Health Care

Underlying the PDUFA V recommendations are the principles that a science-based, transparent, and well-managed review process that appropriately balances benefits and risks can enhance public trust and increase patient access to new medicines.

Kuldip Dave from the Michael J. Fox Foundation discusses his organization's work to reposition drugs for Parkinson's Disease.

Since the development of the first vaccine by Edward Jenner in 1796, we have seen tremendous progress in our ability to prevent deadly childhood infections.

Regulatory review processes are not keeping up with rapidly advancing science and are making the environment for developing new treatments and preventions for deadly and debilitating diseases more difficult.

Bernard Siegel, executive director of the Genetics Policy Institute and co-chair of the World Stem Cell Summit, discusses the latest on NIH funding for embryonic stem cell research and tells us why he believes stem cell research is the future of medicine.

The buzz at BIO India hones in on the lack of clarity and consistency within the clinical trials process

Phyllis Arthur interviews Colonel Randall Larsen, CEO of the WMD Center, on the threat of a pandemic as portrayed in the movie Contagion which opens in theatres nationwide today.

Jack discusses her greatest accomplishments, advice for industry leaders, and the promise of biotech. Pulmatrix is a clinical trial stage biotech company based in Lexington, Mass.

What is ALS? How widespread is the disease? Are there any treatments for ALS? Dr. Steven Perrin discusses his organization's approach to stopping ALS.

Did you know that there is a community of sick and disabled women, children, and men that is so large that it outnumbers all of those with cancer and AIDS combined worldwide?

The biotech industry has shrunk dramatically in recent years based primarily on the continued tight capital markets and increased aversion to risk on the part of investors.

Dr. Napoleone Ferrara was named the 2011 winner of The Dr. Paul Janssen Award for Biomedical Research for his research on angiogenesis, the process of new blood vessel formation, and the isolation and cloning of vascular endothelial growth factor.

Dr. Augustus White is author of “Seeing Patients: Unconscious Bias in Health Care” and a pioneer in equitable care. Dr. White will be delivering the keynote address at this year’s Diversity Summit at the 2011 BIO International Convention in Washington, D.C.

GlycoMimetics’ Rachel King discusses the prevalence of sickle cell disease and urgency to find treatments.

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.
April 4 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit comments in response to the Centers for Medicare & Medicaid Services’ (CMS’s) Final Rule with Comment entitled Medicaid Program; Covered Outpatient Drugs Final Rule with Comment Period (the “FC”).1 As directed by the Agency, the scope of our comments is limited to the single topic open for public comment: “The definition and identification of line extension drugs.”2 
March 13 2016
BIO strongly supports efforts by the Agency, such as the Pilot COA Compendium and recent updates to the FDA’s drug development tool (DDT) qualification website, to promote the efficient development and use of COAs and other DDTs for drug development and regulatory decision-making. We believe that the COA Compendium is a good step in providing information to the public about COAs in development and use, providing a level of transparency and increasing awareness of efforts towards patient-focused drug development and COA information.
February 16 2016
BIO supports FDA’s assertion that “it is critical for sponsors to detect and report, as early as possible, serious and unexpected suspected adverse reactions and clinically important increased rates of previously recognized serious adverse reactions,” and we appreciate the publication of this Draft Guidance to aid Sponsors in this responsibility. However, we are concerned about the prescriptive nature of this Draft Guidance and its emphasis on the Safety Assessment Committee (SAC). We are also concerned that FDA may not fully appreciate the time and resources required of Sponsors to implement the recommendations within the Draft Guidance.
February 8 2016
BIO strongly supports the Prescription Drug User Fee Act (PDUFA 5) program to enhance FDA-Sponsor communication, which is based on FDA’s stated philosophy that “timely interactive communication with Sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner.” BIO applauds FDA’s effort to give IND Sponsors and FDA review staff best practices and procedures for timely, transparent, and effective communications during drug development through this Draft Guidance.

Press Releases

April 25 2016
Washington, D.C. (April 25, 2016) – The Biotechnology Innovation Organization (BIO) issued the following statement today regarding the Campaign for Sustainable Rx Pricing’s policy proposals on prescription drug prices:
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:
March 30 2016
Washington, D.C. (March 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding the American College of Physicians’ policy paper on prescription drugs:
March 17 2016
Washington, D.C. (March 17, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the introduction today by Senators Alexander and Murray of the FDA and NIH Workforce Authorities Modernization Act: