GAIN REGULATORY INSIGHTS2025 BIOLOGICS & BIOSIMILAR SYMPOSIUM
Friday, March 28, 2025 | TORONTO
Friday, March 28, 2025 | TORONTO
For Registered Attendees Only
2025 Biologics and Biosimilar Symposium
PRESENTATIONS & MATERIALS
PRESENTATIONS & MATERIALS
Welcome to the official collection of presentations and materials from the CAPRA 2025 Biologics and Biosimilar Symposium. Whether you attend the Symposium in person or online or are catching up, these resources offer valuable insights, expert perspectives, and practical takeaways that will keep you informed and ahead in your field.
Symposium Speakers
Sophie Sommerer
Health Canada
Director General, BRDD
Denis Arsenault
Health Canada
Manager, Centre for Policy, Pediatrics and International Collaboration
Dr. Chris Ablenas
Health Canada
Senior Evaluator, CBBB, BRDD
Amy Tsung
Sanofi Canada
Head, Regulatory Affairs, CMC
Fiona Frappier
Health Canada
Manager, Centre for Policy, Pediatrics and International Collaboration
Ron Boch
BIOTECanada
Vice President, Biotechnology and Industry Affairs
Johanne Veenstra
Health Canada
Senior Regulatory Policy and Risk Management Advisor, Office of Advanced Therapeutic Products,
Jennifer Wilhelm
Merck Canada
Director, Regulatory Affair
Yatika Kohli
NoNo Inc.
Chief Regulatory
and Strategy Officer
Ryan van Bendegem
AstraZeneca Canada
Senior Manager for CMC,
Regulatory Affairs
Jody Cox
Biosimilars Canada
Vice President
Agenda
| Time | Description | Presentation Overview | Guest Speaker | Duration |
|---|---|---|---|---|
| 7:15 - 8:25 am | Registration and Breakfast | 70 mins | ||
| 8:25 - 8:30 am | Welcoming Remarks | 5 mins | ||
| 8:30 - 8:45 am | Opening Remarks | Sophie Sommerer, Director General, BRDD, Health Canada | 15 mins | |
| 8:45 - 9:30 am | Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products, followed by Q&A | The three CTD Guidance documents applicable to Conventional biotherapeutic products, Biotechnological/biological (Biotech) products, and Blood products have been merged into one document as they shared more than 95% of the content. The revised guidance document was posted in April 2024. An overview of the major changes will be provided during this session. | Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada | 45 mins |
| 9:30 - 10:15 am | Update on ICH M4Q (R2), followed by Q&A | The CTD guidance document M4Q(R1) has been revised for the first time since 2001. It provides a harmonized structure and format for presenting CMC (Chemistry, Manufacturing, and Controls) information in a registration dossier. This session will present an overview of the revised guidance document. | Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada | 45 mins |
| 10:15 - 10:25 am | Question and Answer Period | 10 mins | ||
| 10:25 - 10:45 am | Coffee Break | 20 mins | ||
| 10:45 - 11:20 am | Canadian Biosimilars Landscape Update, followed by Q&A | The biosimilars market has been evolving rapidly in Canada in recent years. This presentation will review the current biosimilars landscape and highlight regulatory priorities that will help support a robust future pipeline of biosimilar medicines for Canadian patients. | Jody Cox, Vice President, Biosimilars Canada | 35 mins |
| 11:20 - 12:15 pm | Discussing the 15-day Clarifax timelines for submitting samples with Health Canada, followed by Q&A | From an industry perspective, consistency sample requests for biologics based on Health Canada’s 15 calendar-day Clarifax timelines can be challenging to manage without advanced notice of the timing or samples required. This has resulted in review clock stops until all samples can be delivered to Health Canada. | Dr. Chris Ablenas, Senior Evaluator, CBBB, BRDD, Health Canada; Amy Tsung, Head, Regulatory Affairs, CMC, Sanofi Canada; Ryan van Bendegem, Senior Manager for CMC, Regulatory Affairs at AstraZeneca Canada | 55 mins |
| 12:15 - 12:30 pm | Question and Answer Period | 15 mins | ||
| 12:30 - 1:30 pm | Lunch Break | 60 mins | ||
| 1:30 - 2:00 pm | Agile Licensing of Drugs and Medical Devices Regulations, followed by Q&A | In December 2022, Health Canada published a regulatory outlining new targeted provisions and regulatory amendments to the Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR) for stakeholder consultation. Building upon regulatory agilities piloted during the pandemic, the proposed regulatory amendments would enable terms and conditions for higher-risk drugs. | Fiona Frappier, Manager, Centre for Policy, Pediatrics and International Collaboration, Health Canada | 30 mins |
| 2:00 - 2:20 pm | Strengthening Canada’s biomanufacturing capacity and life sciences sector through regulatory modernization, followed by Q&A | Canada’s ambition in the Biomanufacturing and Life Sciences Strategy of a modern and agile regulatory system is increasingly important for global and Canadian biotechnology companies. The presentation will highlight how this regulatory reform will position Canada as a global leader in biotechnology, fostering innovation and improving healthcare outcomes. | Ron Boch, Vice President, Biotechnology and Industry Affairs | 20 mins |
| 2:20 - 2:50 pm | Update on ATP, followed by Q&A | Some therapeutic products are so unique or complex that they need a different regulatory approach. The ATP framework provides the ability to authorize ATPs in a flexible and risk-based manner. Health Canada will provide an update regarding the implementation of the framework and current ATP candidates, report on public consultation, and lessons learned. | Johanne Veenstra, Senior Regulatory Policy and Risk Management Advisor, Health Canada | 30 mins |
| 2:50 - 3:10 pm | From Foundations to Frontiers: The Evolving Landscape of Biologics Regulation, followed by Q&A | Biologics continue gaining prominence as vital components of modern medicine, encompassing established therapies and cutting-edge innovations. This presentation will explore the evolving regulatory environment surrounding biologics, offering insights from an industry perspective. | Jennifer Wilhelm, Director, Regulatory Affairs, Merck Canada | 20 mins |
| 3:10 - 3:20 pm | Question and Answer Period | 10 mins | ||
| 3:20 - 3:50 pm | Strategies to Overcome Development and Regulatory Challenges for Small and Medium Companies, followed by Q&A | Small- and medium-sized enterprises (SMEs) often struggle to define “suitable” development paths and regulatory strategies for their products. This session will discuss approaches for development and regulatory strategies that make sense for SMEs. | Yatika Kohli, Chief Regulatory and Strategy Officer, NoNo Inc. | 30 mins |
| 3:50 - 4:00 pm | PM Break | 10 mins | ||
| 4:00 - 4:25 pm | Panel Discussion and Q&A for All Topics | All Topics | All Speakers | 25 mins |
| 4:25 - 4:30 pm | Closing Remarks | 5 mins |
| Time | Description |
|---|---|
| 7:15 - 8:25 am | Registration and Breakfast |
| 8:25 - 8:30 am | Welcoming Remarks |
| 8:30 - 8:45 am | Opening Remarks Sophie Sommerer, Director General, BRDD, Health Canada |
| 8:45 - 9:30 am | Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products, followed by Q&A Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada |
| 9:30 - 10:15 am | Update on ICH M4Q (R2), followed by Q&A Hugo Hamel, Associate Director, CBBB, BRDD, Health Canada |
| 10:15 - 10:25 am | Question and Answer Period |
| 10:25 - 10:45 am | Coffee Break |
| 10:45 - 11:20 am | Canadian Biosimilars Landscape Update, followed by Q&A Jody Cox, Vice President, Biosimilars Canada |
| 11:20 - 12:15 pm | Discussing the 15-day Clarifax timelines for submitting samples with Health Canada, followed by Q&A Dr. Chris Ablenas, Senior Evaluator, CBBB, BRDD, Health Canada; Amy Tsung, Head, Regulatory Affairs, CMC, Sanofi Canada |
| 12:15 - 12:30 pm | Question and Answer Period |
| 12:30 - 1:30 pm | Lunch Break |
| 1:30 - 2:00 pm | Agile Licensing of Drugs and Medical Devices Regulations, followed by Q&A Fiona Frappier, Manager, Centre for Policy, Pediatrics and International Collaboration, Health Canada |
| 2:00 - 2:20 pm | Strengthening Canada’s biomanufacturing capacity and life sciences sector through regulatory modernization, followed by Q&A Ron Boch, Vice President, Biotechnology and Industry Affairs |
| 2:20 - 2:50 pm | Update on ATP, followed by Q&A Johanne Veenstra, Senior Regulatory Policy and Risk Management Advisor, Health Canada |
| 2:50 - 3:10 pm | From Foundations to Frontiers: The Evolving Landscape of Biologics Regulation, followed by Q&A Jennifer Wilhelm, Director, Regulatory Affairs, Merck Canada |
| 3:10 - 3:20 pm | Question and Answer Period |
| 3:20 - 3:50 pm | Strategies to Overcome Development and Regulatory Challenges for Small and Medium Companies, followed by Q&A Yatika Kohli, Chief Regulatory and Strategy Officer, NoNo Inc. |
| 3:50 - 4:00 pm | PM Break |
| 4:00 - 4:25 pm | Panel Discussion and Q&A for All Topics All Speakers |
| 4:25 - 4:30 pm | Closing Remarks |
Thank You to Our Platinum Sponsors
We want to extend our heartfelt gratitude to the sponsors of the 2025 Biologics and Biosimilar Symposium. Your commitment not only helps us bring together the brightest minds in the pharmaceutical and regulatory fields but also ensures the continued success of these knowledge-sharing platforms. Together, we are driving innovation, fostering collaboration, and shaping the future of the industry.
Click on our sponsors' logos to view more resources.
