1. 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 must 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.
2. 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 other’s 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.
3. 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 are 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.
4. 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.
5. WKMJ has readers from over 10 countries
globally. Please share your final words or thoughts ur 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.