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ICRIN/ IMDA Clinical Investigations Conference

ICRIN/ IMDA Clinical Investigations Conference. MitaMed- Our Journey to Commercialisation Michael Loftus CEO Sept 13 th , 2012. CANCER THERAPIES. Objective : To develop a minimally invasive tool for targeted tumour resolution.

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ICRIN/ IMDA Clinical Investigations Conference

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  1. ICRIN/ IMDA Clinical Investigations Conference MitaMed- Our Journey to Commercialisation Michael Loftus CEO Sept 13th, 2012

  2. CANCER THERAPIES Objective: To develop a minimally invasive tool for targeted tumour resolution. Solution: A medical device that electroporates tissue enabling the targeted and enhanced delivery of chemotherapy drugs.

  3. Combination Produces Best Result • EP Alone: No Effect • Bleomycin Alone: No Effect Soden et al., Cancer Letters 2005

  4. Clinical Efficacy • After treatment a crust will form • Needle marks in normal tissue show selectivity of the method. • Healing time approx. 10 weeks.

  5. Inoperable Merkel Cell Carcinoma + 6 months + 2 years Day 0

  6. Canine Colorectal Tumour Day 0 Day 15 Day 34 Day 235

  7. Pathology Report:

  8. The Journey to Date • General Assessment of Suitable IP in Research Centres • Of interest to me • Of interest to the market • Readiness • Engagement with EI • Engagement with TTO • Licence and Shareholder agreements • Spinout • Clinical Engagement • Clinical Investigations • External Funding • Market Penetration

  9. From Concept to Commercialisation State Funding Valley of Death Private Funding

  10. Timing of Funding

  11. Lessons Learned • Ireland- The Low Cost Option for Start-Ups? • Support mechanisms are available • E.g. ICORG; MMI; EI; Access to hospitals; • Treated as pre-commercial support in Ireland Vs commercial contract when abroad • Lower cost Vs longer time is a trade-off.

  12. Lessons Learned • Ireland- Is our Infrastructure Sophisticated? • World class elements across the entire infrastructure • Available aid is not always apparent • Pricing discrepancies portray wide range in interpretation of requirements • E.g. Requirements for CE; Documentation • Need clarity on methods/ interpretation • E.g. Use of templates; Number of patients for the investigation • Scale- availability of patients, resources, funding • Clinical engagement is personal

  13. Lessons Learned • The Regulatory Path • Clarity on the relevant standards is there • Application of standards is open to interpretation • Clinical endorsement Vs Regulatory approval

  14. If Ireland Inc. was a Company… • Write and publish an SOP on how to do Clinical Investigations in Ireland • Steps; sequence; level of detail; deliverables; etc • Use templates, standardised methods • Start with the final destination in mind • Document clinical evidence from the outset in an approved manner • Lean the approval process- centralise where possible • E.g. ethics approval; pre-approved CoE’s • Central resource to offer guidance and linkages

  15. Thanks to… • Enterprise Ireland/ HRB • IMB • MMI • Clinicians • ICORG • Contacts/ IMDA • Infrastructure of companies m.loftus@mitamed.com

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