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BIO Statement on President’s Proposed 2020 Budget
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Patient Advocacy, Cost & Value of Biopharmaceuticals  •  Press Release  •  March 11, 2019
Washington, DC (March 11, 2019) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding President Trump’s FY 2020 budget proposal:
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BIO Applauds FDA Action on AquAdvantage® Salmon
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Food & Farm Innovation  •  Press Release  •  March 8, 2019
The Biotechnology Innovation Organization (BIO) released the following statement on the action taken today by the U.S. Food & Drug Administration (FDA) which will allow AquaBounty Technologies, an American company, to commercialize its genetically engineered AquAdvantage® Salmon in the U.S. market.
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BIO Applauds Multi-Agency Framework for Advancing the Bioeconomy
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Food & Farm Innovation, Sustainable Fuels, Climate Change  •  Press Release  •  March 5, 2019
The Biotechnology Innovation Organization (BIO) today released the following statement in response to the release of The Bioeconomy Initiative: Implementation Framework, a multi-agency strategy aimed at accelerating innovative technologies that harness the nation’s biomass resources for affordable biofuels, bioproducts, and biopower:
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BIO Statement on Ambassador Lighthizer and Secretary Perdue Testimonies
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Food & Farm Innovation  •  Press Release  •  February 27, 2019
BIO President and CEO Jim Greenwood released the following statement on U.S. Trade Representative Robert Lighthizer’s testimony at a House Ways and Means Committee hearing on the U.S.-China trade deal and U.S. Secretary of Agriculture Sonny Perdue’s testimony at a House Agriculture Committee hearing on the state of the rural economy.  
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Treating Diseases With Cell Therapy
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Human Health, Disease Area  •  Toolkit  •  February 27, 2019
Gene therapies are being developed to treat multiple diseases, including hemophilia, inherited retinal diseases, and Huntington’s disease.
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Treating Genetic Diseases With Gene Therapy
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Human Health, Disease Area  •  Toolkit  •  February 27, 2019
Gene therapies are being developed to treat multiple diseases, including hemophilia, inherited retinal diseases, and Huntington’s disease.
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BIO Announces Partnership with Taiwan BIO for 2019 Conference and Exhibition
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Press Release  •  February 20, 2019
Washington, DC (February 20, 2019) – The Biotechnology Innovation Organization (BIO) announced today it will join the Taiwan Bio-Industry Organization (Taiwan BIO) to host BIO Asia-Taiwan from July 24-28 in Taipei, Taiwan. The event is expected to attract more than 1,500 people from 25 countries representing biomedical, pharmaceutical, genomics, biotech services, equipment and instruments, academic research, cosmetology products and bio-based healthcare. Themed “Biotech as the Next Growth Engine for Asia”, the five-day event will feature rich programming, company presentations from Asia and around the world, BIO One-on-One Partnering™ meetings, seminars and workshops, and an exhibition featuring more than 1,700 booths from over 600 companies. “Taiwan is already a global powerhouse in technology, IT and computing systems,” noted Jim Greenwood, President and CEO of BIO. “As biotech evolves, we are marrying new breakthroughs like artificial intelligence with Big Data derived from the human genome. That’s why Taiwan is uniquely situated to play an integral role in the future of our industry.” Johnsee Lee, Chairman of the BIO Asia-Taiwan 2019 Organizing Committee agreed with this analysis. “As many innovative biomedical advances in the future will be closely integrated with digital technologies, and with the ICT industry being a unique advantage of Taiwan, this year's BIO Asia-Taiwan conference will showcase Taiwan's digital advantage in this sector,” he noted. “Applications such as AI, smart hospital and medical devices, precision medicine, etc., will be showcased as Taiwan takes the opportunity to encourage its electronics industry leaders to invest resources in biotech.” BIO’s One-on-One Partnering™, a major feature at the conference, will offer attendees a user-friendly way to schedule individual meetings with potential partners or collaborators by accessing a database with abundant profiles and other information. Meetings can be arranged prior…
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BIO Statement on CMS Proposed Decision Memo for the CAR-T National Coverage Determination
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Human Health, Patient Advocacy  •  Press Release  •  February 15, 2019
BIO Executive Vice President for Health Policy Dan Durham issued the following statement regarding the CMS proposed decision memo for the CAR-T National Coverage Determination.
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BIO Applauds Sens. Tillis, Sinema, Peters, and Perdue for Introducing the Fostering Innovation Act
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Human Health  •  Press Release  •  February 13, 2019
The Biotechnology Innovation Organization (BIO) applauds Sens. Thom Tillis (R-NC), Kyrsten Sinema (D-AZ), Gary Peters (D-MI), and David Perdue (R-GA) for introducing the Fostering Innovation Act (S.452) to build on the success of the Jumpstart Our Business Startups (JOBS) Act. 
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BIO Comments on FDA Draft Guidance on Biomarker Qualification: Evidentiary Framework
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Human Health  •  Letters, Testimony & Comments  •  February 11, 2019
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Biomarker Qualification: Evidentiary Framework. The guidance provides industry and FDA staff with recommendations on considerations to address when developing a biomarker qualification under the 21st Century Cures Act, which added a new section to the Federal Food, Drug and Cosmetic Act. BIO recognizes FDA’s efforts to clarify the evidentiary standards for biomarker qualification but suggests the guidance should include timelines. BIO commends FDA for including language about the use of biomarkers in an individual drug development program (e.g., investigational new drug application, new drug application, or biologics license application submissions), but asks FDA to make note of areas where there may need to be flexibility, such as in the case of rare diseases where there are limited populations. The comments also discuss qualification of a biomarker that already has an established, specific context of use (COU), a pilot program to engage external experts to support the review of biomarker qualification submissions, and FDA’s plans to share information about submissions.
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