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Program

Program Schedule

Workshop participants are required to attend the entire program and must attend all Lecture Sessions. Participants must arrive at the Vail Mountain Marriott Resort no later than 4:00 p.m. on Saturday, July 29 (Vail is approximately 2-3 hours from Denver International Airport). The Workshop will begin promptly at 5:00 pm. A closing reception and banquet will be held on Thursday evening, August 3, after the last Workshop assignment is due. Departure is on Friday morning, August 4.

Program is subject to change.


SATURDAY, JULY 29

Shuttles from Denver International Airport (11:30 am-2:00 pm / 12:30 pm-3:00 pm / 1:15 pm-3:45 pm)

Registration (1:30 pm-6:00 pm)

Welcome/Overview (5:00 pm-5:30 pm)

Protocol Development Group Session 1 / Buffet Dinner (5:30 pm-8:30 pm)


SUNDAY, JULY 30

Breakfast (7:00 am-8:00 am)

Lecture Session 1 (8:00 am-10:40 am)
: Clinical Trial Design: Asking Important Questions that Impact Our Patients - Jyoti D. Patel
: Answering Important Questions: From Hypothesis to Analysis - Meredith M. Regan
: Phase 1 Trial Questions - Patricia M. LoRusso
: Phase 1 Trial Designs - Thomas Braun
: Phase 2 Trial Questions/Objectives - George W. Sledge, Jr.
: Phase 2 Trial Designs - Elizabeth S. Garrett-Mayer

Break (10:40 am-11:00 am)

Lecture Session 2 (11:00 am-12:30 pm)
: Practical Aspects of Asking Good Questions - Michael A. Carducci
: Dose Selection for Oncology Drug Development - Tatiana M. Prowell and Chris H. Takimoto
: Combination and Multimodality Trials: Many Variables but One Question - Karyn A. Goodman and Stuart G. Lutzker

Protocol Development Group 2 / Lunch (12:30 pm-3:45 pm)

Independent Study Time (3:45 pm-7:30 pm)

Office Hours 1 (Biostatisticians Only) (3:45 pm-6:30 pm)

ASSIGNMENT DUE: PROTOCOL SYNOPSIS SHEETS [Background, Objectives, Endpoints, etc.] (7:30 pm)

Dinner (7:30 pm-9:30 pm)


MONDAY, JULY 31

Breakfast (7:00 am-8:00 am)

Lecture Session 3 (8:00 am-10:00 am)
: Feasibility and Reproducibility in Biomarker Studies - Kurt A. Schalper
: Incorporation of Biological Correlative Studies into Early Clinical Trials - Patricia M. LoRusso
: Statistical Aspects of Correlative Studies - Wendy B. London
: Panel Discussion / Q&A - Wendy B. London, Patricia M. LoRusso, Kurt A. Schalper, and Kay F. Kays

Break (10:00 am-10:15 am)

Lecture Session 4 (10:15 am-11:45 am)
: Imaging in the Era of Targeted Therapy and Immunotherapy - Terence Z. Wong
: Special Considerations in the Design of Immunotherapy Studies - Roy S. Herbst
: Inflammatory and Immunologic Biomarkers - Mary L. Disis
: Panel Discussion / Q&A - Mary L. Disis, Roy S. Herbst, Terence Z. Wong, and Katherine Panageas

Protocol Development Group Session 3 / Lunch (11:45 am-3:00 pm)

Office Hours 2: Protocol Related Questions (3:15 pm-5:15 pm)

Independent Study Time / Dinner (5:15 pm-8:30 pm)

ASSIGNMENT DUE: STATISTICAL SECTION (8:30 pm)


TUESDAY, AUGUST 1

Breakfast (7:00 am-8:00 am)

Small Group Discussion Sessions 1-2 (8:00 am-9:00 am)
: First in Human Trials: Understanding the Regulatory Process - Tatiana M. Prowell and Chris H. Takimoto
: Written and Oral Research Presentations That Audiences Remember - Roy S. Herbst and George W. Sledge, Jr.

Small Groups Discussion Sessions 3-4 (9:15 am-10:15 am)
: Defining, Identifying, and Knowing Your Trial’s Clinical Endpoints - Motomi Mori and Walter M. Stadler
: Visual Display of Data - Michael A. Carducci and Sean M. Devlin

Break / Group Photo (10:20 am-10:40 am)

Small Group Discussion Sessions 5-7 (10:40 am-11:40 am)
: Imaging Endpoints - Terence Z. Wong
: Laboratory Correlates - S. Percy Ivy, Wendy B. London, and Kurt A. Schalper
: Molecular Medicine / Selection Eligibility - Edward Chu and Mary W. Redman

Lunch (11:40 am-12:40 pm)

Lecture Session 5 (12:40 pm-1:55 pm)
: Navigating the National Clinical Trials Network - Neal J. Meropol
: Patient-Reported Outcomes - Christopher R. Flowers
: Barriers to Accrual and How to Overcome Them - Carole L. Baas and Neal J. Meropol

Protocol Development Group Session 4 (2:00 pm-4:00 pm)

Independent Study Time/Dinner on Own (4:00 pm-8:30 pm)

Optional Career Sessions (4:15 pm-5:00 pm)
: Careers in Government - S. Percy Ivy and Tatiana M. Prowell
: Careers in Industry - Michael T. Lotze, Stuart G. Lutzker, and Chris H. Takimoto
: Careers in Radiation Oncology - Karyn A. Goodman and Christopher G. Willett
: Working with Patient Advocates - Carole L. Baas, Everett E. Dodson, Kay F. Kays, Pamela R. Moffitt, Laurel Pracht, and Virgil H. Simons

ASSIGNMENT DUE: PROTOCOL DRAFTS (8:30 pm)


WEDNESDAY, AUGUST 2

Breakfast (7:00 am-8:00 am)

Lecture Session 6 (8:00 am-10:00 am)
: Everything You Need to Know About Clinical Trial Ethics and Informed Consent: A Case Study - Jyoti D. Patel, George W. Sledge, Jr., Kay F. Kays, and Pamela R. Moffitt
: You’re In Charge: Investigator Responsibilities - Alex A. Adjei
: Data Collection: It’s All In the Data - Katherine Panageas

Break (10:00 am-10:15 am)

Lecture Session 7 (10:15 am-11:15 am)
: Special Populations in Clinical Trials - Everett E. Dodson, Stuart M. Lichtman, and Franklin O. Smith, III

Protocol Development Group Session 5 (11:15 am-12:45 pm)

Lunch (12:45 pm-1:30 pm)

Office Hours 3 (1:30 pm-3:30 pm)

Independent Study Time/Dinner on own (3:30 pm-8:00 pm)

Optional Networking Session: Women in Academia (4:30 pm-5:30 pm)

ASSIGNMENT DUE: INFORMED CONSENT DOCUMENTS (8:00 pm)


THURSDAY, AUGUST 3

Breakfast (7:00 am-8:00 am)

Special Interest Sessions (8:00 am-9:00 am)
: Taking Your Product to Clinic - Stuart G. Lutzker and Chris H. Takimoto
: Palliative Care and Quality of Life - Stuart M. Lichtman and Laurel Pracht
: Considerations in Design of Trials with Longer Survival: Pediatric and Survivorship Perspective - Rochelle Bagatell, Ralph D’Agostino, and Virgil H. Simons
: Multi-institutional Trials - Tracy T. Batchelor and Gina R. Petroni

Lecture Session 8 (9:05 am-11:05 am)
: Career Development Opportunities: The Government Can Help - Jonathan S. Wiest
: Successful Grantsmanship - Mary L. Disis
: Special Lecture from Workshop Founder: Deep Learning - Daniel D. Von Hoff

Protocol Development Group Session 6 (11:05 am-12:30 pm)

Administration of Post-test (12:40 pm-1:30 pm)

Independent Study Time / Lunch (1:30 pm-7:00 pm)

ASSIGNMENT DUE: FINAL PROTOCOLS, INFORMED CONSENT FORMS, and ALL WORKSHOP EVALUATIONS (7:00 pm)

Closing Reception / Banquet / Dance (7:00 pm-11:00 pm)


FRIDAY, AUGUST 4

Continental Breakfast (5:00 am-8:00 am)

Departure (6:00 am-8:30 am / 7:15 am-9:45 am / 10:00 am-12:30 pm)

Comments from 2016 Workshop Participants:


"Thank you for allowing me to participate in the wonderful experience of this workshop, I learned so much and know this will serve me for my entire career."

"I want to sincerely thank you all for your outstanding mentorship during this Workshop.I have learned so much from you and greatly appreciate your dedication in helping me to improve my protocol/IC. This invaluable experience is something I will carry forward in my career as a clinical investigator."

"I think I speak on behalf of all of us in saying that it was so helpful to step outside our comfort zones and be challenged to discuss our projects and incorporate ideas and advice from an entirely new group of "collaborators."

"THANK YOU FOR THIS WEEK! The best learning experience of my fellowship so far."

"I am surprised by how much I was able to accomplish in such a short but focused time. Many thanks for each and every one of you for their dedication, teaching, (and) mentoring during this amazing course. I learned a lot, and I am sure that this experience will transform my career."

"This was easily one of the most valuable experiences I have had in my training. Thanks for all of your energy and enthusiasm!"

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