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Good Day BIO: 2 minutes on pandemic preparedness
Good Day BIO Newsletter  •  March 25, 2022
What lessons did we learn on supply chains and pandemic preparedness from COVID-19? How would allowing the federal government to exercise “march-in” rights harm university research and future innovation? We answer these questions. (647 words, 3 minutes, 14 seconds)
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Good Day BIO: ETA for net-zero aviation? Soon.
Good Day BIO Newsletter  •  March 24, 2022
BIO member Gevo announced two deals that could bring us closer to net-zero aviation. Today is Lipoprotein(a) Awareness Day, highlighting genetic risk factors for heart disease. The Senate HELP Committee held a hearing yesterday on federal support for mental health care. (816 words, 4 minutes, 4 seconds)  
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Good Day BIO: 7% of the economy, 29% of jobs
Good Day BIO Newsletter  •  March 23, 2022
We take a closer look at the Feeding the Economy report on the economic impact of food and agriculture, while more U.S. Senators are speaking out about the CMS Alzheimer’s coverage proposal. (701 words, 3 minutes, 30 seconds)
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New Season of Biotech Podcast Builds Trust in Science
Press Release  •  March 22, 2022
Washington, D.C.– The Biotechnology Innovation Organization (BIO) today premieres its new season of the I AM BIO podcast, which tells powerful stories across the biotechnology industry and how it heals, fuels, and feeds our world. The season launches with an episode on water conservation, “Water Stress: Can We Avert a Looming Crisis?”, that focuses on technologies that address contaminants, overuse, and plastics. “Right now, biotechnology breakthroughs are saving lives and our planet, and the I AM BIO podcast brings these powerful stories to life,” said BIO’s President and CEO Dr. Michelle McMurry-Heath, a physician-scientist and host of the I AM BIO podcast. “By sharing our industry’s amazing innovations – which address everything from climate change to Alzheimer’s and addiction – we can build greater public awareness of and trust in science.” Additional episodes will cover: How vaccines of all types helped bring us out of the COVID-19 pandemic and the growing potential of mRNA technology to treat and prevent diseases including cancer and other infectious diseases. What makes carbon dioxide so dangerous and creative solutions to curb its impact. Why Alzheimer’s is tricky to address and research in the pipeline. Groundbreaking treatments to save people from overdosing and, ultimately, the disease of addiction.   Guests on the I AM BIO podcast are experts on the topics discussed and use data to explain the science in clear, engaging narratives. The new season will run for a total of 12 episodes – six this spring and six more beginning in September. PR Daily recently named the I AM BIO podcast a finalist for its Social Media & Digital Awards in the podcast category. Listen now on BIO’s website, Apple Podcasts, Google Podcasts, or Spotify.
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BioAustinCTX
BIO Business Solutions - Member Association
Through its partnership with BIO and the Texas Healthcare and Bioscience Institute (THBI), BioAustinCTX 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 BioAustinCTX members to participate.
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Good Day BIO: World Water Day
Good Day BIO Newsletter  •  March 22, 2022
On World Water Day, we launch a new season of the I am BIO Podcast with a look at the biggest threats to water and how biotech can address them. We also have details on the new Feeding the Economy report, released today, and why equitable access matters in colorectal cancer care. (758 words, 3 minutes, 47 seconds)
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Water Stress: Can We Avert a Looming Crisis?
I am BIO Podcast  •  March 22, 2022
More than two-thirds of the Earth’s surface is water, and yet water that is safe enough for human consumption remains a finite resource. In this episode we speak to experts about the biggest threats to water—contamination, overuse, and plastic. We also learn how innovative new tools can ensure there is enough water to hydrate us, our plants, and our animals. 
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BIO Submits Comments in Response to FDA Guidance on Digital Health Technologies
Human Health  •  Letters, Testimony & Comments  •  March 21, 2022
On Monday, March 21st, BIO submitted comments in response to the recent FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. In the comments submitted, BIO expressed appreciation for the issuance of this draft guidance as it provides greater clarity on FDA’s approach to the regulation of remote data acquisition, which will in turn encourage the use of digital health technologies (DHTs) and methods in product development. To further enhance this Guidance, BIO recommended that the Agency expound on the utility these technologies provide for facilitating better oversight of patients participating in remote studies, while allowing sponsors to collect data that is more relevant to patients’ needs. Additionally, though the Guidance encourages leveraging of prior work in verification and validation of DHTs, which will be critical as the field continues to advance; BIO noted that it does not provide specific evidentiary requirements for verification and validation, nor does it reference an available source as guidance. BIO urged the Agency to address these requirements in its final guidance. Furthermore, while the inclusion of topics such as data collection, storage, and protection in this guidance are helpful to sponsors; BIO encouraged the Agency to provide detail on specific issues like source data management, safeguards to ensure data integrity, expectations for raw data submission, and mitigation strategies for connectivity disruptions. Finally, BIO requested the Agency provide further clarity on how and when sponsors should engage with the various centers at FDA during development of a DHT for remote data acquisition in clinical trials.
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Good Day BIO: Fertilizer is a big story—here’s why
Good Day BIO Newsletter  •  March 21, 2022
We’re starting a new week focused on fertilizer—here's why it’s such a big story and what biotech has to do with it. ICYMI, an agreement on a TRIPS waiver for vaccine IP was leaked last week, and we have the industry’s take. Plus, the Senate is taking up legislation on China competitiveness. (743 words, 3 minutes, 42 seconds)
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Good Day BIO: ‘Patient-centric, effective, and inclusive’
Good Day BIO Newsletter  •  March 18, 2022
It’s a health-heavy Friday, with a recap of what BIO’s Dr. Cartier Esham told a House panel yesterday about PDUFA and patient-centric drug development and a new letter urging HHS to reject a “march in” petition for a prostate cancer drug. (710 words, 3 minutes, 33 seconds)
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