The Future Of Pharma: A Q&A With Dr. Steven Projan of Novartis

Dr. Steven Projan, VP and head of global infectious diseases at the Novartis Institute for Biomedical Research (NIBR), always wanted to be a scientist. After determining that math was “too easy” and chemistry was “too dangerous,” Dr. Projan attended M.I.T. as an undergraduate biology major. He received a Ph.D. in molecular genetics from Columbia University and joined the New York Public Health Institute as a postdoctoral fellow. He subsequently became a staff member at the Institute and remained there for 10 years as a fully funded, independent investigator.

During this time, Dr. Projan realized that while he thoroughly enjoyed doing basic research, he wanted to apply what he had learned to discovering new drugs that address “unmet medical needs.” This realization prompted him to join American Cyanamid’s Lederle Laboratories (now Wyeth Pharmaceuticals) in the early 1990s as a group leader for antibacterial research.

Shortly after arriving at Lederle Laboratories, Dr. Projan inherited the glycylcycline antibiotic research program, which ultimately became an approved product called Tygacil (tigecycline) — one of only a handful of new antibiotics to make it to market in the past 30 years. In 2006, he was named VP of biological technologies at Wyeth, charged with building a protein discovery group. He left Wyeth in late 2008 to assume his current position at NIBR. I was able to catch up with Dr. Projan and discuss his views on the pharmaceutical industry and its future.

Life Science Leader (LSL): Much has been written about the demise of the so-called ‘blockbuster drug model’ in the pharmaceutical industry. Is the blockbuster drug really dead?

Projan: No, the blockbuster drug is not dead! During the past decade, the pharmaceutical industry lost sight of its primary mission, which is to discover new drugs to meet unmet medical needs. Too often, because of increasingly stringent regulatory requirements and a high ROI for certain classes of molecules (e.g. proton pump inhibitors and statins), pharmaceutical companies chose to develop so-called ‘copycat’ drugs rather than invest in new drug discovery. In today’s environment, NMEs (new molecular entities) that represent only incremental changes in extant therapies will not gain regulatory approval nor command the revenues they once did.

A good example of a therapeutic area that continues to grow and where there are substantial unmet medical needs is Alzheimer’s disease. At present, the most effective treatment we have for Alzheimer’s disease is Aricept — a palliative medication that doesn’t slow the actual progression of disease. Companies that place the needs of their patients first and also empower scientists and clinicians who understand the size and scope of current unmet medical needs will be the ones to develop tomorrow’s ‘blockbusters.’

LSL: Many pharmaceutical companies that weren’t early adopters of biotechnology are now scrambling to get into the biotechnology business and seem to be betting their futures on it. What are your views on the role that biotechnology may play in shaping the pharmaceutical companies of the future?

Projan: Small molecules still have their place in the industry, but they may not always be the best molecule to develop for certain therapeutic targets. Companies that possess diverse capabilities (e.g. expertise in both small molecules and biotechnology) will likely be the companies that succeed in the future. While many companies are looking to biotechnology to help their bottom lines, it is not a panacea for the pharmaceutical industry. What’s going to save the industry, which admittedly is struggling now, is a return to the principle that places the patient first. If a company is truly serious about addressing unmet medical needs, it cannot close the door on any technology (like biotechnology) that can be used to fulfill those needs. But, as a word of caution, if a company decides to get into biotechnology, it better allocate sufficient monies and hire the right people so its investment pays off. In my experience, it is never a technology, but the talent of the people hired by a company, that determines whether or not a company will be successful.

LSL: Empty pipelines and a desire to get into biotechnology are forcing many pharmaceutical companies to look outside of their own organizations to find novel NMEs and acquire new technologies. Do you think the nature of the relationships between pharma and its academic and biotechnology partners will change in the future to accommodate this change?

Projan: The relationships between pharma and academia have always been strong and productive. We have long recognized that the success of our industry depends upon our ability to forge strong relationships with academic institutions. We need these relationships to gain insights and access to cutting-edge basic research which, by the way, is the lifeblood of our industry. While establishing these relationships is slightly more challenging than in the past, I think pharma will continue to establish close relationships with appropriate academic partners.

Historically, pharma’s relationship with the biotechnology industry has always been challenging. Many past relationships were less than ideal because pharma companies invariably assumed leadership roles after making large financial investments into the companies they partnered with. However, I think the dynamics of these relationships are changing, mostly because many biotechnology companies are now financially sound. In the future, we will likely see more innovative collaborations between pharma and biotech companies where there is a greater shared risk during the postdiscovery and early-development stages for NMEs. Of course, some pharmaceutical companies may elect to buy — rather than partner with — protein therapeutic companies to enter the biotechnology space.

LSL: For the past five years or so, many U.S. pharmaceutical companies have been steadily laying off R&D scientists. This seems paradoxical to me, because discovering new drugs is what keeps pharmaceutical companies in business. How will pharmaceutical companies continue to fill drug pipelines if they continue to eliminate R&D personnel?

Projan: I believe eliminating or laying off R&D personnel is a trend that isn’t good for the industry. In my opinion, you can’t discover drugs with technology alone — you need talented, experienced people to optimize the process. Many U.S. companies have attempted to fill the void (and cut costs) by offshoring or outsourcing many of their R&D activities. While this may be a cost-effective strategy in the short term, it may actually wind up costing a company more because, in my experience, managing operations or doing business with outsourcing partners in Asia and elsewhere is labor-intensive and extremely time-consuming. I believe drug discovery is more of an art than a science. And, as I previously stated, the ROI on discovery operations will be minimal unless the work is performed by talented and experienced R&D personnel. By way of an analogy, I personally wouldn’t hire house painters to paint the Mona Lisa.

LSL: Which therapeutic areas represent future opportunities for the pharmaceutical industry?

Projan: Opportunity can be found in the areas of regenerative medicine, including spinal cord injuries, connective tissue disorders, bone healing, and diseases of aging like Alzheimer’s disease. While embryonic stem cell research gets a lot of publicity, the pharmaceutical products of the future will likely focus on adult stem cells.

I also believe that there will be a renewed interest and emphasis on infectious diseases research. These diseases still cause unacceptable levels of morbidity and mortality on a worldwide basis. Our growing understanding of the contribution of viruses to pathogenesis of chronic diseases like multiple sclerosis and cervical cancer will undoubtedly rekindle interest in this area. Finally, the development of drugs to treat cardiovascular disease, hypertension, and psychiatric illness will slow — although there is room for improvement in some of these areas.

LSL: Do you think the current financial crisis will have a lasting effect on the U.S. pharmaceutical and biotechnology industries?

Projan: Both industries have successfully weathered economic downturns in the recent past, but I don’t think either industry has been impacted as much as the automobile and banking industries. The lack of strong, consistent leadership at FDA for the past eight years has made it very challenging and difficult to get new drugs approved in a timely fashion. The new administration is smart enough to understand that investment into biomedical research is good for society and business/economy. Hopefully, after the U.S. involvement in Iraq ends (or at least is greatly curtailed), the government will be able to restore adequate levels of funding for academic research.

LSL: If we fast-forward 10 years, will the pharmaceutical companies of the future look any different from what they do today?

Projan: Unlike some of my colleagues, I think the pharmaceutical companies of the future will pretty much resemble today’s companies. There will likely be a greater reliance on offshoring and outsourcing, and more emphasis will be placed on infectious diseases, regenerative medicine, and diseases of aging. Also, we may see an increase in the number of scientists and physicians who assume the role of CEO for these companies. In my opinion, it is extremely difficult for corporate executives without medical or scientific backgrounds to make strategic decisions that are in the best interests of a pharmaceutical company and its stakeholders. That is one of the reasons why I left Wyeth to join Novartis — Dan Vasella, Novartis’ CEO, is a physician.

Despite current negative perceptions, pharmaceutical companies have had an enormous positive impact on people’s health for the past hundred years or so. For example, at the turn of the 20th century, the life expectancy for most Americans was 47 years of age — it is now 78. During that same time period, the pharmaceutical industry invested 17% of its revenues into R&D to develop new drugs and treatments for patients with unmet medical needs. Just once, I would like to hear someone say thank you for a job well done! Despite what many naysayers think, I truly believe there is a plethora of new drugs to be discovered in the future if pharmaceutical companies continue to put the patient first!