Last week’s Xconomy New York Life Sciences 2031 symposium produced lots of articulate speculation about the distant future of biotechnology and its related industries. But for those of us who work or invest in life sciences, the discussion did little to answer the pressing question: what can and should we do now to meet the evolving challenges of the next twenty years?
Implicit in the comments of panelists Sam Waksal, Eric Schadt, Barbara Dalton, and Samuel Isaly was the assumption that drug discovery will face the same problems in 2031 that drug discovery faces today: a “good molecule is hard to find” early-discovery environment; an inexact modeling of disease processes (hopefully improved by advanced bioinformatics); a confused FDA that cannot quite balance protection of the public with facilitation of medical progress; and capital markets that vacillate from total avoidance of development stage companies one year to drunken lust for the next big thing in life sciences the next.
So before we venture to 2031 let’s address 2011. How do we make the process, the regulation, and the funding more efficient today? How do we give the future panelists of Life Sciences 2051 more reasons for excitement and fewer reasons for pessimism?
We can start by using a 21st century vocabulary. In an era when we will define more and more diseases by their molecular pathways, genetic mutations, or expression signatures, why do we cling to anatomic and histologic definitions? Is “small cell carcinoma” more precise than “oat cell carcinoma?” As an intern in obstetrics and gynecology in the 1980’s I was taught that the term “ovarian cancer” represented a group of very different diseases, and that a rudimentary biomarker, CA-125, helped tease out one from another.
Yet today, small companies still present their development plans for ovarian cancer drugs with no separation into more specific patient populations—likely ruining the statistical assumptions underlying the trials, and obscuring … Next Page »