Overcoming Challenges of Working with FFPE Samples
Instructor: W. Fraser Symmans, M.D., Professor & Director of Research Operations, Department of Pathology, UT M.D. Anderson Cancer Center
- Non-formalin-based fixatives
- Comparison of methods for preserving morphological, molecular, and protein biomarkers in tissue
- Feasibility data from fine needle aspirates (FNA)
- Assay development
NGS Data Analysis – Determining Clinical Utility of Genome Variants
Instructor: Gabe Rudy, Vice President, Product Development, Golden Helix
- Review advances in NGS such as opportunities to mine genetic data from individuals to populations
- Identify genetic variants and linking sequence data with disease
- Explore genetic data science
- Learn how to determine informed healthcare decisions
Microfluidics for Point-of-Care: Technologies, Applications and Products
Instructor: Holger Becker, Ph.D., Founder & CSO, microfluidic ChipShop GmbH
- Understand the role of microfluidics technology in the development of new products.
- Learn about development strategies in product development.
- Understand different microfabrication methods for low and high volume production.
- Get an overview on existing microfluidics-enabled products in the POC market.
- Understand the current state of the markets and obstacles in the commercialization process.
- Learn about examples of successful and unsuccessful microfluidic product introductions.
Next Generation Sequencing as a Diagnostics Platform
Madhuri Hegde, Ph.D., FACMG, Associate Professor, Human Genetics; Executive Director, Emory Genetics Laboratory, Emory University School of Medicine
Additional Instructors to be Announced
- Technical aspects, tremendous power and pitfalls of next-generation sequencing
- Next generation sequencing for cancer genomic analysis and companion diagnostics
- Data analysis approaches and challenges in next-generation sequencing
- New challenges in test interpretation and genetic counseling
- New requirements for informed consent
- Risks of genetic discrimination
- Impacts of gene patents, government regulation, and direct-to-consumer marketing
- Standardization of NGS assay development
Clinical Trials to Establish Value of Diagnostic Tests: Design and Management
Teresa Raich, Ph.D., Vice President, Cinical and Scientific Affairs, Nanosphere, Inc.
Anita Borek, Senior Manager, Clinical Affairs and Specimen Management, Nanosphere, Inc.
Scott Powell, Clinical Marketing Manager, Nanosphere, Inc.
- Sponsored- and Investigator-Initiated-Study clinical diagnostics processes for successful, compliant and timely execution.
- Specimen Acquisition and Management—Who from, how to acquire, when to acquire, what to acquire and management best practices.
- Clinical study publication planning and execution—Microbiology molecular diagnostic test case presented from market development studies through clinical outcomes/cost-effectiveness studies.
Use of CLIA-Waived Point-of-Care and Rapid Diagnostic Tests in Community Pharmacies
Michael E. Klepser, Pharm. D., FCCP, Ferris State University College of Pharmacy
Donald G. Klepser, Ph. D., University of Nebraska Medical Center College of Pharmacy
Allison Dering-Anderson, Pharm. D., University of Nebraska Medical Center College of Pharmacy
- Community pharmacies – A growth market for diagnostics
- Legislation and state practice acts regarding the use of CLIA-waived POC and RDTs in community pharmacies
- Developing a sustainable business using POC and RDTs in community pharmacies
Regulatory Compliance in Drug-Diagnostics Co-Development
Instructor: Sabah Malek, Associate Director, Global Regulatory Affairs, Eisia, Inc.
Additional Instructors to be Announced
- U.S. requirements and processes
- U.S. government oversight of diagnostics, diagnostic clearance and approval pathways
- Co-development process & timelines
- Integration of Rx and Dx development plans
- Navigating the development process
- Co-development examples and lessons learned
- Diagnostics regulation in the EU, Japan, China and other complex emerging markets
- Developing a successful CDx global regulatory strategy
- Next generation sequencing applications and implications
- Current regulatory pathways
Regulatory and Reimbursement Issues with Next-Generation Sequencing and Multiplex Assays
Part 1: NGS in Clinical Space: Regulatory Considerations
Instructor: Melina Cimler, Ph.D., Vice President, Head of Global Quality Illumina, Inc.
Part 2: Reimbursement of NGS Assays
Instructor to be Announced