Sept. 13, 2007 | DDT’s opening keynoter Frank Douglas, former CEO of Aventis and until his recent resignation, a professor at MIT, asked whether biopharma is prepared for a “black swan event”?
The term comes from “The Black Swan,” a recent book by Nassim Nicholas Taleb, which examines the influence of unpredictable events of enormous impact, such as 9/11 or the Internet. A black swan, Douglas said, is “an outlier, an event beyond normal expectations... by definition a surprise.” In science circles, black swan events include the development of PCR; the Vioxx debacle (“Vioxx turned on its head the notion we want targeted, potent compounds”); and the decline in FDA drug approvals.
With the top 15 pharma companies facing the expiration of 95 drug patents by 2012, Douglas predicted the industry would look very different in ten years. However, the industry is still preoccupied with five key issues:
1) Which targets provide the optimal benefit/risk ratio?
2) Which patients will respond to drug?
3) Which patients are susceptible to side effects?
4) Which strategy — small molecules or biologics — make sense?
5) Which low frequency signal is likely to be a ticking time bomb?
Looking forward, Douglas , the only repeat keynoter in DDT’s history, presented some gedanken (thought) experiments suggesting that big pharma will benefit from a new era of stratified medicine, assuming developmental time and costs can be cut substantially. But he outlined a couple of possible “black swan” scenarios for biopharma. In one scenario, he envisioned the emergence of just 3-4 top pharmas complemented by many small specialty players; strategic global outsourcing; the emergence of virtual research; and VC firms serving as research translators.
But the pressure of external political forces could limit research to conditions such as Alzheimer’s, cancer and orphan diseases; mandatory use of generics; mandatory identification of responders and side effects for drug approval; preferential reimbursement of preventive health measures; and — “heaven forbid!” — price controls.
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