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AACR Annual Meeting 2021 to Feature a Robust “Regulatory Science and Policy Track” During Week 2

May 13, 2021

PHILADELPHIA – The American Association for Cancer Research (AACR) will host Week 2 of the AACR Annual Meeting 2021 virtually May 17-21, 2021. In addition to educational sessions, methods workshops, meet the expert sessions, and professional advancement sessions, the week will feature a full slate of regulatory science and policy sessions with speakers representing academia, government, industry, and the patient advocacy community.

Monday, May 17

REGSCI08: FDA OCE Engagement Efforts: Building an Inclusive Cancer Community

9:45-11:15 a.m. ET

Representatives from the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA) will discuss OCE’s communication and outreach efforts. The session will also feature discussion of OCE efforts to reach underserved patient populations, including Project Community and Project Equity.

REGSCI02: Lessons Learned from COVID-19: Adaptations and Approaches for Trial Modernization

1:45-3:15 p.m. ET

This session will explore adaptations and flexibilities implemented to keep clinical trials functioning while ensuring patient safety during the COVID-19 pandemic. Panelists will also discuss how clinical trials can continue to adapt for the future, what tools are needed to be successful, and what research questions need to be answered to be confident in new trial approaches.

Tuesday, May 18

REGSCI01: Use of Liquid Biopsies in Identifying Minimal Residual Disease in Solid Tumors in the Adjuvant Setting

9:45-11:15 a.m. ET

This session will explore the use of circulating tumor DNA (ctDNA) as an enrichment tool for clinical trials by identifying patients with high-risk early-stage cancers. Additionally, the session will review ongoing efforts from academia and industry to develop and validate liquid biopsy technologies; highlight patient perspectives; and provide regulatory insights on the use of ctDNA as a possible early endpoint in adjuvant drug development.

REGSCI05: FDA-AACR Oncology Educational Fellowship: An Interactive Immersion into Cancer Drug Regulatory Review

1:45-3:15 p.m. ET

Recipients of the inaugural FDA-AACR Oncology Educational Fellowship will discuss what they learned as fellows and how they plan to apply it moving forward.

Wednesday, May 19

REGSCI04: The Promise and Perils of Germline Testing in the Management of Patients with Cancer

1:45-3:15 p.m. ET

Germline testing can unveil cancer predisposition syndromes, predict how a patient may respond to certain anti-cancer therapies, and identify other relevant findings unrelated to a patient’s cancer. Experts in the application of genomic testing in patient care will join FDA staff to discuss the implications of germline testing for the future of cancer care, including tissue agnostic treatments and individualized therapy, as well as regulatory considerations for its use.

Thursday, May 20

REGSCI06: ACCELERATE-ing Pediatric Oncology Drug Discovery and Development

9:45-11:15 a.m. ET

The RACE for Children Act, incorporated as Title V Sec 504 of the FDA Reauthorization Act (FDARA), enacted on August 18, 2017, requires early pediatric assessment of new molecularly targeted drugs and biologics “intended for the treatment of adult cancers and directed at a molecular target substantially relevant to the growth or progression of a pediatric cancer.” All meeting attendees are encouraged to attend this special session whereby stakeholders from the AACR Pediatric Cancer Working Group, the ACCELERATE Innovation for Children and Adolescents with Cancer Platform, the FDA, the European Medicines Agency, industry, academia, and the pediatric cancer advocacy community will discuss the early implementation experience since the full activation of the RACE for Children Act on August 18, 2020. The early impact of the newly established legislative requirements on industry plans and strategies, and discussion of potential metrics to assess the effect of the RACE for Children Act will be explored. Session presentations will also focus on reviewing the potential global impact of the RACE for Children Act and the role of the ACCELERATE platform in facilitating collaborative opportunities to advance the development of innovative anticancer medicines for children.

REGSCI07: Hot Topics in Oncology Regulation

1:45-3:15 p.m. ET

This session will go beyond basic regulatory concepts and consider relevant, contemporary topics in oncology drug and device regulation.

REGSCI13: Discussion on Issues Important to Tobacco Control

2-2:45 p.m. ET

This session featuring AACR Tobacco Products and Cancer Subcommittee members will highlight tobacco control policy and regulation and include a discussion on the health impacts of e-cigarettes, flavored tobacco products such as menthol, the emergency of synthetic nicotine, and the role tobacco plays in exploiting health disparities. This session is a follow-up discussion to a session that was held during Week 1 of the AACR Annual Meeting, which included remarks from Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products.

Friday, May 21

REGSCI03: Racial and Ethnic Diversity in Clinical Trials Evaluating Hematologic Malignancies

9:45-11:15 a.m. ET

Over the past several years, there has been more awareness and an increased effort to diversify patient populations in cancer clinical trials. Unfortunately, despite these efforts, enrollment of minorities in cancer clinical trials continues to be suboptimal and disparities continue to exist. This session will review outcomes of minority patients enrolled in malignant hematological clinical trials, discuss the importance of enrolling minorities in these clinical trials to address disparities, and explore strategies to improve enrollment.

Project Livin’ Label

In addition to the sessions above, encore presentations of four Project Livin’ Label webinars will be made available during the meeting. Project Livin’ Label, a collaboration between OCE and the AACR, is an educational initiative that aims to foster broad understanding of specific oncology product labels and increase awareness of recent oncology drug FDA approvals among physicians, cancer patients and survivors, industry representatives, and others.

Members of the media are invited to attend all AACR Annual Meeting sessions. To view the sessions listed here as well as any other Annual Meeting presentations, journalists should request complimentary meeting registration from the AACR public relations team using the form on the AACR website. Please contact Kathleen Venango at [email protected] with any questions related to meeting registration.