Tuesday September 20

7:30 - 8:50

Registration – Nunavut - 4^th floor
Breakfast – Confederation III

8:50 - 9:00

Welcome from CellCAN – Regenerative Medicine and Cell Therapy Network
Denis Claude Roy, CEO, CellCAN

Confederation I & II

9:00 - 9:20

**Special announcement**

Theme 1: Pushing beyond the limits of CGT manufacturing

The need for greater biomanufacturing capacity has been on the steady rise in Canada, even prior to the onset of the COVID-19 pandemic. Increased domestic biomanufacturing capacity as a pandemic response element has driven the need beyond recent forecasts and forced manufacturers to deploy novel strategies to increase production within existing facilities. Theme 1 will explore novel initiatives, innovative technologies deployed by academia, industry and government to reduce bottlenecks and ramp up domestic biomanufacturing.

Moderator: Renaud Manuguerra-Gagné
Chair: David Courtman, Scientist, Director of Biotherapeutics, Ottawa Hospital Research Institute 

Confederation I & II

9:20 - 10:20

Building Momentum for now and the Future: Canadian Biomanufacturing Strategy and Investment, Rodrigo Arancibia, Innovation Science and Economic Development, Government of Canada

Biomanufacturing and enabling capabilities at the NRC: vaccines and beyond, Kelley Parato, Director, Cell and Gene Therapy Challenge Program, Human Health Therapeutics Research Centre, National Research Council of Canada

Confederation I & II

10:20 - 10:40

Health break and exhibitors visit

10:40 - 12:00

Challenges and answers to Cell Therapy Manufacturing - Issues and solutions to launching clinical trials - Cancer Immunotherapy production for clinical trials and the pathway to commercialization - Louisa Petropoulos, CEO, C3i

Biomanufacturing - Gatekeeper of success in cell & gene therapy, Michael May, CEO, CCRM 

Panel discussion: Pushing beyond the limits of CGT

• Kasondra White, Director of Strategy, Life Sciences and Biomanufacturing Branch, Innovation Science and Economic Development, Government Canada
• Kelley Parato, Director, Human Health Therapeutics, NRC 
• Louisa Petropoulos, CEO, C3i
• Michael May, CEO, CCRM
  

Confederation I & II

12:00 -13:30

Lunch, networking and exhibitors visit

Confederation I & II

Theme 2: Solving the talent development crisis for CGT manufacturing

Biomanufacturing has been identified as the major bottleneck for the advancement of the gene therapy sector as the exponential growth of the field has placed an increasing demand for additional biotherapeutics manufacturing capacity under cGMP. The problem is exacerbated by the dearth of qualified talent required to fill the specific job roles for biomanufacturing; this phenomenon is encountered in every jurisdiction around the globe. A unique opportunity exists to leverage the strengths and synergies between well recognized training and funding organizations to contribute substantially to growing the cell and gene therapy sector, and fill the dearth in available talent of HQP trained and qualified for workflow under aseptic conditions This session will detail initiatives underway to attack the talent development crisis and ensure job creation for the production of advanced therapies.

Moderator: Renaud Manuguerra-Gagné
Chair: Gayle Piat, Operations Manager, Alberta Cell Therapy Manufacturing

Confederation I & II

13:30 - 15:00

Canadian Advanced Therapies Training Institute (CATTI): solving the talent crisis through efficient, advanced training solutions - Craig Hasilo, Chief Scientific Officer, CATTI

Mitacs: Internships for biomanufacturing and biosciences - Fernanda Mendonça, Business Development Specialist, Mitacs

adMare Academy Executive Institute - Developing Canada's life science leaders in a COVID world and beyond - Kristy Lonegan, Senior Director, adMare Academy Sponsored by: 

Panel discussion on solving the talent development crisis

• Craig Hasilo, Chief Scientific Officer, CATTI
• Paul-Xavier Etter, Director of Training, CASTL
• Jennifer Quizi, Director of Manufacturing, OHRI Vector BMC, Director Biotherapeutics Manufacturing Operations, Program Coordinator, CanPrime
• Fernanda Mendonça, Business Development Specialist, Mitacs

Confederation I & II

15:00 - 15:20

Health break and exhibitors visit

15:20 - 15:40

Impact of ALS and treatment options - A caregiver and patient advocacy vision

Patient advocate: Jan Mattingly, ALS Action Canada, mother of ALS patient Wayne Mattingly

Confederation I & II 

15:40 - 16:10

The next frontier of health: Canada’s growing regenerative medicine sector, Cate Murray, President & CEO, Stem Cell Network

Sponsored by: 

Confederation I & II

Theme 3 - Sector Investment: Doing business in Canada

The rapid pace of innovation within the CGT sector has sparked tremendous growth potential and investment opportunities. Reducing manufacturing costs, expanding manufacturing capacity, increasing the domestic supply chain, addressing the bottlenecks in the field, including the required skilled workforce, are all critical elements for continued sector growth. This session focuses on doing business in the Canadian CGT ecosystem, including space allocation for biomanufacturing under GMP, creation of new GMP facilities, government programs, and securing investment from venture capital and other sources.

Moderator: Renaud Manuguerra-Gagné
Chair: Cynthia Lavoie, President & Chief Investment Officer, CCRM Enterprise

Confederation I & II

16:10 - 16:50

Panel discussion

• Ella Korets-Smith, Chief Business Officer, Virica
• Louisa Petropoulos, CEO, C3i Center
• Jonathan Yeh, Partner, Saisei Ventures

Confederation I & II

16:50 - 17:00

Wrap-up of day 1
Armand Keating, Chair, CellCAN Strategic Advisory Committee; Senior Scientist, Krembil Research Institute and Clinician Scientist, Princess Margaret Cancer Centre

Confederation I & II

18:00 - 21:00

CATTI Launch Networking Event - Sponsored by 

Westin Twenty-Two

Wednesday September 21

7:00 - 9:00

Registration – Nunavut - 4th floor
Breakfast – Confederation III

 9:00 - 9:10

Introduction to day 2 activities
Duncan Stewart, Executive Vice-President, Research, The Ottawa Hospital, CEO & Scientific Director, Ottawa Hospital Research Institute

Confederation I & II

 9:10 - 9:30

Hope for a cure - A T1D patient’s view on CGT-based therapies - David Morrison, Manager, BIO-PORTAL/COVID-19 Biobank, Jewish General Hospital

 Confederation I & II 

Theme 4: Regulatory & reimbursement plasticity: lessons from key jurisdictions

Advancements in cell and gene therapy treatments and the evolution of regulatory frameworks in the face of novel technological developments and pandemic response have led to forward-looking, responsive and adaptive approaches to regulating these therapies. Participants will learn how advanced technology health products are regulated through various pathways by Health Canada to enable an adaptive and responsive framework. Health technology assessments and the strategies for the evaluation of reimbursement are under additional pressures from the pandemic response. Participants will learn of the impacts of bringing these novel therapies to the healthcare system, the paradigms in reimbursement and how patient care is impacted.

Moderator: Renaud Manuguerra-Gagné
Chair: Patrick Bedford, President & Founder, WeCanReg

9:30 - 10:20

Keynote Presentation: Setting a national pandemic response plan in action: lessons for future vaccine and therapeutics manufacturing, Mark Lievonen, Co-chair, Canada’s COVID-19 Vaccine Task Force

 Confederation I & II

10:20 - 10:40

Health break, networking and exhibitors visit

10:40 - 11:40

Regulatory reform to support innovation: Health Canada’s agile and advance therapeutic product regulation efforts, Michael Rosu-Myles, Executive Director, Centre for Oncology, Radiopharmaceuticals and Research, Biologics and Radiopharmaceutical Drugs Directorate, Health Canada

Evaluation and reimbursement of advanced therapies, Sylvie Bouchard, Director of Drug and Technology Evaluation for Reimbursement, Institut national d'excellence en santé et en services sociaux (INESSS) 

Panel discussion: Regulatory, reimbursement & patient access

Michael Rosu-Myles, Health Canada

Sylvie Bouchard, INESSS

Confederation I & II

11:40 - 13:30

Lunch, networking and exhibitors visit

Confederation III

11:40 - 13:30 

CellCAN Strategic Advisory Committee lunch workshop (Invitation only)

Provinces I & II

Theme 5: Scaling up: strategies to overcome bottlenecks in biomanufacturing to meet demand

Demand for novel CGT and advanced therapy products have never been greater for regenerative medicine, cancer immunotherapy applications and pandemic response. Canada has a robust pipeline of translational projects and the ecosystem has adapted to the realities of supply chain issues and evolved in the face of increased demand. In this theme, participants will learn how groups are tackling this challenge head on through process closure technologies for late phase clinical trial and commercial manufacturing, establishing new standards to move the needle on technological advancements, upscaling technologies to meet the demand for the Canadian and global CGT market, and increasing Canadian manufacturing capacity through the creation of large scale biomanufacturing campuses.

Moderator: Renaud Manuguerra-Gagné
Chair: Jason Dowd, Vice President, Science & Technology, CCRM

Confederation I & II

13:30 - 15:00

Manufacturing of expanded hematopoietic stem cell-based therapies: Challenges on the path to commercialization, Sven Ansorge, Director of Manufacturing, ExCellThera

Towards standardized metrics to support manufacturing and regulatory approval of mesenchymal stromal cell therapies - Lorena Braid, Canada Chair in Mesenchymal Stromal Cell Research Tier 2, Assistant Professor, Simon Fraser University, CSO, Aurora Biosolutions Inc.

Confederation I & II

The next generation cell therapy clinical trial: pharmaco-optimization - Nicolas Noiseux - Cardiologist, ThéCell

Sponsored by:  

Developing a sanitisation program for cleanrooms and associated support spaces: importance & considerations, Aaron Bazal, Director of Business Development & Strategic Partnership, Vibraclean 

Sponsored by: 

15:00 - 15:20

15:20 - 16:20

Panel discussion: Vision of the future to meet demand in Canada

Gene therapy manufacturing capacity building, Denis-Claude Roy, Director, Hemato-Oncology & Cell Therapy University Institute, Medical Director, Centre d'excellence en thérapie cellulaire, Hôpital Maisonneuve-Rosemont, CSO, C3i, CEO, CellCAN

SmokePond Biologics: Offering a global 'D' to your 'R' for biologics, Rasmus Rajkjaer, CEO, SmokePond Biologics

OmniaBio: Launching commercial CGT-focused biomanufacturing in Canada, Jason Dowd, Vice President, Science & Technology, CCRM

16:20 - 16:30