Table of contents Slide Topic 3 Recap of National Biomanufacturing Consultation 6 2018 National Biomanufacturing Summit Agenda 7 Session Innovative production technologies James Piret ID: 754866
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Slide1
2018 NATIONAL BIOMANUFACTURING SUMMIT REPORTSlide2
Table of contents
Slide
Topic
3
Recap of National Biomanufacturing Consultation
6
2018 National Biomanufacturing Summit Agenda
7
Session: Innovative production technologies
James
Piret
,
The University of British Columbia
Rénald Gilbert, National Research Council Canada
Alain
Doucet
,
Medicago
Summary
11
Session: Success stories in biomanufacturing
David Poon,
Zymeworks
Allison Hagerman,
Oncolytics
Andrew Booth, STEMCELL Technologies
Summary
15
Session: Successes and challenges from bioeconomies across the world
Shay Power, IDA Ireland
Frank Van Lier, National Research Council Canada
Dina Iezzi,
Therapure
Biopharma
Molly S.
McGlaughlin
,
BioVectra
Christelle Fasano, Montréal International
Q&A
SummarySlide3
Background
FBM’s National Consultation on Biomanufacturing
Montréal Dec 7, 2016 86 participantsToronto Feb 23, 2017 68 participantsVancouver March 23, 2017 60 participants
214
participants
600+
individual stakeholders
World
Café discussions
36
1
National map of stakeholders (biotechs, CMOs, VCs,
gov
, etc.)
6
High profile and international speakers
1,000+
Lines of comments capturedSlide4
From consultation to strategy
4 ISSUES IDENTIFIED DURING CONSULTATION
Biotech support ecosystemInfrastructure and production capacitySpecialized training Bridging funding to support biotechs to biomanufacture locallyNext steps…Supporting projects to address 4 key issuesAim to position biomanufacturing as a cornerstone of the Canadian biotech ecosystem
Maintain national dialog on biomanufacturingSlide5
ASSOCIATIONS + GOV
Ultimate goal:
Canadian Biotech Industry : Create One Integrated Cluster
BIOTECHS
CMOs
+
CROs + SUPPLIERS
RM HOSPITALS
BC HUB
Integrate the Canadian biotech industry into a
functional cluster unified by biomanufacturing
QC HUB
ONTARIO HUBSlide6
Agenda – August 15
th
2018, MontréalNational Biomanufacturing Summit: 3 sessionsInnovative production technologiesEric Jervis, STEMCELL Technologies
Success
stories in biomanufacturing
Nigel Shipston, Fujifilm Diosynth Biotechnologies
Successes
and challenges from bioeconomies across the
world
Fiona
Fitzgerald, GE
Healthcare
Moderated by
Moderated by
Moderated by
James Piret, UBC
Technologies Tailored to Address Cell Therapy Bioprocess Challenges
Rénald Gilbert, NRC
Viral Vector
P
roduction for Cell and Gene
T
herapy
Alain
Doucet
,
Medicago
Transforming The Approach to Vaccines and Protein-Based Therapeutics
David Poon, Zymeworks The Zymeworks Journey - From Computational Modeling to Clinical DevelopmentAllison Hagerman, Oncolytics
It takes more than just good data - Validation of a Retrovirus Production ProcessAndrew 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 BioeconomyFrank Van Lier, NRCCanadian Consultation on BiomanufacturingDina Iezzi, Therapure BiopharmaCanadian Case Study 1 – Therapure BiopharmaMolly S. McGlaughlin, BioVectraCanadian Case Study 2 - BioVectraChristelle Fasano, Montréal International Biomanufacturing: Quebec’’s Top Priority in Life SciencesSlide7
James Piret, The University of British Columbia
“
Technologies Tailored to Address Cell Therapy Bioprocess Challenges”Evolution from manufacturing therapeutic proteins to now cells for therapyNovel cell therapies have the potential to increase cancer treatment efficacy vs existing therapies. Challenges include high cost and industrializationBiomanufacturing a crucial step needed to propel cell therapy forwardWhereas protein biologics manufactured in tanks up to 20,000 L, new challenges for cell therapy manufacturing often down to ~1 LAdvancements in acoustic device for perfusion, cell washing and concentration to enable closed system manufacturingRaman spectroscopy a means to monitor the reproducibility of manufacturing process and cell therapy productsChallenges 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
Intro and moderation by Eric Jervis, STEMCELL Technologies
Session: Innovative Production TechnologiesSlide8
Rénald Gilbert, National Research Council Canada
“
Viral Vector Production for Cell and Gene Therapy”NRC is a major player in viral vector bioprocesses and technologyViral 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: 1
st 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: 1st
CAR-T therapy treatment
approved:
Kymriah
(lymphoma)
and
Yeskarta
(lymphoma)
HEK293: 1998: expression
platform patented at NRC; 2003: cGMP cell bank; 2015: scaled up to 500LImprovements: plasmid packaging and improvement of LV purification process Lessons LearnedNRC is a Canadian provider of cGMP HEK cells for viral vector production (both AAV and LV)AAV and LV both require mammalian cells for productionNext generation of HEK293 cells will integrate multi-plasmid packaging systemIntro and moderation by Eric Jervis, STEMCELL Technologies
Session: Innovative production technologiesPDF presentation: add linkSlide9
Alain Doucet,
Medicago
“Transforming The Approach to Vaccines and Protein-Based Therapeutics”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 vaccinesCompetitive
advantages
of
Medicago’s
plant-based platform
Rapid - Clinical grade material in 5-6
weeks
Accurate - No risk of mutation in
plantsVersatile - 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
Intro and moderation by Eric Jervis, STEMCELL Technologies
Session: Innovative
production technologies
PDF presentation:
add
linkSlide10
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
n
etwork groups research centres
, hospitals,
and academic institutions but currently lacks sufficient biomanufacturing capacity to propel clinical development forward and efficiently treat Canadians
S U M M A R Y
Session:
Innovative production technologiesSlide11
David Poon, Zymeworks“
The Zymeworks Journey - From Computational Modeling to Clinical Development
”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-houseExternal work range from gene synthesis, Ab production & in vivo modelsExperienced in managing a complex chain of vendorsFrom an exclusively virtual platform company to focusing on therapeutics development2 lead products in clinical and late-preclinical developmentAnalytics 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 developmentSelecting 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
Intro and moderation by Nigel
Shipston
, Fujifilm
Diosynth
Biotechnologies
PDF presentation:
add link
Session: Success stories in biomanufacturingSlide12
Allison Hagerman, Oncolytics
“
It takes more than just good data - Validation of a Retrovirus Production Process”Oncolytics: a clinical stage Canadian biopharmaceutical company developing an immuno-oncolytic virus in Ph2Manufacturing should not be a limiting factor to bring a product to the clinic!Major manufacturing effort: 4 production scales across 3 different CMOsNRC: a troubleshooting power for technology
transfer and analytical supportDifficulty 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 analyticsInvest in relationship
building
Good planning reduces risk
Intro and moderation by Nigel
Shipston
,
Fujifilm
Diosynth
Biotechnologies
PDF presentation:
add
link
Session: Success stories in biomanufacturingSlide13
Andrew Booth, STEMCELL Technologies
“
STEMCELL Technologies: The Future of Canada’s Largest Biotech Company”Building business on scientific grounds - “Scientists helping scientists”: company’s motto since inception in 1993High Quality Control in reagents at the core of business modelProviding 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 & CEOForecast: $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 positionClient focus for success
Elaborate and sustain a strong in-house talent and career development program
Intro and moderation by Nigel Shipston
, Fujifilm Diosynth Biotechnologies
Session:
Success stories in biomanufacturingSlide14
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)
S U M M A R Y
Session:
Success stories in
biomanufacturingSlide15
Manufacturing: centerpiece of Ireland’s
biopharma
strategyEmployment: 60,000 (50% highly educated) representing a 50-year journeyRecurring investments kept big pharma in Ireland while developing the life sciences industryMajor 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 IrelandChallenge: influencing investment to develop
regions outside of the
capitalFactories of the future: simulate
and de-risk manufacturingLessons 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
!
Intro and moderation by
Fiona Fitzgerald, GE Healthcare
PDF presentation:
add
linkSession: Successes & challenges fr. bioeconomies across the WorldShay Power, IDA Ireland“The Grass is Greener in Ireland – Incentives to Build a World-Class Bioeconomy”Slide16
2016-2017 National biomanufacturing consultation: NRC &
FBM joint effort
Rich Canadian pipeline: 71 institutions & 196 biologics in developmentBiomanufacturing: Critical component of the value chain but still a gap in the Canadian ecosystemNRC 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
LearnedCanada
lacks sufficient biomanufacturing capacity
Opportunity to build on existing biologics pipeline
Joint Industry and Government effort needed to develop biologics and manufacture in Canada
Intro and moderation by
Fiona Fitzgerald, GE Healthcare
PDF presentation:
add
link
Session:
Successes
& challenges
fr. bioeconomies across the WorldFrank van Lier, National Research Council Canada“Canadian Consultation on Biomanufacturing”Slide17
Information on
Therapure
Biopharma can be found at:http://www.therapurebio.com/Intro and moderation by Fiona Fitzgerald, GE Healthcare
Session:
Successes
& challenges
fr.
bioeconomies
across
the
World
Dina Iezzi, Therapure
“
Canadian
Case Study 1 - Therapure Biopharma”Slide18
Information on
BioVectra
can be found at:http://www.biovectra.com/Intro and moderation by Fiona Fitzgerald, GE Healthcare
Session:
Successes
& challenges from
bioeconomies
across
the
World
Molly McGlaughlin, BioVectra
“
Canadian
Case Study 2 - BioVectra
”Slide19
2018 Government of Qu
é
bec’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 MontréalQuébec 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
Intro and moderation by
Fiona Fitzgerald, GE Healthcare
PDF presentation:
add linkSession: Successes & challenges fr. bioeconomies across the WorldChristelle Fasano, Montréal International“Biomanufacturing: Québec’s Top Priority in Life Sciences”Slide20
Intro and moderation by
Fiona Fitzgerald, GE Healthcare
Session:
Successes
& challenges
fr.
bioeconomies
across
the
World
Discussion and Q&AWhat are Canada’s key strengths?
Molly S.
McGlaughlin
,
BioVectra
Dina
Iezzi,
Therapure
Biopharma
Competitive cost of labor
Lower cost of utilities
Talent follows the opportunity
Regulatory system is proactive and harmonized with EU.
Tax
credits as incentives
Global access to Toronto, well positioned to attract clientsMulti-culturally inclusive environmentChallenges include cost of infrastructure prior to revenue generation, while lack of investments is limiting growthFiona Fitzgerald, GE Healthcare
Frank Van Lier, NRCStrong pipeline and a collaborative ecosystemUnique expertise (cell lines and gene therapy)Talent and strong hubs in Canada.Slide21
Intro and moderation by
Fiona Fitzgerald, GE Healthcare
Session:
Successes
& challenges
fr.
bioeconomies
across
the World
Discussion Panel HighlightsMain challenges identified
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 partsSlide22
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
S U M M A R Y
Session:
Successes &
challenges
from
bioeconomies
across
the World