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 Hematology
San Diego Convention Center (SDCC), December 7-10, 2024.
Dec. 6
- 12-5 pm PST - Come visit the FDA Blood Booth! ASH-A-Palooza, Gaslamp Quarter, 5th and K Street entrance.
- 1:30-2, 2:40-3:10, 3:20-3:50 pm PST: Blood Buddies one-on-one mentoring with FDA Staff. ASH-A-Palooza.
- 4:02-4:55 pm PST: Scientific Workshop: Decentralized Clinical Trial/Pragmatic Results and Practice Change: Reality or Optimism? SDCC Room 4. Presenter: Kelly J. Norsworthy
Dec. 7
- 11:15 am-12:15 pm PST - Career Development Lunch, Government Careers (FDA) Table. Grand Hyatt - Coronado Ballroom
- 4-5:30 pm PST – Oral Presentation, Session 902, Paper 0387: Feasibility of Multi-Model Physical Function Data Collection to Assess Treatment Tolerability in Patients with Lymphoma. SDCC Room 6B. Paul Kluetz and Vishal Bhatnagar, co-authors.
- 5:30-7:30 pm PST – Poster Sessions in SDCC Halls G-H
- Paper 1829: Response Rate, Event-Free Survival, and Overall Survival in Higher-Risk Myelodysplastic Syndromes: U.S. Food and Drug Administration Trial-Level and Patient-Level Analyses. Nina Kim and Xin Wang
- Paper 1907: Novel T-Cell Receptor Signature Linked to Plasma Cell Dyscrasias. Yong Zhang
- Paper 2416: FDA Analysis of Enrollment of Pediatric and AYA Patients in Clinical Trials by Race and Ethnicity. Ashley Woods
Dec. 8
6:00-8:00 pm PST – Poster Session – Paper 3806: FDA Analysis of Race and Ethnic Enrollment of Clinical Trials for Drug Registration in Adult Patients for Leukemia and Myelodysplastic Syndrome. Ashley Woods
Dec. 9
10:30 am -12:00 pm PST – ASH-FDA Joint Symposium on Late-Breaking Drug Approvals I. Advancing Drug Development for Hematologic Malignancies. SDCC Room 11
4:30-6 pm PST – ASH-FDA Joint Symposium on Late-Breaking Drug Approvals II. SDCC Room 7
San Antonio Breast Cancer Symposium
Henry B. Gonzalez Convention Center, Dec. 10-13, 2024.
Dec. 10
12-1:45 pm CT: FDA Special Session: New Drug Approvals. Location: Stars at Night 3-4. Laleh Amiri-Kordestani, co-moderator.
- Adjuvant Ribociclib: Presenter Jennifer Gao; panelists: Mallorie Fiero, Tiffany Ricks
- Inavolisib Approval: Presenter: Suparna Wedam; panelist: Mallorie Fiero
- Ovarian Toxicity: Panelist: Suparna Wedam
2-3:45 pm CT: Clinical Workshop: Dose Optimization in Breast Medical Oncology. Location: Stars at Night 1-2. Mirat Shah and Stacy Shord, moderators. Mallorie Fiero, presenter.
2:30-4 pm CT: Career Development: Patient-Driven Protocol Development. Location: Stars at Night 3-4. Designing patient-centric clinical trials: Presenter: Tatiana Prowell
Dec 11
5:30-7 pm CT: Poster Session 2, Halls 2-3 (P2-09-19). Efficacy of cyclin-dependent kinase 4/6 inhibitor + endocrine therapy in patients w/ hormone receptor-positive, HER2-negative advanced or metastatic breast cancer w/ liver or lung only metastases: a US Food & Drug Administration pooled analysis. Raissa Kentsa and Jennifer Gao.
Dec 13
12:30-2 pm CT: The Pathologists Conundrum: IHC Testing in Breast Cancer. Location: Room 221ABC. FDA Perspectives on IHC testing in breast cancer drug development: Reena Philip
Past Events
May 31
- Women's Networking Center (Room S502 MPCC)—Women Supporting Women: The Art of Mentorship, Sponsorship, and Allyship. OCE panelist: Laleh Amiri-Kordestani.
- 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).
June 2
- 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). ASCO Educational Book article: Moving Immunotherapy Into the Treatment of Resectable Non–Small Cell Lung Cancer.
June 3:
- 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
- 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
- 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
- Solving Decades of Drug Shortages in Oncology: What, Who and When? FDA Commissioner Robert Califf (panelist).
- ASCO 2024 FDA Special Session: Improving Global Access to Cancer Therapies Through Regulatory Authority Collaboration. Richard Pazdur (moderator), Angelo de Claro (presentation and panelist).
- Poster Session, Medical Education and Professional Development - Formation and Evaluation of the ASCO Medical Education Community of Practice (Med Ed CoP). Jennifer Gao (co-author), Abstract 9022
- 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
- Careers in Oncology: Government & Industry. Trainee & Early Career Lounge, Hall C. Geetika Srivastava.
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
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