Friday, May 18, 2012

Executive Spotlight: Dr. Alain Baron, President and CEO, Elcelyx Therapeutics

Dr. Alain Baron
Elcelyx Therapeutics is a privately held biotechnology company focused on creating a wide range of products based on the science of nutrient sensing. The company’s novel product candidates are directed at the prevention and treatment of obesity and diabetes. Since joining Elcelyx Therapeutics in 2010, Baron has been focused on advancing the company’s new products to treat metabolic diseases based on a completely novel platform, called “gut sensory modulation.” He brought his expertise as an entrepreneur-in-residence and a member of the life science team at Morgenthaler Ventures, a position he has held since 2008, along with prior experience as senior vice president of research at Amylin Pharmaceuticals. He has held faculty positions at Indiana University School of Medicine in Indianapolis and UCSD, along with the Veterans Administration Medical Center in San Diego. Baron graduated from McGill University in Canada with a bachelor’s degree in biology and a medical degree from the Medical College of Georgia Augusta. He completed postdoctoral studies at UCSD.

Q: Share with us a brief history of the company. How did your leaders come together? How was the company originally funded?

A: Elcelyx was founded by two former Amylin Pharmaceuticals employees, myself and Martin Brown. Elcelyx was first funded by Morgenthaler Ventures in a Series A round in March of 2010. Currently, the company is funded by Morgenthaler Ventures, Kleiner Perkins Caufield & Byers, and Technology Partners.

Q: Tell me some of your biggest goals for the year.

A: Elcelyx is developing new products to treat metabolic diseases based on a completely novel platform, named “gut sensory modulation,” that shows promise to produce very safe and effective oral therapies.

Q: What are the biggest challenges to achieving these goals?

A: Recognizing the importance of safety of therapeutics for metabolic diseases in the current regulatory environment, Elcelyx has focused its efforts at maximizing safety in its development of novel therapeutics.

Q: If you could change a public policy at the state or federal level, what would it be?

A: Given the time and risks involved with drug development, there is a great need to improve dialogue with the U.S. Food and Drug Administration to make their decisions more predictable.

Q: What is the most rewarding part of your job?

A: The collaborative environment created and nurtured at Elcelyx makes for a very productive and enjoyable workplace. Knowing we are working to address large, unmet medical needs is all the more rewarding.

Q: What are you doing when you’re not at work?

A: I love to spend time with my family and friends, read, play tennis and travel.

CHI-Advancing California biomedical research and innovation

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Tuesday, May 15, 2012

Event Spotlight: CHI Hosts Annual Reception and Hill Meetings in Washington, D.C.

House Energy & Commerce Committee Chairman Fred Upton accepts CHI Chairman's Award from CHI President and CEO David Gollaher, Ph.D., and CHI Chairman and Gen-Probe CEO Carl Hull.
CHI honored House Energy and Commerce Committee Chairman Fred Upton (R-MI) with the CHI Chairman’s Award during a reception May 9 in Washington, D.C., at the Folger Shakespeare Library. Guests at the reception and private dinner enjoyed an evening with the California delegation and leaders driving biomedical innovation at the event, called “Invest. Innovate. Compete.” During the dinner, Rep. Brian Bilbray (R-San Diego) expressed his support for the biomedical community and stressed the importance of bringing life-saving cures to patients in need.

Prior to the event, CHI board members participated in meetings on Capitol Hill to discuss the impact of the U.S. Food and Drug Administration and user fee reauthorizations, the importance of National Institutes of Health funding, and the significance of the California life sciences community to continued innovation and job creation. Meetings were held with Energy and Commerce Committee members including: Rep. Brian Bilbray (R-Carlsbad), Rep. Lois Capps (D-Santa Barbara), Rep. Anna Eshoo (D-Atherton), Rep. Phil Gingrey (R-GA), and Rep. Mike Rogers (R-MI). Other member meetings included Sen. Barbara Boxer (D-CA), Rep. David Dreier (R-San Dimas), Rep. Jackie Speier (D-Hillsborough), House Majority Whip Kevin McCarthy (R-Bakersfield) and key legislative staff at the Senate Health, Labor, Education and Pensions (HELP) Committee. Over the course of the day, one message was repeatedly conveyed: the important and successful role of CHI in communicating and contextualizing the importance of consistent, predictable and efficient FDA regulatory processes to continued biomedical research, investment and innovation in our state.

Also that day, CHI released a report on FDA with respect to the agency’s approval of drugs and biologics, building on our earlier study, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry (2011). The report, Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation, presents new data that illustrate important differences in FDA performance from one therapeutic area to another and examines misalignment between regulation and public health needs. It comes as Congress considers critical legislation that would renew and expand fees paid by drug and medical-device companies to help fund the FDA. Current legislation allowing the FDA to collect fees from drug and medical-device companies expires Sept. 30.

Genetic Engineering and Biotechnology News highlighted the report’s findings in a recent article and The Burrill Report featured a one-on-one interview between CHI CEO David L. Gollaher, Ph.D., and Burrill’s Daniel Levine.

CHI-Advancing California biomedical research and innovation

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Thursday, May 3, 2012

Executive Spotlight: Kleanthis Xanthopoulos, Ph.D., CEO of Regulus Therapeutics Inc.

Kleanthis Xanthopoulos
Xanthopoulos understands the biotech business from the inside out. Xanthopoulos is president and CEO of Regulus Therapeutics Inc., which was formed in late 2007 by Alnylam Pharmaceuticals of Cambridge, Mass. and Carlsbad, Calif.-based Isis Pharmaceuticals. It is testing drugs that use microRNA technology, a gene “silencing” technique used for treating various diseases. Regulus has created leading strategic alliances with GlaxoSmithKline and Sanofi-Aventis to develop microRNA therapeutics. Regulus moved to La Jolla in mid-2010 in the proximity of leading academic institutions including The Scripps Research Institute, Salk Institute, Sanford-Burnham Medical Research Institute and UC San Diego.

Before joining Regulus, Xanthopoulos spent time as managing director of Enterprise Partners Venture Capital, where he analyzed the best deals in the biomedical space. Prior to that, he co-founded and served as president and CEO of Anadys Pharmaceuticals, Inc., and served as a member of the board until its acquisition by Roche in late 2011. And before Aurora Biosciences became Vertex Pharmaceuticals, he was vice president from 1997 to 2000. Xanthopoulos participated in The Human Genome Project as a section head of the National Human Genome Research Institute from 1995 to 1997. Previously, he was an associate professor at the Karolinska Institute in Stockholm, Sweden after completing a postdoctoral research fellowship at The Rockefeller University, New York.

An Onassis Foundation scholar, Xanthopoulos received his bachelor’s degree in biology with honors from Aristotle University of Thessaloniki, Greece, and received both his master’s and doctorate degrees in microbiology from the University of Stockholm, Sweden.

Q: You went from being head of a biotech to the investor world, and, now, as head of this company spun out of Alnylam and Isis. What has the transition back been like?

A: Entering biotech life again was a perfectly natural transition, like coming home. I fell in love with the groundbreaking biology and was enamored with the opportunity to translate this big idea into innovative medicines. I like to say that my time spent at the VC firm was as a biotech sabbatical — taking time off from my true passion of building companies.

Q: What led Regulus to locate on the Torrey Pines Mesa as opposed to, say, Carlsbad where Isis is located?

A: It made terrific sense to be incubated within Isis. There is a lot of educational knowledge that we extracted from Isis, and the best way to do this is by osmosis. So, being there was very important for the first years of Regulus’ life. But, ultimately, we wanted our own culture and identity, and we felt that, based on some local collaborations and activities that we have, it would be much better served if we were in the Torrey Mesa as opposed to North County.

Q: Regulus has made some major industry collaborations, big names such as GlaxoSmithKline. What can we expect from the Regulus partnerships in the years to come?

A: Regulus has a dominant locked-in position in the world of microRNAs, which are remarkable and elaborate. They manage control of transcription and post-transcription mechanisms by dictating the half-life of messenger RNA. More than 700 microRNAs have so far been identified in humans, so that means 700 targets. And that, for a small company like us, means collaboration. We have 40 active academic institutions that work with Regulus and many of them are in very close proximity, including one with UCSD. It is part of the strategy and one that we pursued and have benefitted from exceptionally well.

Within six months of formally announcing Regulus, we had the partnership with Glaxo. It is encompassed around four microRNAs. Only one had been identified before the collaboration. So what you should expect is steady stream of news over the period of the collaboration.

Q: Talk about the environment for startups in California. What would be your advice to start-ups looking to grow within the state, such as Regulus has?

A: The good news is that any good, solid idea that is addressing significant needs in the pharmaceutical drug development stage is going to get funded. The bad news is the other ideas, or maybe product ideas alone, have a much more difficult time. Re-licensed or repurposed drug stories, I think, are going to have a harder time moving forward. In the early part of this year, we have seen a resurgence of platform technology stories emerge successful on the biotech scene. These platform stories are getting attention from not only VC firms, but institutional investors looking to take additional risks in their portfolio. This is a departure from the past several years in which companies with later-stage assets were the only investment opportunities for institutional investors. The tide seems to have turned and the early platform companies are now vying for the same Wall Street monies as the later-stage companies. A truly innovative breakthrough idea, such as the one Regulus is pursuing, will get funded.

Q: When Regulus first began, the CEO of Alnylam told investors that he expected Regulus to "dominate the microRNA space.” How do you think Regulus has stood up to that test?

A: Unfortunately, we did better than expected. And by unfortunately, I mean, we have scared away a lot of competition. Many people think that is good. I, personally, think that a little bit of competition is very healthy. So, unfortunately, we don’t have that, so the case of microRNA almost exclusively relies on how good Regulus is going to do.

Q: That has also brought you some healthy collaborations and financial backing. Talk about your growth as a company and where you see yourselves going in the next five to 10 years.

A: The biggest risk for Regulus five years ago was, “Can you target microRNAs and have a sort of peak effect without having a lot of side effects?” That was the big biological risk. Today, we have been able to show in 25 different models of human studies and animal studies that you can do that with a good therapeutic model. So, now you can say that the proof of concept has been established.

So, how do we look five years from now? We are very likely going to be a public company. We are still going to be less than 100 people. We are religiously defending our turf when we can, maintaining that the best brain trust one can possibly have in-house, but also utilizing a lot of extra hands outside. We going to have at least three programs in the clinic and maintain four to six preclinical programs at any given time.

Q: What are some of your proudest accomplishments since Regulus was formed in September 2007?

A: For me, it is all about people, strategy and finance. I think we have been, so far, good on all three fronts, and that’s something I am proud about. We have brilliant people, who are all tremendously seasoned drug hunters or hugely experienced people in finance and operations. We are now at about 55 employees. We are one of the few companies that has been growing at significant rates over the past four years. We have raised over $110 million. The vast majority of this is from the alliances, so it is non-dilutive financing. And I think we have a very good strategy of how to methodically move the pipeline from a big idea to a meaningful set of preclinical and clinical progress.

CHI-Advancing California biomedical research and innovation

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