Health Care

Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time.

In an effort to bring innovative new medicines to patients more efficiently, while protecting and enhancing patient safety, BIO is developing an initiative to modernize clinical trials.

William Schaffner, MD, the immediate past president of the National Foundation for Infectious Diseases, explains why it is important for all adults to become fully immunized according to recommended schedules.

Successful multi-sector global health programs engage partners and policymakers early, communicate openly and frequently with relevant stakeholders, and empower and involve communities, according to a website relaunched this week, Case Studies for Global Health.

BIO Ventures for Global Health (BVGH) and the Biotechnology Industry Organization (BIO) have collaborated on a new report that builds upon the findings in BVGH’s previous analysis, Developing New Drugs and Vaccines for Neglected Diseases of the Poor: The Product Developer Landscape.

Janelle Curtis, Vice President of Programs at the Biotech Institute, interviews Tonia Moore-Davis, a certified Nurse-Midwife and Instructor of Clinical Nursing at the Vanderbilt University School of Nursing and Immediate Past Chair for the Board of Directors of HOSA.

Celiac disease is one of the most common autoimmune conditions in the U.S. but frequently goes undiagnosed. The cause is currently unknown and it can develop at any point in life. In this podcast, Dr. Peter H.R. Green, Director of The Celiac Disease Center at Columbia University, explains what celiac disease is, how it is diagnosed and the treatment options.

In recognition of National Infant Immunization Week, Dr. Yabo Beysolow, Medical Officer at the CDC, talks about the benefits of immunization for children under the age of two.

BIO's President and CEO Jim Greenwood talks to BIO Ventures for Global Health (BVGH) CEO Don Joseph about global health and BVGH's new report on global health.

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important regulatory issues facing the industry, specifically PDUFA reauthorization, the FDA and regulation. Also, hear his programming highlights from the Achieving Regulatory Approval and Compliance Track at the upcoming 2012 BIO International Convention.

Capital formation challenges in the industry have forced many biotech companies to halt projects, lay off staff or shutdown all together. Our analysis shows that the industry is approximately one-quarter smaller than it was in 2008.

BIO believes that the level of support provided by the TDP simply cannot meet the needs of the growing biotech field. As evidence of the project's popularity suggests, Congress should consider extending or expanding the project in order to support American innovation and speed the development of life-saving cures.

The biotech industry is a thriving sector employing 1.3 million Americans in high quality, high paying jobs.

A single dose of an experimental gene therapy boosted production of a missing blood-clotting factor in people with hemophilia, a new study shows.

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: