The Regulatory Science and Policy Track at the AACR Annual Meeting 2022 in New Orleans provided session participants with an opportunity to interact with representatives from the U.S. Food and Drug Administration (FDA), the National Cancer Institute, industry, and academia, including basic researchers and physician scientists.
Policy sessions that were part of the Track examined a wide range of topics in the area of regulatory science—the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products—including issues surrounding methods to determine appropriate dosing for oncology drugs, new approaches to reduce cancer disparities, and ways to use real-world data for regulatory approval, among many other important topics and issues.
All sessions in the Regulatory Science and Policy Track can be viewed on the virtual platform through July 13, 2022. Here’s a rundown of all 11 sessions in the track.
Using Patient-Generated Data to Optimize the Dose for Oncology Drugs
This session was a collaboration between the FDA Oncology Center of Excellence’s (OCE) Patient-Focused Drug Development program and the FDA OCE’s Project Optimus. The session’s speakers reviewed the importance of clinical trial design and clinical data in assessing tolerability, discussed types of patient-generated data that can support dose optimization, and examined how to incorporate patient-generated data into trials intended for dose optimization.
Dose Optimization for Antibody-Drug Conjugates
Presented by the FDA OCE’s Project Optimus, this session focused on the distinct properties of antibody-drug conjugates (ADCs) and unique considerations for dose optimization. Topics included how to incorporate nonclinical data, how to evaluate clinical pharmacology data, and how to develop an understanding of the safety profile, including the potential for on- and off-target toxicities to optimize the dose.
Highlighting the AACR/HBS/MMRF Summit: Reducing Disparities and Democratizing Cancer Care
On October 21, 2021, the AACR, Harvard Business School (HBS), and the Multiple Myeloma Research Foundation (MMRF) collaborated on a summit focused on closing the racial gaps that continue to persist in cancer care. This session continued that discussion, including the possibility of establishing a more formal public-private partnership to address cancer disparities.
Quality Over Quantity: Advancing Real World Data toward Real World Evidence
This session examined the role of real-world data in clinical research and practice. The speakers explored the potential applications of real-world data and topics such as crosstalk with clinical trials to broaden eligibility criteria; assessment of efficacy and safety in populations typically ineligible for clinical trials; providing contemporary data to enhance clinical trials; and rare patient subsets and populations.
Tumor Molecular Profiling of Cancers in Children: Expanding Research and International Collaboration to Advance Clinical Care
This session focused on molecular tumor profiling for clinical care and discovery in pediatric oncology. Experts in pediatric brain tumors, solid malignancies, and leukemia provided a high-level review of existing evidence addressing the contribution of molecular profiling to clinical care.
Accelerated, Conditional, Provisional, or Temporary? A Comparison of International Expedited Approval Programs
The Accelerated Approval (AA) program in the U.S. has been a model for the development of expedited drug approval programs around the world. In this session, speakers discussed the differences and the relative strengths and limitations of various international programs.
Successful Development of Cancer Therapies for Ultra-Rare Indications
This session brought together various stakeholders, including representatives from academic life science incubators, pharmaceutical companies, government agencies, the Cancer Moonshot program, and philanthropic patient advocates and attorneys to discuss strategies to advance therapies for ultra-rare cancer indications.
Supporting Smoking Cessation Among Patients with Cancer Who Use Tobacco Products
This session highlighted research from the National Cancer Institute (NCI) and examined how smoking influences cancer treatment outcomes, identified barriers to utilizing effective smoking cessation interventions for patients with cancer, explored ongoing research needs, and reviewed various implementation models, including the NCI Cancer Center Cessation Initiative.
FDA Oncology Center of Excellence Patient Engagement Initiatives: An Interactive Roundtable Discussion
This roundtable discussion included representatives from the FDA, academia, patient/advocacy groups, and AACR leadership. Together, they explored how different stakeholders can help address the barriers, challenges, and opportunities to promote equity across the spectrum of cancer, including in the development of drugs.
Defining Clinical Benefit: Accelerated Approval in Precision Oncology
The speakers in this session explored the definition of “clinical benefit” using a case study in precision oncology that focused on recent FDA approvals of two RET inhibitors. The session was held in collaboration with principal investigators who led the trials and a patient who participated in one of the trials.
Training the Next Generation of Oncology Leaders
This session highlighted the FDA’s OCE educational programs, which are designed to educate future generations of clinicians and researchers on various regulatory science-related issues, including methods for improving drug development, making clinical trials more accessible to patients, advancing specific policy proposals, and addressing how advocates can become more involved.