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The Big Leap from Academic to Entrepreneur

I’ve always wanted to develop new medicines. I grew up in New York City and studied at Princeton University, both hubs for the pharmaceutical industry, so drug discovery and development is something I have always revered as a profession and life mission. I have been fortunate to have a diverse and successful career, both in academia and as a drug developer in start-ups. A lot has changed since I started, and I’ve learned valuable lessons along the way. Here, I’ll give my view on some of the key factors for success for those looking to make the leap from academia to industry.

It’s very important that you do not underestimate the difference between the academic and industry approach. It takes years to understand how to create and develop drugs. To that end, my first piece of advice is not to start your own company right away, but to get involved in some other capacity and learn about how the creative and development processes work. In my academic career, I worked with scientists at Biogen to develop a therapeutic monoclonal antibody, 5c8, that I had generated and characterized at Columbia University as part of discovering the CD40 ligand. Being involved in drug development (on someone else’s nickel) helped me when I came to set up my first company (which became Vela Pharmaceuticals).

One of the big differences between academia and industry is that much of academia is about criticism, not discovery. That distinction isn’t restricted to the sciences – it also applies to the humanities like literature and art. Creative people, like writers and artists, have traditionally been outside of the Ivory Tower, while the academics on the inside write about them and their work. In discovery, there’s much more accountability – you have to make real progress, not just commentary that proves you are smart, erudite, witty or cruel. Of course, some academics make significant progress on problems, but in industry progress is a requirement and non-productive people cannot survive. For me, that is what makes working in a company so exciting.

When Donald Landry (a colleague) and I decided to start a company in 1996, the first question was, what should we work on? Don answered with another question: “What are the most important problems?” That question really crystallized what we both believe should be the cornerstone of our industry. Pursuing the most important problems has been the key driver for me in all of my endeavors, including my time in academia. In the 1980s and 1990s, I worked on AIDS, and later on autoimmunity and transplantation. I always wanted to tackle problems that lead to the greatest amount of human suffering, because I believe the satisfaction of ameliorating or solving problems is proportional to the need. I have carried that principle right through to the current work Tonix Pharmaceuticals is doing, for example, our new study in post-traumatic stress disorder (PTSD) patients. The “AtEase” study is recruiting subjects who are suffering from military-related PTSD. PTSD takes a huge toll on returning soldiers and their families and I believe that we are probably the world-leading firm in developing a therapeutic for PTSD at this point. We are very excited about the study, because of the potential to help people who have made so much personal sacrifice for our country.

Being ahead of your time is not always a positive. At Vela, one of our programs involved using very low-dose cyclobenzaprine as a bedtime treatment for fibromyalgia. At that time, a lot of doctors were skeptical that fibromyalgia was even a real condition. Despite very promising data, Vela dropped the program. Fifteen years later I’m still working on the same active ingredient and the same therapeutic concept in fibromyalgia. If something is important it’s usually very difficult. Important problems take a long time to solve.

And that brings me to my final piece of advice: be persistent! I was blocked from working on cyclobenzaprine for fibromyalgia after I left Vela because they were reluctant to relinquish the rights. The project languished for five years with no progress. It was a frustrating period because I remained passionate about moving the science forward and making new drugs available. But as you have probably guessed, persistence pays – the rights were eventually transferred back to Don and I, which  led to us founding Tonix.

Now, at Tonix Pharmaceuticals, we are carrying out clinical trials for our new sublingual formulation of cyclobenzaprine for fibromyalgia and for PTSD, as well as developing what we hope will be the first new drug for tension-type headaches in 50 years. I believe these therapies will change people’s lives, and that makes all the effort worthwhile.

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About the Author
Seth Lederman

Seth Lederman is co-founder, CEO and chairman of Tonix Pharmaceuticals Holding Corp., a clinical-stage pharmaceutical company dedicated to the development of novel medicines for disorders of the central nervous system, including fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headache.

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