New Drugs in Oncology

May 31 from 12:30 PM-5:00 PM and June 1 from 7:30 AM-11:00 AM
McCormick Place, Room S100a

Seminar Description

The New Drugs in Oncology Seminar focuses on the theoretical and practical aspects of both recently approved drugs and those on their way to approval. Topics covered include clinical trial design, mechanisms of action, administration, toxicity and side-effect management, and use in the clinic.

This seminar is approved for physician and pharmacist credits. Additional information regarding CE credits is listed below.

Seminar Agenda

Note: Session faculty will be added to the agenda below as presenters are confirmed.

Day 1: Thursday, May 31, 2018: 12:30 PM to 5:00 PM

12:30 PM - 1:00 PM Lunch
1:00 PM - 2:15 PM

Session 1: Tissue Agnostic Drug Development

Shivaani Kummar, MD, FACP—Chair
Stanford University Medical Center


Steven Lemery, MD, MHS
U.S. Food and Drug Administration
Tissue Agnostic Approval—Are They Any Different From Regular Approval?


Keith Flaherty, MD
Massachusetts General Hospital
Tissue Agnostic Drug Development—Operational and Scientific Challenges


MSI- High/MMR-Deficient Cancers as a Tissue-Agnostic Therapeutic Target


David S. Hong, MD
University of Texas MD Anderson Cancer Center
NTRK as a Tissue-Agnostic Therapeutic Target: An Orphan Drug Target


Panel Question and Answer

2:15 PM - 2:30 PM Break
2:30 PM - 3:45 PM

Session 2: Shepherding Cell Based Cancer Therapeutics Toward Approval

Howard L. McLeod, PharmD—Chair
H. Lee Moffitt Cancer Center & Research Institute


Najat Bouchkouj, MD
U.S. Food and Drug Administration
Biology and Challenges From A Regulatory and Investigator Standpoint


Marcela Maus, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
The Academic Experience—Shepherding Development Out of the Labs


Bruce Levine, PhD
Abramson Cancer Center of the University of Pennsylvania
The Difficulties of Getting a New Cell-Based Therapy Into Clinical Development


Terry Fry, MD
National Cancer Institute
The Roadmap of Cell Based Therapies


Panel Question and Answer

3:45 PM - 5:00 PM

Session 3: Continuous Evolution of a Phase I Trial Into An FDA Package

Ashley Ward, MD—Chair
U.S. Food and Drug Administration


Alice T. Shaw, MD, PhD
Massachusetts General Hospital
Lessons Learned From the Rapid Development of ALK Inhibitors


Accelerated Approval of Nivolumab in HCC Based on Phase I Subgroup Data


Matt D. Galsky, MD
Icahn School of Medicine at Moutn Sinai
Is There A Difference In PD-1/PD-L1 Inhibitors for Urothelial Cancer?


FDA Recommendations for Seamless Drug Development


Panel Question and Answer


Day 2: Friday, June 1, 2018: 7:00 AM - 11:00 AM

7:00 AM - 7:30 AM Breakfast
7:30 AM - 8:00 AM

Keynote Lecture: Next Generation Sequencing—Drug Development and Drug Treatment


Roger D. Klein, MD
Cleveland Clinic
The New Era of Drug Development in the Clinic


Panel Question and Answer

8:00 AM - 11:00 AM Session 4: FDA Approvals and Their Incorporation Into Clinical Practice
*Note: To ensure that the session features the most recent and impactful information, the novel agents being discussed in the session will be added to the agenda closer to the meeting.


Seminar Committee

View Seminar Committee Disclosures

George W. Sledge, MD, FASCO​ (Co-Chair)​
Stanford University Medical Center

Howard McLeod, PharmD (Co-Chair)​
H. Lee Moffitt Cancer Center and Research Institute

Howard A. Burris, MD, FASCO​
Sarah Cannon Research Institute

Shivaani Kummar, MD, FACP
Stanford University Medical Center

Patricia LoRusso, DO
Yale University

William Sellers, MD
Broad Institute of MIT and Harvard

Anthony W. Tolcher, MD 
The START Center for Cancer Care

Ashley Ward, MD
Food and Drug Administration


In support of improving patient care, the American Society of Clinical Oncology is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Target Audience

The 2018 New Drugs in Oncology Seminar is designed for the cancer care team; credit is offered for physicians and pharmacists, but all are encouraged to participate, as they may be able to apply for credit through their own licensing organization.

Disclaimer/Unlabeled Usage Statement         

The information presented is that of the contributing authors and does not necessarily represent the views of the American Society of Clinical Oncology and/or any named commercial entity providing financial support. Specific therapies discussed may not be approved and/or specified for use as indicated. Therefore, before prescribing any medication, please review the complete prescribing information including indications, contraindications, warnings, precautions and adverse effects.