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Trk 09: Med Devices-InVitro-CombProd [clear filter]
Monday, June 27
 

10:45am

#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
Limited Capacity seats available

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



Chair
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association... Read More →

Speakers
avatar for Arnold Gelb

Arnold Gelb

Senior Director, Clinical Biomarkers and Companion Diagnostics, EMD Serono Research & Development Institute, Inc.
avatar for Brandon Higgs

Brandon Higgs

Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and... Read More →
MT

Marc Theoret

Associate Director of Immunotherapeutics, OHOP, OND, CDER, FDA
Dr. Theoret is a medical oncologist and the Associate Director of Immunotherapeutics in the Office of Hematology and Oncology Products, CDER, FDA. In his role as Associate Director, Dr. Theoret is leading initiatives in immuno-oncology product development—regulatory, scientific... Read More →


Monday June 27, 2016 10:45am - 12:00pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

4:00pm

#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
Limited Capacity seats available

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



Chair
avatar for Margaret Anderson

Margaret Anderson

Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration... Read More →

Speakers
avatar for Wade Ackerman

Wade Ackerman

Former Senior FDA Counsel for the Senate HELP Committee, NA
Wade Ackerman recently served as Senior FDA Counsel for Ranking Member Patty Murray on the US Senate Committee on Health, Education, Labor and Pensions (HELP) where he handled issues related to pharmaceuticals, medical devices, animal products, cosmetics, and other FDA-related areas... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
ER

Eric Rubin

Vice President and Therapeutic Area Head, Merck Research Laboratories
ES

Ellen Sigal

Chairperson and Founder, Friends of Cancer Research
Dr. Ellen Sigal has been a devoted patient advocate and stanch supporter of cancer research. She founded Friends of Cancer Research in 1996 to mark the anniversary of the National Cancer Act. Friends is a cancer research think tank and advocacy organization based in the Washington... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

2:00pm

#344: Companion Diagnostics: Driving New Business Models for Successful Outcomes
Limited Capacity seats available

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



Chair
avatar for Patrick Phillips

Patrick Phillips

Chief Executive Officer, Health Decisions, Inc.
Dr. Phillips is an experienced and respected clinical development executive and industry leader. He is responsible for executive oversight and strategic leadership of Health Decisions. Before his appointment as CEO, Dr. Phillips served for over two years as Health Decisions’ Vice... Read More →

Speakers
avatar for Robert Bilkovski

Robert Bilkovski

Head, Medical and Clinical Affairs, Abbott Molecular
Following medical school (Rosalind Franklin Univ/Chicago Medical School), Dr. Bilkovski focused on research in sepsis and noninvasive hemodynamic management. After 5 years, he identified his zeal for entrepreneurship and pursued his MBA (Notre Dame). His primary focus has been in... Read More →
avatar for Kelly Pitts

Kelly Pitts

Vice President, Research & Development, Site Manager - Colorado Operations, Corgenix, Inc.
Kelly R. Pitts, PhD is Vice President of R&D at Corgenix, Inc., an IVD company specializing in cardiovascular, autoimmune, and companion diagnostics. He previously held leadership positions at Myogen, Gilead Sciences, and Amgen, focused on drug discovery, development, and commercialization... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?
Limited Capacity seats available

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



Chair
avatar for Heidi Gertner

Heidi Gertner

Partner, Hogan Lovells US LLP
Heidi Gertner is a partner at Hogan Lovells in their drug regulatory group. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at NIH. Heidi then worked at the FDA's Office of Chief... Read More →

Speakers
avatar for Diane Johnson

Diane Johnson

Senior Director, North American Regulatory Affairs Policy and Intelligence, Johnson & Johnson
Diane is responsible for providing key strategic direction and regulatory intelligence across the North America device sector. Supports shaping of growth plans by translating the impact of regulatory environmental changes/trends on Strategic Business Plans. 20yrs of experience in... Read More →
avatar for Lene Sommer

Lene Sommer

Vice President, RA Devices, Novo Nordisk A/S
VP of Regulatory Affairs Devices at Novo Nordisk A/S. Responsible for regulatory strategies for development of devices as well as maintenance of devices on the market. She has more than 18 years of experience in the world of pharmaceuticals (medical devices). She has wide experience... Read More →
avatar for John Weiner

John Weiner

Associate Director for Policy, FDA
John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA