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Wednesday, June 19 • 10:00am - 11:00am
#322: Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-640-L04-P; CME 1.00; RN 1.00

Precision medicine biomarker testing can be achieved in various formats, harnessing results generated in each patient's treating hospital or in centralized laboratories. We will examine resulting regulatory and technical challenges & opportunities.

Learning Objectives

Demonstrate an understanding of different testing models (central vs decentralized); Identify their regulatory consequences for clinical study conduct and approval.

Chair

Mike Wierzba, PhD

Speaker

Panelist
Oliver Stoss, PhD

Panelist
Amanda Baker, PharmD, PhD

Panelist
Ilona Reischl, PhD, MPharm

Panelist
Adriana Racolta, PhD, RAC

Panelist
Philip Kelly, PhD


Speakers
avatar for Mike Wierzba

Mike Wierzba

Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States
Mike Wierzba is a Director within the Precision Medicine & Digital Health, Global Regulatory Affairs team at GSK where he is the diagnostic regulatory lead for multiple development programs and leads efforts related to IVDR. Mike is a participant in EFPIA Precision Medicine Working... Read More →
AB

Amanda Baker

Clinical Development Lead (Director), Pathology Lab, Roche Tissue Diagnostics, United States
Dr. Baker was a faculty member at the University of Arizona for 13 years where her research focused on the characterization of biomarkers associated with stress signaling pathways activated in response to the tumor microenvironment. She also worked for 8 years as a Research Scientist... Read More →
PK

Philip Kelly

IVDR Project Manager | Assessment and Surveillance, Health Products Regulatory Authority (HPRA), Ireland
Philip Kelly serves as the IVDR Project Manager for the HPRA. In this role Philip leads work items focused on ensuring compliance with regulatory requirements and facilitating the safe and effective use of IVDs. Recently as part of the COMBINE project Philip aided in the analysis... Read More →
AR

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States
avatar for Ilona Reischl

Ilona Reischl

Biologics Quality Assessor, Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality... Read More →
avatar for Oliver Stoss

Oliver Stoss

Senior Vice President of Operations, Discovery Life Sciences Biomarker Services GmbH, Germany
Dr. Stoss is leading the clinical trial operations at Discovery Life Sciences in his function as Senior Vice President Operations. Since 2004, he served in different leadership roles in both the USA and Europe and did oversee more than 600 phase I to phase III biomarker driven clinical... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  06: TranslationalDelivery Tech-PrecMedicine, Forum