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BIO Comments on FDA Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies
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Letters, Testimony & Comments  •  June 7, 2022
On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with GLP regulations. Importantly, this regulatory guidance was the first to ever specifically address the use of whole slide images in lieu of glass slides for nonclinical studies. In the comments submitted, BIO recommended the language be revised to align with the terminology widely used in the field of toxicologic pathology today. BIO also offered additional details that would increase the guidance’s instructive value for sponsors. Lastly, BIO broadly suggested that highlighting whether a particular tool and/or process results in the generation of raw data could provide a useful method for clearly outlining the proper approach sponsors should take in handling/documenting various practices associated with the use of WSI for nonclinical toxicology studies.
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Good Day BIO: GM corn does not damage non-target organisms, says USDA
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Good Day BIO Newsletter  •  June 7, 2022
A new study authored by a USDA researcher confirms what we already know: biotech improves farmers' ability to protect their crops against pests—and only pests. We have the details, plus why patient advocacy groups are calling on Congress to restore funding for COVID services for the uninsured. (587 words, 2 minutes, 56 seconds)
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Good Day BIO: This cancer ‘vanished in every single patient’
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Good Day BIO Newsletter  •  June 6, 2022
Back to work after recess and the new week begins with a remarkable cancer trial “first” on National Cancer Survivors Day, and how climate’s having an impact on farmers (and what biotech can do about it). (696 words, 3 minutes, 28 seconds)
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LIVE from Space: It’s Out-of-This-World Biotech Research
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Press Release  •  June 3, 2022
NASA Astronaut Kjell Lindgren, MD, will connect live from the International Space Station to the Biotechnology Innovation Organization’s BIO International Convention on June 14. While the world’s largest biotechnology meeting will take place in person in San Diego, Dr. Lindgren will explain from space how research and development in microgravity helps companies accelerate product development pipelines back on Earth. Dr. Lindgren will be joined by panelists who have experience connecting science from 250 miles above earth and will discuss practical steps to move the biotechnology industry into the future: Jessica Jensen, Vice President, Customer Operations & Integration, SpaceX; Michael López-Alegría, Axiom Space’s Chief Astronaut; Paul Reichert, Ph.D., Research Fellow, Merck; and Ken Savin, Ph.D., Chief Scientific Officer, Redwire.  The panel will be moderated by Jennifer Strong, Editorial Director, Audio and Live, for MIT Technology Review. The International Space Station has hosted more than 3,000 experiments since crew operations began more than 20 years ago. NASA, international partners, and the ISS National Lab have sponsored in total well over 1,200 biological and biotechnology experiments during that time span.  Crew-4 Mission Commander Lindgren has logged more than 141 days in space, participated in two spacewalks, and performed more than a hundred different scientific experiments. “The first all-private astronaut mission in April sparked a renewed interest in space and helped the world see the commercial potential of research and development in microgravity,” said BIO’s President and CEO Michelle McMurry-Heath. “Public-private partnerships are growing the capacity, complexity, and availability of orbital research and development to make it easier for biotechnology companies to participate. These are practical steps forward that will improve medicines and people’s lives.” The BIO International Convention returns in person for the first…
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Good Day BIO: Part D costs expected to fall in 2022
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Good Day BIO Newsletter  •  June 3, 2022
The Medicare Trustees released their annual report yesterday—and there’s an interesting tidbit about Part D costs and drug prices. Plus, we get ready for World Environment Day and explain why biotech could hold the keys to a cleaner planet. (742 words, 3 minutes, 42 seconds)
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Good Day BIO: COVID-19: cases, boosters, and what’s next
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Good Day BIO Newsletter  •  June 2, 2022
Today we look at the latest COVID-19 news—including what’s next for booster schedules, Novavax, and young children—and new research on consumer acceptance of gene-edited food. (739 words, 3 minutes, 41 seconds)
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Good Day BIO: We’re off track to meet our climate goals. Enter biotech.
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Good Day BIO Newsletter  •  June 1, 2022
BIO President and CEO Dr. Michelle McMurry-Heath released a statement on the recent gun violence in the U.S. In today’s news, we look at a new climate performance index—and how biotech can help—and kick off Alzheimer’s and Brain Awareness Month. (725 words, 3 minutes, 37 seconds)
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Good Day BIO: Air pollution kills
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Good Day BIO Newsletter  •  May 31, 2022
We end May with new studies showing links between air pollution and health and what pop star Lance Bass says about Arthritis Awareness Month—plus, news on the Senate’s FDA user fee reauthorization bill. (722 words, 3 minutes, 36 seconds)
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Investors Become Goldilocks in a Bear Market
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I am BIO Podcast  •  May 31, 2022
Current market trends have put investors in a “flight-to-safety” mentality, especially when it comes to biotech companies. What does this mean for getting biotech innovations to the marketplace? This episode explores the daunting challenge of raising capital in a bear market.
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Dr. Michelle McMurry-Heath Statement on Recent Gun Violence
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Press Release  •  May 27, 2022
Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement responding to recent incidences of gun violence across the country: "I couldn’t sleep last night. It has been an incredibly difficult week. First my mother called. Locked in the house recovering from COVID, she confessed she had been unable to stop watching the coverage of the shooting in Texas. “Michelle, what got me is that most of them were just 10 years old, the same age as your daughter.” "Then I picked up my daughter and had to help her process her school’s explanation of the shooting to her and her classmates. And she asked one tragic and unanswerable question, “Why have so many of these shootings been in school, Mommy?” With that question, my heart fell right through my feet.  "So I looked to do what I could. I reached out to a friend whose son had been involved (but luckily escaped uninjured, at least physically) in the recent Burke School shooting in Northwest DC. And suddenly I remembered I had another friend and colleague whose two daughters had been involved in the 2018 Valentine’s Day school shooting in Parkland, Florida. It is remarkable to me that I now have two close friends who have experienced this sort of terror firsthand. I remember the friend saying to me, “You know my wife and I immigrated from Lebanon to escape violence, and yet…“ "…And yet. Here we are. We think of these events as rare, exceptional. And yet since Columbine in 1999, more than 311,000 American students have experienced gun violence at school. 311,000!! And yet in 2020, bullets replaced cars as the biggest cause of death for our children.  "And yet what can we say that has not been said a million times already? We are outraged, we are defeated, we have prayed for the families. But what have we done? What can we do? "In my family we always used to spend Memorial Day visiting the graves of our family members, paying tribute to…
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