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  1. Oncology Center of Excellence

FDA Oncology Center of Excellence Sessions at ASCO 2017

Thursday, June 1, 2017

Preconference: The Economics of Cancer Care, Session 2: Big Data in Oncology (12:30-5 pm, S102)
3:10 to 5:00 pm: Information Exchange and Data Transformation (INFORMED) - Sean Khozin, MD, MPH

Friday, June 2, 2017

Extended Education Session: Moving Beyond the Randomized Controlled Trial: Real World Data to Inform Patient Care and Policy (1-3:15 pm, S504)
1:20-1:40 pm: The FDA Perspective on Real-World Data - Sean Khozin, MD, MPH

Saturday June 3, 2017

Women's Networking Center (S502)
11:30 am-12:15 pm: Lost in Transition: Mid-Career Planning - Tatiana Prowell, MD

Education Session: Best Practices for Clinical Research (1:15-2:30 pm, S404)
1:35-1:55: FDA Perspective on Safety Reporting of Serious Adverse Events - Meredith Kathleen Chuk, MD

Education Session: ASCO/AACR Joint Session: Liquid Biopsies (3-4:30 pm, S406)
3:50-4:10 pm: FDA Perspective - Reena Philip, PhD

Sunday June 4, 2017

Education Session: Strategies to Maximize Patient Participation in Clinical Trials (8-9:15 am, S404)
8-8:20 am: Modernizing Eligibility Criteria for Clinical trials: ASCO-FDA-FOCR Perspective - Julia Beaver, MD-Chair

Trainee & Early Career Oncologist Member Lounge (S501)
10:15-11 am: Career Transitions in Government - Tatiana Prowell, MD

Monday June 5, 2017

Poster Discussion Session: Developmental Therapeutics-Immunotherapy (8-11:30 am, Hall D1)
4:45-6 pm: FDA analysis of patients with baseline autoimmune diseases treated with PD-1/PD-L1 immunotherapy agents - Chana Weinstock, M.D. - First Author

Clinical Science Symposium: Opportunities to Improve Care For Older Adults With Cancer: Clinical Trials Implementation and Survivorship (1:15-2:45 pm, S102)
1:15-1:27 pm: FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the US food and Drug Administration - Harpreet Singh, MD - First Author

Tuesday, June 6, 2017

Education Session: Tumor-Agnostic Drug Approvals: In The Distant Future or Already Here? (9:45-11 am, S406)
9:45-10:05 am: Regulatory Considerations Regarding Tissue Agnostic Development - Steven J. Lemery, MD, MHS – Chair

Posters and Abstracts

Saturday, June 3, 2017 - Monday, June 5, 2017
Day|Date TimeAuthorsTitleCategory/Sub-CategoryLocation Board #
Saturday
6/3/2017
1:15-4:45PM

 

Sean Khozin, MD, MPH
First Author
Rates of PD-L1 expression testing in U.S. community-based oncology practices (USCPs) for patients with metastatic non-small cell lung cancer (mNSCLC) receiving nivolumab (N) or pembrolizumab (P).
Abstract 11596
 
Tumor BiologyHall A Board # 296
 
Monday
6/5/2017
8:00-11:30AM

 

Chana Weinstock, MD
First Author
FDA analysis of patients with baseline autoimmune diseases treated with PD-1/PD-L1 immunotherapy agents.
Abstract 3018
Developmental Therapeutics-ImmunotherapyHall A Board # 113
 
Monday
6/5/2017
8:00-11:30AM

 

Bindu Kanapuru, MD, MBBS
First Author
FDA analysis of patient enrollment by region in clinical trials for approved oncological indications.  
Abstract 2539
Developmental Therapeutics - Clinical Pharmacology and Experimental TherapeuticsHall A Board # 31
Monday
6/5/2017
8:00-11:30AM

 

Marie-Ann Damiette Smit, MD
First Author
FDA analysis of grade 3-4 safety events.
Abstract 2544
Developmental Therapeutics - Clinical Pharmacology and Experimental TherapeuticsHall A Board # 36
 
Monday
6/5/2017
8:00-11:30AM

 

Nicole Gormley, MD
First Author
FDA analysis of MRD data in hematologic malignancy applications.
Abstract 2541
Developmental Therapeutics - Clinical Pharmacology and Experimental TherapeuticsHall A Board # 33
 
Monday
6/5/2017
1:15-1:27PM

 

Harpreet Singh, MD
First Author
FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the US food and Drug Administration.
Abstract 10009
Clinical Science Symposium Session-Opportunities to Improve Care for Older Adults with Cancer: Clinical Trials, Implementation, and SurvivorshipS102