By Rob Wright, Chief Editor, Life Science Leader
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I first met Glenn Gormley, M.D., Ph.D., at the 2014 PhRMA’s (Pharmaceutical Research and Manufacturers of America) annual meeting in Washington, D.C. At the time, I was engaged in a conversation with James (Mit) Spears, EVP and general counsel for PhRMA, and so my discussion with Dr. Gormley was brief. However, our encounter reminded me of an idea I once had for doing an article about Daiichi Sankyo. Though the company has a lengthy history, it had little experience in the area of oncology R&D. As Gormley is the senior executive officer and global head of R&D at Daiichi Sankyo Co., Ltd., as well as chairman of the board, executive chairman and president of Daiichi Sankyo, Inc, I thought perhaps he could share some insight on the company’s approach to entering into the field of developing cancer therapeutics. We conducted our formal interview on June 30, 2014. It resulted in the September 2014 Life Science Leader magazine cover feature — How Daiichi Sankyo Is Venturing Into The Unfamiliar Terrain Of Oncology R&D.
As is my custom, I provide interviewees with questions in advance to guide our discussion. After an article is published, it is rare for me to revisit these questions. Further, it is unheard of for me to receive legally approved written responses to my interview questions — especially after an article is complete. But with Glenn Gormley, I have come to expect the unexpected. What follows are the previously unpublished written responses to my interview questions, which serve to shed additional insight into Daiichi Sankyo’s approach to entering the field of oncology drug development.
Life Science Leader (LSL): Prior to 2011, Daiichi Sanko had very little oncology drug development experience. Explain the company’s approach toward moving this from a minor to a major therapeutic category and why?
Gormley: Daiichi Sankyo does have a strong 100 year history of developing innovative therapeutics, with a strong focus on infectious disease and cardiovascular disease. But we do have two other major areas of focus, and this reflects our recognition of significant unmet medical needs of people across the world – those two areas being oncology and frontier opportunities. I have a long history in the field of oncology, both in my academic career and my pharma career and I believe this influenced my personal commitment to the field and comfort moving the organization in this direction. Our approach has been focused on partnerships and acquisition with small biotech oncology companies.
LSL: Daiichi Sankyo made two strategic acquisitions toward entering the field of oncology R&D (U3 Pharma 2008 and Plexxikon 2011). Explain the process of assessing these companies for acquisition?
Gormley: We of course look at the science and any novel, underlying technology used by other companies that would offer us the opportunity to develop new treatments. We like to partner with smaller companies because they tend to have highly innovative cultures, can be very willing to move quickly, and willing to take on calculated risk. These are all qualities we need to develop more at Daiichi Sankyo. Arqule, U3 and later Plexxikon all brought unique opportunities and highly talented people in close contact with our scientists, I hope for the benefit of everyone. We also should not forget our successful partnership with Amgen on Denosumab and the development of that compound for SRE in cancer and osteoporosis in Japan.
LSL: What best business practices can be learned from the Plexxikon acquisition?
Gormley: We made a decision early on that we would let Plexxikon operate in a highly independent way as long as the exceptional productivity could be sustained. This is a strong philosophical approach I bring to the organization based on my experiences as the CEO of a biotech company. We believe that our willingness to allow our small oncology partners the freedom to maintain their unique culture of innovation contributes to making us a partner of choice.
LSL: Though you were at Gemin X Pharmaceuticals at the time of the Daiichi Sankyo U3 acquisition (June 2008) did this acquisition play a role in your decision to join the company, and if so, how and why?
Gormley: My decision to join Daiichi Sankyo was based on many factors, including the people, the pipeline and the philosophy of our company. As the CEO of GeminX, a small venture backed oncology company, I understood perhaps in a unique way, the importance of the U3 acquisition and the ArQule partnership to the success of Daiichi Sankyo and its approach to partnerships.
LSL: What were the biggest internal and external challenges which had to be overcome in moving a Japanese based company known for CV drugs toward oncology therapeutics?
Gormley: The commitment to strengthen our research and development into Oncology was a natural extension of our company’s commitment to innovation. But I would say one of the challenges around moving into oncology would be getting the organization more comfortable with risk-taking in a field where a high level of uncertainty exists. We also had to take a hard look at our processes, because in cancer research, we had to be quicker in our decision making. We put into place a governance structure which empowers teams to make decisions and minimizes the reporting bureaucracy. Project teams report directly to GEMRAD, our single decision making body. We also realized early on that in order to be successful in oncology, we needed to expand our biologics capabilities to capitalize on the explosion of innovation associated with large molecules. One of the ways we did this was to bring all the biologics expertise together into a single biologics oversight function.
LSL: How were these challenges overcome?
Gormley: We built strong teams and partnerships and put a structure into place where there is strong governance and empowerment.
LSL: What key lessons were learned for what worked well, as well as what would be done differently?
Gormley: What worked well was that we engaged our stakeholders early on to gain their views and input – that included both internal and external stakeholders. Also, there was early agreement that we needed a biomarker strategy and objective. What could have been done differently? I think it is too early in our strategy to know what we could do differently. R&D is a long process and it takes time to see the impact of changes in approach and structure. One observation I have made across our industry is that some organizations seem to be in perpetual change and reorganization without giving the process time to work. At Daiichi Sankyo we make careful decisions to change and we have the patience to see the impact.
LSL: Describe the role played by strategic academic/business partnerships in creating an oncology pipeline.
Gormley: We rely on strategic academic partnerships as an important mechanism to bring new thinking and challenge to our teams. We look for organizations with a similar philosophy of partnership and openness and a track record for unconventional thinking and success. Two recent examples include our partnership with Sanford Burnham and with UCSF Institute for Neurodegenerative Diseases (IND). These are both important collaborations focused on important unmet medical needs.
LSL: The bulk of Daiichi Sankyo’s R&D facilities reside outside of the U.S. What roadblock does this present toward the company’s U.S. drug development and how are these overcome?
Gormley: Our global R&D organization has research or development sites located in many countries including Japan, US (San Francisco and NJ) , the UK, Germany, India, China, Korea and Taiwan, We work as global, empowered teams utilizing our talent across the globe wherever is it located. This diversity is an asset - not a roadblock to our success
LSL: Conversely, how do you intend to improve R&D oncology development in the U.S.?
Gormley: We have a strong clinical development presence in the US and of course, Plexxikon is our research engine in the US. But our goal is not to focus on the US, the goal is to have access to global talent internally and externally.
LSL: In April 2013, Daiichi Sankyo created Venture Science Laboratories (VSL). Why? Where based? What role does it play in oncology? What, if any, model was used as a framework for creating VSL?
Gormley: I believe there is a perception in the Pharma industry that a biotech mindset that drives innovation cannot be found within big Pharma companies. I wanted to challenge that perception and create a unique innovative culture within Daiichi Sankyo’s research organization with many of the same characteristics of a small biotech company. VSL consists of a small group of talented individuals with an entrepreneurial spirit who are willing to challenge everything we do and how we do it. The group is based in Tokyo, working right alongside the rest of our R&D organization. I intentionally resisted the idea that isolation from our broader R&D culture was necessary. In fact, I want both cultures to mix and learn from each other, not to be isolated. Our broader R&D culture is already highly innovative and committed to new ideas and new ways of working. But VSL naturally is developing its own somewhat different culture. I am looking for synergy, not isolation.
The VSL group started with a blank slate to generate and execute ideas that would create innovative first in class medicines. They were not given direction on what to work on, who to collaborate with or how to work. But there was one condition: everything they choose to do had to be in partnership with an academic organization willing to partner in the discovery of important new medicines. They were also given only a small “startup” budget with the commitment that more funding would be provided if the quality of the projects justified the investment. They needed to prove the value of their ideas, since there were no entitlements. This is essentially a start-up company model within a large, established company. They are not focused specifically on oncology, but of course, many innovative ideas are generated around oncology.
LSL: A journal article describes most of Daiichi Sankyo’s oncology projects in development as targeted for growth and survival signals of cancer cells and selective inhibitors in three major clusters of signal pathways. Why take this approach?
Gormley: Growth and survival signal pathways are critical mechanisms that cancer cells use to invade the host and avoid or disable the naturally occurring surveillance systems of our immune system. They represent rich targets for finding new ways to treat and control cancer. They are not the only areas of interest but we believe they have great potential to create new effective medicines.
LSL: How has Daiichi Sankyo been utilizing social media toward the development of its oncology pipeline?
Gormley: Social media has great potential, but we are mindful of the lack of final guidance from regulatory agencies around its use in clinical trials. Although not social media, we are exploring the use of new technology, and have recently launched an app for one of our trials, as a tool for investigational site staff to use. The app demonstrates various protocol related procedures and topics with an FAQ. So far, it has been well received.