Emerging Role of Biomarkers in Improving the Success Rate of Early Oncology Drug Development

Biomarkers, Clinical Trials, Drug Discovery and Development, Life Sciences, Pharmaceutical,
  • March 31, 2015

This webinar is intended to help Oncology drug developers explore Biomarkers in the design of clinical trials.

Many new anticancer drugs target proteins encoded by genes with driver somatic mutations, thus exhibiting efficacy only in a subgroup of patients whose tumors harbor these mutations like KRAS/EGFR and EML4-ALK mutations in NSCLC. This has resulted in changes to standard clinical trial design to include a study population with patients whose tumors carry a particular mutation, set of mutations, or other biomarkers, increasing the potential of response to targeted therapy. Quest Diagnostics will discuss current mutation testing guidelines and best practices for patients with NSCLC, compares and contrasts anaplastic lymphoma kinase (ALK) testing methodologies and discusses the advantages offered by FISH for ALK mutation status testing.

Next-generation sequencing (NGS) has numerous roles in oncology clinical trials from identification of genomic biomarkers for response and/or primary resistance and patient eligibility by diagnostic panels that aid in confirmatory diagnosis. In an unsuccessful clinical trial, NGS data can be assessed to explain unexpected clinical trial outcomes, providing insight into the mechanism of drug effect and possible reasons for intergroup differences in response rate.

One of the latest NGS applications is a patient stratification tool for AML clinical trial programs implementing new molecular markers into the diagnostic algorithms for myeloid neoplasms. This illustrates the principle of innovative molecular monitoring following treatment of AML.

Quest Diagnostics uses next-generation sequencing technologies to develop and offer molecular biomarkers as laboratory-developed tests for clinical trials to mitigate clinical drug development risks thereby improving your company’s probability of successfully developing new oncology treatments.

Keywords:

Speakers

Kamala Maddali, DVM, PhD, Director of Scientific Development, Quest Diagnostics Clinical Trials

Kamala Maddali, DVM, PhD, is Director of Scientific Development for the Clinical Trials group at Quest Diagnostics. Before joining Quest Diagnostics, she held the position of Associate Director of Biomarkers and Companion Diagnostics at Quintiles. Dr. Kamala also formerly worked as a scientist at Huntingdon Life Sciences and Merck Research Laboratories. In her current role, Maddali provides clients with technical training and education/technical support on test choices and methods as well as study protocol design and scientific consultation with Pharmaceutical researchers and scientists. Dr. Maddali is a current and active member of the AAPS Biomarkers in Translational Medicine focus group.

Arturo Anguiano, MD, FFACMG, International Medical Director – Medical Affairs, Quest Diagnostics

Arturo Anguiano, M.D., is International Medical Director – Medical Affairs. In this role, he provides medical oversight for both value creation and value delivery for International sites of Quest Diagnostics.

Dr. Anguiano joined Nichols Institute at San Juan Capistrano CA, now part of Quest Diagnostics, in December 1992. At Nichols Institute, he serves as Medical Director Cytogenetics, and Vice Chairman Genetics.

Dr. Anguiano earned his medical degree from the National Autonomous University of Mexico (UNAM). He completed two fellowships, in Clinical Molecular Genetics and Clinical Cytogenetics, at the Center for Human Genetics of the Boston University Medical Center. He is dual board certified in these specialties by the American Board of Medical Genetics and Genomics. He is a founding fellow of the American College of Medical Genetics and Genomics.

Frederick K. Racke, M.D.,Ph.D., Medical Director, Hematopathology and Coagulation, Quest Diagnostics Nichols Institute

Dr. Racke earned his MD and PhD from the Medical Scientist Training Program at Case Western Reserve University in Cleveland, OH. He completed postdoctoral training in Clinical Pathology followed by training in Hematopathology at University Hospitals of Cleveland. Dr. Racke is board certified in Clinical Pathology and Hematology. Dr. Racke was a faculty member in the Department of Pathology at Johns Hopkins University in Baltimore, MD. He served for 5 years as the co-director of the residency program in charge of the Clinical Pathology curriculum. Following his time at Johns Hopkins, Dr. Racke joined the faculty at The Ohio State University and served as director of the division of Hematopathology and director of the Hematopathology fellowship program. In addition, he served as the leukemia cadre pathology leader for CALGB clinical trial cooperative group. In addition to his clinical activities, Dr. Racke ran a research laboratory which investigated mechanisms involved in platelet production.

Who Should Attend?

This program is intended for:

  • CEO/Presidents of Oncology business units or organizations
  • Director/VPs of clinical operations, clinical trial managers
  • Chief medical and scientific officers
  • Medical science liaisons
  • Clinical development program-leaders and team members
  • R&D directors, managers in pharmaceutical and biotechnology companies
  • Clinical program managers or project managers
  • Procurement/Outsourcing managers
  • Professionals in Translational Medicine, Early Clinical Development

Xtalks Partners

Quest Diagnostics

Quest Diagnostics Clinical Trials provides laboratory solutions through unsurpassed global central laboratory and biomarker services, diagnostics and esoteric testing, anatomic pathology and research & development innovation. Quest Diagnostics Clinical trials has the scientific expertise, laboratory excellence, and global reach to support your oncology clinical program.

Backed by the world’s leading provider of diagnostic information services and leader in cancer diagnostics, Quest Diagnostics Clinical Trials offers top scientific leadership in biomarkers and companion diagnostics to guide your oncology studies to successful conclusions. Let our experience in more than 7,000 clinical trials provide you with the support and insight you need.

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