5 Questions with Thomas “Tommy” Miller, Esq., Senior Counsel and Life Science Lead, Nixon Gwilt Law

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions with Thomas “Tommy” Miller, Esq., Senior Counsel and Life Science Lead, Nixon Gwilt Law.

Thomas (“Tommy”) Miller, Esq., is Senior Counsel and Life Science Lead at Nixon Gwilt Law and is licensed in Virginia, Washington, D.C., and Maryland. Tommy has supported innovation and served clients in the healthcare and life science industries for over 10 years.

Having represented healthcare providers and suppliers on a wide range of payment, reimbursement, compliance, fraud, abuse, and privacy matters, Tommy has gained a deep, practical understanding of the barriers providers face in adopting new technologies.

Tommy took this insight and served as in-house counsel with a global pharmaceutical company where he partnered with the business and learned to “walk in their shoes” on key initiatives in developing and commercializing new and existing drug products. Tommy currently provides a full range of outside general counsel support to FDA regulated clients who manufacture and distribute medical devices and pharmaceutical products.

As the lead of Nixon Gwilt Law’s life science practice, Tommy is partnering with a growing number of startup and established medical device, pharmaceutical, and life science support companies to develop and execute strategic goals. Tommy applies his deep understanding of applicable laws and regulations to his FDA-regulated clients’ business pressures from entity formation to product marketing review.

1. Please introduce yourself to our audience with a look back on your career.

I always knew I wanted to practice law in a healthcare-related field.  I spent a good portion of my time in law school writing on healthcare topics and even clerked with the Centers for Medicare and Medicaid Services, Hearings Office. 

Legal work can be dry, and often times you can leave work feeling like you did not contribute much to society.  Focusing on healthcare and how innovative laws, policies, and thoughtful regulation, can make healthcare better makes me feel like the work I do contributes to that greater good.    

When I look at how I focus my practice, I really try to identify clients with really interesting innovative solutions to the healthcare delivery system here in the US.  I think that is what drew me specifically to the life science and biotech industry.  People in this industry are smart, they think creatively, and generally have a passion for helping others.  When I am able to advise these types of people and the companies they run, I get to be a part of that passion.

I have been able to advise and work closely with inventors and business leaders and help launch so many life-changing solutions.  When I see these companies recognized in trade journals, win innovator awards, and enjoy year over year sales growth – I know that my job as a legal professional and business advisor has paid off.

2. You’re currently with Nixon Gwilt Law as a Senior Counsel, Life Science Lead. Explain your responsibilities and how it’s different from previous roles?

At Nixon Gwilt, we focus exclusively on healthcare innovators in three main buckets: providers, digital health, and life sciences.  When I came to NGL, the firm’s existing clients were beginning to explore areas that blended care delivery and medical technology in ways that may subject them to FDA (and other) legal and regulatory requirements.  Since I have been here, I have served those needs and work with many new companies focusing on pharmaceutical and medical device development, manufacturing, supply chain logistics, and digital therapeutics. 

Unlike other roles I have had, I have had the opportunity to shape how we as a firm talk to these clients about the role of the FDA and how it differs from, but is often a supplement to, the usual reimbursement conversations focused on CMS and other payors. I have the opportunity now, more than ever, to advocate with agency leadership and engage with industry CEOs and founders to help them navigate the various paths that their business can take – all with a focus on how the regulatory obstacles compare to the potential revenue streams.   

Because we approach client work as a team, I also get to play the role of outside general counsel to a lot of up-and-coming start-up companies.  These companies move fast, shift to market pressures, and look for innovative ways to grow market share and revenue.  I rely on my colleagues’ experience and individual expertise to serve our life science clients with other needs outside of the FDA specific legal and regulatory issues.  The collaboration, seamless interactions with colleagues, and the opportunity to really push healthcare innovation make my work at NGL truly differentiated from other positions I have held.

3. Nixon Gwilt Law is focused exclusively on healthcare. Why do you feel it’s important to be focused on this space?

It should be no surprise that the healthcare and life science industries are one of, and I would argue, are, the most highly regulated industries in the US.  Anyone who wants to develop a drug product, a device or healthcare software in the US must navigate through several federal legal frameworks and individual state-level legal frameworks.  Some federal or state statutory scheme regulates everything from manufacturing, distribution, quality control, and payment methodologies.  All of this is on top of the general corporate legal work that any business must do – like business contracting, entity governance, and intellectual property protection. 

Being an experienced life science and healthcare attorney allows me to advise clients through routine and challenging business decisions with a constant awareness of how those business decisions will implicate licensure laws, fraud and abuse claims, agency approvals, quality control, and distribution plans, and other healthcare-specific issues.  There is nothing worse than getting a new client that used a friend of a friend lawyer to get their business formed, only to realize that we have to restructure the business or rewrite a contract to bring the client into compliance with healthcare laws. 

If I can get a client started right, we can save time from the beginning and increase the speed to which that client can bring their new product to market.  That, to me, is worth spending most of my time reading and staying familiar with the ever-changing healthcare legal landscape.

4. How do you view the BioHealth Capital Region of Maryland, DC, and Virginia compared to other hubs around the country? What gaps do you see that we need to fill?

Many pharma companies already have a presence in the area for its proximity to DC and the access to policymakers and lobbyists. Just north of Maryland, in the northeast where biotech is flourishing, I think you find a lot more infrastructure dedicated to drug and biologic discovery and development. 

That is true in NC as well, where you also see many life science companies doing business.  These regions have attracted biotech businesses because of 1) the sheer volume of available talent coming from highly specialized educational institutions, 2) available lab and development space (also a product of world-class research from academia), and 3) friendlier business environments.

I grew up in Virginia, which has not traditionally been attractive to biotech companies to grow and flourish. More recently, I have seen many new and exciting programs that are making the BioHealth Capital Region a growing beacon from biotech innovation.  I work with a growing number of incubators, accelerators, and academic institutions that are really ramping up efforts to make Virginia, Maryland, and DC a place where life science and biotech companies can start, grow, and stay for the long term. 

I still think that there are some efforts that need to be made at the state policy level to increase access and collaboration among state universities to assist in the development of new drug candidates.  I think that new tax incentives, public infrastructure, and grants will also be needed to attract life science businesses to the region. 

Finally, and this is starting to change too, the funding firms, the VCs, the investor groups in the region – which are more familiar with real estate and commodity investing – need to familiarize themselves with life science companies and make more of a concerted effort to put money into new and growing life science and biotech companies. 

5. If You Could Learn Any One Skill in The World Without Trying, Which Would You Pick and Why?

I would want to be a piano aficionado.  I have always been in choral groups, so music is a big part of my life.  The one thing I could never turn that into is proficiency on any other instrument.  I think music has the ability to move people, set the mood, change your day. I go to many places and see an unused piano sitting in a corner or the lobby. 

Usually, people just pass it by and go on about their day.  I would love to be able to just stop what I am doing, sit down, and just play beautiful music – regardless of anyone, in particular, was listening.  I would just put my fingers on the keys and create something in a space that was not there before.  

Thank you to Thomas “Tommy” Miller, Esq. for participating in the ‘5 Questions with BioBuzz’ series. Stay tuned for more interviews with others from across the BioHealth Capital Region and beyond!

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