Companion Diagnostics is becoming a major source of revenue for diagnostics industry. However, it is facing an assemblage of challenges that require collaborative and synergetic work of all the stakeholders. Our Fifth Annual Companion Diagnostics: Strategy & Partnerships conference is designed to facilitate the knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine.
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TUESDAY, AUGUST 19
7:30 am Main Conference Registration & Morning Coffee
8:30 Chairperson’s Opening Remarks
Mitch Raponi, Clovis Oncology
8:40 15 Years of Personalized Medicine in Patient Care: Past, Present and Future
Eric Lai, Ph.D., Senior Vice President & Head, Pharmacogenomics, Takeda Pharmaceuticals
Despite the complete sequencing of the Human Genome and the development of new molecular technologies, especially high-throughput DNA sequencing, the clinical application of personalized medicine is still limited. This presentation will discuss other potential ways of applying pharmacogenomics to drug development and the use of big research datasets to address unmet medical needs and patient stratification strategies for personalized medicine.
9:10 Challenges in Developing Companion Diagnostics with the Complexity of Cancer: Is NGS Assay a Solution?
J. Carl Barrett, Ph.D., Vice President, Translational Sciences, Onc iMed, AstraZeneca
Limitations of tissue and heterogeneity of cancers are both addressed by using NGS to interrogate cancers and select appropriate targeted therapies. Using NGS as a diagnostic however requires a better understanding of the challenges of NGS including target capture, sequencing platforms, variant calling and variant classification. The potential and pitfalls of NGS in clinical trials and diagnostic development will be discussed and illustrated.
9:40 Enabling Precision Medicine in the Age of Big Data
Mick Correll, COO, GenoSpace
Built on a secure, cloud-based infrastructure and using advanced analytical tools, GenoSpace has created a system enabling precision medicine application in research, in the practice of clinical medicine, and in support of patients and patient communities.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
11:00 International Case Study: Brazilian Strategy to Improve Access to Molecular Testing in Oncology - Building a Local Companion Diagnostics Platform
Carlos Gil Ferreira, M.D., Executive Director, INOVA-CANCER; Director, Clinical Research, Brazilian National Cancer Institute
In order to increase the access to high quality molecular testing in oncology, the Ministry of Health has launched a program that aims to develop the industry of companion diagnostics in the country. To that end partnerships between academia, pharma and diagnostic companies, regulatory agencies and government are being built.
11:30 HECON of Personalized Medicine
Nick Poulios, Ph.D., Head, MORE, Medical Outcomes: Reimbursement & Economics, Roche Molecular Systems, Inc.
This presentation will discuss health economics of personalized medicine in general and market access and reimbursement of companion diagnostics in particular.
12:00 pm Cancer Diagnostics in the Genomic Era
Daniel S. Grosu, M.D., MBA, Vice President, Clinical Development & Medical Affairs, Illumina, Inc.
The rapid evolution of high-accuracy and high-throughput genomic technologies has created unprecedented opportunities for translational and clinical applications in cancer. Next generation sequencing approaches now allow the interrogation of germline and somatic variation associated with malignancy across DNA and RNA sequence, structural variation, and epigenetic changes in many tissue types including blood. Potential applications span the continuum of cancer care, from inherited risk assessment and early detection to prediction of treatment response and recurrence monitoring.
12:30 BioMarker Development from Discovery to the Clinic
Hongwei Zhang, Ph.D., Director, R&D and Process Engineering, Luminex Corporation
The development of biomarkers from discovery to clinical implementation as a CDx is a process which is inherently unpredictable; no two development pathways are alike. Given this unpredictability, it is desirable to develop biomarkers using a platform which provides flexibility, but which also reduces complexity as much as possible. The xMAP platform has been used extensively at all stages of biomarker development. The speaker will highlight some examples of discovery, validation and clinical implementation of biomarkers on xMAP.
1:00 Luncheon Presentation I:Development and Commercial Impact of FDA and Payer Evidence Needs for IVDs
David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine
Judi Smith, Vice President, In Vitro Diagnostics and Quality, Precision for Medicine
Choices made during IVD conceptualization and early development can have a large impact on eventual clinical evidence needs for both FDA and payers. Precision will examine the IVD development process to illustrate how and when choices about diagnostic test type, regulatory pathway, and use in guiding clinical decision-making affect FDA's and payers' evidence needs. We will explore implications for the ROI on test development of considering these needs early in the process.
1:30 Luncheon Presentation II: (Sponsorship Opportunity Available)
2:00 Session Break
2:15 Chairperson’s Remarks
Kevin M. Harter, Saladax Biomedical
2:20 Joint Presentation: Development of an NGS-Based Companion Diagnostic for the PARP Inhibitor Rucaparib
Mitch Raponi, Senior Director, Molecular Diagnostics & Translational Medicine, Clovis Oncology
Matthew J. Hawryluk, Ph.D., Senior Director, Corporate & Business Development, Foundation Medicine, Inc.
PARP inhibitors (PARPi) are active in patients (pts) with mutations in BRCA1/2, a critical component of homologous recombination repair (HRR). However, PARPi activity extends beyond BRCA, most likely in pts with tumors with other alterations leading to homologous recombination deficiency (HRD). Rucaparib, an oral PARPi, is being developed for treatment of relapsed, platinum-sensitive high grade serous ovarian cancer (HGSOC). A unique, integrated, translational-clinical program (Assessment of Rucaparib In ovarian cancEr triaLs (ARIEL)) is ongoing to identify HGSOC pts who may benefit from rucaparib treatment. In collaboration with Foundation Medicine, NGS of tumor tissue is being performed to identify somatic BRCA1/2 mutations as well as genomic defects caused by HRD that may be predictive of rucaparib response. The ARIEL trials are strategically aligned to allow for prospective clinical validation of a novel NGS-based companion diagnostic for rucaparib.
3:20 Advances in Genomic Characterization of FFPE Cancer Samples
Eric T Fung, M.D., Ph.D., Vice President, Research and Development, Clinical Applications, Affymetrix
FFPE samples are valuable resources for cancer research and for clinical diagnosis. However, FFPE preservation was developed to preserve morphology with no consideration for the preservation of RNA and DNA. Here we will discuss two approaches for the analysis of degraded, low quality FFPE samples: an assay that provides whole genome copy number with enriched resolution in cancer genes and a fully automated RNA in situ assay for sensitive and specific detection of any RNA transcript.
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing
4:30 Matching the Evolution of Diagnostic and Therapeutic Development: How Early is Early Enough?
Kevin M. Harter, President and CEO, Saladax Biomedical
The convergence of diagnostic and therapeutic development continues. Companion diagnostic development requires proper timing to avoid development and regulatory delays while also avoiding unnecessary costs during the process. This session will explore some critical time parameters in the co-development cycle and provide a framework for decision-making.
5:00 The Art of the Partnership - Claritas Genomics and Boston Children’s Hospital
Catherine Brownstein, M.D., Instructor, Pediatrics, Harvard Medical School and Boston Children’s Hospital
Offering clinical pharmacogenomics programs using state-of-the-art drug/gene knowledge is paramount to offering world-class patient care. In order to attain this goal, Boston Children’s has partnered with Life Technologies to create Claritas Genomics. BCH and Claritas are devoted advancing clinical pharmacogenomics to improve medication safety through precision medicine. There has been an explosion of interest in identifying and classifying genes with pharmacogenomic impact, and institutions, including at BCH, and our clinicians and researchers have been working towards incorporating this information into the medical record and clinical practice.
5:30 Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
6:30 Close of Day
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