Friends of Cancer Research

Interested in becoming a certified ProgressforPatients.org advocate? ProgressforPatients.org is a free online advocacy education program and community by Friends of Cancer Research where patients, advocates, and caregivers can learn about drug development and effectively add their voice to the process. Get involved and become certified by taking the Advocacy Education Course: https://lnkd.in/esFzBmw9 #patientadvocacy

Join Friends of Cancer Research and Parker Institute for Cancer Immunotherapy for a joint public meeting: Unlocking Next-Generation Therapies: Exploring Innovative Development and Manufacturing Models for Cell Therapies. ? The first session, Development and Reimbursement Models for Rare Disease Therapies, will explore the challenges in bringing rare disease therapies to patients and discuss potential solutions to address gaps in development and access. The second session, Manufacturing Models for Rare Disease Therapies, will discuss manufacturing models to reduce upfront costs, provide opportunities to leverage partnerships, and offer scalable manufacturing solutions. ? Register and view the agenda at https://lnkd.in/e__pp_f8, and visit the website for the latest updates on sessions, keynote presentations, and speakers. ? #cellandgenetherapy #celltherapy

The 2025 Q1 Advocate Newsletter is out! Catch up on insights from our recent advocate-focused diagnostic webinar, explore key differences between the FDA and EMA in fast-tracking innovative treatments, and learn about the latest policy developments impacting cancer research and care. ? Read the newsletter today: https://lnkd.in/eeWMXkZd ? #PatientAdvocacy #AdvocacyNewsletter

The inclusion of tissue biopsies in clinical trials is critical to the advancement of precision medicine, biomarker-driven research, improved patient stratification, and enhanced drug development efficiency. However, their use must be carefully considered to balance scientific benefits with ethical and logistical concerns. ? The U.S. Food and Drug Administration (FDA) recently released a draft guidance document, “Considerations for Including Tissue Biopsies in Clinical Trials.” We appreciate the opportunity to comment and commend the FDA’s efforts to provide clarity and direction. ? Read our public comment: https://lnkd.in/es2yrwbE. ? #cancer #clinicaltrials

Join us and Prevision Policy for BioPharma Congress: Ready for a New Era. Key topics will include the future of Accelerated Approval, lessons learned from the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, and real word-implementation of AI guidance. Join us Monday, April 7, 8am-1pm ET. Register today: https://lnkd.in/e2BW9-eq #BioPharmaCongress #AIinHealth

Tomorrow, Mark Stewart, Vice President of Science Policy at Friends of Cancer Research, will join Cynthia A. Bens, Ilan Wapinski, Joe Franklin, and Ezra Cohen on the “Policy Considerations for Facilitating Broad Implementation and Uptake of AI in Personalized Medicine” panel at Precision Med TRI-CON. ? He will discuss the Digital PATH Project and how lessons learned from this project can inform validation approaches for other AI-driven tools, along with the potential uses of standardized reference data sets and the challenges in evaluating performance and establishing “gold standards”. ? Learn more about the Digital PATH Project: https://lnkd.in/gGU8t3VK. #AIinHealth #TRICON

How many oncology drugs granted Accelerated Approval progress to full approval or face withdrawal? To answer this question, Friends of Cancer Research created a data dashboard to analyze the use of Accelerated Approvals, tracking confirmatory trials, full approval conversions, withdrawals, and the endpoints used for regulatory decisions. By using publicly available FDA data, this regularly updated dashboard provides a comprehensive view of how the Accelerated Approval pathway drives oncology drug development, shedding light on regulatory trends, the impact of surrogate endpoints, and the real-world challenges of confirming clinical benefit. https://lnkd.in/ed6qBGkW #AcceleratedApproval #cancertreatments

Biomarker testing provides crucial insights into a patient's unique cancer profile, enabling personalized treatment for better outcomes. ? By digitizing cancer biopsies and leveraging AI-enabled biomarker analysis, we can improve consistency in test outputs and refine patient selection for targeted therapies. This could enhance treatment effectiveness and significantly expand access to novel oncology therapies.? ? Jeff Allen, President and CEO of Friends of Cancer Research, will join the SXSW panel "Entrepreneurship at the Speed of Innovation" to discuss how AI can advance cancer care while addressing related challenges and regulatory considerations. ? Learn more about AI-enabled diagnostic tools through our Digital PATH Project: https://lnkd.in/gGU8t3VK. ? #sxsw #healthinnovation

Friends of Cancer Research submitted comments on FDA’s draft Guidance Documents on “Accelerated Approval - Expedited Programs for Serious Conditions” and “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” ? These guidance documents aim to refine the use of the Accelerated Approval pathway to ensure timely patient access to promising therapies in areas of unmet need. Common in oncology, the use of Accelerated Approval has expanded to other disease areas, such as hematological, neurological, and rare disorders. We support additional Accelerated Approval guidance as the integrity and success of this pathway depend on a transparent process and expectation for timely verification of benefit. ? Read our public comments: https://lnkd.in/e_mJstiP, https://lnkd.in/eFZHxhTE. ? We appreciate the opportunity to provide feedback on the draft guidance documents and thank FDA for considering these recommendations while developing their final versions. ? #AcceleratedApproval #DrugDevelopment

Friends of Cancer Research has released its 2024 Impact Report, highlighting key advancements in cancer research and policy. The report includes our recent projects to: ? Integrate real-world evidence into drug development and regulatory assessment ? Advance the use of digital pathology and AI-based technologies in oncology research and care ? Drive biomarker harmonization to optimize diagnostic tools used to inform treatment decisions These initiatives provide the basis for evidence-based policies to shape the future of cancer treatment and improve patient outcomes. Click to view our 2024 Impact Report: https://lnkd.in/ekz7HqNe #FriendsImpact #healthpolicy