Raising the Stakes in CNS - Pharmaceutical Executive


Raising the Stakes in CNS

Pharmaceutical Executive

Getty Images: John Lund
Conversations around value, and how to create it in 2012, can usually be separated into two categories: hard and soft. Hard value deals with operational efficiencies, getting a drug approved on time and executing on a quarterly sales goal. Soft value, on the other hand, has to do with addressing an unmet need, investing in services around a product, and improving health outcomes. Shire's Jeffrey Jonas, installed in 2008 as senior vice president, R&D, for the specialty business, believes that he can help the company do both, by placing the focus on clinical value, not p value, the latter being a statistical measure used to prove significant change or efficacy with a drug, compared against a chance result.

R&D organizations who are struggling to justify their existence go for a p value. Clinical organizations that are struggling to get a molecule on the market that helps patients are testing for a clinically relevant value. —Jeffrey Jonas
Jonas joined Shire a month after Angus Russell took over as CEO, and quickly went to work on the company's prized ADHD portfolio, which included the newly approved prodrug Vyvanse (lisdexamfetamine dimesylate). With academic and entrepreneurial bona fides beyond dispute—Jonas received his MD from Harvard Medical School and was chief resident in psychopharmacology at Harvard's McLean Hospital, and has also founded and co-founded two biotech companies, in addition to serving as chief medical officer and EVP at Forest Labs, and EVP at Isis Pharmaceuticals—Jonas found himself in a position to change the way Shire approached product development. Based on Vyvanse's mechanism of action, a dopamine modulator, and the safety data produced in ADHD trials, Jonas wanted to test the drug for new indications. "When I got to Shire, there wasn't really much of a lifecycle management program in place for Vyvanse," recalls Jonas. "I was in a meeting very early on, and we had just started talking about a Vyvanse lifecycle management plan, and one of the comments from someone relatively senior was, 'This is very risky to do this. It's our major asset.' And my response was, 'Do you know what's risky? Having an asset with a patent life to 2024 without a lifecycle program. That's risky.'"

In collaboration with the commercial group, Jonas's more aggressive approach toward product development has already resulted in an additional indication from FDA for Vyvanse—as a maintenance treatment for adults with ADHD—and the drug is currently being tested in four new areas: major depressive disorder, negative symptoms and cognitive impairment in schizophrenia, excessive daytime sleepiness, and binge eating disorder. These new clinical programs push the limits of Shire's "search and develop" model, causing the company to make difficult choices about when it makes sense to go into the clinic, and when it makes sense to duck out. If the hard and soft value categories are a Venn diagram, then clinical trials can only go forward in the intersection. For now, Shire isn't interested in doing five-year, Kaplan-Meier-style outcome studies, says Jonas, because those kinds of programs too greatly elongate the development cycle. But Jonas isn't afraid to take his lead asset into a head-to-head trial versus a competitor. In March, Shire announced two Phase IV clinical trials comparing Vyvanse to Concerta. Speaking on the decision to go head-to-head, Jonas says the purpose is to "show that my drug is better, or I'm wrong." The way to de-risk a head-to-head trial or other potentially dangerous clinical adventure, says Jonas, is to take a broader look at the clinical implications beyond sheer efficacy. "R&D organizations who are struggling to justify their existence go for a p value. Clinical organizations that are struggling to get a molecule on the market that helps patients are testing for a clinically relevant value," he says.


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