Attending Biotechnology Innovation Organization International Convention? Jeff Allen will discuss recent trends in Accelerated Approvals and how the mechanism continues to support timely patient access to treatments for serious illness. #BIO2025

#PatientAdvocates, your Q2 Advocate Newsletter is here! Get highlights from our recent conference, trends in Accelerated Approval and breaking news in cancer research. Read the latest issue and subscribe to stay up to date on cancer advocacy and research: friendsofcancerresearch.org/blog/quarterly….

.Santhosh Balasubramanian, PathAI, on how advancing AI/ML-enabled #digitalpathology tools requires collaboration to enhance accuracy & reproducibility. Our discussion guide explores how use of reference datasets can be an efficient approach toward validation: bit.ly/3Egbqwm.

Using publicly available data from review documents on Drugs@FDA, we created a dashboard to assess how four of U.S. FDA’s expedited programs impact the time it takes for new cancer therapies to be approved. Explore the dashboard: bit.ly/4kZJ6yX. #acceleratedapproval

Pragmatic #clinicaltrial elements (i.e. broadening eligibility criteria, utilizing real-world evidence, and embedding trials in routine care) can reduce patient burden, enhance generalizability, and maintain scientific rigor. Read more: bit.ly/4k3KXBm.

We are encouraged by the news that the U.S. FDA and NIH released a glossary of RWD/#RWE terms to help standardize definitions to strengthen communication across studies using innovative trial designs and data sources. Read the full story at Regulatory Affairs Professionals Society: raps.org/News-and-Artic….

Stay informed on the latest developments in #cancerresearch, policy, and regulatory science. Sign up for our newsletter for research updates, event announcements, and opportunities to engage in patient advocacy efforts that drive change: bit.ly/44mUJtM.

A Friends of Cancer Research and ASCO task force found that #clinicaltrial flexibilities can be implemented without compromising data quality, suggesting decentralized elements maintain standards while improving access and increasing enrollment: bit.ly/4kIRwKb.

Many promising #celltherapies for rare diseases stall due to regulatory, manufacturing and access barriers. Our white paper proposes fit-for-purpose CMC frameworks, alternative manufacturing models and cost recovery approaches to expand access. bit.ly/3YYACir

.U.S. FDA’s ODAC voted the benefit-risk profile of 2 #multiplemyeloma combination therapies is not favorable due to concerns around high-rates of toxicity at the proposed dosages, inadequate dose optimization, and poor representation of U.S. patients. friendsofcancerresearch.org/blog/stakehold…

Lost in the language of drug development? Our ProgressforPatients.org course explains key regulatory terms like "Breakthrough Therapy designation" in plain language. Empower your advocacy with knowledge. #patientadvocacy

FDA-approved cancer drugs frequently require additional postmarketing studies to address outstanding safety and efficacy questions. Our PMR/Cs dashboard analyzes novel #oncology therapies approved from 2012-2024, revealing postmarketing landscape trends: bit.ly/4aIVfCx.

Building trust in #AI for #cancercare requires benchmarks that capture real-world representativeness and clinical realities. In our response to National Cancer Institute, we outline key priorities to help AI tools meet regulatory standards and deliver reliable results: bit.ly/40Aju3q.

Register for our Annual Meeting in-person or virtual on November 4 at 10AM. Hear experts explore this year’s topics in single-arm trial designs, trial designs for combination drug development, and control arm selection for multi-regional clinical trials. friendsofcancerresearch.org/event/friends-….

Our ctMoniTR Project manuscript in Clinical Cancer Research demonstrated that #ctDNA clearance is associated with improved overall survival in patients with aNSCLC treated with TKIs. These findings are a foundational step toward using ctDNA as an intermediate endpoint. friendsofcancerresearch.org/news/new-findi….

While early endpoints in #oncology trials enable faster approvals, challenges arise when interim OS data conflicts with positive signals. Our #2024AM white paper explores recent learnings and proposes frameworks and strategies for interpreting interim OS: friendsofcancerresearch.org/wp-content/upl…

The success of early PD(L)1 trials relied on multiple expansion cohorts leading to FDA approval in a few #cancer types. At our Annual Meeting, we will discuss single-arm designs that prioritize patient access and regulatory confidence: Register here: bit.ly/40FVQT9.

Tumor measurements are critical for #cancer therapy efficacy, but RECIST assessments can be biased and inconsistent. Our ai.RECIST Project explores how AI tools could provide consistent measurements and reduce review times, while maintaining standards. bit.ly/4lcjS0L

Cancer drug development has never been more complex. Join us on Nov. 4 at our Annual Meeting. Industry leaders will discuss trial designs for rare diseases, combination drug development, and multi-regional clinical trials. Register today: bit.ly/4fwyZ2x! #FriendsAM25

Jeff Allen will be presenting at Cambridge Healthtech Institute #NGDx on 8/20. “Biomarker Harmonization and Use of AI-Enabled Digital Pathology Tools” and “ctDNA as Early Response Indicator” will explore the future of precision medicine in cancer research and treatment. nextgenerationdx.com