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Tuesday, June 26 • 10:30am - 11:45am
#234: Personalized Medicine Approaches During Early-Phase Clinical Research

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-578-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recent advances in molecular screening, gene sequencing and microarray technology have not only accelerated the identification of novel biomarkers, but are also rapidly revolutionizing the field of personalized medicine, particularly in the oncology arena. As an example, next-generation sequencing is routinely used in early-phase clinical research for the detection of genetic mutations that are associated with disease. Using these novel methodologies, potentially significant mutations and biomarkers can be distinguished from those that are less likely to be significant at an early stage of development. Specifically, this session will discuss some of the novel approaches currently being used to identify and qualify novel biomarkers for tumor targeting and efficacy. Case examples highlighting the clinical use of novel biomarkers will also be presented. Finally, a number of the regulatory concerns and challenges in leveraging novel biomarker technology for early clinical development will also be discussed.

Learning Objectives

Identify cutting-edge methods for shifting through genomic data to identify mutations that have the most potential for clinical significance; Describe some real-word applications of biomarker technology in early clinical development; Discuss the regulatory implications of utilizing biomarkers in drug development.


David J. Pepperl, PhD


From PDX to the Clinic: A Biomarker Story
Pavan Kumar, PhD

Regulatory Considerations for Companion Diagnostic Development
Sabah Malek

Biomarkers as an Integral Part of Modern Drug Discovery and Development
Jannik N. Andersen

avatar for Jannik N. Andersen

Jannik N. Andersen

Vice President, Head of Research, Xios Therapeutics
Jannik has multidisciplinary background in chemical engineering (M.Sc) and human biology (Ph.D). He has spent his professional career working in drug discovery in pharma (Novo Nordisk & Merck), Biotech (XTuit Pharmacuticals & Xios Therapeutics) and at leading university hospitals... Read More →

Pavan Kumar

Director of Biomarkers and Companion Diagnostics, H3 Biomedicine, Inc.
Pavan has been part of the Biomarkers and Diagnostics industry for over 10 years, and is currently responsible for development and execution of clinical biomarker and translation strategies for multiple oncology programs, with special emphasis on liquid biopsies and multiplexed biomarker... Read More →
avatar for Sabah Malek

Sabah Malek

Director, Regulatory Affairs, Oncology Business Group, Eisai Inc.
Within Eisai, Sabah’s responsibilities include developing and delivering effective regulatory strategies to support development of therapeutics, especially those utilizing biomarkers or companion diagnostics (CDx) and managing global regulatory submissions. Prior to this, Sabah... Read More →
avatar for David Pepperl

David Pepperl

Senior Consultant and Nonclinical Group Leader, Biologics Consulting
Dr. David Pepperl is a Sr. Consultant and nonclinical group leader at Biologics Consulting in Alexandria, VA, and has 20 years’ experience in nonclinical development of drugs and biologics. With a background in both pharmacology/toxicology and cell and molecular biology, Dr. Pepperl... Read More →

Tuesday June 26, 2018 10:30am - 11:45am EDT
Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: PreClin Dev-EarlyPhaseCR, Session