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BIO Joins Efforts to Aid in Humanitarian Relief in Ukraine
Human Health  •  Press Release  •  March 2, 2022
The following statement can be attributed to BIO’s President and CEO Dr. Michelle McMurry-Heath in response to the ongoing conflict in Ukraine and the organization’s efforts to help in humanitarian relief: “The conflict in Ukraine and violence from Russia defies international law, norms and modern sensibilities. Unfortunately, those suffering the most are individuals and families across Ukraine as they endure tremendous hardship and threats from immediate military attack, as well as interruptions to their ongoing medical treatments. “In response, the biotechnology industry is working to donate a range of critical medical supplies, equipment, and medications to the people of Ukraine to help reduce their suffering. We are inspired by Ukrainians’ strength and resilience in this difficult hour and are committed to supporting them and standing with the international community against this unwarranted and life-threatening aggression.” Below is a list of medications and medical supplies and equipment which have been requested.  Please note: we are ONLY trying to connect the Ukrainian Government with major corporate/manufacturer level donations at this time. This effort is being led by the U.S. Department of Commerce, U.S. Commercial Service and is being coordinated by the U.S. Embassy in Ankara, Turkey. U.S. Commercial Service Officer, Andrew Glass, can answer any questions you may have.     Andrew Glass Commercial Officer, U.S. Embassy Ankara, Turkey They are accepting donations from anywhere, and in particular are hoping that entities with a footprint in Europe will consider making donations given the geographic proximity in order to expedite these donations to the citizens of Ukraine.  CRITICAL NEEDS: Stomach wash kit Set for catheterization of the bladder Traction tire Portable oxygen cylinders Central vein catheterization kits Set for intraosseous access Kits for lumbar puncture Tracheostomy set …
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Good Day BIO: SOTU: Price Controls, COVID-19, Cancer Moonshot...and more.
Good Day BIO Newsletter  •  March 2, 2022
Everything you need to know about Biden’s State of the Union—plus two U.S. Senators weighed in on the CMS Alzheimer’s decision and Dr. Julie Gerberding’s big news. (847 words, 4 minutes, 14 seconds)
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Good Day BIO: Will Biden renew the call for price controls?
Good Day BIO Newsletter  •  March 1, 2022
Will President Biden talk about drug price controls during the State of the Union? We’ll find out tonight. Plus, the new IPCC report says climate change is happening faster than we thought—but thanks to biotech, adaptation is already underway. (548 words, 2 minutes, 44 seconds)
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BIO Comments on FDA Guidance: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
Patient Advocacy  •  Letters, Testimony & Comments  •  February 28, 2022
On Monday, February 28th, BIO submitted comments in response to the recent Food and Drug Administration (FDA) guidance for sponsors on designing or using an existing registry to support regulatory decision-making about a drug's effectiveness or safety. In addition to a number of specific line edits, BIO presented three key topics for the Agency to consider prior to the guidance’s finalization. First, BIO suggested that the Agency consider the feasibility of certain recommendations in situations where a sponsor is collaborating with a third-party registry holder such as an academic institution. For example, a drug sponsor working with an outside registry holder may be able to audit the registry holder’s processes for data quality but not usually the data themselves due to ethical and/or data privacy reasons. Secondly, BIO noted that it would be useful if the FDA provided additional clarity on which types of registries the guidance applies to. For example, Qualified Clinical Data Registries (QCDRs) that have been created to address CMS quality requirements and “registries” that have been developed via the integration of multiple sources of data, do not obtain patient consent nor are they assembled using a data collection/validation plan. BIO suggested this draft guidance document address only registries where patients are consented and enrolled for a specific purpose with a data collection plan. Lastly, BIO requested that the Agency provide more consistency on the topics covered across guidance documents. Topics that are likely relevant across RWD sources such as claims, EHRs, and registries (e.g., validation, linkage, hypothesis testing, provenance, etc.) are not treated equally across the guidance documents and may be a source of confusion for sponsors.
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Good Day BIO: The economic case for investment in rare diseases
Good Day BIO Newsletter  •  February 28, 2022
On Rare Disease Day, we look at a new report that shows the economic burden of rare disease—and the value of investing in new treatments. Plus, we recap what one BIO Board member said about animal genomics during last week’s USDA Agricultural Outlook Forum. (659 words, 3 minutes, 17 seconds)
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Good Day BIO: Yes, biomanufacturing at scale is possible
Good Day BIO Newsletter  •  February 25, 2022
Ending the week with what experts said about biomanufacturing and another look at why we need to address AMR. (708 words, 3 minutes, 32 seconds)
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Good Day BIO: How to improve cardiovascular disease outcomes
Good Day BIO Newsletter  •  February 24, 2022
We take a closer look at how systemic inequities in both rural and urban communities have affected cardiovascular disease outcomes—and what we can do about it. Also: where’s the next George Washington Carver? (788 words, 3 minutes, 56 seconds)
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Good Day BIO: Biotech is more than just a label
Good Day BIO Newsletter  •  February 23, 2022
Today we look at the impact of new labeling requirements for bioengineered food and how biotech innovations are changing the game for heart health. (954 words, 4 minutes, 46 seconds)
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Good Day BIO: New FDA commissioner puts animals on agenda
Good Day BIO Newsletter  •  February 22, 2022
Beginning the short week with what the newly confirmed FDA Commissioner said about One Health, why CMS “ambushed” efforts to combat pediatric Alzheimer’s, and the start of Rare Disease Week. (886 words, 4 minutes, 25 seconds)
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Good Day BIO: Let’s talk about animal biotech
Good Day BIO Newsletter  •  February 18, 2022
Before you head out for the long weekend, we have BIO’s new letter on animal biotech and a look at the work to be done to eradicate polio and rubella. (778 words, 3 minutes, 53 seconds) We’ll be off on Monday, February 21, for Presidents’ Day. We’ll resume publication on Tuesday, February 22.
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