Building a bridge: Manufacturing, analytics and trials for translational biomedical researchers

 

Workshop Date: September 30 – October 4, 2019

 

Location: University of Ottawa downtown campus, Ottawa, Canada

 

To apply to attend this workshop, click here. The deadline to apply is May 31, 2019 at 11:59pm EST. More details can be found in the application document.

 

Workshop Summary:

 

This workshop, hosted jointly by BioCanRx and the OIRM, is designed to allow participating teams to develop a feasible and realistic plan for manufacturing and clinical testing of their product or procedure in an early-phase clinical trial. The course will use Good Manufacturing, Laboratory and Clinical Practices (GMP, GLP, GCP) as a framework to provide investigators with a working knowledge of the human, physical, and financial resources required, and the timelines needed for clinical translation. The goal is to help investigators translate their discoveries to novel biotherapeutic agents (particularly cells, gene-modified cells, and viruses) for cancer and regenerative medicine applications in an academic setting while working with either a CMO, academic manufacturing facility or developing your own in-house manufacturing.

 

By the end of this workshop, participants will:

 

  • Understand the documentation required and infrastructure resources (human, operational and facilities) required to institute a regulated early-phase clinical trial
  • Understand the skill set required in an interdisciplinary team for the effective management of a new drug development program
  • Understand the GMP, GLP and GCP requirements to be compliant with Canadian federal regulations for clinical drug development
  • Have engaged with a network of experts in the area of GxP and biotherapeutics

 

Approximately six research groups will be invited to attend the workshop, which will have presentations interspersed with case studies and one-on-one discussion periods with various subject matter experts. Successful BioCanRx investigator-led teams will be financially supported to attend.

 

Workshop Format:

 

  • 5-day in-person workshop
  • Didactic curriculum with presentations by content experts supplemented with case studies and experiential anecdotes
  • Dedicated group time during the workshop to work on creating a preclinical program with peer-to-peer interactions and discussions
  • Office hours with subject matter experts to review and advise on the proposed preclinical program
  • Participating research groups are required to include a principal investigator, a trainee and one or two additional personnel that are involved in project management and regulatory issues. The investigator must commit to attending the entire workshop.
  • Final preclinical program presentations by all participants

 

Schedule at a glance:

 

Day 1: Monday, September 30, 2019 (half-day)
Session 1: Building a bridge: Manufacturing, analytics and trials for translational biomedical researchers
Introductions
Building and managing your research team
Knowing your product
Research project presentations

 

Day 2: Tuesday, October 1, 2019
Session 2: Regulatory
Regulatory considerations
Working with Health Canada
Regulatory Compliance
Working with a commercial manufacturing organization (CMO)
Group work and SME Office Hours

 

Session 3: Analytical and Functional Assay Development: Implications for Project Planning
Defining assays and developing an assay panel
Establishing testing criterial; release criteria, MOA and potency
Case Study
Group work and SME Office Hours

 

Day 3: Wednesday, October 2, 2019
Session 4 and 5: Manufacturing
Technology transfer
Product comparability
Quality by design
Target product profile
Stability testing
Raw materials
Case Study
Group work and SME Office Hours

 

Day 4: Thursday, October 3, 2019
Session 6: Manufacturing continued
Technology choices
Scale-up
Justification of manufacturing and assay choices
Case Study
Group work and SME Office Hours

 

Session 7: Gearing up for your Clinical Trial
Building blocks of design
Designing the trial to answer your questions
Case Study
Group work and SME Office Hours

 

Day 5: Friday, October 4, 2019 (half-day)
Sessions 8: Putting it all together
Team presentations: preclinical program strategy
Synopsis and wrap-up