Greenwood Tells House Ag Subcommittee: Farm Bill Energy Programs Are Working

Posted under biofuels, Biofuels & Climate Change, biorefineries, Blog, clean energy, Companies, Diagnostics, energy, Environmental & Industrial, Farm Bill, Funding, Jim Greenwood, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The Subcommittee on Conservation, Energy, and Forestry held its final hearing today on the 2012 Farm Bill. Testimony focused on Formulation of the 2012 Farm Bill: Energy and Forestry Programs. BIO’s President & CEO Jim Greenwood joined the panel testifying about Farm Bill energy programs along with Ryan Stroschein, Agriculture Energy Coalition; Steve Reinford, Reinford Farms Inc.; Jerry Taylor, MFA Oil; and Gary Haer, National Biodiesel Board.

“Farm Bill energy programs are working and BIO member companies are beginning to put steel in the ground,” Greenwood said. He highlighted several companies that have biorefineries today as a result of these programs, including INEOS Bio New Planet Energy in Florida, Myriant in Louisiana, and ZeaChem in Oregon.

Greenwood urged the committee to reauthorize the Farm Bill energy programs, such as the Biorefinery Assistance Program, BCAP, and the Biobased Markets Program, with meaningful mandatory funding to allow them to continue to spur America’s energy and agricultural future.

Farm Bill energy programs have had a tremendous positive impact in revitalizing rural America, helping new agricultural markets emerge, and reducing the need for direct payments to farmers. These programs have unlocked private capital for construction of the nation’s first cellulosic and advanced biofuel biorefineries; put more than 150,000 acres of underutilized farmland in more than 150 counties into production raising next generation energy crops; and led to an explosion of renewable chemicals innovation, demonstration and early commercialization here in the United States. For a modest federal investment a high rate of return has been achieved in terms of viable projects funded and operating.

Renewable energy is cleaner, safer and healthier. We cannot afford to wait to fund renewable energy projects that can create permanent jobs in rural America. Now is not the time to abandon these forward-looking, high return programs.

Other panelists echoed Greenwood’s sentiments in their testimony that energy program funding is necessary to continue bringing these innovative technologies to market and are a vital component to the bipartisan all of the above energy strategy of the United States. Stroschein of the Agriculture Energy Coalition warned that not funding these programs leaves other countries poised to leap ahead in clean energy technologies undermining our national and economic security.

Greenwood added that these energy programs allow American farmers and foresters to play the role they can – and must – play in producing domestic energy and therefore improving national security and rural economic prosperity.

 

Pharma defeats biotech push for rapid approval program

Posted under Biotechnology Industry Organization, biotechs, Blog, Clinical Trials, Companies, Diagnostics, drug development, FDA, Funding, Jim Greenwood, Medical Devices, Medical Supply, Pharmaceuticals, regulatory approvals, Startups, Universities, Videos by Mark Hollmer

Biotechs butted heads with their far-larger pharmaceutical allies over a key lobbying issue, and lost. As Bloomberg reports, biotechnology companies threw their weight behind a plan drafted by North Carolina Democratic Sen. Kay Hagan to launch a more rapid FDA approval program, using fewer human trials, for orphan drugs or treatments that address fatal diseases. Pharmaceutical companies beat back the measure, however, apparently not wanting to dilute existing safety measures.

In a word: awkward. Both industry sectors lobby as part of the Biotechnology Industry Organization, a group that theoretically represents both sides' interests equally as drug development increasingly overlaps between each side. BIO board members representing the far smaller biotechs supported the proposal, but their pharmaceutical industry counterparts nixed the idea, Acorda Therapeutics ($ACOR) CEO Ron Cohen told Bloomberg. (His company, of course, is a biotech.)

Biotechs want the plan because they'd gain a more rapid approval timeline by redefining what efficacy means, using things like biomarkers that measure a drug's potential effectiveness, early trial results, or interim data to support regulatory approval. The idea arguably reflected a more innovative approach typical for biotechs, but they are also still relatively small and not generating significant revenue, so they'd welcome anything that could help better manage the financially punishing cost of traditional, extensive clinical trials. On the other hand, larger pharmaceutical companies want to preserve the existing system, citing safety concerns, but the status quo also helps preserve an important financial stake. Pharmas often help fund biotech clinical trials and then share the revenue once a drug hits the market, University of Michigan business professor Erik Gordon noted to Bloomberg.

A GlaxoSmithKline ($GSK) spokeswoman told Bloomberg that her company (one of the Big Pharma BIO members) preferred changes to existing programs with which regulators and regulated companies already work. Along those lines, BIO, perhaps not surprisingly, is pushing a compromise plan that would add other orphan drug or fatal disease-treatments to an existing program that accelerates approval for both cancer and HIV drugs, BIO CEO Jim Greenwood said in the story. Hagan will submit the new proposal to Congress later this year, Greenwood said, and it may be folded into larger legislation that renews the drug industry fee system that funds FDA regulatory reviews.

The compromise throws biotechs another bone: the use of surrogate endpoints, which show how a drug affects biological activity. But regulators would still require companies to prove clinical outcomes at some point.

- here's the Bloomberg story

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