For BioPharma Enterprise It’s Full Speed Ahead into the Age of Personalized Medicine

As more is understood about diseases and the why and how of their effects on people through advances in biomarkers and genomics, personalized medicine becomes a natural result for biomedical science and a natural trajectory for the innovation-based biopharma industry.   While the majority of those in attendance at last week’s Personalized Medicine: Impacting Healthcare  Conference are deeply immersed in driving this transformation, I was pleased to present the results of  a new Tufts CSDD Impact Report that provides the first look at a year-long effort by the Tufts Medical Schools Center for the Study of Drug Development (Tufts CSDD) to measure progress and prospects in the field by means of interviews and a survey of some 20 companies on the front lines of the movement towards personalized medicine. The company sample consisted of 9 top biotech companies with an average market value of $22B and 12 Big Pharma firms with an average market value of $93B.

While many recognized the challenges ahead, considering the current level of scientific knowledge, all believe that eventually a personalized medicine approach will help to streamline the R&D process, tip the benefit/risk ratio in favor of product approval, and provide options that help reduce overall costs and side effects. Confirming firms’ commitment to push ahead, companies increased their investment in personalized medicine by a median of 30% from 2006 to 2010 (even in a “down” economy), and plan to do so again from 2011 to 2015. Structural change follows the funding flow and all companies have experienced some level of “internal paradigm shifts” in order to integrate the concepts of personalized medicine into their development process, but not without disruptive change in the way decision-making occurs and at what levels.

Regulatory and reimbursement hurdles loom large among the most immediate challenges affecting the advancement of personalized medicines.  Thus, 100% of companies say their discovery strategy involves biomarkers and/or targeted therapies, but having a biomarker was not a requirement to move into clinical development. In fact, the percentage of the pipeline relying on biomarker data decreased as products move downstream, from 60% in preclinical to 50% in early clinical development, and finally 30% in late development. Oncology is much further along with genomic targeting of medicines, but  other therapeutic areas ahead of the curve include cardiovascular, central nervous system and immunologic therapies, while in metabolic, virology, and respiratory research,  personalized medicine is growing but incipient.

The dichotomy of where the industry is at present from where it needs to be is evident from the fact that while 90% of companies say they are investing in personalized medicine, only 10% of compounds in late clinical development actually have companion diagnostics. Nonetheless, the industry commitment in terms of funding, research collaborations, technology uptake, organizational change and unanimous resolve to push forward could signal that rapid advances are on the horizon.

 To read more or purchase the full Tufts Impact Report visit:  http://csdd.tufts.edu/reports/description/ir_summaries