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..

 One out of every eight women is diagnosed with breast cancer.  the number one leading cause of death for women ages 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 ↓ 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 CostsIndirect Costs ActivitiesCost/subje ct Total Cost R&D Cost Device Cost Recruitment Cost Investigator’s Pay Lab Charges Insurance Legal fees Transportation Documentation Data Management software 150£ 200£ 100£ 90£ 50£ 60,000£ 30,000£ 2000£ 6000£ 3000£ Office Rent Staff Salary Courier Charges Stationary Contingency OfficeEquipments Overheads 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.