BIO: Jim Greenwood on the Healthcare Reform Bill and the FDA




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Video title: BIO: Jim Greenwood on the Healthcare Reform Bill and the FDA
Released on: August 05, 2010. © PharmaVentures Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks with Jim Greenwood, CEO of BIO. Filmed at BioChicago 2010 in Chicago, USA, they discuss:

• BIO's perspective on changes over the last 12 months

• BIO's role and achievements in healthcare reform bill implementation

• Positive results emerging on FDA approval rate issue

• Role of the FDA

• Overcoming issues of risk and funding

• Challenges over the next 12 months

• The benefits of biotech companies joining BIO

• The key issues to deal with regarding the FDA

BIO 's perspective on changes over the last 12 months
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BIO International Convention. On this show I have James C. Greenwood, who is President and CEO of BIO , welcome to the show.
James Greenwood:
Thank you for having me.
Fintan Walton:
Jim, a year ago we had an interview in Atlanta, it was a different year a tough year, how has the last 12 months been for your organization?
James Greenwood:
This time last year in Atlanta in my keynote address I said we are facing a perfect storm a combination of world wide recession credit crunch that was really hurting the ability for small companies particularly to attract capital and on top of that we had the policy uncertainty around the forthcoming healthcare reform debate in which Congress was just beginning and of course that added to the worries of investors, they didn't know how the biosimilars legislation was going to come out, didn't know how this the Congress would treat the industry and there were some scientific challenges there has been sort of a slowing in the approval rate of drugs at the FDA. A year later we look back and things have changed quite a bit. The economy is recovering the IPO window is opening a bit in fact the Nasdaq biotech index is higher today than it was at the peak of the market in 2007 and very good sign. And the policy matters are largely settled because healthcare reform is now above the land.
BIO 's achievements in healthcare reform bill implementation
Fintan Walton:
Yes, so the big challenge there was the healthcare reform and getting that bill through it's a big document there is a lot in there, what's your organization gonna do to make sure that that translates now into in an effective bill that is implemented, that will positively impact the biotechnology companies here in the US?
James Greenwood:
Well we focus on a couple of things, one of those in the legislation was biosimilars where had been no statutory pathway by which generic companies could have their products approved by the FDA using our clinical data. We decided not to become the obstacles to that but in fact to become the chief advocates for that getting done, but we've also said there were certain things we needed and one of them was in order to maintain the incentive to invest in biologics we needed 12-years of data exclusivity, we needed this the FDA need lot to say that after the FDA approves the innovative process it can't approve the generic process using our data for 12-years. We succeeded now it's on the implementation, the legislative piece is just a first part then comes the FDA's regulations and guidances so we will be very involved in that. Second thing we focused on looking at the need of our small companies to have short-term revenue to keep them alive, because many of them didn't survive the crisis. We were able to secure in their healthcare reform legislation what we call the Therapeutic Discovery Project Tax Credit and that says that for companies with 250 or fewer employees they can take 50% of their cost of discovery including clinical trials and virtually everything else have that as a tax credit and if they do not have revenues against which to take that credit they would they will receive a cheque from the treasury department equal to 50% of those expenditures. So as a huge victory for us important for the companies and now we are deeply involved because it's a short time frame to work on the implementations, we can get those get the system in place to judge which companies are going to get those grants and make sure that they do.
Fintan Walton:
So at least some of the uncertainty has started to move away?
James Greenwood:
Yes.
Positive results emerging on FDA approval rate issue
Fintan Walton:
You mentioned the biotech stocks have increased in the last few years particularly in the last year they have improved but also one of the issues that you've mentioned a year ago was the approval rate, now are we seeing a shift in that are we seeing more positive results coming out from biotech companies?
James Greenwood:
We are seeing some good results, we've just seen Dendreon's prostate cancer product Provenge which is a novel approach to fighting prostate cancer that company has had it's ups and downs as the FDA wasn't, you know they asked for some additional study, has approved that's very important. Acorda, New York based company has a product for MS patients that the FDA approved. It enhances the ability of those patients to walk in a sustained way that was a nice gain for patients. And we have some good Phase III data, Vertex is looking very good with its hepatitis C drug, Human Genome Sciences has a drug against lupus it's in great Phase III data, so we think that the science is moving a pace. We have a new FDA commissioner and our board just met with her yesterday subset of our board did and we talked about the need to balance benefit and risk. You know that pendulum tends to swing back and forth at the FDA, but we think if the FDA uses good science then all of the safety issues and all of the effectiveness issues can be handled in a very efficient way.
Role of FDA
Fintan Walton:
So do you see the new commissioner changing things at the FDA, do you see a period of change happening now?
James Greenwood:
Well I hope so, The FDA is filled with well intentioned people. They don't have enough resources and it's difficult for them to keep up with the science because they have to be able to compete with industry and hiring great qualified people who are up to date on the latest cutting edge science that's a challenge for them. They are always worried that Congress is going to hold them to some hearing and if there is any kind of a hint of side effects issue that they will be dragged up and what we really need to depend upon is our increasing ability to identify safety signals post market when the drug goes from small clinical trials into the vast marketplace and the more we can depend upon high technology, information technology to see those signals the more confident we can have in approving the drug sooner I think.
Overcoming issues of risk and funding
Fintan Walton:
Right, you mentioned the tax credit success that you've managed to achieve which is obviously very important, but one of the key things obviously for biotech companies is finance, is capital coming in and we are seeing a little bit of returns to some of the IPOs you've already mentioned well creaking of the door opening up, but we are not back yet to the good days of reasonable funding, so the tax credit is it where the government can play a role, what else do you think needs to take place within the financial community because we've also got the issue of risk and the apparent of risk with biotech so how we are going to overcome those sort of issues?
James Greenwood:
Well part of it comes from state programs, you look at on the floor here you'll see not only state but national prevalence every one wants biotech to come to their state, to come to their country. And one way to make that happen is to provide some seed money you know it's not the year 2000 or 2001 or '02 when the bubble was going, investors have become worried, they've learned and then we've all learned that it's not just one gene you fix it and you cure your disease its little more complicated than that. So states that want to build hubs they need to make sure that they have good tech transfer programs from the universities and then they put some money on the table by doing so even if companies fail they are attracting intellectual capital they are building physical capital and infrastructure and then even the companies that fail their entrepreneurs pick themselves up at certain other companies, so I think that's a part of the process as well.
Challenges over the next 12 months
Fintan Walton:
Right, now looking into next year over the next 12 months hopefully we will be speaking again in 12 months time, what are the challenges you see facing the biotech industry and what is BIO going to do to try and mitigate those challenges?
James Greenwood:
Well we talked here about a couple of the elements of the healthcare reform bill but it's 2000 pages long and it is that thick and that's just the law the regulations will be that thick and they are going to be written over the next months and years and so we would be very, very engaged in commenting on inputting into those regulations, commenting on them and to ensure that the regulations up to the extent possible forward innovation.
The benefits for biotech companies in joining BIO
Fintan Walton:
So that's really important for members, for the biotech community to support BIO ?
James Greenwood:
Yes.
Fintan Walton:
I mean this is transformational in a lot of ways this is where, this is how healthcare is going to be run in the US so it's going to be important for the biotech community to join with BIO and support that?
James Greenwood:
Yes, I think one of the greatest benefits of companies joining BIO they can take their particular experiences where a particular regulation or a proposed regulation or a law or a proposed law might have a deleterious or positive effect on them and by being a member they can contribute to the policy development process and make sure that we are helping to steer policy in a way that's conducive to innovation. The other thing we will be focusing on is the Pharmaceutical Drug User Fee Act (PDUFA) reauthorization it's 2.5 years away, but the process has already began so we negotiate beginning the conversations that will lead to negotiations with the FDA will ultimately end in a new law that will set goals for the FDA and will also determine how much we pay in fees to the FDA so that they have the resources to do their job.
Key issues to deal with FDA
Fintan Walton:
And clearly that's as you say is in a few years time, but what are the key issues there? What are the main challenges that you've got to fight?
James Greenwood:
In FDA?
Fintan Walton:
Yes.
James Greenwood:
One of the things that we've been talking to FDA about is relatively recently in the last several years they have developed a system where if there is a communication if the FDA wants to communicate with the company either to tell them something just to response they will ask a question, they will send them a letter and then they have 30, company has 30 days to respond and then that letter goes back and then the FDA has 30 days to respond and this is ping pong of letters, problem is if your company that's burning $5 million a month everyone of those 30 day periods is terribly painful. And in this day and age it ought to be the case that through emails, through the scientists and then companies and the FDA are picking up their phone talking to each other they can resolve some of these issues more quickly.
Fintan Walton:
Its probably 30 days that's the amount of time it takes a horse to get from one side of the cost to the other?
James Greenwood:
Exactly.
Fintan Walton:
So with email you can things can happen a lot easier?
James Greenwood:
Yes, and so there are questions about that because you need documentation you know everyone is so skeptical and suspicious of government right now that some people actually don't like the idea that the FDA scientist could be talking to a company scientist, but I think we need to be realistic and understanding that's a very important way for you know, you think of any conversation any of us have on the telephone and try to have that conversation by 30 day mail it would take forever.
Fintan Walton:
Exactly, yes its best form of communication.
James Greenwood:
Yes.
Fintan Walton:
James Greenwood, thank you very much indeed for coming on the show.
James Greenwood:
Always a pleasure, thank you for having me.
Fintan Walton:
Thank you.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
James C. Greenwood
President and CEO
James C. Greenwood is President and CEO of the Biotechnology Industry Organization (BIO) in Washington, D.C., which represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. Mr. James C. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005. Mr. James Greenwood graduated from Dickinson College in 1973 with a BA in Sociology.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
BIO
BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,200 members worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology technologies. Corporate members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. They also represent state and regional biotech associations, service providers to the industry and academic centers.