grant proposal
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Transcript grant proposal
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
Protocol Development
DCGI &
EC Approval
Patient Recruitment
Staff Recruitment
6
8
10
12
Control Group
Treatment Group
Baseline data collection
Data Entry
Data Analysis
Documentation
Feed Back
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.