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  1. Oncology Center of Excellence

OCE at ASCO Annual Meeting 2023

FDA Oncology Center of Excellence experts will join colleagues in clinical oncology to participate in panel discussions or present research findings during the American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago and online June 2-6, 2023. All times listed are Central Daylight Time.

Saturday, June 3

1:15-4:15 pm Poster Session: Health Services Research and Quality Improvement
Title: Real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets.
Presenter: Collaborators, Friends of Cancer Research
Abstract 6595 | Poster 87
Location: Hall A

Sunday, June 4

8-11 am 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
Location: Hall A

9:45-11 am Education Session: The Future of Equitable Access to Clinical Trials
Speakers: Ana Acuña-Villaorduña, 'Lola Fashoyin-Aje, Steven D. Gore
Location: S100BC
ASCO Educational Book: Equitable Access to Clinical Trials: How Do We Achieve It?

4:15-5 pm Embracing Career Transitions and Professional Growth   
Panelist: Jennifer Gao
Location: Women’s Networking Lounge S502

Monday, June 5

8-9:15 am Educational Session: Accelerated Approvals in Oncology: Balancing Access with Evidence
Speakers: R. Angelo De Claro, Andrew James Schorr, Walid Gellad
Location: S102

8-11 am Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Location: Hall A
Title: FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma
Presenter: May Tun Saung, MD
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

9:45-11:00 am Innovative Solutions to the Challenges of Cancer Clinical Trials: FDA and NCI perspectives
Location: S100BC
Panelists: Richard Pazdur, Paul Kluetz, Monica Bertagnolli, Julie Gralow, James Doroshow, Sheila Prindiville, Michael Morris

1:15-4:15 pm Poster Session: Care Delivery and Regulatory Policy
Location: Hall A
Title: Trends in new and persistent opioid use in older adults with cancer.
Presenter: Collaborators, Yale-Mayo CERSI
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

Tuesday, June 6

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

 

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