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BIO Comments on FDA Draft Guidance on Scientific and Ethical Considerations for Including Pregnant Women in Clinical Trials
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Letters, Testimony & Comments  •  June 8, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry. This guidance is an important step towards providing information to patients and providers about the safety and efficacy of therapies for pregnant women. The guidance provides insight to sponsors on how and when to include pregnant women in drug development clinical trials. BIO provided general and detailed comments to clarify the draft guidance, including what types of studies it applies to, terminology such as the meaning of "nonpregnant women," and how to analyze and interpret data obtained from pregnant women in clinical trials that are not for medical products specifically indicated for pregnant women.
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BIO Comments on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation
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Letters, Testimony & Comments  •  June 8, 2018
BIO submitted comments to the Food and Drug Administration’s (FDA) on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation, following the Public Workshop on May 9, 2018. While advances in genomics and precision medicine have significantly improved the ability to develop medicines aimed at specific molecular targets that may be present in multiple diseases and/or cancers, there is much to be learned through continued research and development. BIO appreciates the FDA taking a forward-looking approach and having early discussions about how these advances may affect other aspects of drug development and review, such as orphan drug designations. In comments following the public workshop, BIO provided several items for the FDA’s consideration, including on the importance of the Orphan Drug Act as well as how to encourage innovation for novel therapies to treat rare diseases. BIO encourages the FDA to consider how to apply a tissue agnostic approach outside of oncology. BIO also asks the FDA to partner with stakeholders to discuss the impacts of tissue agnostic therapies on drug development and review.
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BIO 2018 Makes History in Boston
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BIO One-on-One Partnering  •  Press Release  •  June 7, 2018
Boston, MA – (June 7, 2018) – The 2018 BIO International Convention (BIO 2018) today wrapped up four days of programming under the theme of “Make History.” Hosted by the Biotechnology Innovation Organization(BIO), BIO 2018 attracted thousands of U.S. and international attendees, celebrated innovations that have shaped the past 25 years and recognized the companies, patient groups, academic centers and investors that continue to advance novel solutions to the world’s toughest challenges... 
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BIO Sets the GUINNESS WORLD RECORDS™ Title for the Largest Business Partnering Event
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Business Development, BIO One-on-One Partnering  •  Press Release  •  June 6, 2018
Washington, DC (June 6, 2018) – This morning at the Biotechnology Innovation Organization’s (BIO) International Convention in Boston, BIO proudly attempted – and set– the GUINNESS WORLD RECORDS title for the Largest Business Partnering Event.
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South Dakota Governor Dennis Daugaard Presented BIO Lifetime Champion Award
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Press Release  •  June 6, 2018
Boston, MA (June 6, 2018) –  The Biotechnology Innovation Organization (BIO) presented South Dakota Governor Dennis Daugaard with a Lifetime Champion Award in recognition of his stalwart leadership and commitment to strengthening South Dakota’s growing biotechnology industry. He received the award in conjunction with the 2018 BIO International Convention."Biotechnology innovation is not just good for South Dakota’s economy. It unlocks the door to important medical, food production, animal health and renewable energy advances as well," said Governor Daugaard. "I am proud to say companies across the biotechnology spectrum have taken notice of what we are doing in South Dakota and have decided to put down roots with us. I am honored to receive this acknowledgement on behalf of the State of South Dakota for our support of innovations that help feed, fuel and heal the world.""Thanks to the leadership of Governor Daugaard, South Dakota has steadily grown and diversified its biotechnology industry," said Jim Greenwood, President and CEO of BIO. "Governor Daugaard has demonstrated his unyielding commitment to building a strong bioscience economy in South Dakota. As a champion of innovation, Governor Daugaard recently signed forward-looking legislation that will provide patients more opportunities to address their medical needs, through the substitution of interchangeable biologic medicines. This bill particularly benefits severely ill patients who rely on complex biological treatments, but also ensures better communications between patients, pharmacists and physicians. We thank him for his service!""Governor Daugaard has been an exemplary leader in enhancing South Dakota’s excellence in the field of biotechnology through strong support for policies that benefit a pro-jobs and pro-biotechnology environment. Governor Daugaard has always been a pro-business advocate for initiatives that support the unique needs of our state’s early-stage companies," said…
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BIO Presents the Henri A. Termeer Biotechnology Visionary Award to Gates Foundation’s Dr. Sue Desmond-Hellmann
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Press Release  •  June 6, 2018
Washington, D.C. (June 6, 2018) – The Biotechnology Innovation Organization (BIO) is pleased to announce the establishment of the Henri A. Termeer Biotechnology Visionary Award – created in honor of the late Genzyme CEO who was instrumental in transforming Boston into a thriving hub of life science research, development and innovation... 
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Massachusetts Governor Charlie Baker Presented 2018 BIO Governor of the Year Award
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Press Release  •  June 5, 2018
Boston, MA (June 5, 2018) –  The Biotechnology Innovation Organization (BIO) today presented Massachusetts Governor Charlie Baker with its 2018 Governor of the Year award in recognition of his leadership and commitment to strengthening the bioscience industry within Massachusetts. Governor Baker received the award in conjunction with the 2018 BIO International Convention.“The Commonwealth’s life sciences sector is successful because of strong partnerships between state and local government, industry partners and Massachusetts’ leading colleges and universities,” said Governor Charlie Baker. “I am honored to receive this acknowledgement of our administration’s commitment to playing a role in further expanding the industry and we look forward to continuing this collaborative work to ensure Massachusetts remains a leader in the life sciences.”“Governor Baker has been an exemplary leader in enhancing Massachusetts’ world class biotech hub through strong support for economic development policies that benefit a pro-jobs and pro-biotechnology environment,” said Jim Greenwood, President and CEO of BIO. “His support of programs such as tax incentives and capital investments benefit early-stage companies and are powerful tools for attracting and supporting industry growth. The Governor’s leadership in this field will continue to benefit Massachusetts, in terms of jobs and innovation, for years to come.” “Governor Baker and his Administration are true partners to the life sciences. Under his leadership, best exemplified by his filing of the five-year, $500 million next-phase of life sciences initiative, our industry continues to grow across the state as one of the biggest economic drivers for the Massachusetts economy,” said Robert K. Coughlin, President & CEO of MassBio. “What’s most impressive is his understanding of all facets of the sector – from R&D to biomanufacturing to digital health – and his knowledge of what the state must do to…
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BIO Elects New Board Directors and Section Governing Board Chairs
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Press Release  •  June 5, 2018
Boston, MA (June 5, 2018) – The Biotechnology Innovation Organization (BIO) is pleased to announce the election of 11 new board directors and several new section governing board chairs and vice chairs at the 2018 BIO International Convention.
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National Bioscience Industry Report Shows $2T Economic Impact, Accelerated Venture Capital Investment & Job Growth
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Biotechnology Jobs Report, Council for State Biotechnology Associations (CSBA)  •  Press Release  •  June 5, 2018
A study released today at the BIO International Convention shows that the U.S. bioscience industry has reached $2 trillion in annual economic impact while maintaining accelerated venture capital investment and job growth numbers. Among U.S. technology sectors, the bioscience industry has held a leading position as an economic driver and job generator.
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New Bioscience Report Shows Record-Breaking Economic Impact, Accelerated Venture Capital Investment & Job Growth
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Press Release  •  June 4, 2018
BIO’s latest report shows that the U.S. bioscience industry has reached record setting annual economic impact, venture capital investment and job growth numbers. Among U.S. technology sectors, the bioscience industry is a leading economic driver and job generator across the U.S., with job growth in 41 states.
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