Schedule

Wednesday May 2, 2018

Thursday May 3, 2018

FridayMay 4, 2018

8:30 – 9:30 a.m.

Registration/Continental Breakfast

9:30 a.m. – 12:00 p.m

Core Curriculum

(The Core Curriculum runs concurrently to In-depth Discussion Group I. Academic scholarship recipients are required to attend. The Core Curriculum is designed for investigators with 2 years or less in drug development. Advance approval by the Workshop Administrator is needed for participation. An email will be sent regarding determination of requests.)

9:30 a.m. – 12:00 p.m.

In-Depth Discussion Groups I (Learners attend 1 from this group)

Challenges with New Clinical Trial Designs

Moderators

Industry Perspective

Panelists

Investigator Perspective

Panelists

The Investigational Review Board

Compliance

Patient Perspective

Patient Reported Outcomes (PROs) and Their Use in Cancer Drug Development

Moderators

Introduction

Panelists

What is Important to Patients?

Panelists

21st Century Cures and the Current Regulatory Landscape for PROs in Cancer

Panelists

What PRO Measures are We Reviewing?

Panelists

How do We Measure? What is a Fit Purpose Tool?

Panelists

How do We Analyze and Interpret Data?

Panelists

Discussion

Panelists

  • All Panelists

FDARA 2017 and the Future of Cancer Drug Development in Pediatrics

Moderators

Background and U.S. Regulatory Framework for New Drug Development in Pediatric Populations. BPCA and PREA – Recently Enacted Changes in Their Implementation

Panelists

Expanded Opportunities for Precision Medicine for Pediatric Medicine

Panelists

Clinical Considerations for Evaluation of Molecularly Targeted Drugs in Children

Panelists

Industry Perspective on Changes to PREA

The Impact of Precision Oncology on Health Disparities

Moderators

Patient Perspective

Access to Experimental Drugs Prior to FDA Approval

Moderators

Introduction

Aspects of the Right to Try Proposed Legislation

Panelists

The NCI MATCH Trial

Panelists

The Beat AML Program

Panelists

The Industry Experience and Perspective on Expanded Access

Single Patient Expanded Access

Panelists

10:45 – 11:15 a.m.

Break

12:00 – 1:00 p.m.

Lunch

1:00 – 3:00 p.m.

Plenary Session

Combinatorial Strategies in Immuno-oncology: Biologic Rationale, Statistical Design, and Study Conduct Challenges

Moderators

Opportunities and Challenges in Combinatorial Approaches in Immuno-oncology: Biologic Rationale and Strategy

Statistical Considerations in Study Design

Panelists

Industry Perspective

Panelists

Patient Perspective

3:00 – 3:30 p.m.

Break

3:30 – 5:30 p.m.

Case Studies I

Bavencio® (avelumab), EMD Serono

Besponsa® (inotuzumab ozogamicin), Pfizer Pharmaceuticals

Kymriah™ (tisagenlecleucel), Novartis Pharmaceuticals Corp.

Vyxeos™ (daunorubicin and cytarabine), Jazz Pharmaceuticals

Yescarta™ (axicabtagene ciloleucel), Kite Pharma

5:30 – 7:00 p.m.

Welcome Reception

8:00 – 9:00 a.m.

Continental Breakfast

8:00- 9:00 a.m.

Breakfast Discussion Groups (for Core Curriculum Attendees Only)

9:00 – 10:00 a.m.

Keynote Address

10:00 – 10:30 a.m.

Break

10:30 a.m. – 12:30 p.m.

In-Depth Discussion Group II (learners attend 1 from this group)

Opportunities and Challenges of Using Pragmatic Clinical Trials in Cancer Drug Development

Moderators

Overview of Pragmatic Clinical Trials and Their Role in Drug Development

The TAPUR Study as an Example of a Biomarker-driven Pragmatic Clinical Trial

Panelists

Considerations in Use of Pragmatic Clinical Trials to Support Regulatory Approval of New and Expanded Indications

Panelists

Sponsor Perspective on Opportunities and Challenges of Pragmatic Clinical Trials

Panelists

Patient Perspective on Opportunities and Challenges of Pragmatic Clinical Trials

Panelists

International Clinical Trials in Global Cancer Drug Development

Moderators

Panelists

Neoantigen-based Novel Cancer Therapies

Moderators

Cancer Immunoediting and Neoantigens

Neoantigen-based Peptide Vaccine

Neoantigen-based Cell Therapy

Panelists

Neoantigen Approach: Industry Perspective

Panelists

Patient Perspective

Is Collaboration on Innovation in a “Crowded” Space Feasible?

Moderators

Drug Development for Serious and Life Threatening Hematologic Diseases: A Lesson from Oncology

Moderators

12:30 – 1:30 p.m.

Lunch

1:30 – 3:30 p.m.

Case Studies II (learners attend 1 from this group)

Zejula® (niraparib), Tesaro, Inc.

Keytruda® (pembrolizumab), Merck & Co.

Bavencio® (avelumab), EMD Serono

Besponsa® (inotuzumab ozogamicin), Pfizer Pharmaceuticals

Kymriah™ (tisagenlecleucel), Novartis Pharmaceuticals Corp.

3:30 – 4:00 p.m.

Break

4:00 – 6:00 p.m.

In-Depth Discussion Group III (learners attend 1 from this group)

Approaches to Augmenting Responses to Checkpoint Inhibitors and Risk Mitigation

Moderators

Panelists

Biologic Rationale

Panelists

Clinical Issues

Biomarkers

Panelists

Patient Perspective

Expanded Eligibility Criteria for Clinical Trials

Moderators

Panelists

Patient Perspective

Panelists

Circulating Free Tumor DNA in Cancer Drug Development and Clinical Use

Moderators

Innovative Approaches to ctDNA Detection and Clinical Applications

Panelists

ctDNA in Lung Cancer Drug Development and Clinical Use

Panelists

ctDNA in Breast Cancer Drug Development and Clinical Use

Panelists

Regulatory Perspective on ctDNA Diagnostics for Oncology Applications

Panelists

Patient Perspective

Real World Data: Opportunities for Potential Drug Approval Strategies

Moderators

Bias in Real World Data

Examination of Supplemental Indication in Cardiology Using Real World Data – Lessons Learned

Examination of Time to Treatment Failure as an Endpoint in Evaluating Treatment Using Real World Data

Panelists

Estimation of Treatment Effect Using Real World Data

Panelists

Patient Perspective

Panel Discussion: Regulatory Considerations for Drug Approval Using Real World Data

Panelists

8:00 – 9:00 a.m.

Continental Breakfast

8:00 – 9:00 a.m.

Breakfast Discussion Groups (Core Curriculum attendees only)

9:00 – 11:00 a.m.

Case Studies III (learners attend 1 from this group)

Vyxeos™ (daunorubicin and cytarabine), Jazz Pharmaceuticals

Yescarta™ (axicabtagene ciloleucel), Kite Pharma

Zejula® (niraparib), Tesaro, Inc.

Keytruda® (pembrolizumab), Merck & Co.

Bavencio® (avelumab), EMD Serono

11:00 – 11:30 a.m.

Box Lunches

11:30 – 1:30 p.m.

Case Studies IV (learners attend 1 from this group)

Besponsa® (inotuzumab ozogamicin), Pfizer Pharmaceuticals

Kymriah™ (tisagenlecleucel), Novartis Pharmaceuticals Corp.

Vyxeos™ (daunorubicin and cytarabine), Jazz Pharmaceuticals

Yescarta™ (axicabtagene ciloleucel), Kite Pharma

Zejula® (niraparib), Tesaro, Inc.

1:30 p.m.

Adjourn