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2018 NATIONAL BIOMANUFACTURING SUMMIT REPORT

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2018 NATIONAL BIOMANUFACTURING SUMMIT REPORT

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  1. 2018 NATIONAL BIOMANUFACTURING SUMMIT REPORT

  2. Table of contents

  3. BackgroundFBM’s National Consultation on Biomanufacturing 214 Montréal Dec 7, 2016 86 participants Toronto Feb 23, 2017 68 participants Vancouver March 23, 2017 60 participants participants 36 6 High profile and international speakers World Café discussions 1 600+ National map of stakeholders (biotechs, CMOs, VCs, gov, etc.) individual stakeholders 1,000+ Lines of comments captured

  4. From consultation to strategy 4 ISSUES IDENTIFIED DURING CONSULTATION • Biotech support ecosystem • Infrastructure and production capacity • Specialized training • Bridging funding to support biotechs to biomanufacture locally Next steps… • Supporting projects to address 4 key issues • Aim to position biomanufacturing as a cornerstone of the Canadian biotech ecosystem • Maintain national dialog on biomanufacturing

  5. Ultimate goal:Canadian Biotech Industry : Create One Integrated Cluster BC HUB QC HUB BIOTECHS ONTARIO HUB RM HOSPITALS CMOs + CROs + SUPPLIERS ASSOCIATIONS + GOV Integrate the Canadian biotech industry into a functional cluster unified by biomanufacturing

  6. Agenda – August 15th 2018, MontréalNational Biomanufacturing Summit: 3 sessions Success stories in biomanufacturing Nigel Shipston, Fujifilm Diosynth Biotechnologies Successes and challenges from bioeconomies across the world Fiona Fitzgerald, GE Healthcare Innovative production technologies Eric Jervis, STEMCELL Technologies Moderated by Moderated by Moderated by • James Piret, UBC Technologies Tailored to Address Cell Therapy Bioprocess Challenges • Rénald Gilbert, NRC Viral Vector Production for Cell and Gene Therapy • Alain Doucet, MedicagoTransforming The Approach to Vaccines and Protein-Based Therapeutics • David Poon, Zymeworks The Zymeworks Journey - From Computational Modeling to Clinical Development • Allison Hagerman, OncolyticsIt takes more than just good data - Validation of a Retrovirus Production Process • Andrew Booth, STEMCELL Technologies STEMCELL Technologies: The Future of Canada’s Largest Biotech Company • Shay Power, IDA IrelandThe Grass is Greener in Ireland – Incentives to Build a World-Class Bioeconomy • Frank Van Lier, NRCCanadian Consultation on Biomanufacturing • Dina Iezzi, Therapure BiopharmaCanadian Case Study 1 – Therapure Biopharma • Molly S. McGlaughlin, BioVectraCanadian Case Study 2 - BioVectra • Christelle Fasano, Montréal International Biomanufacturing: Quebec’’s Top Priority in Life Sciences

  7. James Piret, The University of British Columbia“Technologies Tailored to Address Cell Therapy Bioprocess Challenges” • Session: Innovative Production Technologies Intro and moderation by Eric Jervis, STEMCELL Technologies • Evolution from manufacturing therapeutic proteins to now cells for therapy • Novel cell therapies have the potential to increase cancer treatment efficacy vs existing therapies. Challenges include high cost and industrialization • Biomanufacturing a crucial step needed to propel cell therapy forward • Whereas protein biologics manufactured in tanks up to 20,000 L, new challenges for cell therapy manufacturing often down to ~1 L • Advancements in acoustic device for perfusion, cell washing and concentration to enable closed system manufacturing • Raman spectroscopy a means to monitor the reproducibility of manufacturing process and cell therapy products • Challenges remain, including need to overcome immune rejection • Lessons Learned • Process analytical technologies are central for cell therapy manufacturing • Cell therapy network in Canada with strong potential to deliver innovative therapies for Canadians

  8. Rénald Gilbert, National Research Council Canada “Viral Vector Production for Cell and Gene Therapy” • Session: Innovative production technologies Intro and moderation by Eric Jervis, STEMCELL Technologies • NRC is a major player in viral vector bioprocesses and technology • Viral vectors are used for in vivo gene therapy (adeno-associated virus or AAV) and for ex vivo gene therapy (modified cells for cell therapy using lentivirus or LV) • Approved in vivo gene therapies: 2012: 1st gene therapy treatment approved: Glybera(lipoprotein lipase deficiency, LPLD); 2015 Imlygic (melanoma); 2017 Luxturma (hereditary blindness) • Approved ex vivo gene therapy treatments: 2016: 1st stem cell gene therapy treatment approved: Strimvelis(ADA-SCID); 2017: 1stCAR-T therapy treatment approved: Kymriah (lymphoma) and Yeskarta(lymphoma) • HEK293: 1998: expression platform patented at NRC; 2003: cGMP cell bank; 2015: scaled up to 500L • Improvements: plasmid packaging and improvement of LV purification process • Lessons Learned • NRC is a Canadian provider of cGMP HEK cells for viral vector production (both AAV and LV) • AAV and LV both require mammalian cells for production • Next generation of HEK293 cells will integrate multi-plasmid packaging system PDF presentation: add link

  9. Alain Doucet, Medicago“Transforming The Approach to Vaccines and Protein-Based Therapeutics” • Session: Innovative production technologies Intro and moderation by Eric Jervis, STEMCELL Technologies • Quebec City-based clinical biopharmaceutical company with global activities and rapid growth (300+ employees in 2018, targeting 500+ in 2019) • Proprietary platform for transient expression of vaccines & therapeutic proteins in plants to address various infectious diseases worldwide • $245M investment to build facility for commercial production of up to 50M doses of quadrivalent influenza vaccines • Competitive advantages of Medicago’s plant-based platform • Rapid - Clinical grade material in 5-6 weeks • Accurate - No risk of mutation in plants • Versatile - Transient expression, no need for stable transgenic plants • Robust pipeline of antibodies and vaccines up to Ph3 • Lessons Learned • Vertically integrated company with commercial production capacity • Plant-based production allows faster response to pandemic demand than traditional production methods PDF presentation: add link

  10. S U M M A R Y • Session: Innovative production technologies • Cell and gene therapy require standardized production systems with strong analytical support to reach the clinic • Innovative production systems (like plant-based) reduce manufacturing timelines and provide faster response to pandemic demands • Canada’s cell therapy network groups research centres, hospitals, and academic institutions but currently lacks sufficient biomanufacturing capacity to propel clinical development forward and efficiently treat Canadians

  11. David Poon, Zymeworks“The Zymeworks Journey - From Computational Modeling to Clinical Development” • Session: Success stories in biomanufacturing Intro and moderation by Nigel Shipston, Fujifilm Diosynth Biotechnologies • Zymeworks expanding its own lab space while continue to leverage an external network of partners and CROs/CMOs to supplement capabilities: • Computational design and engineering performed in-house • External work range from gene synthesis, Ab production & in vivo models • Experienced in managing a complex chain of vendors • From an exclusively virtual platform company to focusing on therapeutics development • 2 lead products in clinical and late-preclinical development • Analytics and companion assays ensure control over product quality • Risk over product manufacturing is mitigated with parallel suppliers • NRC acts as key wet-lab partner for platform and therapeutics development • Selecting a widely accepted cell line facilitates out-licensing and partnerships • Lessons Learned • US office to hire experts • Big name CMO does not guarantee success • Would keep biomanufacturing in Canada if requirements are met • Off shore challenges: - language barriers • - time zone differences - exposed IP / legal / geopolitical risks PDF presentation: add link

  12. Allison Hagerman, Oncolytics“It takes more than just good data - Validation of a Retrovirus Production Process” • Session: Success stories in biomanufacturing Intro and moderation by Nigel Shipston, Fujifilm Diosynth Biotechnologies • Oncolytics: a clinical stage Canadian biopharmaceutical company developing an immuno-oncolytic virus in Ph2 • Manufacturing should not be a limiting factor to bring a product to the clinic! • Major manufacturing effort: 4 production scales across 3 different CMOs • NRC: a troubleshooting power for technology transfer and analytical support • Difficulty in finding organizations combining production and good quality analytics • Good relationship with suppliers allows early pro-active detection of potential issues • In-house risk assessment of suppliers • To reduce risk: PLAN! PLAN! PLAN! • Lessons Learned • Do not underestimate the importance of analytics • Invest in relationship building • Good planning reduces risk PDF presentation: add link

  13. Andrew Booth, STEMCELL Technologies“STEMCELL Technologies: The Future of Canada’s Largest Biotech Company” • Session: Success stories in biomanufacturing Intro and moderation by Nigel Shipston, Fujifilm Diosynth Biotechnologies • Building business on scientific grounds - “Scientists helping scientists”: company’s motto since inception in 1993 • High Quality Control in reagents at the core of business model • Providing reference gold standard products: 2,500 different products on the market serving scientists in stem cell research • Keep control: 100% Canadian privately held company, owned by Founder/President & CEO • Forecast: $1B company by 2029. Aiming to be in every stem cell lab in the World • From lab stage clientele to now supporting 35 clients in clinical trials • Capacity expansion – new infrastructure project (Burnaby, BC) with Strategic Innovation Fund (SIF) support obtained to meet clients’ commercial needs • Lessons Learned • Be ambitious - A Canadian biotech can have a strong • international position • Client focus for success • Elaborate and sustain a strong in-house talent and career development program

  14. S U M M A R Y • Session: Success stories in biomanufacturing • Lack of capacity for complex biologics • Analytic support is underestimated • Risk assessment needed for Master Plan Manufacturing • Back-up redundancy required for production • Optimization can’t be rushed (repeatability is critical)

  15. Shay Power, IDA Ireland“The Grass is Greener in Ireland – Incentives to Build a World-Class Bioeconomy” • Session: Successes & challenges fr.bioeconomiesacross the World Intro and moderation by Fiona Fitzgerald, GE Healthcare • Manufacturing: centerpiece of Ireland’s biopharma strategy • Employment: 60,000 (50% highly educated) representing a 50-year journey • Recurring investments kept big pharma in Ireland while developing the life sciences industry • Major incentive of corporate taxes: 12.5% tax on manufacturing revenue, 25% R&D tax credit, 6.5% return on knowledge development • HQP training central for success - NIBRT model: exportable training module as franchise • 3 key agencies: Science Foundation Ireland, Industrial Development Authority (IDA), and Enterprise Ireland • Challenge: influencing investment to develop regions outside of the capital • Factories of the future: simulate and de-risk manufacturing • Lessons Learned • Long term commitment to bioeconomy should be independent from political cycles • Creating the right environment is key, including biomanufacturing infrastructure • Need to adapt to change for success! PDF presentation: add link

  16. Frank van Lier, National Research Council Canada“Canadian Consultation on Biomanufacturing” • Session: Successes & challenges fr.bioeconomiesacross the World Intro and moderation by Fiona Fitzgerald, GE Healthcare • 2016-2017 National biomanufacturing consultation: NRC & FBM joint effort • Rich Canadian pipeline: 71 institutions & 196 biologics in development • Biomanufacturing: Critical component of the value chain but still a gap in the Canadian ecosystem • NRC currently transfers its technology to foreign CMOs to support biotech clients due to lack of domestic capacity • Top recommendations: • Establish best practices for functional ecosystem: think global • Build a larger GMP biomanufacturing capacity: stickiness factor for the Canadian pipeline • Focus on people and talent at the center of the national biomanufacturing strategy • Build strong integrated biotech cluster • Lessons Learned • Canada lacks sufficient biomanufacturing capacity • Opportunity to build on existing biologics pipeline • Joint Industry and Government effort needed to develop biologics and manufacture in Canada PDF presentation: add link

  17. Dina Iezzi, Therapure“CanadianCase Study 1 - Therapure Biopharma” • Session: Successes & challenges fr.bioeconomiesacross the World Intro and moderation by Fiona Fitzgerald, GE Healthcare • Information on Therapure Biopharma can be found at: • http://www.therapurebio.com/

  18. Molly McGlaughlin, BioVectra“CanadianCase Study 2 - BioVectra” • Session: Successes & challenges from bioeconomies across the World Intro and moderation by Fiona Fitzgerald, GE Healthcare • Information on BioVectra can be found at: • http://www.biovectra.com/

  19. Christelle Fasano, Montréal International“Biomanufacturing: Québec’s Top Priority in Life Sciences” • Session: Successes & challenges fr.bioeconomies across the World Intro and moderation by Fiona Fitzgerald, GE Healthcare • 2018 Government of Québec’s Life Sciences strategy has a focus on biomanufacturing • Life Sciences sector in Québec represents 56,000 jobs, 80% of which are concentrated in Greater Montréal • Québec has a major talent pool: 30,000 graduates in STEM (Science, Technology, Engineering, Mathematics) fields in 2016, including 5,000 graduates from programs directly related to biomanufacturing • Long term strategy is in place to fast-track expansion of Life Sciences sector in Québec • Major government incentives are in place to attract foreign investments • Multi-departmental (incl. Government of Québec, Investissement Québec, Montréal International, Québec International) approach to attract best investment projects • Lessons Learned • Biomanufacturing is top priority of Québec’s Life Sciences strategy • Act locally to create the right ecosystem to attract international investments • Regional strategy should focus on attracting talent PDF presentation: add link

  20. Discussion and Q&AWhat are Canada’s key strengths? • Session: Successes & challenges fr.bioeconomies across the World Intro and moderation by Fiona Fitzgerald, GE Healthcare

  21. Discussion Panel HighlightsMain challenges identified • Session: Successes & challenges fr.bioeconomiesacross the World Intro and moderation by Fiona Fitzgerald, GE Healthcare • 1 in 14 molecules transfer to commercialization. Weak translation. • Attrition is not due to manufacturing issues but toxicity or lack of efficacy. • Cost of goods can be a limiting factor for good science. • How will disruptive technology impact? Adoption is always reduced to how to adapt with change and provide an ROI. • VC funding does not allow for optimization of process and cell line. This is a challenge for CDMO. • AI may be transformative but most SMEs are reluctant to change the process now. Should consider parallel for downstream processing. Big pharma will do it globally and smaller CDMOs will do it in smaller parts

  22. S U M M A R Y • Session: Successes & challenges from bioeconomies • across the World • Talent is present in Canada but we need to invest in it • CDMOs are present in Canada but investment is a barrier to expansion • CDMO clients are present but they are mostly international • Ireland built the right environment and can serve as a model for development • Long term commitment is needed to succeed • Variety of incentives must be present (tax, land, training, etc.) • Building a stronger ecosystem allows to fill existing gaps • Canadian disconnect: pharmaceutical manufacturing wages exceeds that of the automotive industry: further investment required in biomanufacturing infrastructure