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Trk 04: Preclin Transl-Early Clin Dev [clear filter]
Monday, June 27
 

8:30am EDT

#107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

A recent French clinical trial resulted in one subject dead and five with severe health problems. The panel will examine how to best understand the risks in providing feedback to address participant safety, timelines, and costs.

Learning Objectives

Working with the sponsor, identify IP risks and best understand potential adverse events/serious adverse event (AE/SAE); Formulate a process to best address participant safety; Adapt to clinical information in addressing participant safety and timelines and cost of study.

Chair

William B Smith

Speaker

Panelist
Howard Greenberg, MD

Panelist
Thijs Van Iersel, MD

Panelist
Mary L. Westrick, PhD


Chair
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →

Speakers
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →
avatar for Mattheus Van Iersel

Mattheus Van Iersel

Senior Director, Scientific Affairs - Clinical Pharmacology, PRA Health Sciences
Dr van Iersel is an MD with 25 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Researcher at Urology and as Principal Investigator, Medical... Read More →
avatar for Mary Westrick

Mary Westrick

Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Forum

10:45am EDT

#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 EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Forum |   Trk 04: Preclin Transl-Early Clin Dev, Forum
 
Thursday, June 30
 

10:45am EDT

#405: Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

A moderated panel of phase 1 clinical research experts, representing sponsor, CRO and site perspectives, will identify and discuss several hot button issues that can provoke conflict between sponsors and sites or diminish conduct efficiency. Attendees will be invited to join in.

Learning Objectives

Recognize issues that can provoke sponsor/site conflict or diminish conduct efficiency when they arise in the course of preparing to conduct or conducting phase 1 studies; Discuss how to handle such issues with counterparts when they arise; Describe ways to formulate/negotiate when issues resolution.

Chair

Gary L. Steinman, MS

Speaker

Tales from the Front Lines: An Introduction
Gary L. Steinman, MS

Panelist
William B Smith

Panelist
Mary L. Westrick, PhD


Chair
avatar for Gary Steinman

Gary Steinman

President, Medexetech
Gary Steinman has degrees in Electrical & Systems Engineering from RPI where he also served on the faculty and as Director of the Center for Biomedical Engineering. He then joined the Stanford Cardiology Division, launched Pharmiya Medical Technologies in the People’s Republic of... Read More →

Speakers
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →
avatar for Mary Westrick

Mary Westrick

Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology... Read More →

Thursday June 30, 2016 10:45am - 12:00pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Forum