​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Regulatory Science and Policy Meetings and Events 

Upcoming Events

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Past Events


FDA-AACR: Immuno-oncology Drug Development ​Workshop

Oct. 13-14, 2016
Hyatt Regency Washington on Capitol Hill, Washington, D.C.

The goal of this workshop was to develop a path forward for evaluating an immuno-oncology-focused nonclinical and clinical development paradigm. Ideally, this workshop would help redefine biological outcome measures and clinical endpoints, leading to innovative clinical trial designs and statistical methods in the development of immuno-oncology clinical trials.

Audio recordings/slides and transcripts are now available.
View final agenda.
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​​FDA-AACR: Liquid Biopsies in Oncology Drug and Device Development

July 19, 2016
​Walter E. Washington Convention Center, Washington, D.C.

Co-sponsored by the FDA and the AACR

The analysis of cell-free tumor DNA in plasma, a noninvasive method for detecting genetic alterations in tumors, holds considerable promise both for improving cancer diagnoses and monitoring and in drug development. This technology is advancing quickly, is being incorporated into numerous drug development programs, and is likely to be rapidly integrated into clinical care. This workshop provided a forum for the discussion of relevant scientific advances in the field of liquid biopsies and of the regulatory environment that will support the translation of this emerging technology into improved patient care.

Slide/audio recordings and transcripts are now available.​​​ 

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​FDA-AACR: Oncology Dose-finding Workshop  

June 13, 2016
Walter E. Washington Convention Center, Washington, D.C.

Co-sponsored by the FDA and the AACR

Since the approval of imatinib in 2001, the FDA has approved 26 small-molecule kinase inhibitors for the treatment of oncology indications. Given the recent history of approvals based on the results of early phase trials driven by extraordinary efficacy data, the incentive for conducting rigorous dose-finding trials may not be overtly apparent. However, the increasing need for the development of combination therapy due to resistance to monotherapy and poor tolerance of approved dosing regimens underscores the need for a more efficient process of dose selection in the early stages of study design. Furthermore, the unknown efficacy in light of frequent dose reduction in the post-market setting begs the question of whether efficacy reported in early phase trials is accurate when applied to a real world population.

Learn more and view slide presentations/transcripts.

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Ovarian Cancer Endpoints Workshop

Sept. 3, 2015
FDA White Oak Campus, Silver Spring, Maryland
Co-sponsored by FDA/AACR/SGO/ASCO

The Food and Drug Administration (FDA), hosted  the "Ovarian Cancer Endpoints Workshop" with presentations by the Society of Gynecologic Oncology (SGO),  the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), on Thursday Sept. 3, 2015, at the FDA, White Oak campus Great Room,  from 8 a.m. to 5 p.m.  This workshop provided a forum for discussion of ovarian cancer, from the current state of science to novel clinical trial designs, biomarkers, statistical issues in clinical trials and how to evaluate new classes of agents such as immunotherapies.

View/download the ​worksho​p agenda.

View/dow​nload the list of workshop speakers/panelists.

Objectives of the workshop

The objective of this public workshop on ovarian cancer was to provide a venue for an in-depth discussion of the current science in ovarian cancer and potential new development pathways for ovarian cancer agents with the following goals:​

  • To review the current state of science of ovarian cancer biology and implications for clinical trial design;
  • To discuss and explore emerging measures of treatment effect, including circulating factors and both tissue and imaging biomarkers;
  • To discuss endpoints reflective of the diversity of disease and patient populations and how this impacts available trial designs and context for these endpoints; and
  • To explore novel treatment designs relative to discovery and regulatory approval.​


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Dose-finding of Small Molecule Oncology Drugs​​

May 18-19, 2015, Washington, D.C.
Cosponsored by FDA and AACR

The purpose of this two-day workshop was to provide an interdisciplinary forum to discuss the best practices of dose finding and dose selection for small molecule kinase inhibitors developed for oncology indications. The goal is to promote a movement away from conventional dose escalation trial design and move toward innovative designs that can incorporate key clinical, pharmacologic, pharmacometric data, and when appropriate, non-clinical information to guide dose selection.

Learn more and view slide presentations.​

​​​​Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies​​

March 24, 2015, Washington, D.C.
Cosponsored by FDA/AACR/ASCO

The FDA, AACR, and ASCO cosponsored​ a workshop to examine challenges in the development and use of multiple targeted therapy-companion diagnostic pairs that are directed at the same or similar biomarker(s). 

Learn more and view slide presentations.

Webcast Information

Complexities ​in Personalized Medicine webcast

Session 1: Defining the Problem
​Stakeholder Presentations​
Panel Discussion

Session 2: Comparing the Tests
Industry Working Group Blueprint Proposal and Panel Discussion
Second Panel Discussion

Session 3: Clinical Practice/Education
Panel Discssion, Q&A, and Closing Remarks

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Innovations in Breast Cancer Drug Development-Next Generation Oncology Trials Workshop Co-sponsored by FDA/AACR/ASCO/BCRF       

The AACR cosponsored this workshop to explore means of accelerating the development of highly effective targeted drugs agents for patients with metastatic breast cancer. The workshop examined how best to design a single genomically-driven trial to simultaneously test multiple agents by bringing together an international group of breast cancer experts, FDA, industry representatives, and patient advocates. Stakeholders discussed potential biomarkers, study designs, statistical models, testing platforms, study designs, statistical models, and implementation strategies to optimize the path to regulatory approval. Learn more and view slide presentations. 

Webcast Information

Innovations in Breast Cancer Drug Development webcast

Session 1
Improving Targeted Drug Development For “Small” Populations With Genomic Alterations

Session 2
Combining Targeted Agents

Session 3
Strategies to Implement a Global, Genomically-driven Metastatic Breast Cancer Study

Session 4
Optimizing Regulatory Requirements for a Global, Genomically-driven Metastatic Breast Cancer Study

Detailed event agenda
List of speakers and panelists

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AACR-AdvaMedDx - Transforming Cancer Care Through Diagnostics and Personalized Medicine      

The meeting brought together multiple stakeholders including scientists, patient advocates, representatives from drug and diagnostic companies, payors, and government agencies (NIH, FDA, CMS). The symposium highlighted the progress made in our understanding of cancer genomics, molecular diagnostic testing, and personalized cancer therapies. Panelists and audience members discussed policy issues crucial to the future of personalized medicine in cancer including appropriate regulatory pathways, reliable payment systems and patient access to novel diagnostics.

Harold Varmus, MD, director of the NCI, gave the opening keynote talk on "Why Diagnostics Matter?" During lunch, Charles Sawyers, MD, president of the AACR (2013-2014) facilitated a conversation between Francis Collins, MD, director of the NIH, and Margaret Hamburg, MD, commissioner of the FDA, to discuss "The Path to Personalized Medicine: Where are we Today?"

Videos from the event 
Detailed event agenda

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EORTC - Combining Immunotherapies, Immune Modulators, and Targeted Therapies: Regulatory Opportunities Challenges       

Combining two immunotherapy agents has been shown to produce better tumor regression in early clinical studies. As a result, researchers are now combining immunotherapies, immune modulators, and targeted therapies to achieve better and more durable responses in patients. However, the regulatory approaches, standards, and requirements that are necessary for approving combination immunotherapies are still evolving. Therefore, this timely session examined both the promises and challenges inherent in evidence-based regulatory approval of these therapies. Short presentations from a representative from the U.S. Food and Drug Administration, as well as leaders from academia, industry, and the patient advocacy community were followed by a moderated panel discussion and audience Q and A.

Speakers and Panelists:

  • F. Stephen Hodi, MD, director of the Melanoma Center at Dana-Farber/Brigham and Women's Cancer Center and assistant professor of medicine at Harvard Medical School – (chair and moderator)
  • Ke Liu, MD, PhD, director, Oncology Branch, Office of Cellular Tissue and Gene Therapies (OCTGT) at the FDA Center for Biologics Evaluation and Research (CBER)
  • Michael Postow, MD, Memorial Sloan Kettering Cancer Center and Recipient of the 2013 Conquer Cancer Foundation, Oncology Young Investigator Award
  • Renzo Canetta, MD, vice-president of oncology global clinical research at Bristol-Myers Squibb
  • Louise Perkins, PhD, chief scientific officer, Melanoma Research Alliance

​Watch panel video and audience Q&A

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