinical development, and their
classification of validated and nonvalidated biomarkers.
- The influence of pharmacogenomics on new drug therapies and biomarker detection devices.
- Biomarker deals among pharmaceutical, biotech, and non-profit companies.
- Risks associated with biomarker usage.
- The related fields of theranostics, proteomics, pharmacogenomics, and molecular imaging.
Biomarkers can be
influential in every phase of drug development, from drug discovery
and preclinical evaluations through each phase of clinical
trials and into post-marketing studies. Biomarkers can predict
a patient’s response to a compound, act as a surrogate
endpoint, and aid in making efficacious and cost-saving decisions
or terminating drug entities more quickly during the research
process. Patient enrichment strategies are using biomarkers
to identify certain patient populations that are more likely
to respond to the drug therapy or to avoid specific adverse
events. This shift toward “personalized medicine,” in
which the patient receives a treatment based on their genetic
as well as medical profile, is helping the drug industry to
achieve the goal of cost-effective and faster research.
The decision to utilize a biomarker in a drug program needs to be weighed carefully to ensure that drugs that affect certain biomarkers also affect clinical outcomes. This report provides the necessary scientific and strategic insight for all companies wishing to profit from the use of biomarkers in drug development.
Felix Frueh, FDA Center for Drug Evaluation and Research; Aaron Kantor, SurroMed; David Lester, Pfizer; Rick Ludwig, Indiana Center for Applied Protein Sciences; Robert McBurney, BG Medicine; Rudy Potenzone and Richard Chen, Ingenuity Systems; Michael T. Stocum, Personalized Medicine Partners
About the Authors
Richard Fisler is a consultant with Beachhead consulting (www.beachhead.com), a consulting firm specializing in technology evaluation, strategic planning, and market assessment in the life science industry. Prior to his work at Beachhead, he brought a wide variety of high technology platforms to market through positions in the microarray and live cell microscopy industries. Additionally, he has spent 11 years in management and engineering in the medical imaging field.
Olivia Scaros, PharmD,
graduated from the University of Illinois in 1988 with a Doctor
of Pharmacy degree. She has been employed by various pharmaceutical
firms, including Sandoz Pharmaceuticals, Bayer Corporation,
and Pfizer, Inc., as both an employee and consultant. For the
past 13 years, Olivia’s main focus has been medical writing,
including study reports, clinical protocols, articles, and
other projects for the pharmaceutical industry.