OCE Public Presentations
FDA Oncology Center of Excellence experts regularly join colleagues in clinical oncology and hematologic malignancies to participate in panel discussions, give talks on regulatory topics, or present research findings.
Upcoming
American Association for Cancer Research 2024 Annual Meeting
OCE experts will take part Regulatory Science and Policy (RSP) sessions, held in the San Diego Convention Center, Upper Level, Room 1, as well as other events listed below. Times are listed as Pacific Time.
April 5: 1-2 pm – AACR Oncology Industry Partnering Event, SDCC Upper Level Room 1 – Fireside Chat with OCE Director Richard Pazdur
April 6: 2:30-4 pm – RSP Session: FDA’s Project Endpoint and Overall Survival in Oncology Clinical Trials. OCE panelist: Nicole Gormley
April 7:
- 1-2:30 pm – RSP Session: No More, No Less: Perioperative Pandemonium: Trial Designs in Solid Tumors. OCE moderator: Bernardo Haddock Lobo Goulart. OCE panelist: Harpreet Singh
- 1:30-5 pm – Session Title: Biomarkers, Immune Monitoring, and Immune Assays. Abstract: Toward Best Practices for B-cell Receptor Repertoire Profiling. FDA presenter: Wenming Xiao
April 8
- 10:15-11:45 am – RSP Session: Trading Places: Regulator as Patient, Patient as Regulator. OCE moderator: Richard Pazdur. OCE panelists: Joshua Donaldson, Leslie Doros, 'Lola Fashoyin-Aje, Gwynn Ison, Steven Lemery
- 12:30-2 pm – RSP Session: Disparities in Pediatric Oncology – Pediatric Cancer Health Disparities. OCE panelist: Martha Donoghue
- 1:30–5 pm: Session Title: Outcome Investigation with Real World Data. Abstract: Real World Outcomes Among Patients with Newly Diagnosed Acute Myeloid Leukemia. FDA presenter: Dianne Pulte
- 2:30-4 pm – RSP Session: In the Eye of the Beholder: Equipoise in Cancer Clinical Trials. OCE moderator: Paz Vellanki. OCE panelist: Jeevan Puthiamadathil
April 9
- 10:15-11:45 am – RSP Session: Diversity Plans in Action – FDA, Industry and Community Perspectives. OCE panelist: Asma Dilawari
- 12:30-2 pm – RSP Session: Intent-to-Treat vs. Intent-to-Harm: Putting the Precision Back in Precision Oncology. OCE moderator: Christy Osgood. OCE panelists: Michael Fusco, Flora Mulkey.
Past Events
Poster Session: Health Services Research and Quality Improvement. Title: Real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets. Abstract 6595 | Poster 87
Poster Session: Lung Cancer, Non-Small Cell Metastatic. Title: FDA analysis of toxicity profiles or oral TKIs recently approved for NSCLC based on receipt of prior immune checkpoint inhibitor therapy. Presenter: Yufan Liu. Abstract 9119 | Poster 107
Education Session: The Future of Equitable Access to Clinical Trials. OCE speaker: 'Lola Fashoyin-Aje. Related text: ASCO Educational Book: Equitable Access to Clinical Trials: How Do We Achieve It?
Embracing Career Transitions and Professional Growth (Women's Networking Lounge): OCE speaker: Jennifer Gao
Educational Session: Accelerated Approvals in Oncology: Balancing Access with Evidence. OCE speaker: R. Angelo De Claro
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary.
- Title: FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma. Presenter: May Tun Saung. Abstract 4117 | Poster 438
- Title: Geographical and baseline clinical characteristics of participants enrolled in hepatocellular carcinoma (HCC) trials: Analysis of US FDA approvals. Presenter: Naomi Horiba. Abstract 4115 | Poster 436
Innovative Solutions to the Challenges of Cancer Clinical Trials: FDA and NCI perspectives. OCE speakers: Richard Pazdur, Paul Kluetz.
Poster Session: Care Delivery and Regulatory Policy
- Title: Trends in new and persistent opioid use in older adults with cancer. Abstract 1592 | Poster 186
- Title: Trends in U.S and global patient enrollment from 2014 to 2022 in lung cancer clinical trials supporting marketing applications: An FDA analysis. Presenter: Oladimeji Akinboro. Abstract 1576 | Poster 170
- Title: Dosage Optimization in Drug Development: An FDA Project Optimus analysis of postmarketing requirements Issued to repair the cracks. Presenter: Brian Heiss. Abstract 1598 | Poster 192
Online only publication: Health Services Research and Quality Improvement Track. Enrollment representation of age, race, and ethnicity in ovarian cancer registrational clinical trials (2010-2020): An evaluation by the U.S. Food and Drug Administration. Authors: Felice Yang, Yue Huang, Catherine Lerro, Wei Liu, Mallorie Fiero, Zhou Feng, Bindu Kanapuru, Timil Patel, Laleh Amiri-Kordestani, Gwynn Ison, Lola Fashoyin-Aje, Paul Kluetz, Harpreet Singh, Donna Rivera