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www.regmed.be
RegMed
Building a regional ecosystem for
regenerative medicine
Dr.ir. Jan Schrooten
RegMed Coordinator
Co-Founder & Managing Director Antleron
IP & Regulation Workshop, Leuven (B), March 20, 2015
www.regmed.be
The stem cell claim
• Regenerate defected & diseased tissues/organs
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www.regmed.be
Spare parts for your body
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www.regmed.be
Hype to reality
• 3D (bio) printing
• Stem cells
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Regmed product forecast
• Order of appearance commercial regenerative medicine products
• Orthopaedics
• Cardiology
• Wound healing
• Diabetes
• Neurodegenerative diseases
• 2 to 5 years - Complex skin, cartilage & bone substitutes
• 5 to 10 years - Tissue and organ patches to regenerate damaged tissues and organs (heart & kidneys)
• < 20 years - ‘tissues on demand’ is realistic with continued public funding and support
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MaRS Report Regenerative Medicine, Industry Briefing, 2009
www.regmed.be
What needs, what cells & how many?
Simaria AS. et al, Allogeneic Cell Therapy Bioprocess Economics and Optimization: Single-Use Cell
Expansion Technologies, Biotechnology & Bio-Engineering, 2013
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www.regmed.be
CoG stem cell processing
Simaria AS. et al, Allogeneic Cell Therapy Bioprocess Economics and Optimization: Single-Use Cell Expansion
Technologies, Biotechnology & Bio-Engineering, 2013
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www.regmed.be
Health economicsCase: Reconstruction versus amputation
• > €10k per surgery
direct cost
• Amputations generate
$350k long term social
health care costs
• Need for more cost
effectiveness & utility
analyses of existing
treatments to decide on
novel treatments
• Define niche markets
for regmed therapies2Y Lifetime
$91k
$509k
$81k
$163k
MacKenzie et al., JBJS, 2007
∆ = $346k
∆ = -$10k
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www.regmed.be
Advanced Therapy Medicinal Product
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www.regmed.be
Blueprint for living implants
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www.regmed.be
White paper - Hurdles & challenges
cell-based advanced therapies in EU
• National hurdles, harmonisation
• Hospital exemption, national and subnational differences
• Reimbursement
• Knowledge on the mode of action
• Predictive preclinical efficacy and safety testing
• Need for innovative systems for preclinical testing
• Product characterisation and product potency
• Manufacturing with cost of goods (CoG) in mind
• Clinical trials: design and outcomes
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www.regmed.be
Regional RegMed ecosystem
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www.regmed.be
RegMed Innovation platform
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• 25+ community members and growing
• Goal• Strengthen leading position
• Create added value for regional players
• Develop new activities within & outside region
• Strategy• Build community
• Become regional RegMed catalyst
• Stimulate collaboration
• Complete RegMed value chain
• Sustainable & integrated approach
• Socio-economical ROI
• From lab to patient
www.regmed.be
Regional USP
Regenererative
Medicine
Research initiatives
CELLS
BIOMATERIALS
Tissue & organ
manufacturing
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www.regmed.be
RegMed KPIs
• White paper(s) ‘Regional regenerative ecosystem’
• Strategy for multi-disciplinary accelerator
• Concepts for new business models and financing
• Start-up of follow-on projects (a.o. Interreg, EFRO, bilateral)
• Start-up of collaborations between commmunity members
• Set-up of 'Open Access Lab' for collaborative proof-of-concept testing
• Attrack new stakeholders
• Dissemination• Regional branding, translation to Flemish and international level,
awareness to general public, patient organisations, ...
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www.regmed.be
Ongoing community projects
• Demo projects – technology validation• Lens Free Imaging
• Bioreactor monitoring & control
• Value chain roadmap for 3D printing in hospitals
• From 3D printed personalised guides / metal implants to 3D bioprinted ATMPs (‘living implants’)
• Translational & interregional networking and dissemination
• Lab to patient
• Academic research
• R&D, industrialisation
• Clinical practice
• General public
• Governments, policy
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www.regmed.be
Seminars & workshops
• Customised for and by RegMed community
• IP & Regulation workshop – March 20, 2015• Joint event at Belgium Symposium on Tissue Engineering
(BSTE 2015) – March 19-20, 2015, Leuven, Belgium
• Patenting strategies
• Regulatory challenges
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www.regmed.be
Contact
• www.regmed.be
• Coordination• [email protected]
• +32 (0) 494 91 47 74
• www.antleron.com
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