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 Society of Clinical Oncology 2024 Annual Meeting
OCE experts will present at the following ASCO Annual Meeting sessions at the McCormick Convention Center in Chicago and online. Times listed are Central Time (CT).
Friday, May 31: 2:45-3:45 pm CT, Hall A—Case-based Panel: Multicancer Detection: Is It Ready for Prime Time? Title: The Regulatory Perspective: Hurdles to Overcome. OCE speaker: Jamie Brewer (presentation and panelist).
Sunday, June 2:
9:45-10:45 am CT, Hall B1—Education session: Integrating Immunotherapy into Early-Stage Lung Cancer. Title: Too Many Options: Assessing the Best Trial Designs. OCE speaker: Bernardo Goulart (presentation and panelist).
9 am-12 pm CT—Poster Session, Quality Care/Health Services Research.
- Project Facilitate: An analysis of the increased utilization in the oncology single patient expanded access pathway. Mitchell Chan, Abstract 11029
- Patient-reported outcomes corresponding to most common symptomatic adverse events in lung cancer clinical trials. Erica Horodniceanu, Abstract 11103
- Under-representation of Asian Americans, and Native Hawaiians, and other Pacific Islanders in cancer therapeutic clinical trials that led to the FDA approvals in 2010-2022. Ruby Leong, Abstract 11026
1:30-4:30 pm CT—Poster Session, Lung Cancer – Non-Small Cell Metastatic: FDA Analysis of Immune Checkpoint Inhibitors in Combination with Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitors in the Second-line Treatment of Patients with Advanced Non-Small Cell Lung Cancer. Justin Malinou, Abstract 8595
Tuesday June 4:
9 am-12 pm CT—Poster Session, Quality Care/Health Services Research. Impact of the COVID-19 pandemic mitigation strategies on cancer treatment trials: A meta-analysis of industry and NCI studies. Timil Patel (co-author on behalf of ASCO/Friends Protocol Adherence Task Force), Abstract 11021
ASCO Abstracts - Online Publication
- Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals During COVID-19. Timil Patel, e13802
- Enrollment of older adults in clinical trials for oncology indications, 2010-2020: An evaluation by the FDA. Felice Yang, e23029
- FDA Analysis of representation of Indian Americans and Indians in cancer clinical trials leading to approval from 2010 to 2022. Geetika Srivastava, e13779
Past Events
April 5: AACR Oncology Industry Partnering Event, SDCC Upper Level Room 1 – Fireside Chat with OCE Director Richard Pazdur
April 6: FDA’s Project Endpoint and Overall Survival in Oncology Clinical Trials. OCE panelist: Nicole Gormley
April 7:
- No More, No Less: Perioperative Pandemonium: Trial Designs in Solid Tumors. OCE moderator: Bernardo Haddock Lobo Goulart. OCE panelist: Harpreet Singh
- Biomarkers, Immune Monitoring, and Immune Assays. Abstract: Toward Best Practices for B-cell Receptor Repertoire Profiling. FDA presenter: Wenming Xiao
April 8
- 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
- Disparities in Pediatric Oncology. OCE panelist: Martha Donoghue
- Outcome Investigation with Real World Data. Abstract: Real World Outcomes Among Patients with Newly Diagnosed Acute Myeloid Leukemia. FDA presenter: Dianne Pulte
- In the Eye of the Beholder: Equipoise in Cancer Clinical Trials. OCE moderator: Paz Vellanki. OCE panelist: Jeevan Puthiamadathil
April 9
- Diversity Plans in Action – FDA, Industry and Community Perspectives. OCE panelist: Asma Dilawari
- Putting the Precision Back in Precision Oncology. OCE moderator: Christy Osgood. OCE panelists: Michael Fusco, Flora Mulkey.
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