We are proud to host our yearly Annual Meeting with support from the American Association for Cancer Research, American Society of Clinical Oncology, and Susan G. Komen to address critical issues in the development of new oncology drugs. As of 2016, the Conference on Clinical Cancer Research has become the Friends Annual Meeting. From 2007 until 2015,Friends worked in conjunction with the Engelberg Center for Healthcare Reform at the Brookings Institution with support fromSusan G. Komen for the Cureand theAmerican Society of Clinical Oncology to host the annual meeting.

This meeting convenes a diverse group of experts in the cancer drug development field, including academic and clinical research centers, federal health and regulatory agencies, patient advocacy organizations, and the private sector to develop practical, consensus-driven solutions to critical challenges in the development of drugs for cancer.

The meeting emphasizes outcomes, and many of the panels have led to improvements in cancer care, including:

• The 2012 passage of the Advancing Breakthrough Therapies for Patients Act
• The development of Lung-MAP
• The creation of the 2010 Guidance for FDA on how to test novel drugs in combination

In addition to the items listed above, other outcomes from theFriendsAnnual Meeting include:

2016

• Full Meeting Report with Issue Briefs from Each Panel
• Panel 1 Slides: Modernization of Eligibility Criteria
• Panel 2 Slides: Examining the Feasibility of Real World Evidence Through Pilot Studies
• Panel 3 Slides: Global Harmonization of Drug Development

2015

• Modernizing Measurement of Tumor Response to Therapy: Application to Immunotherapeutics
• Capturing Symptomatic Adverse Events From the Patients’ Perspective: The Potential Role of the National Cancer Institute’s PRO-CTCAE Measurement System
• The Blurring of Phase 1, 2, and 3 Trials in Oncology: Expansion Cohorts in Phase 1 Trials

2014

• The Role of Non-Randomized Trials for the Evaluation of Oncology Drugs
• Improving Evidence Developed from Population-Level Experience with Targeted Agents
• Considerations for Summary Review of Supplemental NDA/BLA Submissions in Oncology

2013

• Facilitating the Development of Immunotherapies: Intermediate Endpoints for Immune Checkpoint Modulators
• Lung Cancer Master Protocol Activation Announcement
• Optimizing Dosing of Oncology Drugs

2012

• Developing Standards for Breakthrough Therapy Designation
• Design of a Disease-Specific Master Protocol
• Re-evaluating Criteria for Accelerated Approval

2011

• Alternative Trial Designs Based on Tumor Genetics/Pathway Characteristics Instead of Histology
• Evidence for Use of Maintenance Therapy
• Symptom Measurement in Clinical Trials
• Development Paths for New Drugs with Large Treatment Effects Seen Early

2010

• Adaptive Clinical Trial Designs for Simultaneous Testing of Matched Diagnostics and Therapeutics
• Identification and Elucidation of the Biology of Adverse Events: The Challenges of Safety Assessment and Translational Medicine
• Integrating Pain Metrics into Oncology Clinical Trials
• Using Patient-Initiated Study Participation in the Development of Evidence for Personalized Cancer Therapy

2009

• Data Submission Standards and Evidence Requirements;
• Blinded Independent Central Review of PFS Endpoint
• Accelerating Development and Approval of Targeted Cancer Therapies
• Development of Rational Drug Combinations with Investigational Targeted Agents

2008

• Data Submissions Standards and Evidence Requirements
• Improved Insights into Effects of Cancer Therapies
• Co-Development of Diagnostics and Therapeutics

Other partners for the Annual Meeting include:

• Cancer Information and Support Network
• CDER, FDA
• Clinical Investigation Branch, NCI
• Columbia University Medical Center
• Dana-Farber Cancer Institute
• FDA Office of Hematology and Oncology Products
• Fight Colorectal Cancer
• Foundation Medicine
• Fred Hutchinson Cancer Center
• Gemini Group
• Marti Nelson Cancer Foundation
• Massachusetts General Hospital Cancer Center
• Mayo Clinic
• MD Anderson Cancer Center
• Medical University of South Carolina
• Melanoma Research Alliance
• Office of Biostatistics, FDA
• UC Davis Cancer Center
• University of Chicago
• University of North Carolina, Chapel Hill
• Yale Cancer Center

Friends has partnered with Alexandria Real Estate Equities, Inc. for the last few years to host the seriesA Blueprint for Drug/Diagnostic Co-development. This summit brings together researchers, regulators, sponsors, and advocates to discuss possible approaches to improving and expediting development of diagnostics.

In addition to starting and continuing the conversation around this topic, white papers and articles have been developed in coordination with the summit. Those documents include:

• A Blueprint for Drug/Diagnostic Development: Facilitating Development and Use of Curated Genetic Databases
• A Risk-based Approach for In Vitro Companion Diagnostics Device FDA Approval Process Associated with Therapies that have Breakthrough Designation
• A Blueprint for Drug/Diagnostic Co-Development: Next-Generation Sequencing (NGS) in Oncology
• Considerations for the successful co-development of targeted cancer therapies and companion diagnostics

Additional partners on the series include:

• CDER, FDA
• CDRH, FDA
• Centers for Medicare and Medicaid Services (CMS)
• Division of Cancer Treatment and Diagnosis, NCI
• Fight Colorectal Cancer
• Massachusetts General Hospital
• Memorial Sloan-Kettering Cancer Center
• National Cancer Institute (NCI)
• Office of Clinical Pharmacology, FDA
• Office of Hematology & Oncology Products, FDA
• Washington University, School of Medicine

Lung-MAP is an unprecedented public-private collaboration among the National Cancer Institute, SWOG Cancer Research, the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (FNIH), Foundation Medicine and several lung cancer advocacy organizations. First proposed at the 2012FriendsAnnual Meeting, the final design was announced at the 2013 Annual Meeting, with the trial itself being in operation since 2014. As of September 2017, Lung-MAP is operating at more than 700 sites across the country.

• Design of a Disease-Specific Master Protocol
• Lung Cancer Master Protocol Activation Announcement

Additional partners for Lung-MAP include:

• Addario Lung Cancer Foundation
• American Cancer Society
• American Lung Association
• Fred Hutchinson Cancer Center
• Free to Breathe
• Lung Cancer Alliance
• Lung Cancer Foundation of America
• LUNGevity Foundation
• MD Anderson Cancer Center
• UC Davis Cancer Center
• Uniting Against Lung Cancer
• Yale Cancer Center

Since moving the breakthrough therapy designation from concept to reality in 2012,Friends has been instrumental in continuing to improve upon the designation and process.

In the last year,Friends has started work with University of North Carolina – Chapel Hill, FDA, NCI, Brookings Institution, and Cancer Information and Support Network on developing a tool to measure symptomatic adverse events related to cancer treatment from the patient perspective. This tool is called Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

• Capturing Symptomatic Adverse Events From the Patients’ Perspective: The Potential Role of the National Cancer Institute’s PRO-CTCAE Measurement System

• Alexandria Real Estate Equities, Inc., Alexandria Venture Investments
• American Association for Cancer Research
• American Cancer Society
• American Society of Clinical Oncology
• Arizona State University
• Association of American Cancer Institutes
• Battelle Memorial Institute
• Deerfield Management
• GMMB
• Mayer Brown LLP
• Prevent Cancer Foundation
• RCYMedicine
• Research!America
• The Sherry Lansing Foundation
• The Weizmann Institute of Science