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Unlocking Regulatory Success for Digital Health Product Developers
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BIO Professional Development Courses  •  September 8, 2023
It’s difficult for digital innovators to know how to interact with regulators, which ones, and when. This course will remove the mystery. Learn how to build a fit-for-purpose regulatory strategy that strengthens your business strategy and differentiates your product in today’s digital health market. While this course applies to anyone focused on developing digital health products, the following learners may find the course particularly valuable: Product managers, program leads, and clinical R&D specialists focused on building digital health products Regulatory affairs or regulatory strategy professionals, particularly those focused on digital health Senior leaders and decision makers leading digital health organizations Quality engineers and professionals Engineer(s) and designers building or updating digital health products Junior associates at VC firms/investor community  Topics include: The ‘why’: Why a fit-for-purpose regulatory strategy is essential for business success. The basics: Current (and evolving) landscape of digital health product regulation by FDA – what should you know? The ‘what’: What are the components of a fit-for-purpose regulatory strategy?  Optimizing your regulatory strategy for success over time. The ‘how’: How to implement your regulatory strategy for optimal success? The impact: How do robust regulatory strategies build trust?  BIO Members receive a discounted rate for course registration. To request the discount code, BIO members should email courseshelp@bio.org with the following: The BIO Member Company's name, city, state/province, and country The Course Registrant's full name and email address The Course Title
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Is China embracing biotech crops?
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Bio.News  •  September 8, 2023
Happy Friday. We look at news from China on biotech crops plus what experts have been saying about drug price controls. (553 words, 2 minutes, 45 seconds)
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Cell and Gene Therapy
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Cell and gene therapy (CGT) products have the potential to cure intractable diseases, bring hope and meaningful benefit to patients in need, and change the way we approach treating disease.  These therapies often target rare diseases and conditions, where patients often have limited treatment options.  As the CGT product development cycle presents unique challenges and opportunities, BIO is engaging in regulatory advocacy efforts across the product lifecycle.  Here you will find BIO consensus documents describing policy positions on a variety of topics, from nonclinical to manufacturing and clinical phases. 
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BIO Finance & Tax Committee Meeting
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September 7, 2023
The Committee concentrates on tax, financial services, securities, and accounting policies that impact member companies and biotech capital formation. This committee advises BIO staff about the impact of legislation and regulations affecting these policy matters and supports BIO’s engagement with Treasury, the SEC, and the IRS, as well as Congress and the Administration. For more information and to join the Committee, please contact Emily Berst (eberst@bio.org).
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Talking with Rachel King
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Bio.News  •  September 7, 2023
BIO CEO Rachel King discussed price controls, investment opportunities, and much more on two new podcasts—here are a few takeaways. Plus, a long-term opportunity with short corn and news about COVID. (807 words, 4 minutes, 2 seconds)
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Flu and flesh-eating infections rise
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Bio.News  •  September 6, 2023
A busy season of flu infections is projected, and ocean warming is also increasing attacks of flesh-eating bacteria. (531 words, 2 minutes, 36 seconds)
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BIOArkansas
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BIO Business Solutions - Member Association
Through its partnership with BIO, BIOArkansas offers its members the opportunity to take advantage of the BIO Business Solutions® programs listed below. Click on the company name to learn more. There is no fee for BIOArkansas members to participate.
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Can we save the horseshoe crab?
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Bio.News  •  September 5, 2023
We’re back—and so’s the Senate. Here’s all the news you missed last week plus the launch of the new season of the I am BIO Podcast. (646 words, 3 minutes, 13 seconds)
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The Horseshoe Crab Saved Us. Can We Save the Horseshoe Crab?
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I am BIO Podcast  •  September 5, 2023
The horseshoe crab has endured for over 450 million years. In this episode we talk with three experts about how this animal’s unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.
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BIO Applauds FTC Settlement Decision
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Business Development, Rare Diseases  •  Press Release  •  September 1, 2023
Yesterday the Federal Trade Commission (FTC) announced the decision to settle its Amgen-Horizon merger challenge. The settlement will give the Commission the relief it needs to protect competition, while allowing rare disease patients to enjoy the deal's pro-competitive benefits without delay. BIO applauds the FTC's decision, which is in the best interest of not just U.S. patients, but patients around the world who rely on innovative new drugs to live longer and healthier lives. Shortly before the FTC's announcement, BIO -- along with Illinois BIO, Illinois Manufacturers' Association, and Chicagoland Chamber of Commerce -- filed a "friend of the court" brief warning that what appeared to be an abrupt shift in the FTC's approach to biotech merger enforcement would potentially endanger the drug development pipeline.  As the brief explained, acquisition of small innovators by larger, better established pharmaceutical companies is an important component of a dynamic innovation ecosystem. Smaller, nimbler companies, with a unique "breakthrough" culture, may not be well positioned to manage costly clinical trials, FDA approval, and global distribution. Acquisition by a larger company with all of these capabilities is an important potential solution. Consequently, FTC merger enforcement that views such transactions as inherently suspect is not in the public interest. Statement from John Delacourt, Deputy General Counsel, BIO: "BIO commends the Commission for settling litigation that disincentivized investment in treatments and cures for patients. Now BIO encourages FTC to efficiently and effectively support commercialization of these therapeutics. We believe the government can protect competition while enhancing the value of biotech M&A activity.”
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