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Unique Names for Biosimilar Products: Letter to Commissioner Hamburg

Jul 3 2012

IP Attache Program: BIO's Congressional Hearing Comments

Jun 27 2012
The U.S. Intellectual Property Rights Attaché Program has had significant success and holds immense promise in helping to enhance IP protection abroad for U.S. interests.

Oppose Costly & Confusing Labeling Amendment to the Agriculture Reform, Food and Jobs Act of 2012

Jun 21 2012
Senators Sanders and Boxer have introduced an amendment that will result in costly and extreme food labeling requirements.

The Farm Bill: BIO Opposes the Sanders-Boxer Amendment

Jun 21 2012
BIO, which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations around the world, strongly opposes the Sanders-Boxer Amendment (#2310) to the Farm Bill.

2012 BIO International Convention Chair's Keynote, H. Thomas Watkins of Human Genome Sciences

Jun 20 2012

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Celebrating the Promise of Biotechnology, 2012 Biotechnology Industry Address, Jim Greenwood, President and CEO BIO

Jun 19 2012
In his 2012 Biotechnology Industry Address, Jim Greenwood, President and CEO BIO, celebrated the researchers who worked on some of the newly approved breakthroughs, and the patients whose lives they've changed.

BIO Comments on IOM Report - Ranking Vaccines: A Prioritization Framework

Jun 15 2012
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Institute of Medicine’s (IOM’s) new report entitled,Ranking Vaccines: A Prioritization Framework, which was developed for the National Vaccine Program Office (NVPO). 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 biotechnology products.  BIO membership includes both current and future vaccine developers and manufacturers who have worked closely with the public health community to support policies that help ensure access to innovative and life-saving vaccines for all individuals. BIO commends this worthy effort to improve the process for identifying and prioritizing new preventive vaccines for development.  The SMART Vaccines software has the potential to help governmental, non-governmental, and commercial enterprises reach consensus regarding mutually beneficial priorities and collaborations which will guide the future investment of resources.  Today, on average, a new vaccine takes 8 to10 years and over $1 billion to develop.  The advanced vaccines of today are even more challenging to make as they often require very complex technologies to address new diseases and indications that were not able to be conquered with more traditional vaccine methods.  Due to high development costs and lengthy processes, BIO believes that it is critical that limited resources are spent on vaccines that are considered priorities by many immunization stakeholders. Recommendations SMART Vaccines is a subjective, user-reliant model.  As such, it should be used in an appropriate and transparent manner to aid and clarify the vaccine prioritization process.  To help increase the utility of this tool for vaccine developers and manufacturers, BIO supports and recommends the following: 1.      BIO recommends users, including the U.S. government, make inputs and rankings transparent to industry to help companies understand how major purchasers, regulators, and policy makers perceive future markets and to inform private sector investment decisions; 2.      BIO recommends that the IOM Committee and NVPO carefully consider how frequently SMART Vaccines will be used to inform prioritization; 3.      BIO recommends that the SMART Vaccines model be modified to account for the quality of data used; 4.      BIO supports the use of a multi-attribute utility approach for the SMART Vaccines software and recommends the addition of several attributes, including “likelihood of a recommendation for routine use by the Centers for Disease Control and Prevention (CDC)”; and 5.      BIO supports the public release of SMART Vaccines 1.0 to allow companies and other users to test the software using various vaccine candidates.  

BIO Comments on IOM Report - Ranking Vaccines: A Prioritization Framework

Jun 15 2012
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Institute of Medicine’s (IOM’s) new report entitled,Ranking Vaccines: A Prioritization Framework, which was developed for the National Vaccine Program Office (NVPO). 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 biotechnology products.  BIO membership includes both current and future vaccine developers and manufacturers who have worked closely with the public health community to support policies that help ensure access to innovative and life-saving vaccines for all individuals. BIO commends this worthy effort to improve the process for identifying and prioritizing new preventive vaccines for development.  The SMART Vaccines software has the potential to help governmental, non-governmental, and commercial enterprises reach consensus regarding mutually beneficial priorities and collaborations which will guide the future investment of resources.  Today, on average, a new vaccine takes 8 to10 years and over $1 billion to develop.  The advanced vaccines of today are even more challenging to make as they often require very complex technologies to address new diseases and indications that were not able to be conquered with more traditional vaccine methods.  Due to high development costs and lengthy processes, BIO believes that it is critical that limited resources are spent on vaccines that are considered priorities by many immunization stakeholders. Recommendations SMART Vaccines is a subjective, user-reliant model.  As such, it should be used in an appropriate and transparent manner to aid and clarify the vaccine prioritization process.  To help increase the utility of this tool for vaccine developers and manufacturers, BIO supports and recommends the following: 1.      BIO recommends users, including the U.S. government, make inputs and rankings transparent to industry to help companies understand how major purchasers, regulators, and policy makers perceive future markets and to inform private sector investment decisions; 2.      BIO recommends that the IOM Committee and NVPO carefully consider how frequently SMART Vaccines will be used to inform prioritization; 3.      BIO recommends that the SMART Vaccines model be modified to account for the quality of data used; 4.      BIO supports the use of a multi-attribute utility approach for the SMART Vaccines software and recommends the addition of several attributes, including “likelihood of a recommendation for routine use by the Centers for Disease Control and Prevention (CDC)”; and 5.      BIO supports the public release of SMART Vaccines 1.0 to allow companies and other users to test the software using various vaccine candidates.  

More than Myriad: Gene Patent Discussion Must Not Forget Industrial, Environmental, Food and Agricultural Biotech

Jun 11 2012
On behalf of the 23 undersigned industrial, environmental, food and agricultural biotechnology companies, we write to express our concerns over the pending appeal in the case of Association for Molecular Pathology et al. v. Myriad Genetics et al (AMP) before the U.S. Court of Appeals for the Federal Circuit.

Clinical Trials: BIO Submits Comments on FDA's Modernizing the Regulation of Clinical Trials

May 30 2012

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