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BIO Comments on FDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing
Letters, Testimony & Comments  •  June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells. Overall, BIO found the guidance to be a well-written resource that will be useful once further experience is gained with these therapies. However, given the field is rapidly advancing, BIO recommended the Agency revise certain sections of the guidance to make it more informative and practical for sponsors to implement. For example, expanding the scope of this guidance beyond human somatic cells to include cells derived from adult and pluripotent stem cells, would provide valuable insight to sponsors on FDA’s current thinking. Additionally, the Guidance would be enhanced by a more comprehensive discussion of how safety, efficacy, durability, and quality of a GE product are factoring into FDA’s regulatory decisions. In particular, given the field of GE products is rapidly maturing, BIO believes the Guidance should more fully discuss the benefit-risk considerations at marketing application review, including discussion of how the perspectives of patients will be incorporated. Furthermore, BIO challenged FDA’s implication that sponsors should be incorporating the best available technology in each GE product application, as newly discovered and yet untested and unproven technologies, should not distract from the objective and focused review of existing technologies that have matured to the point of being incorporated into GE products.
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Good Day BIO: 2 things about drug prices (and 1 about jobs)
Good Day BIO Newsletter  •  June 10, 2022
Before we head to the BIO International Convention, we have news on inflation and health care costs, the FTC’s plans to investigate pharmacy middlemen, and booming life sciences job growth. And be sure to check your inbox on Monday morning—we’ll be coming to you live from San Diego with something special! In the meantime, you can follow along on bio.news. (695 words, 3 minutes, 28 seconds)
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Good Day BIO: House passes user fee reauthorization; Senate's up next
Good Day BIO Newsletter  •  June 9, 2022
The House passed FDA user fee reauthorization yesterday, which will help fund FDA research to bring more breakthroughs to patients. We have details and what’s next in the Senate. And with a soil shortage looming, a study finds regenerative farming can boost soil health and food nutrition. Plus, nominations are open for BIO’s George Washington Carver and Rosalind Franklin Awards – details below. (915 words, 4 minutes, 34 seconds)
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Do You Know a Game-Changer in the Bioeconomy? Nominations for BIO’s Prestigious Innovation Awards Open Today
Agriculture & Environment  •  Press Release  •  June 8, 2022
The Biotechnology Innovation Organization today announced the opening of nominations for two awards to honor significant leaders driving cutting-edge, sustainable breakthroughs in the fields of agriculture and the environment.  The George Washington Carver Award recognizes individuals who have advanced biotech innovation to make supply chains greener and have worked successfully toward that goal in the private sector, government or academia. Those submitting nominations should single out individuals who have demonstrated significant and innovative accomplishments within the industry to advance a biobased economy and industrial sustainability. Named for celebrated agricultural scientist George Washington Carver, whose discoveries improved the lives of farmers and the health of American soils, the award pays tribute to those who are building on Carver’s legacy. “Just as George Washington Carver’s vision and achievements transformed agriculture and addressed the soil conservation challenges of his day, today’s scientists are applying the tools of biotechnology to help farmers and manufacturers of biobased products be the problem solvers our world needs now, to ensure we can meet our food and resource demands sustainably,” said BIO President Michelle McMurry-Heath. The Rosalind Franklin Award is presented to a pioneering woman in the agricultural and environmental biotechnology sectors. The award recognizes women who are leading today’s innovations in agriculture, food systems, sustainable energy and biobased manufacturing. Rosalind Franklin is renowned for her work to map the molecular structure of DNA in the 1950s, a time when women did not have as many opportunities as men to enter science and research or to be credited for their contributions to the field. “We still have work to do to improve gender equality in science careers and research,” said McMurry-Heath. “That’s why we at BIO are proud to honor women whose work is expanding knowledge and…
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Do You Know a Game-Changer in the Bioeconomy? Nominations for BIO’s Prestigious Innovation Awards Open Today
Agriculture & Environment  •  Press Release  •  June 8, 2022
The Biotechnology Innovation Organization today announced the opening of nominations for two awards to honor significant leaders driving cutting-edge, sustainable breakthroughs in the fields of agriculture and the environment. BIO will accept nominations until 5:00 p.m., Friday, June 24, 2022. The George Washington Carver Award recognizes individuals who have advanced biotech innovation to make supply chains greener and have worked successfully toward that goal in the private sector, government or academia. Those submitting nominations should single out individuals who have demonstrated significant and innovative accomplishments within the industry to advance a biobased economy and industrial sustainability. Named for celebrated agricultural scientist George Washington Carver, whose discoveries improved the lives of farmers and the health of American soils, the award pays tribute to those who are building on Carver’s legacy. “Just as George Washington Carver’s vision and achievements transformed agriculture and addressed the soil conservation challenges of his day, today’s scientists are applying the tools of biotechnology to help farmers and manufacturers of biobased products be the problem solvers our world needs now, to ensure we can meet our food and resource demands sustainably,” said BIO President Michelle McMurry-Heath. The Rosalind Franklin Award is presented to a pioneering woman in the agricultural and environmental biotechnology sectors. The award recognizes women who are leading today’s innovations in agriculture, food systems, sustainable energy and biobased manufacturing. Rosalind Franklin is renowned for her work to map the molecular structure of DNA in the 1950s, a time when women did not have as many opportunities as men to enter science and research or to be credited for their contributions to the field. “We still have work to do to improve gender equality in science careers and research,” said McMurry-Heath. “That’s why we at BIO are proud…
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Good Day BIO: A monkeypox vaccine – and a new COVID vaccine?
Good Day BIO Newsletter  •  June 8, 2022
Today, we have an exclusive look at how the industry is responding to monkeypox—thanks in large part to sustained investment in medical preparedness. Plus, an FDA advisory committee recommends emergency use authorization of the Novavax COVID-19 vaccine—so what’s next? (821 words, 4 minutes, 6 seconds)
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BIO Comments on FDA Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies
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
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’
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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