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Spotlight on Clinical Translation: Making the leap from the lab bench to Phase I Clinical Trials

Note: This event is hosted online.

The Stem Cell Network and Medicine by Design are partnering to host Spotlight on Clinical Translation: Making the leap from the lab bench to Phase I Clinical Trials.

This workshop will provide investigators and trainees with a basic understanding of the clinical pipeline, from essential pre-clinical studies to Phase I first in human trials. The invited speakers will review processes involved in clinical trial submission, regulatory approval and product manufacturing. An interactive Q&A session will ensure participants can ask questions relevant to their research along with leveraging this opportunity to connect with clinical trial experts.

Clinical studies are a key element on the pathway of translational cell and gene therapies. It is, therefore, essential that principal investigators, researchers, trainees, clinical research fellows and ecosystem partners working in Canada undertaking translational research have a thorough understanding of the clinical trial pipeline; focused specifically on the early phase clinical trial design processes.

Register here to attend.

Registration deadline:
Attendance at this event is limited; all those interested in participating must register by June 8, 2022, at 11:59 PM local time.

Speakers:

  • Linh Nguyen,PhD, Staff Scientist/Head, Cell Manufacturing Team, Tumor Immunotherapy Program, Princess Margaret Cancer Centre
  • Natasha Kekre, MD, Hematologist, The Ottawa Hospital Transplant and Cellular Therapy Program, and Scientist, Ottawa Hospital Research Institute
  • Patrick Bedford, MSc, Managing Director, weCANreg Consulting Group Inc.

Chairs:

  • Harold Atkins, MD, Attending Physician, The Ottawa Hospital Transplant and Cell Therapy Program, and Scientist, Ottawa Hospital Research Institute
  • Darshan H. Brahmbhatt, MA MB BChir MPhil MRCS MRCP CCDS, Ted Rogers Centre for Heart Function and Ajmera Transplant Centre, University of Toronto

 

Event Format and Dates:
This event will be hosted online via Zoom on Thursday, June 9, 2022 from 1 PM – 3 PM ET.
A link to the online session will be provided to registrants.

Agenda: 

Time Details
1:00-1:05 pm ET Opening Remarks
Moderators: Harold Atkins and Darshan Brahmbhatt
1:05-1:40 pm ET Speaker: Natasha Kekre, MD, Hematologist, The Ottawa Hospital  Transplant and Cellular Therapy Program, and Scientist, Ottawa Hospital Research Institute

Presentation title: Building the pre-CTA and CTA package for Phase I trials: Case study using CLIC CAR-T trial for relapsed/refractory CD19 positive hematologic malignancies

1:45-2:10 pm ET Speaker: Patrick Bedford, MSc, Managing Director, weCANreg Consulting Group Inc.

Presentation title: Leveraging a regulatory rerspective on your path to trials

2:15-2:40 pm ET Speaker: Linh Nguyen, PhD, Staff Scientist/Head, Cell Manufacturing Team, Tumor Immunotherapy Program, Princess Margaret Cancer Centre

Presentation title: Developing a cell manufacturing process for an early phase clinical trial

2:40-2:45 pm ET Break
2:45-3:00 pm ET General Discussion/Q&A session
3:00 pm ET Closing Remarks

 

Questions:
For further information on this event or for registration related enquiries, please contact Ellie Arnold at earnold@stemcellnetwork.ca or Sonam Dubey at sonam.dubey@utoronto.ca.

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