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<p>Want to stay up to date on news and events relevant to patients, caregivers, and others affected by rare diseases? We just launched a brand new newsletter!</p> <p><a class="btn btn-accent3" href="https://asgct.informz.net/asgct/pages/Patient_Press_Signup" target="_blank">Subscribe to <em>The Patient Press</em></a></p> <h3>In This Issue:</h3> <p><a href="#story1">Attend a New FDA-Partnered Workshop on AAV Gene Therapies</a><br /> <a href="#story2">Read Our Response to FDA’s Draft Strategic Plan on AMT</a><br /> <a href="#story3">Serve on a Policy or Outreach Committee in 2025</a><br /> <a href="#story4">Submit Feedback on New Cell Therapy Standards </a><br /> <a href="#story5">Patient Outreach Committee Members Recap FDA Listening Session</a><br /> <a href="#story6">NCATS Final Strategic Plan Supports CGT Development </a><br /> <a href="#story7">New ASGCT Newsletter Highlights Patients, Caregivers, and Advocates</a><br /> <a href="#events">Events</a><br /> <a href="#policynews">Policy News</a></p> <p><a id="story1" name="story1"></a></p> <p><img alt="FULL-WIDTH-P-A-NL-Banner.png" src="/ASGCT/media/about/FULL-WIDTH-P-A-NL-Banner-(1).png" title="FULL-WIDTH-P-A-NL-Banner.png" /></p> <h2>ASGCT Advocacy</h2> <hr /> <h3>Attend a New FDA-Partnered Workshop on AAV Gene Therapies</h3> <p>ASGCT and FDA have joined forces to present a critical scientific workshop addressing one of gene therapy's most pressing challenges: immunogenicity in AAV-based treatments. <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="/asgct-events/january-2025/class-considerations-on-immunogenicity-for-aav-gen" target="_blank">Class Considerations on Immunogenicity for AAV Gene Therapy Products: Assessing Current Practice and New Data</a> will convene virtually on Jan. 22 and 23, 2025, from 9 a.m.- 1 p.m. ET. The event will bring together experts from industry, academia, and FDA to tackle complex questions surrounding immune responses <a id="story2" name="story2"></a>to AAV vectors.</p> <p>The comprehensive program will cover key topics including immunogenicity, strategies for antibody testing, immunosuppression regimens, and approaches to redosing. Through presentations and interactive panel discussions, attendees will gain valuable insights into managing immunogenicity challenges while hearing directly from FDA representatives about regulatory perspectives and expectations. This workshop is a unique opportunity for researchers, clinicians, and regulatory affairs professionals to engage in collaborative discussions on scientific innovation and regulatory frameworks. <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/asgct-events/january-2025/class-considerations-on-immunogenicity-for-aav-gen?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">Register today</a>!</p> <h3>Read Our Response to FDA’s Draft Strategic Plan on AMT</h3> <p paraeid="{892dc1e3-b4f3-4fe9-b0bb-f76cc7a19c0b}{250}" paraid="378809125">FDA recently released a <a href="https://www.federalregister.gov/documents/2024/09/12/2024-20665/the-food-and-drug-administrations-draft-strategy-document-on-innovative-manufacturing-technologies" rel="noreferrer noopener" target="_blank">draft strategy document </a>outlining its plans to facilitate the adoption of innovative manufacturing technologies, such as advanced manufacturing technologies (AMTs), for drugs and biologics including CGTs. This effort is part of the FDA's commitments under the Prescription Drug User Fee Act (PDUFA) VII and the 2022 Food and Drug Omnibus Reform Act (FDORA) to support the use and implementation of innovative manufacturing approaches. </p> <p paraeid="{4421149c-b095-4b44-bdf2-4f6169466afb}{36}" paraid="1296559105">AMTs such as continuous manufacturing, distributed manufacturing, and novel analytical methods have significant potential to improve product development speed, strengthen supply chains, and prevent drug shortages - key considerations for the rapidly growing CGT field. However, regulatory and technical barriers have slowed broader adoption of these technologies. </p> <p paraeid="{4421149c-b095-4b44-bdf2-4f6169466afb}{66}" paraid="925043925">To address these challenges, FDA's draft strategy outlines initiatives such as enhancing the Emerging Technology Program (ETP), collaborating with international regulators on harmonization, and implementing the new <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-manufacturing-technologies-designation-program" rel="noreferrer noopener" target="_blank">Advanced Manufacturing Technologies Designation Program </a>(AMTDP) established by Congress. In addition to <a href="https://www.asgct.org/advocacy/policy-statement-landing/2024/advanced-manufacturing-technologies-designation-pr" rel="noreferrer noopener" target="_blank">previous comments</a> on the AMTDP draft guidance, ASGCT <a href="/advocacy/policy-statement-landing/2024/fda-amt-strategic-plan" target="_blank">recently submitted a detailed response</a> to FDA’s draft strategy document:  </p> <ul role="list"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="1" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="18" role="listitem"> <p paraeid="{4421149c-b095-4b44-bdf2-4f6169466afb}{142}" paraid="120299028"><strong>AMTDP Independence</strong>: ASGCT supports FDA’s AMTDP as a distinct pathway and recommends that AMT eligibility remain separate from the Advanced Technologies Team (CATT) criteria. That would prevent restrictive overlaps and support broader access for innovative CGT manufacturing approaches.  </p> </li> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="2" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="18" role="listitem"> <p paraeid="{4421149c-b095-4b44-bdf2-4f6169466afb}{162}" paraid="2057193769"><strong><a id="story3" name="story3"></a>Biologics License Applications (BLAs), AMT data, and Drug Master Files (DMFs)</strong>: ASGCT recommends FDA permit BLAs to cite AMT data in DMFs, which would streamline regulatory submissions and support investment in new manufacturing approaches while addressing intellectual property concerns. </p> </li> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="3" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="18" role="listitem"> <p paraeid="{4421149c-b095-4b44-bdf2-4f6169466afb}{192}" paraid="1597369537"><strong>Clarification on designation criteria and benefits</strong>: ASGCT advocates for clear guidance on eligibility criteria, especially around “substantial improvement” metrics, and calls for a “Graduated AMT” status to maintain regulatory benefits as FDA familiarity with these technologies expands. </p> </li> </ul> <p>ASGCT emphasized that realizing the full benefits of AMTs will be crucial as the CGT field continues to grow and diversify. The Society looks forward to working with FDA to find solutions to these modern-day challenges.  </p> <h3>Serve on a Policy or Outreach Committee in 2025</h3> <p>ASGCT is now accepting applications for its <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/membership/standing-committees?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">standing</a> and <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/membership/scientific-committees?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">scientific</a> committees. This is a valuable opportunity for members to become actively involved in shaping the Society's initiatives and to support the advancement of CGT.</p> <p>Policy and outreach committees offer a unique chance to engage with ASGCT's advocacy efforts. In addition to contributing program proposals for the Annual Meeting, those committees are responsible for:</p> <ul> <li>The <strong>Government Relations Committee</strong> develops relationships with government entities, including Congress, NIH, and CMS. They also recommend <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/advocacy/policy-statements?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">policy positions</a> that support CGT research, development, and access.</li> <li>The <strong>Regulatory Affairs Committee</strong> educates members on the worldwide regulatory environment and interacts directly with FDA, including through FDA <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/advocacy/policy-statements?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">guidance comments</a>, <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/asgct-fda-liaison-meeting?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" id="story4" name="story4" target="_blank">liaison meetings</a>, and other engagement opportunities. They also provide Society representation to entities developing field standards.</li> <li>The <strong>CMC Committee</strong> focuses on the Chemistry, Manufacturing, and Controls (CMC) space, providing focused expertise for guidance comments and other FDA interactions. Along with Government Relations and Regulatory Affairs, the CMC Committee helps plan the annual <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/advocacy/events-and-opportunities/policy-summit?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">Policy Summit</a>.</li> <li>The <strong>Patient Outreach Committee</strong> develops a wide range of <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://patienteducation.asgct.org/" target="_blank">accessible resources</a> and events that educate on CGT topics, with a focus on patient audiences and other members of the public.</li> <li>The <strong>Global Outreach Committee</strong> develops programs for research collaborations, award opportunities, and outreach efforts with the goal of fostering equitable access to gene therapies throughout the world. The committee focuses on low- and middle-income countries.</li> </ul> <p>Share with your colleagues and <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/membership/volunteer/volunteer-to-serve-on-a-committee?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">apply today</a>! You can find a full list of ASGCT committees and more information on the application process and timeline <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/global/documents/committee-member-process-and-expectations.aspx?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">here</a>.</p> <h3><a id="story5" name="story5"></a>Submit Feedback on New Cell Therapy Standards </h3> <p paraeid="{1470f6af-dfb0-437c-95f3-b5334272a725}{129}" paraid="1406428929">The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) are seeking public comments on two important draft standards documents: the <a href="https://factglobal.org/media/yv0dgttp/sts_5_2_049_draft-fact-jacie-standards-for-hct-9th-ed-r1_10082024.pdf" rel="noreferrer noopener" target="_blank">Ninth Edition of Hematopoietic Cellular Therapy Standards</a> and the <a href="https://factglobal.org/media/ve1hbomh/sts_5_2_048_-draft-fact-jacie-international-immune-effector-cell-standards-3rd-ed-r1_10072024.pdf" rel="noreferrer noopener" target="_blank">Third Edition of Immune Effector Cell Standards</a>. Given the critical need to maintain high-quality standards in cellular therapy, we invite stakeholders to review and provide feedback on these drafts by Dec. 15. Key updates include consolidated collection standards, REMS practices, and new audit requirements. Please complete the <a href="https://redcap.factglobal.org/surveys/?s=JFK339PTPYEKHYLF" rel="noreferrer noopener" target="_blank">HCT survey </a>for comments on HCT/combined practices, and/or the <a href="https://redcap.factglobal.org/surveys/?s=koJZcuXUNzszjHV8" rel="noreferrer noopener" target="_blank">IEC survey </a>for IEC-specific feedback. Your input is essential for ensuring these standards effectively serve our field. </p> <h3>Patient Outreach Committee Members Recap FDA Listening Session</h3> <p>FDA conducted listening sessions with patients and caregivers to gather insights on their experiences and concerns regarding the short- and long-term risks of approved gene therapies. These sessions, <a id="story6" name="story6"></a>organized by the Center for Biologics Evaluation and Research (CBER), aim to develop patient-centered protocols for long-term post-market studies and to understand what information patients find valuable in making treatment decisions. Participants discussed the types of information they would need when choosing gene therapy, their perspectives on potential risks, and their experiences with long-term follow-up studies.</p> <p>For a more detailed summary on this first listening session, <a data-informz-do-not-track="false" data-informz-link="true" data-informz-link-name="" href="https://www.asgct.org/publications/news/november-2024/cber-committed-to-ensuring-patient-voice-remains-c?utm_source=Informz&utm_medium=Email&utm_campaign=ASGCT" target="_blank">read this piece</a> from Allison Bradbury, PhD, Lauren Beretich, PhD, MS, CGC, and Yulia Grishchuk, PhD, members of ASGCT’s Patient Outreach Committee.</p> <h3 paraeid="{1470f6af-dfb0-437c-95f3-b5334272a725}{232}" paraid="1767687894">NCATS Final Strategic Plan Supports CGT Development </h3> <p paraeid="{1470f6af-dfb0-437c-95f3-b5334272a725}{238}" paraid="658829002">ASGCT commends the National Center for Advancing Translational Sciences (NCATS) on its final <a href="https://ncats.nih.gov/sites/default/files/2024-09/NCATS-Strategic-Plan-2025-2030_508.pdf" rel="noreferrer noopener" target="_blank">2025-2030 Strategic Plan</a>, which reflects meaningful input from the gene and cell therapy community. The strategic plan demonstrates a strengthened commitment to advancing treatments for rare diseases, improving clinical trial diversity, and accelerating translational science. </p> <p paraeid="{d1a32edc-d06b-4d95-bcec-49d5a2da3e1b}{2}" paraid="646476524"><a id="story7" name="story7"></a>ASGCT is particularly encouraged by the plan's enhanced focus on platform technologies, collaboration with regulatory agencies, and strategies to address health disparities. The final plan incorporates several <a href="https://www.asgct.org/advocacy/policy-statement-landing/2024/comments-on-predecisional-draft-ncats-strategic-pl" rel="noreferrer noopener" target="_blank">key recommendations</a><a href="/advocacy/policy-statement-landing/2024/comments-on-predecisional-draft-ncats-strategic-pl" target="_blank"> </a>from ASGCT, including more robust language around decentralized clinical trials, patient engagement, and the unique challenges of developing therapies for rare diseases. </p> <p paraeid="{d1a32edc-d06b-4d95-bcec-49d5a2da3e1b}{17}" paraid="738392517">ASGCT remains committed to partnering with NCATS and other federal agencies to advance cutting-edge cell and gene therapies that offer hope to patients with currently untreatable conditions. The Society applauds NCATS' forward-looking vision and looks forward to continued collaboration in transforming scientific discoveries into life-changing medical treatments. </p> <h3 paraeid="{d1a32edc-d06b-4d95-bcec-49d5a2da3e1b}{17}" paraid="738392517">New Newsletter Highlights Patients, Caregivers, Advocates</h3> <p paraeid="{d1a32edc-d06b-4d95-bcec-49d5a2da3e1b}{33}" paraid="872345730">ASGCT is pleased to announce the launch of <a href="/publications/the-patient-press" rel="noreferrer noopener" target="_blank">The Patient Press</a>, our new bimonthly newsletter dedicated to keeping the patient community informed and engaged in the rapidly evolving CGT <a id="events" name="events"></a>landscape. The inaugural edition, launched in October, marks an important expansion of ASGCT's patient-focused initiatives. The Patient Press delivers accessible coverage of CGT fundamentals, upcoming events, regulatory approvals, research breakthroughs, and more.  </p> <p paraeid="{d1a32edc-d06b-4d95-bcec-49d5a2da3e1b}{50}" paraid="204997885"><a href="https://www.asgct.org/publications/the-patient-press/october-2024" rel="noreferrer noopener" target="_blank">The first issue</a> featured the <a href="https://www.asgct.org/asgct-events/march-2025/empowering-patients-2025-a-cell-and-gene-therapie" rel="noreferrer noopener" target="_blank">Empowering Patients 2025 Summit,</a> our <a href="https://patienteducation.asgct.org/about-asgct/glossary" rel="noreferrer noopener" target="_blank">CGT glossary</a> release, and highlights on research developments in genetic conditions. ASGCT believes that patient perspectives are vital to advancing drug development; this newsletter represents our commitment to providing reliable, actionable information to our patient community. Stay connected with the latest in CGTs by <a href="https://asgct.informz.net/asgct/pages/Patient_Press_Signup" rel="noreferrer noopener" target="_blank">signing up </a>for future editions of The Patient Press. </p> <div> <h2>Events</h2> <hr /> <h3>Register for Empowering Patients 2025: A Cell and Gene Therapies Summit</h3> <p>Coming next spring: <a href="https://www.asgct.org/asgct-events/march-2025/empowering-patients-2025-a-cell-and-gene-therapie?_ga=2.265420687.1035663532.1728917423-1335923092.1725890207&_gl=1*zd5k9f*_ga*MTMzNTkyMzA5Mi4xNzI1ODkwMjA3*_ga_Q37QKR6TCJ*MTcyOTA5MzE3Ni4xNTYuMC4xNzI5MDkzMTc2LjAuMC4w" target="_blank">A new, free, virtual event</a> hosted by ASGCT on March 12-13, 2025. This event will be two half-days of educational material geared toward foundation leaders, patients, and caregivers to provide timely information to support their CGT journey. It will feature educational sessions and engaging discussions on the CGT landscape, exploring the unique challenges impacting patient communities at various stages of the CGT pipeline. <a href="https://www.asgct.org/asgct-events/march-2025/empowering-patients-2025-a-cell-and-gene-therapie?_ga=2.101599233.1262405345.1731942990-1335923092.1725890207&_gl=1*m60ys4*_ga*MTMzNTkyMzA5Mi4xNzI1ODkwMjA3*_ga_Q37QKR6TCJ*MTczMjA0NTI5MC4yNjkuMC4xNzMyMDQ1MjkwLjAuMC4w" target="_blank">Register today</a>!</p> <h3>Dec. 2: Explore ATMP Research in South America</h3> <p><a href="https://www.asgct.org/asgct-events/december-2024/advanced-therapy-medicinal-production-(atmp)-resea" rel="noreferrer noopener" target="_blank">Join ASGCT and ABT-Cel Gen</a> Dec. 2 from 12-1 p.m. ET for a free webinar on Advanced Therapy Medicinal Production (ATMP) Research in South America. This event will explore the latest advancements and unique challenges in ATMP research across South America, featuring insights from leading experts in the field. Discover how regional innovation is driving global progress in cell and gene therapy and learn about the transformative potential of these therapies in a rapidly evolving landscape. Don't miss this opportunity to gain a global perspective on ATMP research – <a href="https://www.asgct.org/events-registration?EventKey=ATW_DEC24" rel="noreferrer noopener" target="_blank">register today</a>.  </p> <h3 paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{119}" paraid="461071293">Watch + Register for CBER Patient and Care Partner Listening Meetings</h3> <p paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{119}" paraid="461071293">FDA is <a href="https://www.fda.gov/news-events/2024-cber-patient-and-care-partner-listening-meetings/meeting-1-patient-and-care-partner-perspectives-safety-considerations-approved-gene-therapy" target="_blank">holding listening sessions</a> to engage with patients and caregivers on their experiences, perspectives, and informational needs regarding the short-term and long-term risks of approved gene therapies. These meetings will help inform patient-centered protocols for long-term post-market studies of these transformative treatments. Watch the recording of the first meeting and register for the second meeting on Dec. 4.</p> <ul role="list"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="1" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="8" role="listitem"> <p paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{132}" paraid="292915802">Meeting 1: <a href="https://www.fda.gov/news-events/2024-cber-patient-and-care-partner-listening-meetings/meeting-1-patient-and-care-partner-perspectives-safety-considerations-approved-gene-therapy" rel="noreferrer noopener" target="_blank">Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases</a>  </p> </li> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="2" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="8" role="listitem"> <p paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{141}" paraid="1470744309">Meeting 2: <a href="https://www.fda.gov/news-events/meeting-2-patient-and-care-partner-perspectives-early-enrollment-gene-therapy-clinical-trials-rare" rel="noreferrer noopener" target="_blank">Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases</a> </p> </li> </ul> <h3 paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{141}" paraid="1470744309">Free FDA Workshop Will Explore Patient Experience Data</h3> <p paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{250}" paraid="1058567365">The FDA is hosting a <a href="https://www.fda.gov/drugs/news-events-human-drugs/patient-focused-drug-development-workshop-discuss-methodologic-and-other-challenges-related-patient?source=email" rel="noreferrer noopener" target="_blank">virtual public workshop</a> on Dec. 13 to address methodological challenges in incorporating patient experience data into regulatory decision-making, such as benefit-risk assessment and product labeling. This workshop will explore various types of patient experience data, submission considerations, and the FDA's utilization of such data, featuring expert presentations and panel discussions. Initiated under PDUFA VII, this workshop builds on public input from a <a href="https://www.federalregister.gov/documents/2023/05/02/2023-09265/methodological-challenges-related-to-patient-experience-data-request-for-information-and-comments" rel="noreferrer noopener" target="_blank">recent Request for Information</a> and aims to advance patient-focused drug development approaches. For <a href="https://fda.zoomgov.com/webinar/register/WN_Jb5xMhbVS1-wYhLn6fwMng#/registration" rel="noreferrer noopener" target="_blank">registration details,</a> <a id="policynews" name="policynews"></a>visit the FDA website. </p> <h3 paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{250}" paraid="1058567365">OTP Town Hall to Address Effective Regulatory Interactions  </h3> <p paraeid="{9a2ee911-4609-4691-a58a-ffb861118793}{250}" paraid="1058567365">The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) will host a <a href="https://www.fda.gov/news-events/otp-events-meetings-and-workshops/otp-town-hall-best-practices-regulatory-interactions-otp-12122024" rel="noreferrer noopener" target="_blank">virtual town hall </a>on Dec. 12, focusing on best practices for regulatory interactions with OTP. Experts from the Office of Review Management & Regulatory Review (ORMRR) will address questions from advanced therapy developers on effective engagement with OTP throughout the development lifecycle, including formal meeting processes under the IND/BLA pathway. Questions can be submitted ahead of time through the <a href="https://web.cvent.com/event/2096ad70-37d5-45e5-b630-0afbceccc92a/summary" rel="noreferrer noopener" target="_blank">registration process</a>. </p> <h2>Policy News</h2> <hr /> <ul role="list"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="1" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="14" role="listitem"> <p paraeid="{e38264e1-5ab2-45d7-8c87-2fd9c17c7c53}{72}" paraid="2061197763">The FDA is<a href="https://www.fiercepharma.com/pharma/it-was-good-lesson-fda-reconsiders-car-t-boxed-warning-secondary-cancers-peter-marks-says" rel="noreferrer noopener" target="_blank"> reconsidering </a>the black box warnings on CD19-mediated CAR-T cell therapies, acknowledging the risk of secondary cancers may have been overestimated. The agency is considering removing or modifying <a href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-boxed-warning-t-cell-malignancies-following-treatment-bcma-directed-or-cd19-directed" rel="noreferrer noopener" target="_blank">the warnings</a>, especially for CAR-T therapies in development for autoimmune diseases, and is encouraging companies to continue their CAR-T programs while engaging with the FDA on safety signals. </p> </li> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="2" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="14" role="listitem"> <p paraeid="{e38264e1-5ab2-45d7-8c87-2fd9c17c7c53}{92}" paraid="1104596177">FDA held a public meeting in mid-October on their new <a href="https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/fda-rare-disease-innovation-hub" rel="noreferrer noopener" target="_blank">Rare Disease Innovation Hub</a>.  <a href="https://www.regulations.gov/document/FDA-2024-N-3528-0001/comment" rel="noreferrer noopener" target="_blank">Comments </a>from different organizations are now available on the registrar regarding suggestions and prioritization for the Hub’s activities. </p> </li> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="3" data-font="Symbol" data-leveltext="" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-listid="14" role="listitem"> <p paraeid="{e38264e1-5ab2-45d7-8c87-2fd9c17c7c53}{134}" paraid="1722465726">The FDA <a href="https://endpts.com/fda-expands-faster-drug-review-pilot-from-supplemental-to-full-applications/" rel="noreferrer noopener" target="_blank">announced</a> it will expand a program next month to accelerate review of certain drugs and biologics that show potential for substantial improvement in serious conditions with unmet needs. The <a href="https://www.fda.gov/drugs/development-resources/split-real-time-application-review-star" rel="noreferrer noopener" target="_blank">Split Real Time Application Review </a>(STAR) program, previously only for follow-on indications, will now consider original applications for products before approval. </p> </li> </ul> <p> </p> <p> </p> </div> </main> <aside> <div class="asideBox"> <h4>Related Pages</h4> <ul> <li><a href="/advocacy/events-and-opportunities">Events and Opportunities</a> </li> <li><a href="/advocacy/policy-priorities">Policy Priorities</a> </li> <li class="active"><a href="/advocacy/the-advocate">The Advocate</a> <ul> <li><a href="/advocacy/the-advocate/subscribe-to-the-advocate">Subscribe to The Advocate</a></li> </ul> </li class="active"> <li><a href="/advocacy/policy-statements-letters">Policy Statements & Letters</a> </li> <li><a href="/advocacy/responsible-use-of-technology">Responsible Use of Technology</a> </li> <li><a href="/advocacy/genetic-screening-testing">Genetic Screening & Testing</a> </li> <li><a href="/advocacy/payment-policy">Payment Policy</a> </li> <li><a href="/advocacy/global-access-to-gene-therapies">Global Access to Gene Therapies</a> </li> </ul> </div> </aside> </div> </section> <div class="event-row"> <div class="year">2024</div> <div class="content"> <h2>Breakthroughs in Muscular Dystrophy</h2> <p>November 19-20, 2024 | Chicago, IL</p> </div> <div class="action"><a class="btn btn-white" href="/events/breakthroughs-in-muscular-dystrophy">Learn More</a></div> </div> <footer> <div class="container"> <div class="footerColContainer"> <div class="footerCol"> <p><img alt="logo-footer.png" class="footerLogo" src="/getmedia/c77b7df1-12a2-4998-9809-0a880c107341/ASGCT_Web_Horz_White.aspx" title="logo-footer.png" /></p> <p>20800 Swenson Dr.<br /> Suite 300<br /> Waukesha, WI 53186</p> </div> <div class="footerCol"> <ul> <li><a href="/about">About</a></li> <li><a href="/membership">Membership</a></li> <li><a href="https://annualmeeting.asgct.org" target="_blank">Annual Meeting</a></li> <li><a href="http://www.cell.com/molecular-therapy-family/home" target="_blank">Journal</a></li> </ul> </div> <div class="footerCol"> <ul> <li><a href="/education">Education</a></li> <li><a href="/advocacy">Advocacy</a></li> <li><a href="https://asgct.org/awards" target="_blank">Awards</a></li> <li><a href="https://asgct.org/about/privacy-policy" target="_blank">Privacy Policy</a></li> </ul> </div> <div class="footerCol"> <p class="altStyle">Connect with ASGCT</p> <p><strong>Phone:</strong> 414.278.1341<br /> <a href="mailto:info@asgct.org">info@asgct.org</a><div class="footerSocial"><div id="ctl00_bkSiteFooter_rptFooterBlocks_ctl04_widget1_ctl00_divSocialLinks" class="socialLinks footerSocial"> <ul> <li><a href="https://twitter.com/ASGCTherapy" target="_blank"><i class="bk-icon-twitter"></i></a></li> <li><a href="https://www.facebook.com/asgctherapy" target="_blank"><i class="bk-icon-facebook"></i></a></li> <li><a href="https://www.instagram.com/asgctherapy" target="_blank"><i class="bk-icon-instagram"></i></a></li> <li><a href="https://www.youtube.com/user/ASGCT" target="_blank"><i class="bk-icon-youtube"></i></a></li> <li><a href="https://www.linkedin.com/company/asgct/" target="_blank"><i class="bk-icon-linkedin"></i></a></li> </ul> </div></div></p> </div> </div> </div> </footer> <div class="postFooter"> <div class="container"> <p>© 2000-2024 All rights reserved. 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