Within a decade since its inception, Kinexum has earned recognition as a distinguished resource for research, development, and commercialization of life science products. What major philosophies and goals drive Kinexum to provide the excellence it does today?
Kinexum owes its character and success to founder and Executive Chairman G. Alexander (“Zan”) Fleming, M.D., whom I sometimes half-jokingly refer to as a “rock star” in the life sciences regulatory world. Zan trained at Emory, Vanderbilt, and NIH, and was a senior reviewer at the US FDA, leading reviews of landmark approvals including the first statin, insulin analog and metformin.
From its original roots in regulatory and clinical development of small molecules for diabetes and other metabolic diseases, the firm has grown to assist over 300 companies to date from around the globe, respecting a range of therapeutic areas and modalities.
One of the things I bring to Kinexum is the clients’ perspective. Having been on the operating side, I have lived the pressures on many CEOs of our emerging company clients, who have to juggle the expectations of investors and manage a limited cash runway. So at Kinexum, we prioritize the following four things:
First, taking extreme ownership by stepping in the shoes of our clients – we are more than just domain experts and advisors; we are constructively members of our clients’ teams.
Second, striving for operational excellence, even if it’s just 1% better per project.
Third, practicing the “human touch,” treating clients, regulators, collaborators and others with whom we interact with respect, establishing ethos, then pathos, before pressing logos (after Aristotle/St. Thomas Aquinas/Stephen Covey).
Lastly, doing our part to advance translational science to accelerate useful products for patients.
Mr. Seoh, you’ve been appointed as the new CEO at Kinexum this past April. What about the organization drew you to become a prospective leader and key member in the company’s business endeavors?
Zan and I actually met a decade and a half ago. We share a mutual mentor, Leigh Thompson, M.D., Ph.D., former Chief Scientific Officer of Eli Lilly, whom I came to know when Leigh joined the board of Guilford Pharmaceuticals, where I was working. Kinexum organized a couple conferences in Leigh’s honor that I was privileged to attend.
We then went our separate ways until last fall, when I published a blog post on lean start-up methodologies in life science start-ups. Zan responded warmly. We started talking about my joining Kinexum to supplement its consulting services with my background in corporate strategy and corporate development, but our discussion broadened to building the Kinexum institution and brand. A few months later, I came on board as CEO.
What attracted me about Kinexum was the prospect of working with Zan and his band of experts, who typically have decades of experience in regulatory agencies, industry and/or academia, and share a mutual respect and collegiality for each others’ expertise and skills, as well as a commitment to help accelerate medical products to patients. What was particularly intriguing was that the firm had grown primarily by word-of-mouth, so I am really curious what we can do with concerted new practice development.
Examples of projects I’ve been involved with in just these first months include preparing and filing an IND within an extremely compressed period of about 30 days for a Korean company that is bringing its small molecule clinical program to the U.S.; conducting the Human Factors testing for a medical device for which a European client wants to file a 510(k) clearance application; and helping Zan and his co-chair, Professor Larry Steinman of Stanford organize the World Congress on Metabesity that is to take place in London this October (www.metabesity2017.com), which will assemble world renowned scientists and their peers in policy and industry in a call to action for a “moonshot” program to develop common solutions to major non-communicable diseases of aging such as diabetes, neurodegenerative disease and cancer.
You’ve had ample experience and previous titles in entrepreneurship, including your roles as President and CEO at Eqalix, Inc., President at NexGen Medical Systems, Inc., and CEO at Faust Pharmaceuticals S.A. prior to Kinexum. What would you say are the top three priority assets or skill sets necessary for success in the life science industry?
A simple answer might be money, a product that is safe, effective and clinically and commercially relevant, and people who know what they are doing. But I would offer three critical mindsets:
One, a focus on customer benefits, as well as technical features. The life science business involves making a business out of life sciences. Thus, while technology characterizes the business, the success or failure of the business depends on a clear demonstration of benefits for the customers (patients, payers, healthcare providers, etc.). Like any business, it doesn’t matter how good the mousetrap is, customers have to reject alternatives to buy your mousetrap in sufficient volumes at a sufficient profit, or you’ve failed.
Two, perseverance and belief, tempered by evidence. Drug and other medical product development is a highly regulated space, the things that have to go right are complex and interdependent, and it practically always takes longer and costs more than expected. To succeed, one has to be patient, persistent and resilient, so passion and belief are critical. At the same time, Nobel Laureate physicist Richard Feynman once said something like it’s easy to fool ourselves, and science is the best way humans have come up with to help us not to fool ourselves. So I advise entrepreneurs to hold an unshakeable belief in the purpose of helping patients, but don’t live or die by a specific technology or approach, which has to be assessed by the best available scientific evidence.
Three, risk management. Life science product development is basically buying a series of real options. A business case must justify staking an amount of money to buy a card to turn over, to use a poker analogy. Depending on the learnings, you buy another card, or cash in. Entrepreneurs should be extremely careful about ‘going all in’ based on one set of cards. Rather, buy meaningful incremental sets of cards and be ready to pivot based on the results.
Before pursuing entrepreneurship in pharmaceuticals, you formerly studied law and proceeded to become a corporate attorney. What compelled you to work within the medical industry?
I wish I could tell you that where I am today is the result of a decades-long strategic plan. But in fact, I kind of fell into life sciences, and before that, into law.
My initial intended major as a college freshman was cosmology, but I ended up studying philosophy and history and going to law school with the intention of becoming a jurisprude. I ended up practicing corporate law in New York and London, then going in-house as General Counsel at a couple companies, including a mid-size pharma in Orange County. There, I got exposed to the La Jolla biotech beach culture, read The Billion Dollar Molecule, landed a job at Guilford in Baltimore, and I was on my way.
WKMJ has readers from over 10 countries globally. Please share your final words or thoughts our readers.
First, I am very honored to be included among the company of other entrepreneurial interviewees of your publication, and thank you for your interest.
We live in fascinating times, with the explosion of scientific knowledge and technologies that are revolutionizing human health. At the same time, I see fundamental innovations in business models, for instance the emergence of lean start-up methodology and de-complexification of many previously multipart activities, such as by Amazon, Uber and Airbnb.
This is particularly promising for your global readership, because I believe that there will be increasing ‘democratization’ of the life science product development process. Countries and companies around the globe have a ‘third generation subway’ opportunity to leapfrog current discovery, development, regulatory and commercialization models to better serve human health.
Thomas Seoh, J.D.
President and Chief Executive Officer, Kinexum
Thomas Seoh, J.D. is the current President and CEO of Kinexum, a distinguished resource for research, development and commercialization of life science products. Mr. Seoh is a life sciences executive and entrepreneur with ample experience and functional expertise in corporate and business development and law. His previous titles in entrepreneurship include his roles as President and CEO at Eqalix, Inc., President at NexGen Medical Systems, Inc., and CEO at Faust Pharmaceuticals S.A. prior to his current occupation at Kinexum. With a fervor for start-up and emerging companies, Mr. Seoh has held senior and leadership positions in public and private biotech, pharmaceutical, medtech and other companies. In addition, he has been and continues to act as an invaluable advisor to academic teams on commercializing their research.