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Navigating the Regulatory Steps in Biotherapeutic Translation Workshop

The Stem Cell Network is pleased to offer financial support to enable investigator & trainee teams to attend the Navigating the Regulatory Steps in Biotherapeutic Translation Workshop.

The Navigating the Regulatory Steps in Biotherapeutic Translation workshop, jointly hosted by BioCanRx, OIRM and SCN, is designed to provide scientists with an overview of the regulatory landscape and clarify the processes and steps required to translate discoveries into clinical trials. The workshop will provide participating teams with an overview of the steps necessary for developing pre- and full Clinical Trials Application (CTA) submissions to Health Canada, in addition to outlining the process of engaging with Health Canada as pre- and full CTAs are evaluated.  In this interactive workshop teams will also gain exposure to the regulatory considerations surrounding manufacturing and clinical testing, as well as discuss the workshop content and their own use scenarios with subject matter experts in the clinical trials, regulatory processes and cell and virus manufacturing fields.

The goal is to provide investigators with an understanding of the key stages and steps that will be required during the translation of their discoveries into novel biotherapeutic agents, particularly using cells, gene-modified cells, and/or viruses, for cancer and regenerative medicine applications in an academic setting.

Learning Objectives:
By the end of this workshop, participants will:

  • Be familiar with the Canadian regulatory landscape;
  • Understand the process of developing submissions, such as Clinical Trial Applications (CTAs), to Canadian regulators;
  • Understand good documentation practices (GDP) required to institute a regulated early-phase clinical trial;
  • Understand at a high-level how to develop a pre-CTA and CTA, and understand the key steps and decision time points involved;
  • Understand sourcing and requirements of raw materials in clinical manufacturing;
  • Understand at a high-level the basics of effective clinical trial design;
  • Have engaged with a network of experts in the area of regulatory processes and biotherapeutics.

Workshop Format:

  • 2 day in-person workshop;
  • Didactic curriculum with presentations by content experts, and supplemented with case studies and experiential anecdotes;
  • Interactive discussion sessions with subject matter experts.

Participant criteria:
Up to nine teams will be invited to attend the workshop. Successful investigator-led teams will be financially supported to attend by their respective network. Participating research groups are expected to include a principal investigator, a trainee and up to one or two additional personnel that are involved in project management. The principal investigator must commit to attending the entire workshop.

Schedule at a glance:
Evening before Day 1

  • Welcome dinner and networking

Day 1: Regulatory processes

  • Introduction to the regulatory landscape
  • Developing your regulatory submission (pre-CTA and CTA)
  • Case Study: The pre-CTA process
  • Panel discussion and Q&A session

Day 2:

Session 1: Putting the pieces together

  • Compliance & good documentation practices
  • Raw materials, process and product characterization
  • Case Study: Manufacturing and scale-up

Session 2: Gearing up for your Clinical Trial

  • Building blocks of design
  • Designing the trial to answer your questions
  • Panel discussion and Q&A session

Course Dates:  January 16-17, 2020
A reception and networking dinner are planned for the evening of Wednesday January 15.

Course Location:  University of Ottawa, Ottawa, Canada

Application Deadline: Monday, November 25, 2019
Notification of Award: Early December, 2019

Details of the SCN Award and Application Procedure:
This SCN award provides financial assistance for eligible trainees to attend this workshop

Financial Support Available
BioCanRx, the Ontario Institute for Regenerative Medicine (OIRM) and Stem Cell Network are offering a limited number of awards to enable eligible teams to attend this workshop. All those who submit an application to attend will automatically be considered for sponsorship and travel bursaries through the appropriate network. Applicants will be required to pay a nominal registration fee of $500 per team (BioCanRx, OIRM). The $500 registration fee will be covered for successful SCN teams. More details will be circulated with application notifications.

Eligibility (BioCanRx)
We will be accepting applications from currently funded BioCanRx Network Investigators, those applying for funding (have submitted an LOI), or those who had applied to a BioCanRx Catalyst or Enabling award. Attendees must have a biotherapeutic discovery with intended applications for cancer treatment. Note: It is not mandatory that your discovery and associated strategic plan relate to a currently funded BioCanRx-funded project; however, priority will be given to projects currently funded by BioCanRx.

Eligibility (OIRM)
We will be accepting applications from both funded and non-funded OIRM Network Investigators. Attendees must have a cell-based discovery with intended applications for clinical treatment. Priority will be given to those teams already receiving OIRM funding or have demonstrated project advancement towards the clinic.

Eligibility (SCN)
Applications will be accepted from Investigators from a Canadian lab who are seeking to translate a discovery in the field of stem cells and regenerative medicine. Applicants must clearly demonstrate that they will apply the techniques learned at the course to their own research project within one year.

Award Conditions:
SCN

  • Application deadline is 11:59pm (sender’s time), November 25, 2019.
  • The SCN award will cover travel expenses associated with attending the course, for teams not based in Ottawa:
    • Travel to/from the course location
    • Up to three nights accommodation at our designated hotel, dependent on the location of the team.
  • The SCN award will also cover the workshop registration fee of $500.
  • Successful applicants will be automatically registered for the course by the Stem Cell Network upon confirmation of their acceptance of the award.
  • Reimbursement will be processed following the course, in accordance with the SCN Travel Booking & Reimbursement Policy (policy will be provided to the selected applicants).
  • Accommodation during the course will be provided for Investigators and trainees not based in Ottawa. Two trainees of the same gender may be required to share a room.

BioCanRx

  • Successful applications will have all expenses associated with travel, accommodations and meals paid for by BioCanRx for the project leader (investigator), a senior team member and a trainee to attend.

OIRM

  • Successful applications will have a portion of expenses associated with travel, accommodations and meals paid for by OIRM, the remaining expenses are expected to be charged to your Disease Team grant. A full travel policy will be provided to applications upon being accepted to this workshop.

Application Procedure for all Networks:

  1. Complete the application form and return it, along with any additional documents required, by 11:59pm (sender’s time), November 25, 2019. All applications should be directed to Rebecca Cadwalader, Stem Cell Network by emailing info@stemcellnetwork.ca.
  2. The BioCanRx/OIRM/SCN Training & Education Committees will review all complete applications, and applicants will be informed of the competition outcome by early December, 2019.

Reporting and Communication Requirements:
By accepting a BioCanRx/OIRM/SCN award, the recipient agrees to provide a report describing the value of the training and networking opportunities made available through the award. This information will be used at BioCanRx/OIRM/SCN discretion on their respective websites, newsletters and for the purpose of reporting to its funding agency. By accepting an award, attendees also accept to have their pictures taken during the workshop, which may be used in the reporting tools mentioned above. Please note that expense reimbursement will be processed only once the completed report is received.

Please direct your questions about workshop content, the application process and reimbursement to your appropriate network contact:

  • BioCanRx: Megan Mahoney, Manager of HQP Training Programs, memahoney@biocanrx.com, 613-737-8149
  • OIRM: Marc Frigault, Senior Manager, Business Operations, marc.frigault@oirm.ca, 647-546-6479
  • SCN: Jon Draper, Program Director, Research and Partnerships, jdraper@stemcellnetwork.ca, 613-298-5802

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