Module-2GRANT 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 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

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 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£

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.