韩国裸舞

In Vitro Diagnostic (IVD) Product Development Bootcamp: Making the Move from Academic and Entrepreneur to Product Development | June 9-12, 2025

COURSE FORMAT

Online only. Course will be live to online participants approximately 8:00 AM to 2:00 PM (Montreal time) each day June 9-12, 2025. All content will be recorded and accessible to participants until July 1, 2025.

DESCRIPTION

The IVD Product Development Bootcamp is meant to train and equip academics, entrepreneurs, and early-stage companies with an improved understanding of the skills, principles, and systems required for effective In Vitro Diagnostics (IVD) product development. This training will help attendees to make the transition from academic and grant-based research to regulatory and quality compliant product development. Attendees will learn the FUNDAMENTALS for moving an IVD product from concept through development.

Scope:

• IVD development with an emphasis on diagnostics for infectious disease and antimicrobial resistance (but applicable to all IVDs)
• Product development 鈥� concept, technical feasibility, and development stages
• The fundamentals of IVD development 鈥� what they are, why they are important, and when you need to implement them

The course will include interactive learning exercises, panel discussions with experts and opportunity for Q&A.

COURSE DIRECTORS

Betsy Wonderly Trainor, BSc
IVD R&D Founder (CARB-X, FIND, Daktari)

Peter J. Dailey, PhD, MPH
Independent IVD R&D consultant (Cepheid, Roche, Chiron)

Cedric Yansouni, MD, FRCPC, DTM&H
Director, JD MacLean Centre for Tropical and Geographic Medicine,
Divisions of Microbiology & Infectious Diseases,
韩国裸舞 Health Centre

COURSE FACULTY

• Jennifer Osborn, Independent IVD Engineering and Market Research Consultant (Gates, PGAFF)
• Michelle Zaharik, Independent IVD Regulatory and Quality Consultant
• Debkishore Mitra, Independent consultant, Entrepreneur (IIT, Lucira Health Founder)
• Stuart Palmer, Independent IVD R&D and Quality consultant (Abbott, Roche)
• Chandrakar Nair, CEO Bigtec (Molbio)

Faculty are still being confirmed and there may be changes to the above list.

CONTENT

There are many hurdles (valleys of death) between research and the successful commercialization of an innovative infectious disease diagnostic assay. The democratization of diagnostics requires local, indigenous innovation, development, and manufacture. What is often neglected is an understanding and implementation of the key systems and disciplines of good DEVELOPMENT practices and when to implement them. The aim of this course is to fill in that gap. Lectures will include engaging examples, stories, case studies, and illustrative successes and disasters from the instructors鈥� experience. An emphasis will be placed on making the material relevant for LMIC innovators. Topics include:

• The Product Development Process
• The Customer as your Compass: Target product profiles, Market Requirement and Product Requirement Documents
• Design Controls
• Development in a Quality Management System
• Good Laboratory Practices
• Challenges in making the culture change from Academia/Entrepreneur to Product Development: Implementing and Embracing a Development 鈥淐ulture鈥�
• Case-Study: Why the Fundamentals Matter
• Global Regulatory Landscape and Strategy

OBJECTIVES

By the end of the course, participants will:

• Understand the IVD product development process and describe the difference between the phases: Concept, Technical Feasibility, and Design & Development
• Be able to draft an intended use statement
• Understand when and how to incorporate design controls, quality management system and good laboratory practices in the development process
• Understand what funding agencies are looking for in IVD product development grant proposals
• Review the challenges involved in leading and managing the transition from academic research to product development

TARGET AUDIENCE

• Academic and entrepreneurial research and development leaders interested in transitioning to infectious disease diagnostic product development
• R&D managers and scientists in early-stage diagnostic companies / academic groups
• Graduate students in bioengineering and infectious disease research interested in the development of diagnostics
• Academic innovation and industry accelerator hubs
• Scientists and managers including:
  • Funding agencies, grant and contract reviewers
  • Product Development Partnerships
  • Public health agency policy makers and implementers

Participants from LMICs and indigenous communities are encouraged to apply.

ENROLMENT

Limited to 80 online participants.

Note that 50% of registrations will be reserved for participants from LMICs and indigenous communities up until May 1, 2025.