Drug Discovery and Development

States and regions throughout the United States are investing to create a business climate that supports the specific needs of the biosciences sector.

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.

Letters, Testimony & Comments

April 17 2016
BIO member companies are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.
October 22 2015
RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry, entitled “Rare Diseases: Common Issues in Drug Development” (Draft Guidance).   BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
August 16 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”
April 23 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case.
March 22 2015
The Biotechnology Industry Organization (BIO) thanks the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) for the opportunity to submit comments on the Notice of Proposed Rulemaking (NPRM) entitled Clinical Trials Registration and Results Submission.

Press Releases

April 6 2016
Washington, D.C. (April 6, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding today’s Senate HELP Committee mark-up of legislation as part of the Senate biomedical innovation initiative:
February 26 2016
Washington, D.C. (February 26, 2016) – The Biotechnology Innovation Organization (BIO) Executive Vice President for Health Policy Dan Durham released the following statement regarding yesterday’s White House announcement of actions to accelerate the Precision Medicine Initiative:
January 21 2016
Washington, D.C. (January 21, 2016) – The Biotechnology Innovation Organization (BIO) applauds the Industry Declaration on Combating Antimicrobial Resistance, signed by 85 biopharmaceutical and diagnostic companies and released today at the World Economic Forum in Davos, Switzerland.
November 18 2014
Washington, D.C. (November 18, 2014) – BIO issued the following statement in response to a study released today by the Tufts Center for the Study of Drug Development, which estimated the cost of developing a new prescription medicine that gains marketing approval at $2.558 billion (in 2013 dollars), including the cost of promising therapies that did not achieve FDA approval. These findings represent an increase of 145 percent, or 8.5 percent compound annual growth, since a previous study in 2003, in which Tufts estimated that cost at $1.044 billion (also in 2013 dollars).