R&D: lessons learned at GSK

In an exclusive interview broadcast just last week, Meetheboss.com's Adam Burns met with GlaxoSmithKline's Medicine Development Leader, Dr Anne Phillips.

During the interview, which was conducted at the Next Generation Pharmaceutical Summit in West Lake Village, California, Dr Phillips talked about the challenges associated with multi-center and multi-site R&D. The interview also focused on the lessons learned from the Avandia fallout, something Dr Phillips was on the frontline for, having been vice president of clinical development at GSK during that time.

The incident, a particularly difficult time in GSK's recent history, saw the firm - a United Kingdom-based pharmaceutical company ranked as second in the world - caught in the crosshairs over the marketing of its cardiovascular drug Avandia when it became apparent the drug carried with it significantly high risk factors.

Speaking of the incident specifically, Dr Phillips told Adam, "I worked on the Avandia team and at the time it was very, very difficult internally.

"We had worked with the drug since it was marketed in the US in 1999 and so had worked with Avandia for many years," she continued. "We knew the drug, we knew the science and we knew the studies, and so to know that package of data and then see how it was being interpreted in the media was very difficult to watch and be a part of."

Phillip's also talks about her current role, which perfectly places her to explain the challenges associated with modern day drug delivery, most notably how you coordinate all the elements associated with multi-center and multi-site research and development.

She discusses how these processes can both be a blessing and a curse to any Big Pharma company, detailing that though multi-site R&D does offer a fantastic diversity in getting subjects enrolled in clinical trials - not to mention the diversity it creates in terms of input and expertise - challenges associated to things as simple as geography and time zones can create problems. She does, however, offer that diversity always outweighs the challenges.

For Dr Phillips though her real challenge is to get the strategy right, and she explains how she believe the lessons learned - particularly following the Avandia fallout - have been that the key with any drug is transparency. "What we have learned is what the impact of a soundbite, or what an interpretation of data can be, what it can do and what it can mean. But most of all we have learned that you have to be rigorous about the science and the safety profile of any drug and you have to be transparent about it."

You discover more about the learning curves of R&D at GSK and access the whole interview with Dr Phillips, by visiting Meettheboss.com or by following this link.

10/09/09

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