Navigating the Regulatory Steps in Biotherapeutic Translation Workshop
Workshop date: Jan 16-17, 2020
Workshop location: Ottawa, Ontario
Deadline for Applications: November 25, 2019
To apply to this workshop, click here. The deadline to apply is 11:59pm (sender’s time), November 25, 2019. More details can be found in the application document.
About the 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.
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.
- 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.
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:
|PRE-WORKSHOP EVENT Wednesday, January 15, 2020:|
|6:00 pm||Networking Dinner|
|DAY 1 Thursday, January 16, 2020:|
|8:00 – 8:30 am||Breakfast|
|8:30 – 8:45 am||Welcome and Introduction|
|8:45 – 9:30 am||Introduction to the regulatory landscape|
|9:30 – 10:40 am||Are you ready to engage with HC?|
|10:40 – 11:10 am||Break|
|11:10 – 11:40 am||Case study 1: The pre-CTA process and engagement with Health Canada|
|11:40 – 12:10 pm||Case study 2: The pre-CTA process and engagement with Health Canada|
|12:10 – 1:15 pm||Lunch|
|1:15 – 1:45 pm||What does a CTA application look like?|
|1:45 – 2:30 pm||Flash-points in your regulatory submission|
|2:30 – 3 pm||Contracts|
|3:00 – 3:15 pm||Break|
|3:15 – 3:45 pm||Program management|
|3:45 – 5:00 pm||Panel Discussion and Q&A (All speakers)|
|DAY 2 Friday, January 17, 2020:|
|8:00 – 8:30 am||Breakfast|
|8:30 – 9:00 am||New substances notification|
|9:00 – 9:30 am||Compliance and GDP|
|9:30 – 10 am||Use of materials, reagents and excipients, special considerations for animal-derived materials|
|10 – 10:30 am||Process characterization|
|10:30 – 11:00 am||Break|
|11:00 – 11:30 am||Product characterization|
|11:30 – 12:15 pm||Case study: scale-up and manufacturing|
|12:15 – 1:15 pm||Lunch|
|1:15 – 1:45 pm||Pre-clinical studies|
|1:45 – 2:45 pm||Clinical studies|
|2:45 – 3:00 pm||Break|
|3:00 – 3:45 pm||Panel Discussion and Q&A|
|3:45 – 4:00 pm||Debrief and workshop wrap-up|
Workshop 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
Invitation notification to attend: Early December, 2019
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). More details will be circulated with invitation notifications.
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.
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.
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.
BioCanRx Application & Reimbursement Details:
- Application deadline is 11:59pm (sender’s time), November 25, 2019.
- BioCanRx travel awards for eligible participants 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.
- Attendees will be required to pay a team registration fee of $500 CAD.
Application Procedure for all Networks:
- 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 firstname.lastname@example.org.
- 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 travel 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: