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BIO Comments on FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins
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Human Health  •  Letters, Testimony & Comments  •  November 9, 2020
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a discussion on the potential of generalizing information between ADCs that share the same payload and for further information to understand, from FDA’s perspective, under what conditions it would be possible to apply information from a DDI study conducted using an ADC to another ADC that had the same payload. Additionally, while the Guidance focuses on CYP-related DDIs, BIO suggests clarifying when there should be assessments for potential transporter related DDIs with TPs [1],[2]. If FDA decides to include such a discussion, potentially as part of Section III.B (pages 5-6; starting at line 196), endogenous CYP/drug transporter substrates may help define the potential for clinically significant DDIs. BIO appreciates the opportunity for sponsors to consider the specifics of their particular therapeutic proteins in the context of specific indications and concomitant medications and propose a fit-for-purpose development strategy in consultation with the Agency. In addition, the recognition of the potential contribution and value of model-based analyses, such as PBPK modeling, affords additional tools to interrogate the potential for DDIs and make informed decisions or scientific justifications. BIO looks forward to final guidance on this topic.
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What the election results mean for health policy and science
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Good Day BIO Newsletter  •  November 9, 2020
By now, you know that Joe Biden won the election—here’s BIO President and CEO Dr. Michelle McMurry-Heath’s statement. Today, we take a closer look at the implications for health care and science, as well as news about Germany’s pork industry that has us hungry for modernization of animal biotech regulation. Read to the end for a jam-packed BIO Beltway Report. (820 words, 4 minutes)
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BIO’s Dr. Michelle McMurry-Heath Congratulates President-Elect Biden & Other Newly Elected Leaders of Both Parties Who Won
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Agriculture & Environment, Intellectual Property, Human Health  •  Press Release  •  November 7, 2020
"What a historic election for our country! For the first time in 120 years, American voter participation shattered many turnout records.    "At BIO we undertook an effort to mobilize and activate voters in our industry with Biotech Votes 2020, and while we certainly did not pick sides or endorse any candidates, I’m extremely gratified that the companies of the biotechnology innovation organization made a tremendous effort to make registering and voting as easy as possible for their employees.   "I want to congratulate all of the election winners of both parties across the country. I’d like to congratulate President-elect Joe Biden and his running mate Vice President-elect Kamala Harris on their win. I pledge that BIO will work hard with your administration and the new Congress.   “For many years, President-elect Biden has championed a ‘cancer cure moonshot’ and I’m happy to report dozens of our companies are already working around the clock on this fight and other diseases starting with COVID. Biotech companies have mounted an unprecedented response to the novel Coronavirus, and have in development more than 800 vaccines or treatments already.    "In addition, we look forward to working with all elected officials and hope to have an open dialogue on how we can best use biotech to reduce greenhouse gas for our planet and ending food deserts in communities all over the country.   "America faces many challenges and has many opportunities. On behalf of the 1,000 member companies of BIO and the nearly two million people who work in the biotech industry, I want to congratulate all the newly elected officials across the United States, and we know that if we work together our scientists will continue to lead the world.”
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Thank You for Requesting the Recording
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Thank you for requesting a copy of the webinar recording.  You will receive an email shortly with your copy inside.
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To Pool, Pledge, or License – Allocating IP Rights during COVID-19 R&D
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Policy

What we know, and what we STILL don’t
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Good Day BIO Newsletter  •  November 6, 2020
You made it to Friday. We’re closing the week with a quick update on what we know—and what we still don’t—as the vote count continues on. (540 words, just under 3 minutes)
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The state of the states
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Good Day BIO Newsletter  •  November 5, 2020
It's Thursday, and we're still unpacking the election results. BIO’s VP of State Government Affairs Patrick Plues is back with an update on what we know about the state races, and we also take a look at results that could impact agriculture, biofuels, and climate policy. (820 words, 4 minutes, 5 seconds)
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What we know, and what we don't
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Good Day BIO Newsletter  •  November 4, 2020
Yesterday, Mike Mattoon, BIO’s VP of Federal Government Relations, urged you to stock up on coffee and Red Bull—and we hope you took him seriously. He's back today with a quick look at what we know and what we don't know. Plus, we share a powerful call for bipartisanship—and for protecting The Bayh-Dole Act. (730 words, 3 minutes, 40 seconds)
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What BIO's watching on Election Day
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Good Day BIO Newsletter  •  November 3, 2020
It’s Election Day. For a look at what to watch today, we’re handing over Good Day BIO to the government relations team: Mike Mattoon, BIO’s VP of Federal Government Relations, and Patrick Plues, BIO’s VP of State Government Affairs. (940 words, 4 minutes, 40 seconds)
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BIO Submits Comments on NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products
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Letters, Testimony & Comments  •  November 2, 2020
On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period in line with WTO recommendations in the future. BIO’s preliminary review is generally supportive of the guideline, commending China “for joining the growing number of countries preparing its regulatory system for the proliferation of these innovative therapies.” BIO was also pleased to note the document’s references to relevant ICH guidelines and applauded NMPA’s engagement in ICH, including on the Management Committee. BIO looks forward to the NMPA’s final guidance on the topic.
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