Health Care

BIOtechNOW’s Tracy Cooley talks to Hillary Theakston, of The Clearity Foundation, is a non-profit organization dedicated to providing personalized treatment information to women with ovarian cancer.

BIOtechNOW’s Tracy Cooley talks to Dr. Reed from the   Sanford-Burnham Medical Institute about the NIH’s new National Center for Advancing Translational Sciences.

Some of the most pressing challenges for the advent of personalized medicine relate to the reimbursement of novel diagnostics. Reimbursement policies must reflect the potential benefit that novel diagnostics can bring to patients and the healthcare system. This value proposition can be realized through reimbursement policy reforms that provide a clear and consistent pathway to obtain affirmative coverage, appropriate and timely coding, and market-based payment for diagnostic tests. BIO recommends that the following reforms be made to diagnostic reimbursement policy.

The number of Americans diagnosed with diabetes — the seventh leading cause of death in the U.S. — has risen by epidemic proportions. In addition, the disease is estimated to affect 435 million people worldwide by 2030. BIO and the Juvenile Diabetes Research Foundation will feature a two-day diabetes forum for the first time at the 2011 BIO International Convention in Washington, DC. The sessions will showcase the latest research in novel therapies, vaccines, and biomarkers.

BIOtechNOW speaks with Dr. Trounson is a pioneer of human in vitro fertilisation (IVF) and associated reproductive technologies.

BIO is committed to increased access to biologic medicines for patients throughout the world. 

Emerging biotech companies with promising scientific innovation need a policy environment that will enable them to continue critical research and development of medical advancements and breakthroughs.

The world’s largest biotech hubs are busy planning their delegations’ visits to the  BIO International Convention  next month. The international program at the Convention will be one of the most robust to date, with International Case Studies, breakout sessions focused on globalization and Super Sessions focused on the emerging markets.

BIOtechNOW’s talks to Bernard Siegel about recent developments in stem cell research and the upcoming BIO International Convention.

Soelkner discusses the benefits of working with a contract manufacturing organization and how to identify, select and work with CMOs.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

April is Parkinson's Awareness Month so it seemed like a good opportunity to learn more about the Michael J. Fox Foundation for Parkinson's Research.

April is Parkinson's Awareness Month so it seemed like a good opportunity to learn more about the Michael J. Fox Foundation for Parkinson's Research.

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and interfered with the growth and survival of small private biotechnology companies and the development of promising technologies and products

Letters, Testimony & Comments

July 10 2015
We applaud Chairman Fred Upton (R-MI), Ranking Member Frank Pallone (D-NJ) and Congresswoman Diana DeGette’s (D-CO) efforts on H.R. 6., which takes important steps toward placing patients at the center of the drug development process, and we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on rare conditions and other unmet medical needs. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
June 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
June 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
February 23 2015
The Biotechnology Industry Organization (BIO) thanks you for the opportunity to provide our initial thoughts on your report Innovation for Healthier Americans. 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.
February 5 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (the "Notification Guidance) (Collectively the "LDT Guidance").

Press Releases

November 18 2015
BIO released a list of seven proposed topics for the November 20th U.S. Department of Health and Human Services (HHS) Forum on Pharmaceutical Innovation, Access, Affordability and Better Health. The consideration of these topics at the Forum will help to ensure that patients have access to the most innovative new treatments and cures.
October 8 2015
Communication Important for Patients and Physicians