DIA 2016 Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-562-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, the panelists will give a state-of-the-art overview of the exciting new area of cancer immunotherapies, the current learnings and methodologies, the benefits and challenges, as well as an outlook into the future.

Part 1 is scheduled for Monday, June 27, 2016, 8:30-9:45 AM.

Learning Objectives

Discuss examples of clinical implementation of biomarkers in the development of cancer immunotherapies; Describe what the future looks like for cancer immunotherapies; Explain the role of new technologies for companion diagnostics.

Chair

Holger G. Adelmann

Speaker

Panelist
Arnold B. Gelb

Panelist
Brandon Higgs, PhD

Panelist
Marc Theoret, MD

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The historic structure of FDA is oriented around the products it regulates. Today, the treatment of many diseases involves numerous different technologies and interventions centered on providing optimal care for the patient, and a patient-centered orientation to reflect the current multimodal approach to patient care is being proposed. Cross-center Institutes of Excellence could help FDA to further advance the promotion of human health. These institutes could foster increased intellectual collaboration and a consistent FDA approach by forming teams of Agency staff with cutting-edge expertise in the treatment and prevention of specific types of diseases. Consolidating disease-oriented activities at FDA may help reduce redundancies within the current FDA Centers and better consolidate core competencies to focus on scientific advancement within the Agency and streamline processes for the review of products to treat high impact disease areas. The benefits of such a restructuring will be explored and discussed by a panel of experts.

Learning Objectives

Describe how the proposed reorganization could affect drug development and review by FDA; Discuss whether the proposed reorganization could benefit patients; Explain path forward and potential challenges associated with the proposed reorganization.

Chair

Margaret A. Anderson, MA

Speaker

Panelist
Wade Ackerman, JD

Panelist
Steven K. Galson

Panelist
Eric H. Rubin, MD

Panelist
Ellen Sigal, PhD

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This forum will identify critical issues and success factors in the evolving field of companion diagnostics, with a focus on addressing operational challenges and delivering benefits to patients through successful business partnerships.

Learning Objectives

Describe the evolving field of companion diagnostics; Identify best practices for successful collaborations between pharmaceutical and diagnostics companies.

Chair

Patrick Phillips

Speaker

Panelist
Robert Bilkovski

Panelist
Kelly R. Pitts, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

Cross-labeling poses regulatory challenges. Device and drug labeling may mention another product, but the reference is not mirrored. This session will present the challenges faced by both FDA and regulated industry to properly align labels of drugs and devices intended to be used together.

Learning Objectives

Discuss the regulatory challenges of aligning the labels of drugs and devices approved for combined use under separate applications; Explore the possible regulatory solutions to better aligning labels for drugs and devices intended to be used together; Identify the challenges misaligned labeling presents for industry, patients, health care practitioners, and regulators.

Chair

Heidi F. Gertner

Speaker

Panelist
Lene Garde Sommer

Panelist
Diane Macculloch Johnson, MS

Panelist
John Barlow Weiner, JD