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21st Annual BIO CEO & Investor Conference Programming Announced
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Press Release  •  November 28, 2018
The Biotechnology Innovation Organization (BIO) today announced preliminary programming for the upcoming BIO CEO & Investor Conference to be held February 11-12, 2019 in New York City. Program lineup covers policy, investment, innovation and patient access. New this year, BIO is offering Executive Leadership courses to help companies develop tools for striking deals and improving corporate reputation. Participants will choose between one of two interactive courses which are based on real-life biopharma experiences and will run on Sunday, February 10.
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BIO Statement on Unsubstantiated Reports of Heritable Human Genome Editing Experiments in China
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Press Release  •  November 28, 2018
The Biotechnology Innovation Organization (BIO) issued the following statement regarding unsubstantiated reports this week of experiments involving heritable human genome editing in China.
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BIO Comments on FDA Draft Guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics
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Letters, Testimony & Comments  •  November 28, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics: Draft Guidance for Industry, which provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials. BIO says this important draft guidance will help companies use adaptive trial designs to provide evidence of the effectiveness and safety of a drug or biologic. BIO suggests additional information to include in the guidance as well as how to clarify the guidance.
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BIO Comments on FDA Draft Guidance on Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics
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Letters, Testimony & Comments  •  November 28, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry. BIO welcomes guidance with information on master protocols. The comments provide suggestions for how to improve the clarity and completeness of the guidance.  
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BIO Welcomes 21 New Companies to Industrial & Environmental Section
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Press Release  •  November 28, 2018
The Biotechnology Innovation Organization today announced 21 companies have joined the Industrial & Environmental Section over the past year. BIO will work closely with these diverse new members as it continues to lead advocacy efforts that advance the development and adoption of biotechnology into industrial and environmental processes, such as the production of bio-based products and biofuels.
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BIO Statement on Proposed Changes to Medicare Advantage and Part D Plans
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Press Release  •  November 27, 2018
“Today’s proposed rule to roll back critical protections afforded to some of America’s sickest and most vulnerable Medicare beneficiaries would, if adopted, severely limit seniors’ access to the drugs most appropriate for them, and is yet another unfortunate example of Administration proposals that will financially benefit insurance plans and other middlemen in the drug supply chain at the expense of patients."
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New Report Shows Global Link Between Pro-Innovation Policies and Biotech Advances
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Press Release  •  November 19, 2018
Washington, D.C. (November 19, 2018) – A study released today highlights strategies, policies and best practices that have been successful in creating an environment in which biotechnology innovation can flourish around the world.The fifth edition of the Building the Bioeconomy report shows the correlation between economies with pro-innovation policy frameworks and those achieving strong biotechnology outputs. By examining 28 different indicators, the report provides a full and detailed analysis of the biotechnology environment for 33 countries from all major regions of the world.“Regulations need to strike a balance that stimulates innovation without dampening broader economic efficiencies. More than in other industry, the interplay between biotechnology innovation and regulation has important social and economic implications, said Joseph Damond, Executive Vice President, International Affairs at BIO. “As this report demonstrates, countries that are leading the biotech economy are the ones where forward-looking regulations encourage, not hinder, innovation.” This data-driven report developed by Pugatch Consilium compares economies on over 20 policy inputs and biotech outputs showing how regulations effect success or failure in driving industry growth. Economies that have stronger environments with all enabling policy factors in place yield higher biotechnology outputs. Adopting a strong policy framework is key to reaping the economic and social benefit of this important industry.“Designing policies to foster biotech innovation is not an easy task,” said Prof. Meir Pugatch, IPKM Chair, University of Maastricht and Managing Director, Pugatch Consilium. “To build a thriving biotechnology sector, whether it be agriculture, health or industrial applications, countries need strong intellectual property protections, a pro-innovation regulatory environment and robust technology transfer procedures. Funding research without establishing these elements is simply…
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BIO Comments on FDA Draft Guidance on Product Identifiers Under the Drug Supply Chain Security Act Q&A
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Letters, Testimony & Comments  •  November 19, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers. BIO member companies are committed to ensuring the U.S. drug supply chain is secure, patients are receiving authentic products, and legitimate medications continue to move through the supply chain without unnecessary delays. The Drug Supply Chain Security Act (DSCSA) will improve the security of the U.S. pharmaceutical supply chain only with collaboration among all supply-chain stakeholders. In the comments, BIO says this Q&A document will help sponsors and stakeholders better understand the use of product identifiers. BIO provides suggestions on how to make the guidance more clear and effective, regarding the order and format of product identifier requirements, expiration date formatting, use of the GTIN and NDC, and the timely release of guidance documents.  
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BIO Releases Third Report in a Series on the State of Innovation in Highly Prevalent Chronic Diseases
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Press Release  •  November 15, 2018
Washington, DC (October 26, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Volume III Type 2 Diabetes and Obesity Therapeutics, the third in a series on the current funding and R&D landscape for drugs to treat highly prevalent, chronic diseases.
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BIO Comments on FDA Draft Guidance on Testing of Retroviral Vector-Based Human Gene Therapy Products
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Letters, Testimony & Comments  •  November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up. BIO agrees with most recommendations in the draft guidance on product testing for replication competent retrovirus (RCR). In particular, BIO commends the FDA for inviting the gene therapy community to publish findings of relevant studies, which will benefit and advance the field. BIO suggests FDA convene a public workshop with industry, academia, and other stakeholders to discuss current scientific data regarding RCR in gene therapy applications. BIO would be happy to help FDA with this effort. In addition, BIO suggested passages in the draft guidance that could be clarified.
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