Dr. Ron Cohen is the president and CEO of Acorda Therapeutics, a company he founded in 1995. He serves on the board of BIO, the Biotechnology Industry Organization, and he is chairman of the Emerging Company Section of BIO.

BIO SmartBrief editor Tom Parks interviewed Ron about how U.S. regulations and potential investments might affect the future of the biotechnology industry.

The Food and Drug Administration approved 56 new drugs in the past two fiscal years, and one of them was Acorda Therapeutics’ Ampyra, an oral treatment to improve walking in people with multiple sclerosis. How can the regulatory process be improved to get promising drugs to patients?

The FDA has a difficult job — determining whether drugs meet what we as a society determine to be an acceptable risk/benefit profile. This job has been made more difficult in recent years by chronic underfunding, which limits the agency’s ability to attract and retain talent, and also modernize their approach to drug application evaluation. One of the most serious repercussions of this funding crisis has been that regulatory processes are not keeping up with rapidly advancing science and are making it a more difficult environment to develop new therapies and products.

Regulatory uncertainty, in turn, is having a major negative impact on our funding of biomedical innovation — 61% of venture capitalists now cite FDA regulatory challenges as having the highest impact on their investment decisions, and 40% expect to decrease investment in development of new therapies. Fully realizing the promise of biotechnology requires a comprehensive national strategy that fine tunes some policies and overhauls others.

Part of that national strategy should include creating a 21st century FDA that recognizes its role in advancing innovation by reviewing product applications in a timely manner and promoting a science-based decision-making process that is reflective of patient needs.

That strategy should include elevating the status of the FDA as an independent agency and establishing a fixed term of office for the commissioner. It should also include improvements to the FDA’s advisory committees so that regulators have the most up-to-date information on advancements in medical knowledge, techniques and technology. Lastly, the strategy should enable modernized, patient-centric clinical development of new therapies.

BIO has drafted a proposal under the title Unleashing the Promise of Biotechnology that can contribute to the blueprint for this strategy.

What trends do you expect to see in partnerships and investment?

Global market dynamics will likely continue to strongly influence biotech market performance over the coming year. They’ve already taken a toll on IPO offerings. There has been only one successful IPO since June, with five companies withdrawing their IPOs. Of the nine biotech IPOs in 2011, five are down more than 30% and only one was able to raise the original amount filed for. First-time fundings of life-science ventures from 2010 to mid-2011 decreased by more than 50% compared to prior years.

Over the past several years, as big pharma has approached multiple patent cliffs, there has been a persistent expectation of a tsunami of M&A and partnering activity. Large pharmaceutical companies have strong cash positions but so far have engaged in a slow trickle of acquisitions and partnerships, many in the private sector, and a few large deals in the public sector. The wave will likely surge, but probably not until most observers have concluded that it won’t!

Finally, what areas of biotechnology do you think will bear fruit in 2012?

The industry overall is facing enormous challenges raising capital for development and commercialization. Venture capitalists are seeking shorter-term investments with less risk. America’s genius for innovation persists across health care, agriculture and industrial biotechnology — including new applications of stem cells, gene therapy and diagnostics for personalized medicine, disease-resistant and drought-tolerant plants, and aviation biofuels and renewable chemicals. These could bear fruit in the near future. Continued progress by industry in bringing these innovations to market would be aided and accelerated by stable policies and updating of regulatory processes at the federal level.

Image courtesy of Ron Cohen.

This question-and-answer session was produced as part of SmartBrief’s 2011 Best Of reports, which capture the year’s most important stories in each industry. Sign up now for BIO SmartBrief to get tomorrow’s report on the top must-read stories from the biotechnology industry.

Related Posts

2 Responses to “Q-and-A with Ron Cohen, CEO of Acorda Therapeutics”

  1. Robert Falcon says:

    Realizing the promise of biotechnology, which requires a much better/streamline approach in the review and approval process within the FDA to meet the medical needs presented in today's market. In the same breath what is going to stimulate growth not only nationally, but worldwide starts within the US through innovation and speed. Mr. Cohen outlines, innovation will continue to the hallmark of our success. I found this article to be well thought out, informative and transparent!

  2. G. Scott Nass says:

    Drugs are not failing in phase III because of the FDA. The facts of the failed trials often show a lack of fundamental understanding of disease biology when drugs enter phase III. There is often an inadequate proof of clinical mechanism when drugs enter expensive phase III trials. A relevant example is Lilly's Semagacestat for Alzheimer's that failed last year caused skin cancer in patients and caused a worsening in dimentia. The company has not released imaging from that study. It's not the regulators fault if corporations have focused on short-term investments (and profits) and have rushed things into phase III without a good understanding of the underlying biology.

    The FDA does recognize that there is room for improvement in their process, especially in the area of devices. Using the industry's problem of failed trials to point the finger at the FDA is a cheap shot and feels like more of the same tired anti-government argument that in this case is excusing the real causes of the problem, the businesses themselves.