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BIO Submits Comments on FDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
Letters, Testimony & Comments  •  September 26, 2022
On Monday, September 26th, BIO submitted comments in response to the FDA’s draft guidance on clinical pharmacology considerations for development of oligonucleotide therapeutics, which provided recommendations on when certain PKPD assessments may be appropriate and which types of assessments should be considered. In the comments submitted, BIO voiced strong agreement with the FDA’s assessment that this modality is rapidly evolving and has strong potential to treat both rare and common diseases. However, BIO noted that oligonucleotide therapeutics represent a wide range of unique and diverse products with key differences in characteristics such as molecular structure, mechanism of action, and formulation/delivery. Therefore, the inclusion of precise and accurate terminology in the final guidance is paramount. In addition to requesting that FDA reconsider the terminology used, BIO also urged FDA to adjust the scope of the guidance to be more inclusive of this wide range of products. BIO also provided a number of line edits requesting clarification on topics such as determining the potential for QT/QTc prolongation and evaluating oligonucleotides in patients with varying levels of renal/hepatic function.
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BIO Sends Letter to President Biden Strongly Opposing Expansion of the WTO TRIPS Waiver
Letters, Testimony & Comments  •  September 26, 2022
We are writing to express our strong opposition to any form of expansion of the WTO TRIPS waiver to COVID-19 therapeutics or diagnostics. Support for an intellectual property (IP) waiver would send U.S.-developed innovative technologies and biomanufacturing jobs overseas and, consequently, weaken the ability for U.S. biotech firms - including the hundreds of small and medium-sized enterprises (SMEs) involved in the development of COVID-19 therapeutics - to compete globally and grow jobs domestically. This would be an outcome clearly inconsistent with the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy issued on September 12.
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Good Day BIO: COVID IP waiver ‘clearly inconsistent’ with biotech EO
Good Day BIO Newsletter  •  September 26, 2022
BIO’s calling out the inconsistency between Biden’s new biotech EO and U.S. support for an expanded COVID IP waiver—plus, the Dept. of Energy released a roadmap to achieve major SAF and emissions goals. (672 words, 3 minutes, 21 seconds)
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BIO Comments on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
Patient Advocacy  •  Letters, Testimony & Comments  •  September 24, 2022
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit from more explanation, examples, and references. We have identified through our comments areas where these additions would be beneficial. BIO commends this shift to a fit-for-purpose evidentiary framework and believes this will support thoughtful and pragmatic COA development. BIO also supports the draft guidance’s recognition that some health aspects are complex, more than one type of COA might be used to assess different aspects of a concept of interest, and COAs might measure concepts of interest that are indirect reflections of a meaningful health concept.  However, BIO notes that with a shift in thinking, the draft guidance introduces new terminology and concepts that have not been previously discussed in prior PFDD guidances or discussion documents. We request that the Agency consider providing an updated glossary and/or detailing new or shifting terminology between the final guidance and previous PFDD guidances. To further enhance the guidance, BIO recommends the inclusion of references and case examples (real/hypothetical). Furthermore, BIO emphasizes the importance of clearly defined opportunities for FDA-sponsor interactions early and throughout drug development. Given the new concepts and methods introduced in this draft guidance, communication between sponsors and FDA will be necessary to ensure that the guidance recommendations are implemented correctly. Lastly, BIO encourages FDA to describe whether and how digital health technology tools (i.e., digital endpoints) could be utilized to support regulatory decision-making in this guidance. 
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BIO Submits Comments on FDA Guidance: Conducting Remote Regulatory Assessments – Q&As
Letters, Testimony & Comments  •  September 23, 2022
On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others. In the comment submitted, BIO expressed general support for the modernization of inspection activities and appreciation for the development of this draft guidance to assist industry with the conduct of RRAs. Given their potential benefits, BIO recommended that FDA leverage these assessments as part of its routine surveillance process. However, BIO requested further clarification on the intended scope and role of RRAs relative to pre-approval/pre-licensure inspections (PAI/PLI). Additionally, BIO recommended that the Agency clarify the similarities and differences in what an establishment might expect to happen during voluntary and mandatory RRAs. As RRAs may be more resource intensive for establishments, BIO suggested that FDA clearly explain the outcomes desired by continual use of RRAs outside public health emergencies along with metrics that could be used to evaluate impact. In addition to specific line edits, BIO also requested that FDA consider the impact and potential unintended consequences of RRAs on GxP facilities, as FDA does not currently use these assessments to indicate or recognize cGMP/GLP compliance.
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Good Day BIO: USDA nominee calls for 'science-based decison-making'
Good Day BIO Newsletter  •  September 23, 2022
Ending the week with USDA nominee Alexis Taylor’s hearing at the Senate Ag Committee, BIO’s webinar on the impacts of the new drug price controls—and a deal on prescription drug user fees. Enjoy the weekend. (883 words, 4 minutes, 24 seconds)
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Announcement of PDUFA Agreement in Congress Supports Biomedical Innovation, Helps Patients
Press Release  •  September 22, 2022
Biotechnology Industry Organization (BIO) President and CEO, Dr. Michelle McMurry-Heath, released the following statement following the announcement that Congress reached an agreement on the Prescription Drug User Fee Act (PDUFA): “For 30 years, PDUFA has been absolutely critical to equipping the Food and Drug Administration (FDA) with the tools they need to safely and efficiently review innovative drugs and biologics that Americans rely on to live healthy lives. “BIO has long touted the importance of PDUFA, and we’ve been very vocal about the need for timely reauthorization this year. While we eagerly await final passage, the announcement of a deal to reauthorize the user fee agreements paves the way for continued stability for the FDA and its ability to usher in the next generation of medicines and safeguard public health. The importance of this mission has never been made more clear than the work the agency carried out during the COVID-19 pandemic. “A newly finalized agreement will also bring some much-needed stability to biopharma companies working on the next generation of cures. This is especially crucial for the small and mid-sized companies responsible for the lion’s share of biomedical innovation. According to the Congressional Budget Office, small drug companies now account for more than 70 percent of the nearly 3,000 drugs in phase III clinical trials.  It will also ensure continued transparency and consistency within the FDA for new drug approvals, thereby streamlining the process to bring breakthrough drugs and therapies to vulnerable patients. “BIO, on behalf of our member companies, thanks leaders in Congress for their efforts toward completing the reauthorization of PDUFA. We will continue looking for ways to support our companies in their shared goals of pushing the boundaries of biomedical innovation and bringing groundbreaking cures to patients.”  
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Good Day BIO: We need action – on sickle cell disease and climate goals
Good Day BIO Newsletter  •  September 22, 2022
Today we look at the investment landscape for sickle cell disease and an alarming new climate report that shows the need for biotech solutions, plus two brand-new reports showing both progress and setbacks in fighting cancer and other non-communicable diseases. (685 words, 3 minutes, 25 seconds)
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BIO Joins Letter to Congress Urging for Expeditious Confirmation of Doug McKalip as Chief Agricultural Negotiator at USTR
Agriculture & Environment  •  Letters, Testimony & Comments  •  September 21, 2022
On behalf of the broad and diverse stakeholders in American Agriculture we represent, we urge you to work with your colleagues to expeditiously confirm Doug  McKalip as Chief Agricultural Negotiator at the Office of the U.S. Trade Representative (USTR).
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Good Day BIO: SBIR/STTR passes Senate, fungus concerns grow, and more
Good Day BIO Newsletter  •  September 21, 2022
Tons of news: SBIR/STTR bill passed the Senate and goes to the House (thanks in part to BIO advocacy), Ways & Means rejected a Resolution of Inquiry on the WTO’s IP waiver (see the extended Beltway Report), and we’re tweeting up a storm for Fungal Disease Awareness Week. (698 words, 3 minutes, 29 seconds) Don’t forget to join today’s webinar on the drug provisions of the Inflation Reduction Act—register here.
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