Clinical game plan
India is critical to our future, says Robert R Ruffolo, 57, President, Wyeth Research & Development. That may sound like just another feel-good sound byte from a visiting foreign honcho, but Ruffolo and Wyeth have very good reasons for banking so heavily on India. As a company Wyeth, one of the world’s largest research-driven pharmaceutical and healthcare products companies, has close to 7,000 people in research & development (R&D) in the US. Here’s why India is critical. “In India, we have 1,000 people, not Wyeth employees, but working 100 per cent for Wyeth, which is equivalent to 15 per cent of our R&D personnel,” says Ruffolo, who is also Senior Vice President of Wyeth.
That is not all. It is doing clinical trials in the country. “About 22 per cent of the patients for our new antibiotic that was just approved by the USFDA came from India and the quality of data was very high. We are now studying three cancer drugs and a new vaccine in the country,” adds Ruffolo, who has been with Wyeth for the last seven years; prior to that he spent 17 long years at SmithKline Beecham. Ruffolo was in Hyderabad recently to announce the setting up of a dedicated chemistry research centre by GVK Biosciences for Wyeth Pharmaceuticals.
Ruffolo’s research team works with quantitative targets for new drug discoveries. “Seven years ago, we set up a new R&D productivity model and set for ourselves a target of two new drugs in the market every year, which means at least 15 drugs need to be discovered each year. Working backwards, based on known chances of success and failure rates, we arrived at this model (referred to within the company as the 15-12-3-2 formula).” Of the 15 new drug discoveries, 12 would have to reach the stage of investigational new drugs (INDs) to start phase I clinical trials.
The next step is to turn these 12 into phase III trials. All of Wyeth’s research initiatives, including the one with GVK Biosciences, seem to revolve around this formula. With the Hyderabad Chemistry Centre launched at GVK Biosciences, Wyeth gets a built-tosuit research facility with 150 dedicated chemists. Says Ruffolo: “This increases our chemistry capacity by 30 per cent. We today have about 350 medicinal chemists, which takes us close to 500 and which means we are okay for now for the next couple of years.”
Given his 15-12-3-2 formula, it is not surprising when Ruffolo disputes the point that there is a shortage of blockbuster drugs in the global pharma market. “There is no shortage of blockbusters but there is a shortage of approvals for new blockbusters.” Wyeth currently has 66 drugs in the pipeline in various stages of development, of which three-four are believed to be likely blockbusters. “About 25 per cent of our late stage pipeline is believed to be blockbusters,” says Ruffolo.
Away from blockbusters, Wyeth is focussing on personalised medicines. For this, it entered into a unique collaboration last year with four universities in Scotland. Called the Translational Medicine Research Collaboration (TMRC), it is a unique collaboration involving Scotland and Wyeth, which (the government and Wyeth) will jointly pick up the tab for such studies. The TMRC will see more than £50 million injected into clinical research in Scotland over a five-year timeframe.
Another major initiative Wyeth has going in India is a contract with Accenture. “Wyeth was the first company to completely outsource clinical data management. That was five years ago and there are 520 people there right now in Bangalore dedicated to managing our clinical data,” explains Ruffolo. Accenture also manages the India Clinical Research Centre (ICRC), which enables Wyeth to have a 24-hour day as this is in sync with its research labs back home in Pennsylvania.
Wyeth has had a direct presence in India for decades with its headquarters in Mumbai. However, as Ruffolo points out: “We have chosen to focus on partnerships, like the one with GVK Bio, for our research efforts rather than build them up ourselves because we believe that this is far more efficient.” That may be the best way forward for the pharma MNCs in India.
