EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/407647
EW NEWS & OPINION 14 November 2014 Dr. Chang: American clinicians are frustrated that so many devices and treatments are available else- where but not in the U.S. Should we be hopeful that this might soon change? Dr. Kliman: Yes. Innovation and FDA regulation go through cycles, and we have been in a slower cycle of FDA approval over the last 5 years, but that is changing. There are tremen- dous efforts underway throughout the FDA to speed up the process of approval and give better guidance to companies on how to do clini- cal trials and obtain approval. This will not happen overnight, but the trends are encouraging, and I do not believe the U.S. will fall significantly behind the rest of the world in our availability of the best treatments for patients. There may be more treat- ment options available outside the U.S., but many are not validated due to lower regulatory barriers, so more is not necessarily better. Dr. Ianchulev: We should all work to accelerate access to innovation in the U.S. We are a mature society and with that comes a healthy dose of risk-aversion. It is important for doctors to get involved—who else but physicians can best weigh in on the risk-benefit debate for medi- cal technology and innovation? EyeWorld previously published my testimony to Congress on that very topic when I was asked to provide an expert opinion regarding regulat- ed innovation in the U.S. It is a dif- ficult topic with many opinions on both sides of the bar, but the reality is clear—the world is "flatter" today than at any time in history and the trajectory of innovation does not stop at the border. In our field, we see a lot more technology being studied, tested, developed, and com- mercialized outside the U.S. first. I came to the U.S. from Bulgaria to be close to what's new and latest in our field, and yet my mother who is a retinal specialist in Bulgaria now has more access to such innovation than Americans. Dr. Cunningham: I don't see a quick fix when it comes to the cost or time to approval for drugs and devices in the U.S. Regulatory costs and time- lines are increasing outside the U.S. as well, so the gap may be narrow- ing. Many like to blame the FDA for this, but I think that's a gross over- simplification and frankly unfair. Most of the time and cost is pre-FDA submission. It just takes a lot of time and money to advance drugs capital environment to be much more stimulating and dynamic, with something new revealed every day. My favorite part of the job is doing first meetings with startup compa- nies. The entrepreneurs in these startups are some of the smartest and most impressive people, and their passion and knowledge is always inspiring. Many are aca- demics themselves, finding ways to innovate devices and drugs while maintaining an academic career, so I still feel very connected to my roots in academia. I learn more every day by meeting with companies than in any other learning environment I have been in! But the real reward is being involved in successful com- panies that commercialize globally. The impact I can have on ophthal- mology through global products as a venture capitalist dwarfs anything I could deliver with my own two hands in a lifetime of patient care. Dr. Ianchulev: I love academia and continue to be actively involved in teaching as an associate clinical professor at UCSF. I feel academia is a great place for research and discovery but a challenging envi- ronment for product development, validation, and introduction of new technologies. The world of FDA-regulated clinical development is highly complex and quite inde- pendent of the process of research and discovery. Yet it can be equally rewarding once you introduce tech- nologies that change the practice of medicine. For example, there are hundreds of thousands of patients treated with anti-VEGF therapy today, and I believe more than 250,000 patients achieved superi- or cataract surgical outcomes with intraoperative aberrometry in the last year. Around 20% of all cataract patients undergoing phaco may benefit from a combined glaucoma treatment with the supraciliary microstent technology being devel- oped by Transcend Medical. Being part of that either on the venture side or the operational side is quite rewarding. The title matters less— whether you are a professor or executive, we all work toward making a difference for patients. Dr. Cunningham: VC is one of my many active interests and pursuits. I still teach, speak, and write—much the same as I did when I was on the full-time UCSF faculty. The one big difference is that I no longer run a laboratory. In fact, many of the most academically active people in ophthalmology function outside of universities. Ophthalmologists in venture capital continued from page 13 private, VC-funded biotech com- pany that developed the first anti- VEGF agent for neovascular AMD, Macugen, which was approved in 2004. The company was VC funded, and I had frequent interactions with VC investors on the board. I knew I wanted to stay actively involved with innovation in ophthalmology, so for me the choice was joining an- other startup or established compa- ny, or VC. I chose VC for the intel- lectual and financial diversification. Of course, I still work actively with a number of companies, including several in ophthalmology. Dr. Chang: Why did you choose this route over a traditional academic career? Dr. Kliman: It was a tough choice between traditional ophthalmology and venture capital. I enjoyed academics and patient care but found the venture Coming soon: The December issue of Ophthalmology Business Including … • Demystifying the defined benefit pension plan • New app can increase patient referrals • Changes your practice or ASC can make to improve performance in 2015 • 7 simple rules to follow when investing … and more! continued on page 16 digital.ophthalmologybusiness.org