Professor Timothy O'Brien discusses several themes in the document. He argues that Ireland working together as a single entity can have global impact in clinical translation, especially in medical device technology and regenerative medicine. He emphasizes that the needs of patients always come first and that Irish healthcare must contribute to economic recovery through innovation, job creation, and industry engagement. O'Brien also discusses the work done at NUI Galway in areas like regenerative medicine, stem cell research, and clinical research facilities. He advocates for Ireland presenting itself as a single entity for clinical research to attract industry partnerships.

1. Professor Timothy O’Brien MD, PhD, FRCPI, FRCP,
FACP
Professor of Medicine, NUI Galway
Consultant Endocrinologist, West Northwest Hospital Group
Director of REMEDI and CCMI,
Dean of the College of Medicine, Nursing and Health Sciences, NUI Galway
Research, Clinical Practice and
Service Delivery

2. Conflicts
• Founder, Director and Equity holder in
Orbsen Therapeutics

3. Theme 1
• Ireland working as a single entity can have global
impact in clinical translation in defined areas
• Medical Device Technology and Regenerative
Medicine

6. Theme 2
• The needs of the patient always come first
• State of the art clinical care
• Educate health care providers
• Create the clinical care of the future

7. Theme 3
• Irish healthcare system must contribute to
economic recovery through
• Innovation
• Job creation
• Industry engagement

8. healthcare
education
innovation research

9. Academic
Business Clinic

10. Innovation
• Definition: something new or different introduced
• From a clinical perspective one might add that it is
necessary for the invention to be useful and to
represent an advance in clinical practice
• Additionally for the innovation to have impact it
must be affordable
• Who should innovate? – all healthcare workers

11. Innovation will create conflict of interest
• Hospital groups need to have systems to
engage with industry
• IP policy – full time hospital staff versus
academic clinicians
• COI policy – disclosure and management
• Inventors and innovators should be
rewarded

12. Benefits that academic medicine bring to health
service (BMA)
• Critical appraisal
• Financial gains and economic growth
• New ideas, evidence and products
• Better patient care and decreased costs
• Direct benefits to patients treated
• Contribution to high quality clinical services
• Contribution to international health care

13. Principals underlying academic health science
centres (UK Government)
• Excellence in biomedical, clinical, and applied health
research
• International standing and critical mass
• Excellence in patient care
• Excellence in education
• Partnerships for delivery benefits in patient care

14. Expertise - Access to clinical specialists and networks
- Clinical trial management
- Research nursing support
- Biostatistical and methodological support on study design and analysis
- Data management and IT support
Clinical Research Facility
CRFG provides the infrastructure,
physical space, facilities, expertise and
culture needed to optimally support
patient-focused research studies and
clinical studies
The CRFG has a very experienced
leadership team with extensive
international pre-clinical, translational,
and clinical research experience allied to
global regulatory and reimbursement
achievements.

15. NUI Galway infrastructure

16. Major priority for enhancing clinical
research in Ireland
• Ireland needs to present itself as a single
entity for clinical research
• CRFs linked to health care facilities
• Single point of entry for industry
• Distributive model

17. Distributive Model
• All centres capable of performing high
quality clinical research
• Biobanking
• Biometrics
• Education and Competence
• Study management and quality

18. Regenerative Medicine
• Aims to augment, repair, replace or
regenerate organs and tissues that have
been damaged by disease, injury or natural
aging
• It represents a new paradigm in human
health with the potential to resolve unmet
medical needs by addressing the
underlying causes of diseaseAlliance for Regenerative Medicine Annual Report 2012-13

19. New paradigm
• Most therapies today focus on the delay of
disease progression and prevention of
associated complications
• Regenerative medicine is an
interdisciplinary field translating basic
science into regenerative technologies

20. Healthcare Challenges
• Increasing cost ($3 trillion to $6 trillion in
the USA over the next 20 years)
• Increasing cost is not only due to
technology but is also due to
demographics and the aging population
• Increase in chronic disease burden
• Many conditions of unmet medical need

21. Healthcare Spending
• 75% on chronic diseases
• WHO have defined chronic disease as the
priority of the century
• 60% occurs in the last year of life

22. Aging
• Aging is associated with many
degenerative diseases
• Regenerative Medicine has the potential to
restore the patient with chronic disease to
health

23. Regenerative Medicine Needs
• Advances in fundamental science – multidisciplinary
and may be on the borders of traditional disciplines
• Clinical trials – demonstrate a major clinically
meaningful benefit
• Industrialization of product manufacture
• Innovative regulatory strategies
• Innovative business models and re-imbursement
strategies
• Demonstrate cost saving through robust health
economic analysis

24. Expertise - Cell therapies for vascular and arthritic diseases
- Cell manufacturing and bioprocessing - Medical devices
- Basic stem cell biology - Flow cytometry
- Biomaterials - Immunology
- Translational research - Gene therapy
Infrastructure - Fully Equipped Pre-Clinical Facility
- Centre for Cell Manufacturing Ireland (GMP-compliant cell manufacturing)
- Flow Cytometry Core (Facs Canto and Aria, Guava etc)
- Histology Core
- Microscopy Core (TEM, confocal, etc)
- Tissue Culture Core
- Gene Vector Core
- Clinical Research Facility
Key Research - Patented technologies including novel therapeutics for vascular disease, antibodies for
stem cell isolation and devices for stem cell delivery
- Established Orbsen Therapeutics to commercialise REMEDI technology
- Five EU FP7-funded projects
- >550 publications and 25,000 citations since 2004.
The Regenerative Medicine Institute
(REMEDI)

25. Expertise - Adult stem cells, mesenchymal stem cells (MSCs) in particular
- Induced pluripotent stem cells
- Serum-free culture media - Developmental biology
- Regulation and commitment - Stem cell host interactions
Stem Cell Biology
MSC –stimulated cardiac repair
Use of iPSCs in
human disease
modelling e.g.
schizophrenia
Differing osteogenic
potential of sorted
clones from one cell
line
MSCs cultivated in different media. a) 2% FCS
media supplemented with EGF and PDGF (b)
10% FCS media supplemented with FGF-2
www.purstem.eu

26. Expertise - Preclinical models, small and large animal
- Cardiovascular and peripheral vascular disease
- Patented angiogenic molecules
- Patented “next generation” stem cells
- Stem cell homing and tracking
Cell Therapy for Vascular Disease
MSCs increase blood
flow in ischemic
limbs of diabetic
mice
Blood flow restoration
Therapeutic Approach:
MSCs
Porcine acute
myocardial infarct
Acute Infarct
Region
Diabetic mouse (left)
Normal mouse (right)

27. Expertise - Good manufacturing practice
- Cell processing including isolation, expansion, characterisation
- Clinical trials
- Media formulation
- Cleanrooms
Cell Manufacturing (CCMI)
The CCMI is a versatile cleanroom with standout
features including two parallel production
suites. Each of the two suites is capable of clinical
grade manufacturing of cellular therapy products
and small molecules for therapeutic applications.
CCMI are very interested in discussing
opportunities with clients interested in
procuring human GMP-grade
mesenchymal stem cells or a custom
manufacturing service

28. REMEDI – International Academic Network
Mayo Clinic
Arizona
Cleveland
Georgia Tech
Barcelona
Gustafe-Roussy
Leeds
Newcastle
Edinburgh Genoa
Toronto
Singapore
Xian
Shanghai
Rotterdam
Israel
Lithuania
published with authors from 197 other institutions worldwide
published with over 895 authors nationally and internationally
published with authors from 20 different countries worldwide
REMEDI Investigators
have:

29. “Delivercell”
“Osteocoat”
“Cell Enhance”
“Chondroscaff”
“Angiocell”
“Angiocap”

30. Orbsen Therapeutics
1. Human ORB1+MSC: best-in-class stromal cell purification for therapeutic
use – two patents generating over €1M in private equity
• 2. Leveraged private equity to generate €20M in R&D funding from non-
exchequer (FP7) sources
• Orbsen - €2.7M from EU FP7 awards; NUI Galway – €2.5 in funding from Orbsen
collabtorations Orbsen. Ireland – Over €6.1M to Irish FP7 Partners. EU and USA –
Over €20M for all FP7 partners
• 3. Top 15 Irish companies in the EU FP7 : 55% success rate
• 4. Employment for highly-skilled Irish Graduates :Company has grown from 1
FTE to 16 FTE in 18 months. Hired 9 Irish Graduates on 3 year contracts
• 5. The Irish Times InterTradeIreland Innovation Awards 2014 : Short-listed to
Top 18 Innovations in Ireland
• 6. Three FP7-funded Clinical trials testing CD362+MSC : 2015 – Phase 1b trial -
REDDSTAR FP7; 2016 – Phase 2a trial - MERLIN FP7; 2017 – Phase 1b trial -
VISICORT FP7

31. CURAM
• National Centre for Medical Device
Research

32. Team

33. Industry
Partner
s
26 SMEs
3 Start-Ups
13 MNC’s

34. Research Programme

35. Trainingand
Education

36. Key Performance Indicators
KPIs
Academic
Outputs
Human
Capital
Commercialisation
New TreatmentsFunding

37. Conclusion
• Affordable innovation is crucial to contain
the future costs of healthcare
• The focus should be on the development of
more effective treatments of chronic and
burdensome diseases
• Progress will involve partnership between
hospital, academia and industry.
• Ireland should function as a single entity in
translational medicine