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Personalized Medicine

Personalized Medicine and Diagnostics (PMDx) Working Group Mission Statement

The PMDxWorking Group endeavors to foster a positive public policy environment that maximizes the potential impact of the personalized medicine industry for the benefit of patients.

Podcast Part I: John Sterling, Editor in Chief of Genetic Engineering and Biotechnology News (GEN)

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 Need Friends Too

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

Laurence Marton on Personalized Medicine

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

Hillary Theakston, The Clearity Foundation

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.

Recommendations for Novel Diagnostics Coverage and Reimbursement

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.

Prof. Alan Trounson, Ph.D., President of the California Institute for Regenerative Medicine

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

Bernard Siegel speaks about recent developments in stem cell research

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

On a Roll: Governor Seeks Continued Investment in BioMaryland 2020

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

John Sterling, editor-in-chief of Genetic Engineering and Biotechnology News (GEN)

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

Top Ten "Must Attend" Breakout Sessions at the 2011 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.

Countdown to Partnering With John Carroll from Fierce Biotech

John Carroll discusses the upcoming BIO International Convention.

Countdown to Partnering - John Carroll, Editor of Fierce Biotech

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

The Reimbursement Landscape for Novel Diagnostics: Current Limitations.

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.

New Report Analyzes Impact of Limitations of Current Reimbursement System on Development of Novel Diagnostics

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.

Letters, Testimony & Comments

BIO Comments on New CMS Clinical Lab Fee Schedule Codes and Payment Determinations
October 4 2012
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical...
Companion Diagnostics: BIO Comments on FDA Draft Guidance
October 14 2011
RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology...
BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only
September 1 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
BIO Comments Following FDA Public Meeting: Ultra High Throughput Sequencing for Clinical Diagnostic Applications
July 23 2011
BIO commends the FDA for prospectively seeking input from industry to ensure that the regulatory environment is supportive of the rapid...
BIO Comments on the FDA's Draft Guidance for the Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies
April 19 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
More Letters, Testimony & Comments →

Press Releases

TREAT Act Offers Renewed Hope for Patients
February 15 2012
Washington, DC (February 15, 2012) – Today, the Biotechnology Industry Organization (BIO) praised Sen. Kay...
Challenges in Reimbursement Hamper Development of Novel Diagnostics
January 6 2011
WASHINGTON, D.C. (Thursday, January 06, 2011) - The Biotechnology Industry Organization (BIO) released today a report...
Media Registration for the 2011 BIO International Convention Now Available Online
January 3 2011
WASHINGTON, D.C. (Monday, January 03, 2011) - The Biotechnology Industry Organization (BIO) announced today that...
BIO Hails Court of Appeals Action to Lift Injunction on Embryonic Stem Cell Research
September 29 2010
WASHINGTON, D.C. (Wednesday, September 29, 2010) - Biotechnology Industry Organization (BIO) President and CEO Jim...
New BIO Report Highlights Value of Biotechnology to Individuals and Society
May 4 2010
 WASHINGTON, D.C. (May 4, 2010) --  A new report issued by the Biotechnology Industry Organization...
More Press Releases →