IA-Forum: A number of important and fast paced scientific advancements are progressing in the biotech field. How is this affecting the pharmaceutical industry?
Dr. Devyn Smith: This is an exciting time. In 2001, the human genome was sequenced. And now, 15 years on, we’re really beginning to see the benefits of this scientific breakthrough with multiple drugs that target specific mutations in diseases like cancer. In addition, there are many new, innovative technologies that are emerging driven by increased investment in basic science from entities like the NIH and private disease focused foundations. For example, at Sigilon, the company I recently joined, we are utilizing new technology that prevents the rejection of implanted materials or implanted cells in the body, a problem that has plagued medical practice for years. If a cell implant can be hidden from the immune system, missing proteins can be restored at more normal levels for long periods of time, creating a type of “living pill” to deliver biotherapeutics more effectively. We hope this will free patients from symptoms for a broad range of chronic diseases that are not adequately treated today.
IA-Forum: Other external players, namely legislation and insurance, are also affecting the industry…
Dr. Smith: An important thing we’ve seen recently is a shift in the FDA. In 2012, the FDA added the designation, breakthrough therapy. This provides an accelerated path to being able to get to the clinic and to get approval. That has been a big bump for the industry and that has been positive. This has been mirrored by other regulatory agencies around the world.
However, there are some headwinds for the industry from insurance companies as well as unknowns around the future of the Affordable Care Act.
IA-Forum: Would you talk a little bit about challenges that are presented when developing a new drug, from R&D up to bringing it to market?
Dr. Smith: The latest cost estimate is approximately $2 billion is required to get a drug to market which includes all the failures that occur along the way. The problem is the high attrition rates in drug discovery. For example, if you start 10,000 putative drugs in early development, by the time you get to the clinic, you’re probably down to 100 putative drugs remaining. After 10-15 years, you are down to the launch of a single drug from the 10,000 you started with. The pharmaceutical industry is very different from a lot of other industries in that perspective. The one industry that’s probably similar is oil and gas, where billions of dollars are spent in the deep-sea drilling trying to find oil pockets.
IA-Forum: An expanding technical area that affects the pharmaceutical industry is big data. How is the industry embracing it?
Dr. Smith: I think that’s one of the big benefits that have come in the last decade from the tech side. Suddenly, there’s all this human genome data, where you can generate more human genome data in a week than you probably could in ten years back in the ‘90s. Consequently, there are massive amounts of data, but if the tools to do some analytics with the data aren’t there, the data is useless. However, there are some nice tools that allow the industry to utilize big data to improve processes and output. Watch this space as it is rapidly evolving.
IA-Forum: You have worked in the United States and overseas. Do you feel that your international experience has been an asset?
Dr. Smith: Absolutely. I think that understanding other cultures and the different approaches to leadership and decision making has really strengthened my strategic and leadership skills. In particular, I learned a lot about the importance of culture to the success of an organization. Getting exposed to other cultures and expanding your breadth and depth helps you to think differently about strategies, because you’ve got a much broader view of the world.
IA-Forum: At a high level, what key elements would you say are necessary for an effective strategy?
Dr. Smith: I think you need to understand the environment you’re working in and what that environment is going to look like five years from now. From there, it’s crucial to understand what are your core competencies are today, and what you hope they’ll be in the future – in essence, your vision. Once you’ve got an understanding of where you want to go, and where the environment’s going, then it’s a matter of building out a strategy that allows you to execute on that vision. Identifying the investment and resources required for execution is an important part of making a strategy a success.
Devyn recently joined Sigilon, a biotechnology company, as its Chief Operating Officer tasked with building out strategy and operational elements of the company as it builds a portfolio of potential new medicines. Prior to Sigilon, Devyn was part of Pfizer's Medicinal Sciences Division of R&D as Head of Business Operations & Strategy. The focus of this role was both day to day business operations of the division, as well insuring implementable strategies were developed. Medicinal Sciences encompasses the groups focused on discovery, formulation, and early manufacturing of the large molecule, small molecule, cell and gene therapy programs in Pfizer R&D. Prior to this Devyn was Head of Strategy for the Pharmatherapeutics Division of Pfizer R&D focused on developing and implementing core strategies in Winning by Design in Small Molecules as well as optimizing the ROI on novel technology inventions. Before this role, Devyn was part of Pfizer's Neusentis Research Unit in the UK as Chief Operating Officer responsible for strategy, operations and implementing key strategies. In addition, he supported the Pharmatherapeutics Global Clinical Research Organization as the Chief Operating Officer. He joined Pfizer's Strategic Management Group in August 2009.
Prior to joining Pfizer, Devyn was a principal for The Frankel Group (a boutique management consulting firm in New York City and Cambridge). In his consulting experience, Devyn led a wide range of projects, across multiple therapeutic areas and a host of technology platforms, including basic R&D tools, regenerative medicine, gene therapy, and macromolecules/biologic products. Client relationships have ranged from large pharma to small biotech companies. Regenerative Medicine has been an area of strong focus with over 30 engagements, several published papers, and numerous invited conference presentations. Prior to joining The Frankel Group, Devyn worked as a management consultant at Adventis Corporation focused on clients in information intensive companies.
Devyn received his Ph.D. in Genetics from Harvard Medical School where his research culminated in 12 publications in leading journals such as Cell, Nature, and Development. He also holds an MS in Biology from Idaho State University and a BS in Zoology from Brigham Young University.
Dr. Smith will be the keynote speaker at next month's Association for Strategic Planning Annual Conference.