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Module-2
GRANT PROPOSAL
ICRI
Mumbai.
Cranfield university.u.k
The development of an
unique integrated
DNA – Protein system
device (Biognosis) for early
detection of Breast Cancer in
females.
We and our Partners…
 Cranfield Health, UK : the master mind.
 Siemens : the device developer.
 Apothecaries Ltd, India : the trial conductor.
Facts and figures..
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.
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.
Our product
• The details.
Why you should be interested
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.
The trials…
 Study Duration: 1 year.
 Number of volunteers: 150.
 Ages Eligible for Study: 40 Years and
above.
 Genders Eligible for Study: Female.
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.
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
Time (months)→
Activities ↓
2
4
Device Development
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Protocol Development
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DCGI &
EC Approval
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Patient Recruitment
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Staff Recruitment
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6
8
10
12
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Control Group
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Treatment Group
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Baseline data collection
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Data Entry
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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.
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.
The money factor..
Direct Costs
Activities
R&D Cost
Device Cost
Recruitment Cost
Investigator’s Pay
Lab Charges
Insurance
Legal fees
Transportation
Documentation
Data Management
software
Cost/subje
ct
150£
200£
100£
90£
50£
Indirect Costs
Total
Cost
60,000£ Office Rent
Staff Salary
Courier Charges
Stationary
Contingency
OfficeEquipments
30,000£ Overheads
2000£
6000£
3000£
15,000£
5,00,000£
1000£
8000£
50,000£
12,000£
20,000£
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.