Facing the Challenges of Pharma Research
Roche introduced a new operating model for its global research and development activities in July, 2007. At that time, Lee Babiss was appointed as the Global Head of Roche Pharma Research. Prior to that, he was the Research Site Head in Nutley (USA). In this position he is leading and managing Research within Roche Pharma, including research sites in Basel, Nutley, Palo Alto, Penzberg and Shanghai. SCREENING - Trends in Drug Discovery talked to Dr. Lee Babiss about his experiences in his position and the Roche Research organization.
SCREENING: Could you please outline your personal career?
L. Babiss: Before I began my current role in July 2007 - I was Vice President, Preclinical Research and Development for Roche in Nutley, New Jersey, where I developed and directed the research strategies for Oncology, Metabolic diseases and Inflammation. Before joining Roche in 1998, I was vice president of Biological Sciences and Genetics at GlaxoWellcome where I helped to develop their drug discovery strategy in Oncology.
I was born and raised in New York and I graduated from Columbia University with a Ph.D. in Microbiology and Molecular Virology. Following postdoctoral training, I was an Assistant and then an Associate Professor of Molecular Cell Biology at The Rockefeller University in New York City.
What is special about working for Roche in comparison to other companies?
L. Babiss: I joined Roche because I was very passionate about the emerging area of personalized healthcare. Working at Glaxo from 1990 to 1998, I could see that there was a deficit in the ability to put a lot of our plans into action because we did not have the diagnostic know-how and component as part of the company. The unique combination of therapeutic and diagnostic units was a major motivation to join Roche. That and the chance to stay involved in all aspects of drug discovery - particularly in the areas - metabolism and oncology - that I enjoy working in most.
Which were your most influential decisions during your career?
L. Babiss: One very important decision for me was my transition from academia into the industry.
I made the decision at a time when it was not very popular to do that; academic colleagues viewed you as sort of "selling out" or being a failure. Personally, that attitude really motivated me to show that we could do great science and be innovative in Pharma - and that we could make a great difference for patients.
The other big decision was when I left Glaxo, which had been a great company for me. That's where I learned how to do drug discovery. But the opportunities at Roche and the culture that I discovered here leave me with no regrets whatsoever. I think my career has blossomed. And my ability to have an impact on drug discovery and to stay close to the science - which has been fostered at Roche - has been very important to me.
In your current position as Head of Roche's Global Pharma Research organization, what are your major duties and responsibilities?
L. Babiss: I'm privileged to lead a fairly large research organization that is focused on five, what we call, Disease Biology Areas. We have close to 3,000 scientists supporting these endeavors in CNS, Virology, Oncology, Metabolism and Inflammation. I coordinate, facilitate and oversee the Discovery Heads for these organizations. We have a large portfolio of programs that we need to progress and bring into the clinic for validation of our pre-clinical ideas.
In the research organization, we also have a number of global functions that support our disease area biologists with excellence in everything we do, from chemistry and discovery technologies to Non-Clinical Safety and formulation work - all the aspects required to do drug discovery.
We are, I think, one of the companies that are best-positioned for success, not only in small molecules and therapeutic proteins, but also in the emerging area of RNAi therapeutics, where Roche has made a significant commitment.
Along with my Research Leadership Team I'm also focused on leading the research organization's efforts in a number of other areas ranging from building a world-class research organization in China to ensuring that we help drive Roche's leadership in personalized healthcare. Everything that we do is driven by the science, and as long as we stay true to that, I think that we can and will be very successful.
In 2007 Roche restructured its global R&D activities. What changed through restructuring?
L. Babiss: One consequence has been, as I mentioned earlier, a stronger focus in certain Disease Biology Areas that helps our scientists know where we should focus and where we shouldn't, and that's always important when you have limited resources.
But the biggest and the most important aspect of the model has been about creating a whole new area of clinical research and exploratory development. This was lacking in our company. Taking a Phase III registration trial mentality to do Phase I studies, just doesn't work.
We also simplified or eliminated processes that were getting in the way of creativity; we put leadership teams in place for each disease area who now have the accountability to really take control and to run everything from target discovery all the way through clinical proof of concept. These teams include four senior leaders focused on discovery, clinical research and exploratory development, development and strategic marketing.
So far, what have been the advantages of the new model?
L. Babiss: We're a year and a half into this, and I see strategies for the Disease Biology Areas that are superb. I see a lot of work being done on biomarkers and on exploratory development that would never have been done in the past. I see greater ownership of the portfolio amongst the five Disease Biology leadership teams. I think ownership and passion are two of the main drivers of our success. Having a day-to-day focus on the portfolio is going to be very important for us and drive our future success.
With Roche's research organized around five Disease Biology Areas in several locations around the world, how is knowledge sharing organized and assured?
L. Babiss: Again, science is the driver. What we're seeing today - through our work in systems biology both internally and predominantly outside of Roche - is that our understanding of disease biology and at the signaling level is telling us that many of our targets have applications not just in one, but in multiple diseases.
The leaders of our Disease Biology Areas recognize this and are often sharing knowledge and know-how, targets and expertise. This allows us look at targets which may have been thought to be important in oncology and think about them in terms of metabolism or inflammation.
Networking, knowledge sharing and engagement also come by way of having a strong Research Leadership Team. I think we have done a good job of creating a good balance between the activities that are ongoing in each of our Disease Biology Areas and across our global functions. We recognize that what we're trying to achieve as a research organization requires the contribution not only of the Disease Biology Areas, but also the functions and the administrative support. I believe a true culture of drug discovery is achieved when everyone is singularly focused on great science driven by a passion for discovering differentiated medicines.
What is your perspective of pharma industry?
L. Babiss: I think the pharma industry is at a crossroads in terms of the large number of products that will go generic. Clearly, there's going to be a tremendous loss of revenue during the next five years for the whole industry. That loss of revenue will translate to a lesser spend in R&D, which seems counterintuitive at a time when we need future products to drive future growth. That's the reality. We have to treat every program as being a precious part of our companies and do everything we can to drive those programs to success.
That being said, I think the smart companies are the ones that are not diversifying. I think the smart companies are being true to their business - investing appropriately to discover new, medically-differentiated healthcare products, because in the end that's what our business is about. To get into generics or other types of industries is not playing into our strength. Again, I believe good science from the labs to the clinic, thoughtfully executed, will help us to succeed.
What do you see as the future challenges of Pharma research in general?
L. Babiss: I think we have to accept that the world is changing around us. We have always had a vision where we believe we have and do great research internally. But we recognize there is great science around us. Roche has always been committed to partnering with both academia and biotech and even other large pharma companies when it makes sense to drive great science as we focus on drug discovery.
Much of the work that I do today in leading the research organization is to tap into the impressive and immense intellectual know-how that exists outside of our company. That includes contract research all the way through to innovative, leading-edge drug discovery. Our partnership with Alynlam and our recent acquisition of Mirus - all to help us accelerate our commitment to RNAi - are two of many examples I could cite.
That said, doing great science in our industry is not enough. When we do science we have make sure that we do it in a way that's focused on delivering a final product that serves an unmet medical need. If our role was just to create new knowledge then I think we are already a leader. But our role is to create an innovation in the form of new medicines. That's our business and that's where our scientists have to be disciplined.
How do you see the development of Roche Pharma in the next five years?
L. Babiss: From a research perspective, I see more of our work going in silico and more of our scientists' time being spent at a computer and less doing wet lab work. I think that's a good thing because that tells me that all of the vast information that we've created can now be nterrogated and we can do more and better prediction type of research.
But fundamentally, drug discovery is drug discovery - it still requires the brilliance of selecting the right target, coming up with the right hypothesis, and testing these in silico or in the wet lab environment and then ultimately testing those concepts in patients who are suffering with various diseases.