Personalized Medicine

John discusses the state of the industry and what he expects will be the top three issues highlighted at this year's BIO International Convention.  For more information on GEN, please visit http://www.genengnews.com/

Drugs approved with companion diagnostic tests represent the next wave of personalized medicine and have the potential to significantly improve patient outcomes.

BIOtech-NOW talks to Laurence Marton, Co-Chair of the Personalized Medicine World Conference 2012, about the outlook for personalized medicine.

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.

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.

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

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

The Maryland initiative’s 10-year plan helps build biotech access to funding

BIOtechNOW talks to GEN's John Sterling regarding the upcoming BIO International Convention.

GEN's Editor-in-Chief John Sterling outlines his picks for the top ten "must attend" breakout sessions at the 2011 BIO International Convention.

 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO International Convention.

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time.

A report by Health Advances found that significant limitations in the current reimbursement system for novel diagnostics lead to inconsistent coverage decisions and impede the investment necessary for the development of the next generation of diagnostics.

July 23 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for Medicare and Medicaid Services (CMS) on May 9, 2013.
July 10 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.
October 4 2012
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations published by the Centers for Medicare and Medicaid Services (CMS) on August 31, 2012. BIO represents more than 1,100 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 biotechnologies, thereby expanding the boundaries of science to benefit society by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. Specifically related to advanced personalized diagnostic products, a number of BIO companies develop and market in vitro diagnostic technologies for a variety of research, investigational, and clinical uses. BIO is deeply concerned with CMS’ payment proposal regarding Multi-Analyte Assays with Algorithmic Analyses (MAAAs), and is concerned generally with the lack of transparency in the process through the annual CLFS meeting and publication of the proposed payment methodologies. BIO believes these proposed payments will threaten access to molecular pathology tests by Medicare beneficiaries and have a devastating impact on the advancement of personalized medicine.
September 1 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (“the Draft Guidance”).
February 15 2012
The bill will modernize the FDA and accelerate patient access to cures and new treatments.
January 6 2011
BIO releases a report by Health Advances on the limitations of the nation’s reimbursement system for novel diagnostics and the impact of these limitations. 
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.
September 29 2010
BIO President and CEO Jim Greenwood released the following statement on action by the U.S. Circuit Court of Appeals last night to stay the lower court’s injunction on federally funded embryonic stem cell research...
May 4 2010
A new report issued by the Biotechnology Industry Organization underscores how biotechnology is benefiting society now more than ever, and is poised to help address some of the world’s most pressing challenges.