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An Experience of International and Intersectoral Career Mobility

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Pre-clinical development. Regulatory submissions ... Knowledge of clinical trial design and regulatory issues ... Modules on clinical research strategies ... – PowerPoint PPT presentation

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Title: An Experience of International and Intersectoral Career Mobility


1
An Experience of International and Intersectoral
Career Mobility
  • Mary Murphy, PhD

2
Traditional Academic Scientist Career Format
  • Independent isolated laboratory
  • Leadership centers around individual PI
  • Small university departments devoted to a single
    discipline
  • Substantial teaching commitments
  • Individual investigator grant support for
    research
  • Early tenure
  • Expects to remain for life
  • Main reporting structure includes grant
    applications and peer-reviewed publications

3
Industry Scientist Career Format
  • Teambased approach
  • Role of individual scientist less important than
    the team
  • Crosses multiple disciplines
  • Heavy emphasis on strategic planning and project
    planning
  • Short reporting cycle (1 month)
  • Constant appraisal and reassessment
  • Frequent changes in direction
  • Subject to remote commercial pressures

4
The Academic Laboratory
  • Under full control of PI
  • Informal
  • Written laboratory notebooks
  • Frequent public disclosure at conferences, in
    theses and abstracts
  • Poor appreciation of the value of IP
  • Little attention to Standard Operating Protocols
  • Little attention to monthly reports
  • Hands-off approach by senior management
  • No application of Good Laboratory Practice
  • Often poor safety standards

5
The Industrial Laboratory
  • Matrix management, multiple reporting structures
  • Highly organised
  • Document control systems
  • Strong emphasis on protection of IP
  • Public disclosure only after patent filing
  • All procedures defined by Standard Operating
    Protocols
  • Multiple written reports (at least monthly)
  • Full compliance with GLP necessary
  • Strong emphasis on safety

6
University-Industry Partnership
  • Many scientists now move between industry and
    academia
  • University research must have industry relevance
    (SFI, IDA)
  • Traditional university department structure less
    relevant
  • Centre-like behaviour
  • Economic development depends on research having
    some industrial relevance
  • New metrics include patents filed,
    commercialization activities based on spin-off
    enterprise and technology licensing
  • Technology Transfer Office more relevant

7
International and Intersectoral
8
Academic Research Experience
  • Ireland
  • Small research groups
  • Little exposure to other research strands or
    collaborative research
  • Few post-doctoral researchers
  • Specific projects with limited development of
    skills
  • Few opportunities to develop presentation or
    report writing skills
  • Little input by clinicians

9
Academic Research Experience
  • US
  • Clustered research
  • Groups with broad range of skills
  • High proportion of postdoctoral researchers
  • Greater emphasis on presentations
  • Strong involvement of clinicians

10
Industrial Research Experience
  • Stem cell company start-up
  • Multi-tasking
  • Project-oriented with multidisciplinary group
  • Research
  • Quality assay development
  • Pre-clinical development
  • Regulatory submissions
  • Strong emphasis on IP but also publications and
    conference presentations
  • Grant-writing enabled and encouraged

11
Regenerative Medicine Institute (REMEDI)
  • Located at NUI, Galway and UCHG
  • Funded under SFI campus-industry partnership
    Centres for Science Engineering and Technology
    (CSET) programme
  • Vision
  • To develop a new and realisable paradigm for
    medicine in the future utilising minimally
    invasive therapeutic approaches to promote organ
    and tissue repair and regeneration rather than
    replacement
  • Stem cell and gene therapy

12
Bone Marrow Stem Cells
13
Stem Cell
14
REMEDI Programmes in Stem Cell Biology
  • Adult stem cells
  • Bone marrow
  • Adult peripheral blood
  • Cardiac stem cells
  • Umbilical cord blood
  • Adipose Tissue
  • Stem Cell Proteomics and Phage Display
  • Stem Cell Genomics
  • Transcription factors
  • Regulation of Differentiation
  • Stem cells in disease
  • Osteoarthritis
  • Type 1 diabetes

15
Target Research Areas in Stem Cell and Gene
Therapy
  • Cardiovascular diseases
  • Orthopaedic diseases
  • Pulmonary diseases
  • Neurological diseases
  • Basic stem cell biology
  • Gene vector development

16
REMEDI Partners
  • Medtronic
  • Cardiovascular diseases
  • Charles River BioLabs
  • Animal models of human disease

17
Regenerative Medicine Institute
Gene Therapy
Adult Stem Cell Therapy
Genomics
Basic Research
Immunology
Proteomics
Toxicology/Preclinical Testing
GMP Manufacturing
Clinical Development
Commercialization
18
Industry Partnerships and Knowledge Transfer at
REMEDI
  • Full partner involvement in drawing up research
    programme plans
  • Clear reporting structures
  • Involvement of the industry partners in REMEDI
    management activities
  • Quarterly detailed progress reports
  • Regular visits of REMEDI Directors to partner
    headquarters and vice versa
  • Partner membership of the REMEDI IP Advisory
    Committee and full access to information on
    invention disclosures and patent filings
  • Review of all manuscripts, abstracts, posters
    etc. prior to submission
  • A close and bilateral working relationship
    between REMEDI project scientists and partner
    scientists

19
RESEARCHER Skills for Industry
  • Skills that industry needs from researchers
    coming out of university
  • Broad skills base
  • Flexibility
  • Knowledge of GLP, GMP, Quality Issues
  • Understanding of Intellectual Property Issues
  • Knowledge of clinical trial design and regulatory
    issues
  • Good presentation skills to diverse audiences
  • Understanding of project-oriented management
  • Team-based
  • Deadline-oriented

20
Can Universities/Institutes meet this challenge?
  • More practical courses
  • Increase industrial placements
  • Team-based projects
  • Business modules in science degrees
  • IP
  • Project management techniques
  • Legal/regulatory affairs
  • Modules on clinical research strategies
  • Modules taught by industry leaders
  • Post-graduate entrepreneurial courses
  • Business writing courses

21
Universities/Institutes - Industry
  • Greater interaction/trust
  • Courses created after consultation
  • University/Industry/Clinicians
  • Constant feedback
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