LIVE BLOG: Opththalmology Innovation Summit, Part 2
Healio.com/Ophthalmology is live blogging the Ophthalmology Innovation Summit in New Orleans:
The Ophthalmology Innovation Summit has ended. Thanks for tuning in.
5:33pm: Hoffman: "There are places for investors to invest in device companies. The health care investor base want to diversify, so they will invest in device."
5:31pm: Cooley: "Today's buyers are more discerning."
5:30pm: Cooley: "Set appropriate expectations; not just for the short-term, but for the long-term. You are going to make mistakes. Just be upfront about it. Inevitably, it will increase your credibility."
5:29pm: Hoffman: "Do not go before you are ready. Under-promise and over-deliver. You are going to be working with these investors for a long time. Be transparent."
5:27pm: Redlick: "Don't yo-yo the stock."
5:25pm: Guyers asked the panel for do's and don'ts of IPOs. Myers: "Keep it simple. Don't overestimate the knowledge of the audience. Don't get caught up in your own data."
5:20pm: Hoffman: "Run the company not to go public, but run the company to finalize the vision. You don't want to over-promise and under-deliver as a public company. It is important to have that access to capital."
5:15pm: Redlick: "It's very important to have a credit management team. It's also critical to have a good finance team. You need to have people who are knowledgeable and experienced in talking to wall street, a CEO on that scale, and an [Investor Relations] person."
5:13pm: Redlick: "The lawyers and bankers together get into a room and describe the business of the company and the risk."
5:10pm: Guyer asked: What does it take to go public? Galakatos: "The companies that deserve to go public have compelling, differentiating stories that are very easy to tell. "
5:07pm: Guyer: "You need to close as quickly as possible. You never know when the window is going to close."
5:06pm: Panelists include Jeffery Hoffman, managing director and head of west coast healthcare investment banking at JPMorgan; Dan Myers, co-founder, president and CEO at Alimera Sciences; Nicholas Galakatos, PhD, managing director at Clarus Ventures; David E. Redlick, partner and co-chair of the Life Sciences Group at WilmerHale; and Chris Cooley, CFA, managing director at Stephens.
5:05pm: David R. Guyer, MD, chief executive officer of Ophthotech, moderates a panel on “Going Public — Who, When and Why?”
5:02pm: Durrie: "I look at my fellowship program over the years. Recently, they are fired up again. I am very optimistic. This meeting is a big deal. Emmett and Gil and Bill, this has been fabulous for the physicians. I think a lot of entrepreneurs will come out just because of this meeting."
5:00pm: Epstein: "Innovation is part of the culture of America."
4:59pm: Blumenkranz: "I think we have a new breed of entrepreneurs. ... There is no challenge too big for them to undertake. They're completely fearless because they have no battle scars. My take is we are in great shape."
4:58pm: Blumenkranz: "I don't think we've ever had a better regulatory environment. We couldn't be luckier with it."
4:55pm: Lindstrom asked what the future of medical device and pharmaceutical innovation is? Blumenkratz: "Maybe I am a bit of a pollyanna, but the future has never been brighter. I think the environment is better. Anti-VEGF is the penicillin of ophthalmology. It has changed the world."
4:54pm: Lindstrom: "Persisting and perservering are critical."
4:54pm: Blumenkranz: "One, you have to find great partners. If you have problems in that regard, it can be lethal. As much as you can, getting it right in the beginning is very important. Second, under-promise and over-deliver. Three, be patient. It is going to take a long time."
4:53pm: Durrie: "If you don't have the support of your family and your practice, this is very difficult."
4:52pm: Lindstrom: "To me, how much work it is, how much it costs and how much time does it take?"
4:51pm: de Juan: "Time. Where does a physician get the time? We parachute in, say everything and we're confident and parachute out. We don't have time in the university or private practice."
4:50pm: Lindsrom: "John Pinto says that less than 1% of ophthalmic practices have a business plan. It is difficult for an ophthalmologist to even write a business plan."
4:47pm: Epstein: "Culture. Culture of your institution or association. The culture of a physician is different from the culture of an entrepreneur."
4:45pm: Lindstrom: "What do you view as the greatest challenges to physician entrepreneurship today? Is it getting easier or harder today?"
4:44pm: Epstein: "You need to know when to kill an idea."
4:40pm: Durrie: "The other thing I hear a lot in my practice is all lifestyle, private pay. I think there's a lifestyle market out there that's growing."
4:40pm: Durrie: "What I like to do is take an idea and try to share and partner with it very early. I have a lot of patents, but I didn't file them myself. The mistakes I made before were not sharing my ideas early enough. The biggest mistake I made on things I thought were a great idea is not understanding that the most difficult thing is to change the way people practice medicine. That's really hard. It may be a great product but that's been the biggest resistance."
4:38pm: Lindstrom: "I often find that I need to help them understand how big the individual commitment is. Please share with us one or two of your biggest mistakes and what would you do differently?"
4:38pm: de Juan: "Mostly, people who come to me for advice are asking about an idea. They're saying they want to participate. They are expressing a desire. ... You mainly need to tell them, 'That's not a good idea, but it's a good place to focus.'"
4:35pm: Lindstrom: "I find myself continuously amazed at how little preparation someone has done when they bring forth an idea. I ask, have you registered your idea; have you gotten a patent; do you have a preliminary business plan; have you reviewed the literature? How big of a commitment does it really take?"
4:31pm: Epstein: "I tell them to go for it. They need to understand what it takes to bring a product to market."
4:31pm: Lindstrom asked how do you counsel aspiring physicians. de Juan: "I really focus on the person and what he wants more than I focus on a product."
4:30pm: Charles: "It's about problem solving, not the money game. Money's the fuel to make it happen, but it's about real world problem solving."
4:30pm: Durrie: "Who knows the unmet needs better than physicians? When we're looking at partnership with industry, what are we missing out on? We need that interaction. The physicians really need to be involved."
4:29pm: Blumenkratz: "Entrepreneurial was a pejorative term."
4:29pm: Blumenkranz: "I think it's possible to teach entrepreneurship. Entrepreneurs are born but they can also be taught and learn."
4:28pm: De Juan: "All of us as physicians didn't start out wanting to be entrepreneurs. We don't have a pure business sense."
4:27pm: Charles: "Hang out in the lab and be the conduit between the technology and the clinical application. Do patent searches yourself. It is stunning to me how many business plans have something in it that can already be bought. Do your own research and immerse yourself in it. Invest your own money. It's a major time commitment. Major companies need your advice, but if you are really entrepreneurial, put your own money and time into it."
4:26pm: Lindstrom: "The purpose of this panel is to speak to the younger entrepreneurial physician ophthalmologists who have an idea and what to do with it."
4:26pm: Lindstrom: "What are the opportunities and challenges. They'll share some of their successes and failures."
4:26pm: Lindstrom: "People in the group have been on the pharma side and device side."
4:25pm: Richard L. Lindstrom, MD, founder and attending surgeon at Minnesota Eye Consultants, moderates a panel on “Physician Entrepreneurship in Ophthalmology.” Panelists include Mark S. Blumenkranz, MD, professor and chairman of the Department of Ophthalmology at Stanford University; Eugene de Juan, MD, founder and vice chairman at InSight Labs; David L. Epstein, MD, MMM, Joseph A.C. Wadsworth clinical professor of ophthalmology and chairman of Duke Eye Center at the Duke University School of Medicine; Steve Charles, CEO at CamPlex; and Daniel Durrie, MD, founder and president at Durrie Vision.
3:54pm: Kilman asked what country is the best to enter first in Europe for a reimbursed device. Attias: "Germany for a reimbursed device, but for pharmaceuticals, it's quite a tricky space. Audience voted overwhelming for Germany again."
3:47pm: Kilman asked what country's commercial success correlates the most with the subsequent U.S. market post FDA approval. Mazzo advocated for the southern part of Europe. The audience, who is voting via a text poll, voted for Germany in a significant way.
3:46pm: Muller: "You have to look at each country with the knowledge and behavior of that country."
3:44pm: Corley: "Big pharma has an advantage of start-ups. Start-ups have to connect to physicians through distributors. Distributors play a wonderful role but they have to sell a lot of products to stay in business. Who represents you in the market has a lot to do with [your success]."
3:40pm: Corley: "You are not going to make money going to Europe, in my opinion. But I still think it is a gamble that the management team of every start-up needs to consider."
3:38pm: Corley: "Prior to FDA approval. And it gives some confidence that you'll be able to sell some product."
3:36pm: Kilman asks when is the right time for EU commercialization.
3:36pm: Attias: "Clearly, as a big company, we get a great clinical insight [going into Europe]."
3:35pm: Mazzo: "Anytime you can have competition in Europe than, say, other markets, simply because of the amount of products [that are in Europe] then the better you will validate your product."
3:32pm: Kilman asked what is the best reason to seek out commercialization in Europe. Pyott: "If you think your device is very well prepared, then I would go with commercial validation of technology."
3:30pm: Gilbert Kilman, MD, managing director at InterWest Partners, moderates a panel on “EU Commercialization Strategies.” Panelists include Laurent Attias, head and commercial strategy of Alcon; David Muller, president and CEO of Avedro; David E.I. Pyott, chairman of the board and CEO of Allergan; James Mazzo, operating partner of Versant Ventures; and Andy Corley, venture partner of Versant Ventures.
3:00pm: Panelists include Luke Duster, principal at Capital Royalty; Gregory Shearer, managing director at Healthios Capital Markets; Brian Demmert, managing partner at Armentum Partners; and Buzz Benson, managing director at Sightline Partners.
2:57pm: Charles Warden, managing director at Versant Ventures, moderates a panel on “Alternative Financing Strategies.”
2:54pm: Eydelman: "Another way is through workshops. On February 26 is a workshop on MIGS, and on March 28 is a workshop on novel IOL endpoints."
2:53: Eydelman: "We are trying to share our knowledge with the community in new ways. One is called leapfrog guidance."
2:51pm: Chambers: "It is important that you say when you disagree with something. If we heard from you and there is disagreement, there are formal mechanisms."
2:48pm: Eydelman: "Before people jump to conclusions, they need to come to us to find out if we need more information, or if there has been a miscommunication."
2:45pm: Cunningham asked how a company can productively disagree with the FDA. Eydelman: "Nobody is perfect. So we would definitely like to hear your thoughts. Please start by reaching out to the team leader. Then go up to the food chain."
2:42pm: Chambers: "Our goal is to stop you from doing things that are harmful, but other than that, we want to give people the best pathway to have a product developed."
2:40pm: Chambers: "One piece advice I give is 'Don't ask a question you are unable to deal with the answer.'"
2:33pm: Chambers: "The only question we will not answer is whether your application is going to be approved or not."
2:33pm: Chambers: "This is not a competition, but I will call back within 24 hours."
2:32pm: Chambers: "Any question is fair game."
2:31pm: Eydelman: "I have established a policy to respond to any inquiry within 48 hours."
2:30pm: Cunningham asked if an academic without a company could still set up a pre-submission meeting. Eydelman answered yes.
2:27pm: Eydelman: "Pre-submission, we encourage people to come and ask us questions very early."
2:23pm: Eydelman: "The number of submissions we have been receiving has drastically increased."
2:22pm: Eydelman: "Fifty percent of 510(k)s we had to refuse in the first round. Industry really needs to be on their toes to go on our website and find out what we are requiring."
2:22pm: Eydelman: "One of the 510(k) clearances is that a month ago we issued a final guidance on medical mobile apps."
2:21pm: Eydelman: "Total time for PMA clearances seems to have gone down in 2013."
2:21pm: Eydelman: "We have met just about all of our goals."
2:20pm: Eydelman: "In exchange, the FDA has committed to quite stringent deadlines for all of the submissions."
2:20pm: Eydelman: "My division ... due to funding we were able to split my division into two. It also allowed us to create different branches ... which allows for better oversight."
2:19pm: Emmett T. Cunningham Jr., MD, PhD, MPH, partner at Clarus Ventures, moderates a panel on “Developing an Effective Dialogue with the FDA.” Panelists include Wiley A. Chambers, MD, deputy director of the Division of Transplant and Ophthalmology Products and Center for Drug Evaluation and Research; and Malvina B. Eydelman, MD, director of the Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office and Device Evaluation Center of Devices and Radiological Health.
2:17pm: Parke: "Product will launch on Sunday morning [Nov. 17]."
2:16pm: Parke: "We project we'll have 20 million encounters in there by 2016."
2:15pm: Parke: "Even in our beta phase, we have 370,000 patient encounters."
2:15pm: Parke: "Registry will be launched within the next 90 days."
2:14pm: Parke: "Does it improve patient care? No one wants to be below average."
2:13pm: Parke: "Information goes into medical record and is uploaded to the database overnight."
2:13pm: Parke: "Value proposition for the members: Revenue for a typical ophthalmic practice is $10,000. We are offering it for free. No work on the part of the ophthalmologist."
2:12pm: Parke: "The MD owns his or her data and no one else can get to that data."
2:11pm: Parke: "What we are using now is some new technology that basically makes it hassle free for the ophthalmologist."
2:11pm: Parke: "The IRIS Registry has one primary purpose: to enhance quality and care in ophthalmology."
2:10pm: Parke: "Today I'm going to talk about the IRIS Registry, which we are referring to internally as 'ophthalmology's moon shot'."
2:10pm: Parke: "We [the AAO] are a company and we do our own R&D."
2:09pm: David W. Parke, MD, CEO of the American Academy of Ophthalmology, discusses “Ophthalmic Innovation 2013 — A View from the AAO.”
2:07pm: Sieving: "NEI funds basic research. The NEI is fully committed to working with you and the private sector to fund the basic discoveries."
2:03pm: Sieving: "The NEI budget is $662 million. These are your tax dollars that I am spending. This is the medical venture funding that primes the innovation we are talking about today."
2:00pm: Paul Sieving, MD, director of the National Eye Institute and National Institutes of Health, discusses “Ophthalmic Innovation 2013 — A View from the NEI.”
1:38pm: William J. Link, PhD, managing director of Versant Ventures, interviews Burns and Hill.
1:32pm: OIS Innovator's Award being given to Thomas Burns, CEO of Glaukos, and Richard Hill, MD, co-founder of Glaukos and inventor of the iStent.
1:27pm: Pyott: "A great leave behind message: Companies like us really need you ... We constantly need to look for ideas and new platforms outside of the company."
1:26pm: Pyott: "I think in all of this, it's important to be clear in one's own mind ... How do we create value?"
1:25pm: Pyott: "If you are small company, you have to really be focused on what you want to be when you grow up."
1:24pm: Pyott: "One thing we have to take into account is there are very few players left."
1:23pm: Pyott: "On the industry structure of ophthalmology, some of the large pharmaceutical companies have exited (Pfizer, Merck). Then, there are permanent residents. And there are new entrants (Regeneron, Valeant, Thrombogenics and Shire)."
1:23pm: Pyott: "This is very encouraging. We see new entrants (into ophthalmology)."
1:22pm: Pyott: "For us in the future in ophthalmology, we're particularly focused on retina glaucoma, dry eye, anti-infectives, anti-inflammatories and medical devices."
1:21pm: Pyott: "We have had 11 product approvals since 2010."
1:20pm: Pyott: "Since I became CEO at the end of 1997 you can see a huge ramp up in R&D. Up to a billion dollars this year. Investment is very much accelerating."
1:20pm: Pyott: "Allergan has a mix model of pharmaceuticals from other therapeutics areas. Ophthalmology and perhaps dermatology are unique in the ability to reformulate."
1:19pm: Pyott: "What I have been doing with the Allergan management team -- We made a huge investment in R&D."
1:18pm: Pyott: "In all of this, we need to invest in making sure the physicians, our customers, are well-trained in how to use our products."
1:16pm: Pyott: "We need to address how to become more efficient."
1:14pm: Pyott: "Despite all of this we remain in an attractive industry."
1:14pm: Pyott: "Quicker to market still [exists] in Europe but that is going to get tougher."
1:13pm: Pyott: "In general, I take the view that many things that start in the pharmaceutical industry move over to the device industry."
1:11pm: Pyott: "Very soon everybody is going to be subject to the Sunshine Act. And this sucks up a lot of time and a lot of resources."
1:11pm: Pyott: "Another element beyond certainty is how we deal with the rising cost of regulation ... you have more and more regulation on compliance."
1:10pm: Pyott: "Whenever I speak to elected officials, whether it be here or overseas, I always point out whenever you have tough things to do and be very clear about what you want to do ... uncertainty is never a good thing.
1:09pm: Pyott: "If we look at the front end of innovation, we should have our eye on the budget of the NIH and the budget of the National Eye Institute."
1:07pm: David E.I. Pyott, chairman of the board and CEO of Allergan delivers “Keynote: Sustaining Innovation in Ophthalmology - A View from the Top.”
— by David Mullin, Joan-Marie Stiglich, Daniel Morgan and Patricia Nale