module-2 grant proposal icri mumbai. cranfield university.u.k
TRANSCRIPT
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Module-2GRANT PROPOSAL
ICRI
Mumbai.Cranfield university.u.k
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The development of an unique integrated DNA – Protein system device (Biognosis) for
early detection of Breast Cancer in
females.
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We and our Partners…
Cranfield Health, UK : the master mind.
Siemens : the device developer.
Apothecaries Ltd, India : the trial conductor.
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Facts and figures..
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Facts and figures..
One out of every eight women is diagnosed with breast cancer.
the number one leading cause of death for women ages 40-44 years old.
It can be detected by self examinations and mammograms.
Till date there is no availability of a good, cheap, & quick diagnostic equipments.
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Simpler, quicker and cheaper.
• Biognosis, a unique, integrated DNA – Protein system device for applications in medical diagnostics .
• cost effective, easy to handle, minimally invasive, fast and reliable .
point of care and doctor’s office applications, e.g. early cancer recognition.
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Our product
• The details.
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Why you should be interested
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The trials…
Study Centre: TIFR (TATA Institute of fundamental research), Navi Mumbai, Maharashtra.
Study Design: Comparative Randomized
Trial, Safety/Efficacy Study. Primary Outcome Measures: To evaluate the
safety and to determine the efficacy of the tool.
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The trials…
Study Duration: 1 year. Number of volunteers: 150. Ages Eligible for Study: 40 Years and
above. Genders Eligible for Study: Female.
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The trials…
Milestones: Preclinical studies including invitro and invivo studies suggest that the device is 100% effective in detecting cancerous oncogenes as compared to other devices.
Assays for cancer diagnosis via DNA or marker proteins demonstrated.
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The final results.
Detection before progression to advanced stage.
Easy distinction between aggressive and harmless lesions.
Low rate of “false positive” and “false negative” tests
Inexpensive and accepted by population
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Time (months)→Activities ↓
2 4 6 8 10 12
Device Development
Protocol Development
DCGI &EC Approval
Patient Recruitment
Staff Recruitment
Control Group
Treatment Group
Baseline data collection
Data Entry
Data Analysis
Documentation
Feed Back
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Contingency Planning
Protocol Amendment.Change of investigator.Site accident.Device Inventory.ADRS observed in patients.Patient Retention.Staff retention.
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Risk Management:
• Insurance.• Any mishaps such as accidents, or natural calamity
issue etc will be dealt and will be dully compensated as mentioned in the policy.
• No risk involved during the trial of the medical device, except for the chance of infection while doing the blood test.
• If needed a separate department of risk management group will be formed.
• Acute precaution is taken for the preservation of data.
• Confidentiality is maintained at all costs.
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The money factor..
Direct Costs Indirect CostsActivities Cost/
subjectTotal
Cost
R&D CostDevice CostRecruitment CostInvestigator’s PayLab ChargesInsuranceLegal feesTransportationDocumentationData Management
software
150£200£100£90£50£
60,000£
30,000£2000£6000£3000£
Office RentStaff SalaryCourier ChargesStationaryContingencyOfficeEquipmentsOverheads
15,000£5,00,000£1000£8000£50,000£12,000£20,000£
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The money factor..
• The approximate budget estimated is 7,96,090£ approximately .
Where!• Apothecaries Ltd., India - 20% of Funds • Siemens., U.K - 30% of Funds .• Cranfiled Health, U.K. - 30% of Funds.
And• The remaining 20% (1,59,218£.approximately)
is the needed fund.
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