Friends of Cancer Research

Friends of Cancer Research founder Ellen Sigal has been diagnosed with a non-aggressive form of #kidneycancer—a diagnosis that, thanks to decades of research and progress, is treatable.     Read Ellen's article in the American Society of Clinical Oncology (ASCO) Post sharing her experience as a patient and the state of the field of #oncology today and what we need to focus on as we look to the future:     https://lnkd.in/ekfiuYE4 

Thank you to the FDA for putting forth draft guidance to integrate randomized control trials (RCTs) into routine care. Our public comments to the Agency highlight the importance of encouraging efficient and accessible trials that support the enrollment of more representative populations to enhance study generalizability. Friends advocates for identifying suitable scenarios where it is appropriate to integrate RCTs into clinical workflows, given the existing safety and efficacy data. Further clarity on how to identify these scenarios and the necessary data to collect can help realize the goal of modernizing clinical trial methodologies and enable integration of clinical trials into clinical practice at point of care. Read our full public comments here: https://lnkd.in/ee-X8MhP   We appreciate the opportunity to provide feedback on the draft guidance and thank FDA for considering these recommendations while developing a final version of this guidance document.

Q4 of Friends Advocacy Newsletter is here, rounding up the year with key updates from our 2024 Annual Meeting, FDA oncology advancements, and advocate perspectives by David Mitchell, Eva A. May, and Carol Vallett. Read the article below to stay informed as we reflect on our collaborative achievements and look forward to new opportunities and events in 2025.  #FriendsAdvocacy #Oncology #PatientAdvocacy

Join Friends of Cancer Research's public meeting, "Advancing the Future of Diagnostics and Regulatory Innovations" featuring an opening keynote from Dr. Michelle Tarver, Director of the FDA Center for Devices and Radiological Health (CDRH).    Focusing on driving innovation in diagnostics and regulatory policy, expert panelists will discuss evidence generation for novel technologies in diagnostic testing and unveil new data from the Digital PATH Harmonization project. In addition, they will discuss strategies for developing diagnostic tests for rare biomarkers and addressing future regulatory considerations for cutting-edge tools.    Join key thought leaders on February 4, 2025, to explore how these innovations can accelerate progress in precision medicine and improve patient outcomes. Register today! https://lnkd.in/e_nRAbE9     #AIoncology #cancerbiomarkers 

NEW RESULTS: New findings from our Digital PATH project showing the extent of agreement between 10 different AI-enabled digital pathology tools used to evaluate HER2 status were presented at the San Antonio Breast Cancer Symposium. HER2 is an important marker in breast cancer that can help determine the best course of treatment. Specialized targeted therapies called antibody drug conjugates (ADCs) can deliver potent anti-cancer medicines directly to targets, like HER2, on cancer cells. Advances in digital and computational pathology tools have enabled the identification of patients with low and ultralow HER2 expression that can benefit from these new targeted therapies - but optimal treatment requires accurate test results. Through the use of a common set of digitized biopsy slides, this unique collaboration compared the outputs from different tools. This provides a model to help ensure consistency in test results across different digital pathology tools and pave the way for the next generation of targeted ADC therapies. More about the Digital and Computational Pathology Tool Harmonization (Digital PATH) Project: https://lnkd.in/eAdT7d3m Many thanks to our collaborators in this innovative endeavor: Friends of Cancer Research, NCI Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), ZAS - Ziekenhuis aan de Stroom, Lunit Oncology, Panakeia, PathAI, University of North Carolina at Chapel Hill, Indica Labs, Caris Life Sciences, GSK, 4D Path, FDA, GA Green Consulting LLC, AstraZeneca, Bristol Myers Squibb, MOLECULAR CHARACTERIZATION LABORATORY at Frederick National Lab, KULIG CONSULTING LLC, BostonGene, Emory University, Amgen, Nucleai, Merck & Co., Inc. #AIOncology #SABCS24

Director of Regulatory Affairs, Brittany Avin McKelvey, presented new findings from the Friends of Cancer Research Digital PATH Project at the San Antonio Breast Cancer Symposium entitled "Agreement Across 10 Artificial Intelligence Models in Assessing HER2 in Breast Cancer Whole Slide Images."    The findings demonstrate the level of agreement of HER2 biomarker assessment across independently developed computational #pathology models. These preliminary findings suggest that the level of agreement of predicted HER2 scores across models is similar to published agreement measures across pathologists.     - View the poster here: https://lnkd.in/dk5QPwqB   For complete project findings, join us at the Friends meeting "Advancing the Future of Diagnostics and Regulatory Innovations" on February 4, 2025.     - Register here: https://lnkd.in/e_nRAbE9     #SABCS24 #breastcancer 

What is ctDNA and why does it matter for oncology drug development and patient advocacy? At the Friends of Cancer Research Annual Meeting recap event for advocates, Carol Vallett, Friends Advisory Advocate, and Dr. Alex Wyatt, Associate Professor, The University of British Columbia, discussed Friends' collaborative efforts in advancing ctDNA and highlighted the role of patient advocates in research. Watch the video below or read the full recap here: https://lnkd.in/ea6MWW62 #ctDNAFriends #patientadvocacy #oncology

Determining a breast cancer patient’s HER2 status from a biopsy sample is inarguably one of the most consequential tests at the start of the treatment journey as it determines the subsequent therapeutic options available, most importantly those eligible for treatment with novel antibody-drug conjugates. AI-enabled digital pathology solutions have a big role to play in expediting determination of HER2 status, especially when HER2 expression levels are low and status is difficult to determine by eye.  At this year’s San Antonio Breast Cancer Symposium we are proud to have co-authored a study conducted as part of a research partnership to describe and evaluate the agreement of HER2 biomarker assessment across independently developed AI models put together by Friends of Cancer Research. The study concluded that while variability exists, these models routinely determined HER2 status successfully. We are filled with hope and anticipation for the continuation of this study which will inform the future development of AI models and set a gold standard for the ever-evolving landscape in the context of clinical application.   Abstract title: Agreement Across 10 Artificial Intelligence Models in Assessing HER2 in Breast Cancer Whole Slide Images: Findings from the Friends of Cancer Research Digital PATH Project  Abstract no: P2-02-18 Booth: #1433 in the Exhibit Hall, Halls 2-3 Time and date: Poster Session 2, 5:30 – 7:00 p.m. CST, Wednesday, December 11 Read the full abstract here: https://lnkd.in/enX25nD9 #SABCS24 #breastcancer #biomarker #HER2 #cancer #precisionmedicine #moleculardiagnostics

Thank you for joining “Friends of Cancer Research's Annual Meeting 2024 Recap: Sharing Next Steps and Opportunities with Advocates.” We deeply appreciate everyone's engagement during the webinar and look forward to you joining us in the future! The panel discussion and live audience Q&A demonstrated the importance of patient voices in research and highlighted the need for regulatory efforts to drive meaningful progress in shaping trial designs and advancing outcomes that better reflect patient experiences. The webinar recapped the following topics from our Annual Meeting: ctDNA’s potential as an early endpoint could expedite drug development, providing early insights into treatment efficacy that may correlate with improved overall survival (OS) given the trend of robust evidence in efforts to validate the biomarker. The complexities of navigating the disconnect that can arise between short-term endpoints and assessing interim OS at the same time. We discussed approaches to strategically interpret early survival analyses, as immature data could lead to incorrect assumptions about safety or efficacy, thereby delaying approvals. The importance of designing pragmatic trials by incorporating pragmatic data elements, such as collecting data from electronic health records (EHRs) to ease the burden on patients, providers, and clinical trial sites and make clinical trials more accessible and representative of real-world populations. Missed the webinar? Click here: https://lnkd.in/ephfkqRM #FriendsAM24

"Beyond day-to-day use of ctDNA in the clinic, we’re asking the simple question, can ctDNA measurements in clinical trials tell us about whether a drug is effective much earlier and much more accurately... What we wanted to define with this white paper and this working group effort is what do we need to do as a community to prove that #ctDNA is an early endpoint that can give us all of that information. " Working group member Alexander Wyatt at Friends Annual Meeting 2024 Recap: Sharing Next Steps and Opportunities with Advocates. - Click to watch the full meeting: https://lnkd.in/ephfkqRM To view the 2024 Friends of Cancer Research ctDNA working group white paper click here: https://lnkd.in/eEMFsw4u