The Lynch-pin

The entrepreneur responsible for much of the area's biomedical footprint wants a stronger statewide voice [From the May/June issue of Nashville Post magazine]

It all started in a Harvard library.

Samuel Lynch, embarking on doctoral work at the Massachusetts university in the 1980s, agreed to some free labor – hitting the books to help an oncology researcher advance his side project on wound healing.

One thing led to another. The initial research progressed to further studies. Discoveries led to patents.

Decades later, the work conducted over 10 years in that Harvard laboratory formed the foundation for Franklin-based publicly traded biotechnology company BioMimetic Therapeutics Inc., which has successfully developed and sold the rights to one bone regeneration product, is advancing through the FDA approval process for its second, and is developing a pipeline for the future.

That's not to say Lynch's path from library stacks to CEO suite was either linear or easy. Lacking a business background, Lynch was unable to launch the company straight from his Harvard roots.

"People I'd ask to invest in the company would say, 'It looks like you're a good researcher, a great scientist and maybe a good clinician and doctor – but you have no experience running a company,'" he says.

So Lynch left academia to spend more than four years working for a pharmaceutical firm. It wasn't until 2001 that he'd secured the pile of necessary patent rights – including those tied up in a failed business venture by his former research partner – and landed the $8.5 million in venture backing needed to start BioMimetic. Since then, his company has raised nearly $200 million through venture funding, equity financings and its 2006 initial public offering.

Lynch recently spoke with Nashville Post about entering the business world from academia and the challenges of starting and building a biotechnology company in Middle Tennessee.

Was it difficult to transition from academia to business?

It's an enormous change in your mindset and priorities. To many academic researchers and professors, entrepreneurship and developing something to be sold is almost like a dirty word, a tainted concept.
[In business,] you have investors and an obligation to create value, and they don't really care how many publications in Science or Nature you have – they want to know if you can develop a product that can be sold, or at least developed to a point where some other big pharma or biotech company might buy you.

What were the greatest challenges you faced in launching BioMimetic, and what advice would you give to others starting out?

Certainly, the first was gaining the adequate amount of investment needed to start and build the company. A large number of early-stage venture companies fail because they lack sufficient capitalization. So the first thing you've got to be able to do is raise a lot of money -- tens of millions of dollars -- because it's just not possible, at least not in the biomedical area, to really grow a company without a significant investment.

Once you get the funding and once you have the technology, you've got to be able to recruit a strong team of experienced professionals. For us, that also meant that we needed to have adequate facilities. When we moved to Middle Tennessee, there were no facilities for biomedical companies, and there were virtually no people here with  experience in developing drugs and devices, and certainly not a combination drug/device product. So you've got to be a good recruiter, and you've got to be able to sell your idea not only to investors, but to very strong, experienced professionals.

The FDA approval process has become more rigorous in recent years. How has that impacted BioMimetic?

Well, it's extending the timelines and, again, the amount of money it takes to be successful in your product development efforts. The FDA has become, just over the last two or three years, much more conservative and slower in their responses.

In 2005, we would have projected to have our lead orthopedic product [Augment] on the market by now; instead, we're in the final phases of filing the FDA review and approval.

You've been involved in trying to promote Middle Tennessee as a destination for life sciences companies. How do you view the prospects for building the industry locally?

I'd say one of the main things we need is a much stronger statewide advocacy organization for the industry. We really don't have a good voice for the biomedical industry across the state. Because of that, we've got a lot of individual voices and individual companies, but we don't come together well to explain what we do and provide compelling economic arguments for why the industry should be promoted.