The blueprint calls for more public-private collaboration to advance biotech discovery, particularly in the pre-competitive
arena that may involve sharing of information and resources. Such collaboration, the blueprint notes, already is advancing
clinical trial design and biomarker discovery. A prime example is the National Institutes of Health (NIH) initiative to translate
biomedical discoveries into effective therapies more efficiently, specifically NIH Director Francis Collins' campaign to find
new uses for existing drug compounds.
Collins rolled out the first project in this area in May 2012, announcing that the NIH National Center for Advancing Translational
Sciences (NCATS) is linking up with Pfizer, AstraZeneca, and Eli Lilly to support independent studies on approximately 20
drugs that the companies previously tested but never brought to market. NIH will provide $20 million in grants in 2013 to
fund promising research proposals and provide templates for agreements on dealing with intellectual property and other rights.
Under the program, which was expanded in June to include Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, and Sanofi,
manufacturers will give researchers the compounds and relevant data, while retaining rights to their products. Independent
researchers will be able to publish study results and negotiate licenses on new discoveries. The research agreement templates
are key to speeding up negotiations among all parties and making the program work. NIH plans to publish a list of compounds
available for research in a few months, with an eye on awarding initial grants next spring. Manufacturers see the NIH program
as a way to extend the kinds of arrangements they already have with individual research institutes, including AstraZeneca's
partnership with the UK's Medical Research Program.
Despite these positive developments, manufacturers believe that more US support for biopharmaceutical research and product
development is needed to prevent innovative firms from looking overseas for financial and regulatory support. An analysis
of R&D investments and policies at 18 industrial and emerging countries by the Battelle Technology Partnership Practice, released
in May, for the Pharmaceutical Research and Manufacturers of American (PhRMA) warns that the US may lose its pre-eminent position
in biotech discovery and product development without more pro-innovation policies. Although pharmaceutical output continues
to expand in the US and the EU, the fastest growth now is in China, Russia, Israel, and Singapore, which have established
innovation strategies targeted to the biopharmaceutical sector as part of national agendas to establish knowledge-based economies.
The US biopharmaceutical sector indirectly supports four million US jobs and pays hefty state and federal taxes, according
to Battelle. Yet, challenges in managing clinical trials, dealing with complex regulatory processes, and obtaining adequate
coverage and payment for new treatments makes it hard for US firms to resist foreign overtures accompanied by tax benefits,
research support, and favorable regulatory policies. Even the White House blueprint acknowledges that new initiatives are
necessary to counter a 30-year decline in pharmaceutical industry productivity, as measured by new molecular entities per
dollar spent on R&D (adjusted to reflect inflation). While R&D costs have increased 50-fold during this time period, drug
candidates and new drug applications have been flat.
The PhRMA report points out that the R&D tax credit has never become permanent in the US, and corporate taxes remain high,
while other countries are offering a variety of tax relief for start-ups and their investors. Federal funding of biomedical
research has been static for several years and faces cutbacks, compared to other nations that are funding more biotech research,
nurturing young scientists and engineers, and offering incentives to attract world-class researchers to their institutions.
The US still leads the world in many areas that are crucial to R&D, but the challenges facing biotech manufacturers require
a more sustained response.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, email@example.com