Friends of Cancer Research

CAR T-cell therapies are revolutionizing cancer treatment, yet their potential remains constrained by centralized development models that hinder the development of therapies for rare cancers. Additionally, these promising therapies face significant barriers due to prohibitive costs and manufacturing complexity. ? Throughout 2024, Friends of Cancer Research addressed these challenges. ? We published “Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products," which outlined strategic approaches to expedite cellular therapy development and evidence generation. ? Additionally, in collaboration with the Parker Institute for Cancer Immunotherapy, we convened a public meeting to reimagine cell therapy trials and treatments for patients. ? Read our article in Cytotherapy and register to join us at the 2025 Unlocking Next-Generation Therapies public meeting: https://lnkd.in/e__pp_f8. ? #CARTcelltherapy #cellandgenetherapy

The integration of Artificial Intelligence (AI) and Machine Learning (ML) into drug development and diagnostics presents unprecedented opportunities to enhance patient care, streamline drug discovery, and improve the accuracy of diagnosis and treatment selection. However, these technologies may require a new regulatory paradigm, particularly given their adaptive nature. To ensure safety, efficacy, and reliability, regulatory frameworks must evolve to accommodate AI-driven innovations while maintaining robust oversight mechanisms. ? We outlined key considerations for AI drug development in our comment to the White House's Request for Information (RFI) on the development of an AI Action Plan. These include: ? ?? Adapting FDA regulatory pathways for AI/ML platforms ?? Developing expedited validation processes with reference data sets ?? Defining performance metrics and standards, and ?? Identifying policy actions and opportunities ? We appreciate the opportunity to contribute to this RFI and look forward to working collaboratively with policymakers to consider these recommendations in developing an AI Action Plan that promotes both innovation and patient safety. ? Read the full comment on our website: https://lnkd.in/eX34gBY8 ? #DrugDevelopment #ArtificalIntelligence

Lung-MAP, an innovative umbrella clinical trial for patients with advanced NSCLC and rare alterations or molecular subtypes, has continued to adapt to the fast-paced science and drug development landscape. ? Launched in late 2024, Lung-MAP 3.0 is the third generation of the trial and includes a major expansion of genomic screening options. To make the trial more pragmatic, patients and their physicians can now utilize almost any CLIA-certified next-generation sequencing platform. On-study pre-screening or at the time of progression is still available to patients at no cost through the Foundation Medicine platform. ? The trial, a collaboration between Friends of Cancer Research, Foundation for the National Institutes of Health, SWOG Cancer Research Network, and pharmaceutical companies, provides a model for more efficient, cooperative trials and has been cited in over 40 publications just within the last year. ? Learn more: https://lung-map.org/ ? #clinicaltrial #LCSM

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