Health Care

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.

Dr. Tettelin discusses his research in reverse vaccinology and as a pioneer of the pan-genome concept.

Moree discusses the Forum and the importance of partnering to improving the health of people in developing countries.

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.

Letters, Testimony & Comments

May 8 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format .”
May 7 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the FDA Draft Plan on “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making.”
April 19 2013
BIO appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology.” 
April 12 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products.”
April 8 2013
BIO supports the goals of the Affordable Care Act (ACA) in providing greater transparency regarding financial relationships with healthcare providers and we recognize the significant challenges that were presented in implementation of these ACA provisions. 

Press Releases

May 24 2013
Rx Response elevates to Alert status to address potential impact from Moore tornado on supply chain.
February 28 2013
BIO lauds the Senate for passing H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), yesterday by a unanimous vote.
January 25 2013
Bill will accelerate R&D to help support nation’s preparedness against chemical, biological, radiological and nuclear threats.
October 1 2012
Pharmaceutical Research and Manufacturers of America PhRMA President and CEO John J. Castellani and BIO President and CEO Jim Greenwood released the following joint statement on the implementation of the Prescription Drug User Fee Act (PDUFA V).
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.