21st International Molecular Medicine Tri-Conference
February 11, 2014 | 5:20-6:30pm
These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
Click on this link to sign up for the Break-out Discussions. Please take a minute to look at the list of topics, Moderators, and bullets below. Let us know that you are interested in participating by selecting a Break-out Discussion that you would like to join.
Real World Coverage and Reimbursement: Implications for Molecular Testing
William McGivney, Ph.D., Principal, McGivney Global Advisors LLC
- Coverage hurdles to the introduction, use, and payment for molecular tests
- Inside the coverage processes and considerations of public and private payers
- Impact of guidelines, pathways, electronic decision-assist tools, etc.
- The setting of reimbursement levels in an environment of change in payment methodologies
Taking the Cardiac Biomarker ST2 from Discovery to Clinical Adoption
James V. Snider, Ph.D., President, Critical Diagnostics
- Defining clinical utility for a novel test
- Developing and IVD test and technology options
- Regulatory, coding and reimbursement
How Do Diagnostic Providers Demonstrate Clinical Utility and Cost-Effectiveness?
Harry Glorikian, Managing Director, Strategy, Precision for Medicine
- How did you identify the clinical need you are aiming to address?
- Who is your customer and how will you demonstrate clinical utility to justify this additional step?
- How will you demonstrate cost-effectiveness to justify this additional cost?
- How will you drive adoption and reach your customer base?
Big Data's Big Role in Understanding Complex Diseases
Andreas Kogelnik, M.D., Ph.D., Founder and Director, Open Medicine Institute
- High performance platform for integrating molecular/genomic and clinical data
- Applying science and medicine to crowd-sourced data
- Enabling longitudinal outcomes studies with genomics and informatics
The Future of Prenatal Genomic Testing
Christopher Robinson, M.D., MSCR, Associate Professor, Maternal Fetal Medicine, Obstetrics and Gynecology, University of Virginia
- Transitioning from high risk patients to global screening with NIPT
- Is there potential for NIPT to achieve diagnostic capability in prenatal testing?
- Cost effectiveness and outcomes following implementation of NIPT
Extracting Biological Information from WGS/WES
German Pihan, M.D., Director, Hematopathology Lab, Pathology, Beth Israel Deaconess Medical Center & Harvard Medical School
- Searching for pearls in rough seas: Finding cancer genome sequence variants with predictable clinical impact.
- Imagining cancer biology: In silico prediction and modelling of the biological impact of cancer genome variants.
- Quo vadis cancer genome: What's next in the analysis of cancer genomes?
Exosomes: Research Trends and Diagnostic Potential
Enal Razvi, Ph.D., Biotechnology Analyst
- Research Methodology and Approaches for Exosome Isolation
- Interrogating the Biomarker Cargo in Exosomes
- Potential of Exosomes for Diagnostics
- Current Status of the Field and Drivers of Opportunity
The Value Proposition of Digital Pathology
Anil Parwani, M.D., Ph.D., Director, Pathology Informatics, Pathology, University of Pittsburgh Medical Center
- Significant advances in technology allow us to rapidly digitize large number of pathology slides
- An important question is what is the value proposition of this to the pathology laboratory
- Is the cost prohibitive to adopt the technology?
- Can we use the technology for some applications where the justification for the added cost
- What are some challenges and barriers for adoption of this technology
Use of Whole Slide Imaging for Primary Diagnosis in Canada
Andrew J. Evans, M.D., Ph.D., FRCPC, Staff Pathologist & Associate Professor, University Health Network, Laboratory Medicine Program
- Required due diligence concerning medical malpractice/liability coverage
- Health Canada’s classification and approval of specific WSI platforms for routine diagnostic use
- Health Canada and CE mark approval for WSI versus the FDA process
- Peer-reviewed literature showing non-inferiority of WSI relative to the light microscope
- Importance of WSI-LIS integration to support larger volume digital reporting
Very Fast (Extreme) PCR
Carl Wittwer, M.D., Ph.D., Professor, Pathology, University of Utah
- What are the uses of PCR in under 1 min?
- Is extreme PCR practical?
- How can you maintain specificity with high primer and polymerase concentrations?
PCR Quality Control Considerations
Rebecca Sanders, Researcher, Nucleic Acid Metrology, Molecular Biology, Science and Technology Division, LGC
- Special considerations for dPCR
- Publishing accurate, clear data
- Ensuring reliable reagents
- Strategies for experimental design
Biobanking Considerations in Translation Research
Cary D. Austin, M.D., Ph.D., Pathologist, Department of Pathology, Genentech, Inc.
- Biospecimen quality control indicators: which are most useful?
- Fit-for-purpose approaches to use of archived biospecimens
- Budgeting for procurement: leveraging project-driven versus biobank-driven funding
Biospecimen Considerations in Biomarker-Driven Clinical Trials
Rebecca Blanchard, Ph.D., Executive Director, Clinical Research; Head, Clinical Genetics, Merck & Co., Inc.
- Ability to consent for genome wide studies as part of main study consent (mandatory)
- Approaches to successful voluntary consent language to allow for genome wide studies in large multi-national studies
- Future prospects for generating whole genome sequence data from banked samples as routine practice, with storage and retrieval of banked data as important (or more important?) that storing and retrieving the banked sample
Sample Prep Challenges for NGS-Based Clinical Assays:
Jamie L. Platt, Ph.D., Scientific Director, Advanced Sequencing, Quest Diagnostics Nichols Institute
- Limited sample availability and sampling bias
- ccfDNA, FFPE and difficult sample types
- Unmet sample prep automation needs
The Value of an Integrated Clinical Trials Management System that Facilitates Collaboration Both in and Outside of the Organization:
Wessam Sonbol, Product Manager, Clinical Research & Informatics, Remedy Informatics
- What should an integrated system look like?
- What are the obstacles standing in the way of developing and launching an integrated clinical trials management system?
- What obstacles might stand in the way of adoption of such a system amongst healthcare and life sciences professionals?
Precision Medicine Approaches Applied to Epigenetic Targets
Dominique Verhelle, Ph.D., MBA, Director, Epigenetics, Tumor Cell Biology, Oncology Research Unit, Pfizer, Inc.
- What are current strategies to expand indications for epigenetic therapies?
- What are the pitfalls to avoid?
- When is target expression not the best indicator for predictive response?
- When are target silencing experiments misleading the prediction for predictive response?
Challenges Surrounding Biomarker Discovery for Novel Epigenetic Inhibitors
Helai Mohammad, Ph.D., Investigator, Cancer Epigenetics DPU, Oncology R&D, GlaxoSmithKline
- What are the critical limitations in identifying biomarkers for novel epigenetic inhibitors?
- What measures are being taken to overcome these issues?
- What are clear-cut and feasible opportunities?
Transcriptomics to Therapeutics: Bridging the lncRNA Divide
Leonard Lipovich, Ph.D., Associate Professor, Center for Molecular Medicine and Genetics, Wayne State University School of Medicine
- Have exomes and RNA-Seq hindered, rather than helped, lncRNA disease genomics?
- How can we proceed from disease lncRNA discovery, in GWAS and functional studies, to translational therapeutics?
- Which of the currently known lncRNA mechanisms present the best opportunities for therapeutic targeting?
- What are the limitations of animal models for studying lncRNA function, in view of lncRNA evolutionary non-conservation?
- In the absence of a "national institute of RNA" or lncRNA study sections at the NIH, can pharmaceutical companies drive clinical-translational work in this field through academic-industry partnerships?
Overcoming Limitations in Single-Cell Sequencing
Jan Vijg, Ph.D., Professor & Chair, Department of Genetics, Albert Einstein College of Medicine
- Why single-cell genomics?
- What are the critical limitations of single cell sequencing of genomes and transcriptomes and what measures are being taken to overcome these issues?
- Can single-cell genomics be applied in a cost-effective, high-throughput mode?
- What are the key computational and/or statistical issues in single-cell genomics?
- What are the main clinical and industrial applications of single-cell genomics?
Clinical-Grade Genomic Interpretation and the Role of Clinical Data Sharing
Gabe Rudy, Vice President, Product Development, Golden Helix
- What are the critical limitations in interpreting genomic data?
- How do you incorporate the latest genomic annotations and research while providing a certifiable dry-bench clinical test?
- Are the proposed federally sponsored clinical variant repository ClinVar sufficient as data sharing platform?
- For the patient with an undiagnosed genetic disorder: is the risk of privacy violation of data sharing outweighed by the potential benefits?
- What are both the ideal and the pragmatic solution to re-analyzing samples as public annotations variant’s classifications change and when is notifying physicians and patients warranted?
- How should the level of certainty of a given genomic interpretation be communicated to the physician and patient?
Translational Strategies to Support Combination of Cancer Immunotherapy with Chemotherapy and Radiation
Rakesh Dixit, Ph.D., DABT, Vice President, R&D and Global Head, Biologics Safety Assessment, MedImmune
- Understanding the MOAs of potential combinations
- How to select the best possible combinations to maximize efficacy and DFS
- What combinations may work and may not work
- PHC strategies and diagnostics
- Preclinical studies to support combinations
- How to conduct safety risk assessment for combinations
International Collaborative Efforts between Academia and Industry – Predictive Preclinical Models as a Showcase
Ralph Graeser, Ph.D., Associate Director, Janssen Pharmaceutica NV
- Why improve on preclinical models – how to prove they predict better?
- How to align goals from academia, CROs, and industry in a consortium?
- Collaboration between industry – confined to pre-competitive space?
Metastatic Tumor Models – Development, Application, and Challenges
Kevin G. Leong, Ph.D., Scientist, Discovery Oncology, Genentech, Inc.
- Existing and novel metastatic models - advantages, disadvantages, and clinical relevance
- Application of metastatic models for testing novel therapies that target the metastatic process or established metastases
- Challenges associated with translatability of preclinical findings
How to Best Utilize Patient Derived Xenografts in Oncology Drug Development
Elizabeth Bruckheimer, Ph.D., Vice President, Scientific Operations, Champions Oncology, Inc.
- What types of PDX study designs are best for early stage compounds? Late stage compounds?
- What are the important questions we want answered from PDX models?
- Where are the gaps in the currently available oncology models?
Collaboration, Externalization and Privacy
Michael H. Elliott, CEO, Atrium Research & Consulting
- At what extent is data exchange required in the era of R&D virtualization?
- How do we balance collaboration with security risk?
- What tools are required to enable virtualization? Will these be vendor supplied or custom?
Biological Registration Systems
Arturo J. Morales, Ph.D., Global Lead, Biology Platform Informatics, Novartis Institutes for Biomedical Research
- How do we implement systems that users want to use?
- What are some good practices?
- Where are data standards making a difference?
Data Integration Today
Ajay Shah, Ph.D., Director, Research Informatics, City of Hope National Medical Center
- Building extensible software platform for integrating basic, clinical and translational research data - technology, data and cultural challenges
- Integrating deeper analysis and natural language processing tools to leverage the platform for translational research
- Case studies from participants and discussion
Shoibal Datta, Director, Data Sciences, Biogen Idec
- What does the perfect translational informatics platform look like and how do we get there?
- Where does translation stop?
- What does the Affordable Care Act mean to the future of Real World Evidence
Big Data: Should it be Top-down or Bottom-up??
Michael Liebman, Ph.D., Managing Director, Strategic Medicine, Inc.
Sabrina Molinaro, Ph.D., Institute for Clinical Physiology, National Research Council, Italy
- What is the difference and why is it important?
- How much data is enough (to solve critical problems)?
- Genomics, proteomics, clinical data....what else?
- Quality vs quantity in data
- The issues of data vs knowledge
The Application of Next-Generation Sequencing as a Tool for Translational and Clinical Research
Philip Brohawn, Manager, Research & Development, Translational Science, MedImmune
- With the declining cost of whole genome sequencing, what role is it likely to play as a clinical research tool?
- With the boost in sensitivity for detecting low frequency mutations by NGS, will there be a practical update for currently existing molecular diagnostics based on mutation detection?
- What is the promising aspect of next-generation sequencing as it applies to translational and clinical research?
Clinical Evaluation of Exosomes as Oncology Biomarkers
Shidong Jia, Ph.D., Scientist, Oncology Biomarker Development, Genentech, Inc.
Are Current CTC Analysis Technologies Ready for Primetime Clinical Use?
Steven A. Soper, Ph.D., Biomedical Engineering, Chemistry; William H. Pryor Emeritus Professor, Director, Center for BioModular Multi-Scale Systems, University of North Carolina, Chapel Hill
- Define a CTC
- Evaluate positive selection markers and devices
- Learn what information is needed for the clinic
- Discuss what additional research is required
- Review FDA approved technologies for CTC selection
Circulating Tumor Cells (CTCs) vs. ctDNA: Which is Best for Liquid Biopsy?
Klaus Pantel, M.D., Professor & Founding Director, Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf, University of Hamburg
Catherine Alix-Panabières, Ph.D., Maître de Conférence, Praticien Hospitalier, Associate Professor, Director, Laboratory of Rare Human Circulating Cells, Institute of Research in Biotherapy, Saint-Eloi Hospital, University Medical Centre of Montpellier
- Technologies for CTCs and ctDNA detection and characterization
- Potential and limitations of CTCs as Liquid Biopsy
- Potential and limitations of ctDNA as biomarker
- Relationship between CTCs and ctDNA
Digitizing Traditional PCR Formats
Valerie Taly, Ph.D., Group Leader/CNRS Researcher, Université Paris-Descartes