When Pfizer discontinued Exubera, its disastrously unsuccessful inhaled insulin, in 2007, the soul searching wasn't limited to Manhattan's East 42nd Street.
BLAIR JACKSON
Vice President of Business Development and New Product Planning, Alkermes
(JOHN HALPERN)
When Pfizer discontinued Exubera, its disastrously unsuccessful inhaled insulin, in 2007, the soul searching wasn't limited to Manhattan's East 42nd Street. One of the companies that found itself reeling was Alkermes, a biotech with deep experience in drug delivery, which had been partnering with Lilly on a prospective inhaled insulin product—one that Lilly cancelled not long after Exubera bit the dust."That caused us to really take stock of what we were doing and how we were moving forward," recalls Blair Jackson. At the time the Lilly project was pulled, Alkermes had only one proprietary program in development, Vivitrol (naltrexone) for alchohol dependency; the rest of the company's resources were focused on developing drugs for partners. Suddenly that ratio looked wrong. "Over the course of the next year," says Jackson, "we moved from being a single- to a multiple-product developing company. We ended up doing more than 25 clinical and nonclincal studies. We had five or six regulatory filings. It was a fundamental shift in the organization." And leading the way was Jackson's program leadership team. The lessons of turning the battleship? "One of the most important things is flexibility," says Jackson. "When you look at severeal development programs at once, you find that the plan going in at the beginning of the year is completely different from the plan coming out at the back end. But what does remain the same is the budget."
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.