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#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics
Monday June 15, 2026 11:00am - 12:15pm EDT
116
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-516-L04-P; CME 1.25; RN 1.25

In this session, we will address the challenges of conducting clinical research in Europe under IVDR and CTR, and explore stakeholder-proposed solutions. We will also discuss the evolving regulatory landscape for combined clinical trials.

Learning Objectives

Explain the key principles involved in biomarker-driven approvals; Describe the role of in vitro diagnostics; Identify the types of detailed information required in applications to meet regulatory expectations for biomarker-guided medicinal products.

Chair

Ana Trullas, PHARMD, MSC

Speaker

Building Bridges, Not Silos: Lilly's IVDR-Driven Transformation
Lauren Tobe, JD

tbd. In vitro biomarker tests for patient selection for efficacy
Martin Mengel

Companion Diagnostics and Medicinal Products: A notified Body perspective on Co-development under IVDR
Rolf Thermann, PHD

Combined studies in the EU- overview and considerations for industry
Joshua D Levin, MA


Speakers
avatar for Joshua Levin

Joshua Levin

Director, Global Regulatory Affairs, Precision Medicine and Digital Health, GSK, United States
MM

Martin Mengel

Federal Institute for Drugs and Medical Devices, Germany
avatar for Rolf Thermann

Rolf Thermann

Section Manager IVD, Companion Diagnostics lead, TÜV Rheinland, Germany
Rolf Thermann is currently Auditor and Technical Expert with a focus on Companion Diagnostics at TÜV Rheinland LGA Products GmbH. Before joining TÜV Rheinland in 2018 he worked in the Pharmaceutical Industry involved in Antiviral Drug Discovery and as a Head of Product Development... Read More →
avatar for Lauren Tobe

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →
avatar for Ana Trullas

Ana Trullas

Senior scientific specialist, European Medicines Agency, Netherlands
Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

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