Upcoming Learning Opportunities

Workshop Overview

This multi-day workshop provides a practical introduction to the preclinical development pathway for academic researchers advancing cancer immunotherapies to the clinic. Through expert-led sessions, case studies, and discussion, participants will work through key activities in preclinical development, including safety and efficacy studies, manufacturing and CMC planning, and regulatory requirements for initiating clinical trials.

Participants will leave with an actionable roadmap outlining the preclinical activities, expertise, and planning required to support submission of a Clinical Trial Application (CTA) to Health Canada.

Subject matter experts will facilitate sessions on:

• Overview of Health Canada regulation of investigational products in Canada and components of clinical trial applications
• Preclinical safety and efficacy requirements, including model selection, testing strategies, and GLP expectations
• Manufacturing process development, quality control strategies, and analytical development
• Working with CDMOs and CROs
• Program management for translation, milestone planning, budgeting and preparation for regulatory review
• Preparing and strategizing for engagements with regulators

Who Should Attend?

This workshop is intended for academic investigators who are in the early stages of developing a cancer immunotherapy product with the intent to advance it to the clinic. It is ideal for research teams that:

• Have limited or no prior experience in preclinical development,
• Are beginning to plan or conduct preclinical studies,
• Would benefit from structured guidance and expert input to navigate the translational research process 

For those familiar with our research program, this workshop is intended for teams who would be positioned to apply for Catalyst funding or beginning to plan Enabling Studies.

Participant Eligibility

• Academic investigators at Canadian institutions who are actively developing a cancer immunotherapy product for clinical application in Canada
• Be able to articulate a translational goal and the need to build or refine their preclinical development strategy, and/or knowledge gaps within their research team
• Priority will be given to BioCanRx-funded research teams, particularly those supported under Catalyst or Enabling Studies programs, as well as research teams intending to apply to BioCanRx’s next funding competition

Research groups selected to attend are expected to include a small, focused team composed of:

• 1 Principal Investigator
• 1 Senior research staff/project manager with responsibility for coordinating preclinical activities;
• 1 Trainee (optional), where participation is well-aligned with the goals of the workshop and the trainee’s role in the project;
• 1 Industry partner (optional), where relevant to the stage and needs of the program

Learning Objectives:

By the end of this workshop, participants will be able to:

• Assess whether their current data and development plans are aligned with intended clinical application

• Define and apply a Target Product Profile to guide preclinical study design, execution, and regulatory strategy

• Identify gaps in expertise or partnerships and outline next steps for engaging collaborators
• Generate a preclinical development roadmap with key decision points and supporting activities
• Anticipate risks and hurdles in preclinical development and develop risk mitigation strategies

Application Process:

• Research teams submit an application that includes details about:
  1. Product being developed
  2. Stage of translational development
  3. Proposed team, including description of expertise and role in the project
  4. Description of resources available at local institutions
  5. Anticipated goals of the applicant from attending this workshop
• Organizing Committee will evaluate applicants and select research teams

Timeline:

1. Applications Open – mid-March, 2026
2. Applicants notified – mid-April, 2026
3. Workshop Delivery – June 9 – 11, 2026

For more information please contact Julie Jonkhans (jjonkhans@biocanrx.com)