Clinical Research: Phase 1 - Phase 4

Pharmaceutical Executive – Small Biotechs Gain As the Span of Clinical Trial Outsourcing Grows

A customer approached me recently for advice on hiring a chief medical officer. My answer: “Don’t.”

The last thing his two-person company needed was to spend a lot of money increasing its staff by 50% and still not achieving its real objective. Not that there’s anything wrong with CMOs—I am one, after all—but tiny, virtual pharma companies like this client can, and should, invest their very limited resources more effectively.

“Why do you need a CMO at this stage?” I asked. “You’re two people. Why would you employ someone at such a high cost,”—the therapeutic specialty and New Jersey locations together would command a premium price—“when there are much more cost-effective options?”

What he really wanted was a medical expert who would help them design a development program and give them credibility in front of current and prospective investors. Even if they found a great candidate, I advised, they would still be better off engaging a CRO that has a depth of expertise and clinical trial experience. No matter how experienced and well-credentialed, one medical expert can offer only one set of viewpoints and experiences.

Our industry loves the romantic notion of small pharma and biotech upstarts driving big innovations in medical science, and the positive effect these companies have on drug development is beyond question. But the stakes could hardly be higher, with clinical trial costs in the stratosphere, and more than 99% of new compounds never reaching the market. These pioneers clearly need to balance their ambition and optimism with a strong dose of realism.

Read more at Pharmaceutical Executive.