Drug Discovery and Development

This paper is an overview of a variety of ways that have been suggested to encourage innovation/research and development for diseases that are endemic to the developing world but not the developed world.

Biotechnology, the combination of biology and technology, includes biologic applications, diagnostic tools and businesses that improve everyday life by providing solutions to some of life's most vexing problems.

Dr. Moira Gunn and David Ewing Duncan report from the BIO International Convention.

Thirty six thousand Americans die from seasonal flu each year, now there is additional threat a possible global avian flu pandemic.

Has a member of your family been vaccinated against hepatitis B? Do you know someone who has diabetes? Has anyone in your family had heart disease?

The public has a strong interest in protecting research and research participants. Federal policy must find the right balance in protecting participants while allowing critical research to continue.

Providers and policy makers must collectively address the profound effect the red-tape hassle can have on the practice of oncology.

As people age they walk a minefield of life-threatening and debilitating diseases.

May 20 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in this time of budgetary constraint, it is crucial that we not allow this to happen. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.
May 16 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.
April 14 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public trust in the clinical trial enterprise. 
September 13 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.” BIO commends FDA on the release of this Draft Guidance and shares the Agency’s commitment to ensure that safe and effective medicines are available for children.
August 26 2013
BIO fully supported the expansion and modernization of FDA’s Accelerated Approval pathway and the enactment of the new Breakthrough Therapy Designation Process under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA, P.L. 112-144).
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.
November 18 2013
BIO commends the Senate for approving H.R. 3204, the Drug Quality and Security Act.
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
March 28 2012
H.R. 4274 will encourage continued investment in pediatric research.
May 25 2011
BIO commends Reps. Davis (D-Ca) and Schwartz (D-PA) for their continued efforts to extend the Qualifying Therapeutic Discovery Project Tax Credit.