parna Singh (AS), Program Manager with Frost & Sullivan’s Chemical Materials and Foods team caught up with Dr. Michael Kolb (Dr. MK) at Frost & Sullivan’s Opportunities in Lifescience Molecules: Global Partnership Summit 2006. This annual summit was held at Goa (India) from 21st -23rd May, 2006.
Dr. Kolb is currently the Vice President, Chemical Development at Wyeth Research. He joined Wyeth in 1996 to head their Chemical Development Business function. At Wyeth, he has streamlined the Chemical Development business with the objective to meet company pipeline goals. Dr. Kolb was born in Germany and obtained his PhD at the Justus Liebig University. He then joined the California Institute of Technology for a post-doctoral stay. He started his career in 1976 with Merrell-Toraude at Strasbourg, which later became a part of Sanofi-Aventis. He worked there for 13 years, engaged originally in basic research and then overseeing scale-up activities at the Center. In 1989, Dr. Kolb joined MMD’s Research Center in Cincinnati as head of Chemical Development. Then in 1995, he was asked to act as the Site Director for MMD Research Institute in Tucson.
AS: To begin with, since this would be of interest to the Indian market, can you tell u a little bit about Wyeth’s approach to offshoring? What are the company’s strategic plans here, in terms of key regions and benefits that are you looking at?
Dr. MK: Wyeth has no API production facilities, everything that goes into end of phase 2 studies, phase 3 or commercialization, is out-sourced to companies which typically are in Europe, and now, more and more, in the Asian region – India, Japan, South Korea and China. On the discovery side, we’ve just started this year a collaboration with GVK, and I believe that they will have about 70 chemists on board this year – with the goal to increase the workforce to 150 chemists who all will work on discovery projects.
On the bio statistics side, with Accenture, we transfer data to India, where they are analyzed and the results send back to the US.
AS: We would like to know more about Wyeth’s ‘Clinical Development Model’ - fundamentally, how is this ‘learn and confirm’ approach different from the conventional new drug creation process? What concrete steps is Wyeth taking to put this into action, and what are the likely benefits that will accrue?
Dr. MK: The concept - its not new at all, its over 10 years old – I remember it was published around 1980. The idea is that instead of going through a rigid process of phase I to phase II and then to phase III clinical trials, a more flexible and adaptable process of ‘Learn and confirm’ is implemented. – There is an early phase where we go into the clinic and learn about the compound, and then there is a later phase where we confirm the learning of the compound. There are no strict boundaries anymore between the individual clinical phases. Also, in the past, typically each compound had a project team, which was championing the specific compound. Competition for resources and decision on the priority of their compound were issues. Now we have learnt and confirmed teams, which don’t work on one single compound, but on all compounds falling into the therapeutical area of this team. So the team might have five compounds in CNS and can learn from all of them in order to move the best one forward.
AS: What about regulatory issues as far as this system is concerned?
Dr. MK: We presented this to the FDA and they liked it. They are only concerned that sufficient supporting data are available for a compound when we go to the NDA.
AS: Beyond contract manufacturing which are the main areas in the value chain that Wyeth has looked at for any contract services? How do you see this, going forward in the next 4-5 years?
Dr. MK: In the clinical domain, we’re now developing the concept of Early Clinical Development Center (ECDC). In the past, what we used to do is, once a compound went in for clinical trials, it used to be sent to one hospital, and, as an example, you might need 200 patients to do the study, who might be difficult to recruit in one hospital. Now that we have ECDCs all around the world, we may recruit 80 patients in India, 100 in China, and 20 in Europe, which eventually also gives us access to the needed 200 patients. This allows us to do the trials much faster because we don’t have to wait for recruiting all 200 patients at one hospital. An additional benefit is that with this system we obtain a broad genetic spread of patients and can ensure the desired mix of age groups and so on. Of course, one other benefit is the lower costs of doing trials in India, China or South America.
AS: What has been the company’s experience as far as IPR compliance in the Indian market is concerned? Do you see any significant changes in the business environment with India acceding to the new patent laws?
Dr. MK: I don’t think we ever had a problem, but then, I don’t think we ever put any sensitive IP in this area. I guess the attitude will change, but right now, a lot of people have the attitude of let’s wait and see!
AS: With outsourcing becoming a critical component for most pharmaceutical majors, has your company invested in any measurement systems designed to evaluate their cost-benefit?
Dr. MK: One area is cost. We routinely compare our own cost estimates for making an API with offers we obtain from our out-sourcing partners in Europe, Asia, etc. We maintain a database not just on cost, but also on items of on-time delivery, reliability, and quality for all our outsourced API activities. Again we measure all our suppliers on these parameters and see what their performance is.
AS: Which countries are currently the leaders in each segment – such as drug discovery services, clinical research and custom synthesis?
Dr. MK: Discovery until recently, we never outsourced, and now the first country we have come to is India. The way I look at it is that the talent is available and the cost is attractive. API manufacturing – India is strong, but IP issues still need to be resolved in some areas. However it really depends on which are the critical issues about your API synthesis. If cost is a big issue, one would go to India, or China, or South Korea to find a supplier. If cost is not that critical, at the end of the day, a chemist in Europe is as good as a chemist in India, but might have more experience in the specific technology you are looking for.
AS: Going forward, what do you see as the outlook in different contract services for the Indian market?
Dr. MK: For me, the biggest areas are API manufacturing and Drug discovery. Outsourcing of API manufacturing is already very active in India, but outsourcing of drug discovery will increase. The big driver, as I see it right now, is still cost, though this may change with time.
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