Projects
Research Partnerships
Our research partnerships are data-driven collaborations. Friends aggregates and analyzes data from partners conducting clinical trials, administering diagnostics, and providing routine patient care. These projects generate evidence and alignment to advance the use of innovative measures and approaches in oncology, advancing policy and improving patient outcomes.
HRD Harmonization Project, Digital PATH Project, TMB Harmonization Project
Diagnostic tests provide critical information to guide care for patients with cancer. Our diagnostics portfolio assesses variability across diagnostic tests and identifies areas for improved alignment.
ctMoniTR, Baseline ctDNA, Regulatory Roadmap for ctDNA
Intermediate endpoints that are reasonably likely to predict long-term outcomes can facilitate more efficient clinical trials. The measurement of circulating tumor DNA (ctDNA) may serve as one of these endpoints, and we are working to generate evidence to support use of ctDNA for regulatory decisions.
RWE Pilots 1.0 and 2.0, rw-Response, rwCare, External Control Arms
Real-world data are routinely collected and have the potential to inform regulatory decision-making. Our Real-World Evidence portfolio develops and establishes methodology for using RWD to assess treatment outcomes.
Policy Initiatives
Our policy & regulatory initiatives bring together stakeholders to assess emerging challenges in oncology drug development and policy to help inform recommendations for modernizing regulatory frameworks and clinical trials.
Cell & Gene Therapies
Our cell and gene therapies (CGT) work focuses on enhancing the translation of evidence to support clinical development and adoption of these therapies.
Clinical Trial Eligibility Criteria
Friends partnered with the American Society of Clinical Oncology to develop recommendations for broadening overly restrictive eligibility criteria used in cancer clinical trials.
Lung-MAP
Friends is a founding member of Lung-MAP, a first-of-its kind public-private collaboration to reimagine and accelerate the way investigational biomarker-defined therapies for lung cancer are tested and approved.
Tolerability & Dosing
Friends works to ensure oncology clinical trials include patient-centered approaches to dosage optimization.
Friends Annual Meeting
The Friends Annual Meeting brings together stakeholders each November to discuss topics that address emerging challenges in oncology drug development to facilitate continued progress.
Emerging Topics
Friends continually works to identify issues in oncology drug development that require collaborative solutions.
Data Driven Insights & Analyses
Friends uses publicly available regulatory data to develop a series of interactive tools for exploring data and trends on oncology drug approvals. We hope these resources empower users to uncover their own insights and identify emerging trends.
Expedited Programs, Accelerated Approvals, Postmarketing Requirements and Commitments
Friends created interactive dashboards to gain data driven insights into the landscape of oncology drug development and FDA drug approvals.
About Breakthrough Therapies, Search Breakthrough Therapies
Friends worked with partners in all sectors to develop and implement the Breakthrough Therapy Designation (BTD). Today, we track the 500+ drugs that have received the designation to provide a tool for assessing BTD’s impact.
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