[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 95 Introduced in House (IH)]

114th CONGRESS
  1st Session
H. RES. 95

     Recognizing the importance of transformative breakthroughs in 
    biomedicine, biotechnology, and life sciences in the diagnosis, 
  management, curing, and treatment of illness and the existence of a 
  ``Valley of Death'' in biotechnology and life sciences funding that 
     stifles innovation and impedes translational medical research.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 5, 2015

 Mr. Vargas submitted the following resolution; which was referred to 
                  the Committee on Energy and Commerce

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                               RESOLUTION


 
     Recognizing the importance of transformative breakthroughs in 
    biomedicine, biotechnology, and life sciences in the diagnosis, 
  management, curing, and treatment of illness and the existence of a 
  ``Valley of Death'' in biotechnology and life sciences funding that 
     stifles innovation and impedes translational medical research.

Whereas cancer, rare and orphan diseases, diabetes, and Alzheimer's are just a 
        few of a growing number of large-scale challenges confronting modern 
        society that can be addressed only through the sustained collaboration 
        of thousands of highly skilled, dedicated, and independent individuals 
        over many years;
Whereas many promising breakthroughs have occurred in biomedicine in recent 
        years, including gene therapies, molecularly targeted drugs, new modes 
        of medical imaging and radiosurgery, biomarkers for drug response, human 
        genome sequencing, and advances in bioinformatics that enabled many of 
        these new applications;
Whereas biomedicine is far more advanced today than even a decade ago is 
        indisputable, but breakthroughs require years of translational research 
        at a cost of hundreds of millions of dollars and have a substantial 
        likelihood of failure;
Whereas the drug development pipeline is laden with unfavorable probabilities;
Whereas for every 5,000 to 10,000 compounds that enter the drug discovery 
        pipeline, just 250 progress to preclinical development, and only one 
        will become an approved drug;
Whereas the aggregate research and development budget of the pharmaceutical 
        industry has nearly doubled from $68,000,000,000 in 2002 to 
        $127,000,000,000 in 2010, there has been little appreciable impact on 
        the number of new drugs approved;
Whereas Congress must work in a bipartisan fashion to reform the Food and Drug 
        Administration's (FDA) review process for drug development and 
        biomedical innovation in order to facilitate expeditious approval of 
        safe and effective new products, better outcomes for patients, and more 
        efficient and effective uses of FDA's limited resources;
Whereas biomedical innovation has become much more challenging to finance with 
        private and public equity;
Whereas there is a growing concern within and outside the industry that the 
        process of translating biomedical research into effective treatments is 
        obsolete;
Whereas biotech and life sciences traditional financing vehicles of private and 
        public equity are becoming less effective funding sources because the 
        needs and expectations of limited partners and shareholders are not 
        consistent with the increasing complexity and risk of biomedical 
        innovation;
Whereas the lengthy process of biomedical innovation is becoming increasingly 
        complex, expensive, uncertain, and fraught with conflicting motivations 
        and public-policy implications;
Whereas industry professionals frequently refer to the ``Valley of Death'', a 
        steadily widening funding and resource gap that currently exists between 
        basic research and clinical development, effectively limiting the field 
        of potential novel therapies, technologies, and treatments for patients;
Whereas the life sciences industry needs novel approaches to early-stage drug 
        development that better manage risk, lower capital cost, improve 
        research effectiveness, create diverse portfolios, leverage risk-
        tolerant capital, and access new capital sources; and
Whereas innovative financial structures can achieve the necessary grand scale of 
        capital needed to support effective diversification of biotech 
        investments and create stable and attractive investment opportunities 
        along the development pipeline: Now, therefore, be it
    Resolved, That the House of Representatives--
            (1) recognizes the importance of transformative 
        breakthroughs in biomedicine, biotechnology, and life sciences 
        in the diagnosis, management, curing, and treatment of illness;
            (2) recognizes the need for bipartisan reform of the Food 
        and Drug Administration (FDA) in order to facilitate 
        expeditious approval of safe and effective new products, better 
        outcomes for patients, and more efficient and effective uses of 
        FDA's limited resources;
            (3) recognizes the existence of a ``Valley of Death'' in 
        biomedicine, biotechnology, and life sciences funding, a 
        steadily widening funding and resource gap that currently 
        exists between basic research and clinical development, 
        effectively limiting the field of potential novel therapies and 
        drugs for patients; and
            (4) recognizes innovative financial structures can achieve 
        the necessary grand scale of capital needed to support 
        translational research and development in biomedicine, 
        biotechnology, and life sciences.
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