Monday, August 23 • 2:00-5:00pm
(SC1) Roadmap for Accelerating Commercialization of Molecular Diagnostics
This short course is focused on development of molecular diagnostics as they make their way from biomarker discovery and initial proof of clinical performance through to commercial launch and market development. The course will emphasize identification of critical hurdles that when addressed early, can materially accelerate progress. Vital areas to be covered include reimbursement strategies, regulatory path decisions, physician education and key opinion leader development. A case study of an early stage molecular diagnostics company will be shared to illustrate a real world roadmap including:
- Rationale for reimbursement – understanding coverage
- FDA clearance and navigating claims language and timing
- Maximizing clinical study results while addressing costs
Instructors:
William Cook, MBA, Principal, Strategy and Business Development Clinical Diagnostics, WECA
Patrick Terry, CEO, Applied Clinical Genomics, Technic Solutions, LLC
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP
(SC2) Micro- and Nanofluidics in Diagnostics and Life Sciences:
Technologies and Applications
The course is designed for scientists, managers, technicians and engineers who would like to acquire a comprehensive overview of the field of microfluidics. Starting with the underlying physical principles of miniaturization, the course includes an introduction into microfabrication technologies for microfluidic devices covering a wide range of existing materials (glass, silicon, polymers) and manufacturing technologies and describes the complete development cycle of a microfluidic device from the design to the ready-to-use device. Applications of microfluidics in point-of-care and clinical diagnostics, analytical and synthetic chemistry, biotechnology and cell biology will be presented. The course will also provide an insight into the business aspects of the field and the uptake of microfluidic technology in various markets.
Learning Objectives:
- Understand the basic physical principles and scaling laws governing miniaturization
- Identify the suitable material for a given microfluidic application
- Understand the basic technologies available for the microfabrication of glass, silicon and polymer materials and follow the device manufacturing process from design to the finished microfluidic device
- Learn application examples of microfluidic devices in a wide range of disciplines
- Understand the current state of the markets and obstacles in the commercialization process
Instructor:
Holger Becker, Ph.D., CSO, microfluidic ChipShop
Wednesday, August 25 • 6:30-8:30pm
(SC3) Future of Point-of-Care Platforms
This short course looks at POCT markets and technologies from the point of view of senior executives making strategic choices about priorities and market directions. The discussion will focus on the changes in healthcare markets overall and the implications for POCT companies, especially as affected by molecular medicine. The multiple paths to market and potential barriers for POCT firms in the changing healthcare environment will be covered along with a range of potential strategies for success. The audience which can benefit will include decision-makers from POCT firms and their investors as well as diagnostic firms and scientists seeking a broader business view of point of care.
This course will answer the following questions:
- How are Dx POCT markets changing?
- Which platforms will win? What’s going to happen to the big box diagnostic companies?
- Hospital, MD offices, or home?
- What are the bottlenecks as markets change?
- Where will the new markets be and how will they be organized?
- What strategies make sense for Dx and POCT companies?
Course Instructors:
Keith F. Batchelder, M.D., CEO, Genomic Healthcare Strategies
Peter S. Miller, COO, Genomic Healthcare Strategies