FEB 24, 2016 07:00 AM PST

Precision Medicine Approaches and the Future of Drug Development in Oncology

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  • Strategic Innovation Leader, Pharma Development, Roche Diagnostics
      Tom Metcalfe joined Pharma Development (PD) Strategic Innovation as a Strategic Innovation Leader in March 2015. The Strategic Innovation group has the task of enabling PD to meet the challenges of 2020 and beyond by building innovative new skills, capabilities, processes and organizations. Tom's particular focus is on Precision Medicine. Prior to this appointment Tom worked for a year leading part of Project TRINiTY, a project within the Roche Pharma Regulatory Community in Europe. He rejoined Roche from Oncotest GmbH where he was Managing Director and co-CEO. Oncotest is a preclinical CRO which assesses the preclinical efficacy of oncology molecules using well characterized Patient Derived Tumorgrafts.

      Before this Tom spent 18 years working for Roche in a variety of functions. He joined Roche's Diagnostics business in 1993. In 1998 he was appointed Global Head of Strategic Marketing of Roche Applied Sciences. In 2001 he moved to Roche Molecular Diagnostics as Head of BD and the Clinical Genomics business. In 2004 Tom joined Roche Pharma as Global Head of the Roche Biomarker Program and from 2007 onwards became Head of Roche's Personalised Healthcare Portfolio. In 2010 Tom joined the Translational Research Sciences group of Roche's Pharma Research and Exploratory Development organization, where he was responsible for external collaborations.

      Tom studied Biochemistry at King's College, London University in 1982 and gained an MBA from the Open University, UK in 1996.

      Tom also spent 18 months between 2009 and 2011 as chair of the European Biopharmaceutical Enterprises' Task Force on Personalised Medicines.


    A number of recently publications have heralded the advent of Precision Medicine in Oncology, where next generation sequencing technology, other ’omics technologies, serial biopsies, sophisticated treatment algorithms and access to databases detailing response to therapy by molecular subtype can be applied to an individual cancer patient’s genomic profile to generate a specific “matching” cancer treatment. This matching treatment can subsequently be modified, with the help of additional biopsies and further analysis, to continue to match the cancer’s specific genomic characteristics upon disease progression.
    Many cancers with poor prognoses are characterized by high genomic heterogeneity and rapid escape from therapy. Outcomes improvements in patients suffering from these and other similar cancers will likely continue to be very difficult to achieve unless Precision Medicine approaches are applied. However, in order for the practice of Precision Medicine in Oncology to advance several major challenges must be overcome:

    1. Development of detailed standards for the identification and reporting of actionable somatic genomic variants in cancer patient samples
    2. Establishment of data repositories, adhering to actionable somatic genomic variant calling standards, for recording cancer patient responses to therapy and matching the responses to their genomic profiles
    3. Clinical validation of the algorithm generation approach
    4. Development of frameworks to allow companies to collaborate and to give treating oncologists access to a broad range of experimental medicines, allowing them to treat patients with optimal combinations
    5. Clinical programs and regulatory frameworks supporting these approaches, allowing successful approaches to be commercialized 

    Many of these challenges require broad collaborations across company and specialization boundaries to involve academics, treating clinicians, pathologists, regulators and diagnostic, pharma and IT companies. My presentation will focus on the drug development challenges which will likely follow the application of precision medicine approaches in the field of oncology.

    Learning Objectives:
    1. Understanding the impact that Next Gen. Sequencing will have on Oncology Drug Development
    2. Understanding the opportunities and challenges which are likely to arise as  consequence of the implementation of Precision Medicine approaches in Oncology.

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