G7 PRE-ECLAMPSIA DIAGNOSTIC DEVICE - DEVELOPMENT

AND IP COST.

Signed & Approved byCEO- Vinie Varkie

General Manager- Shrishti Jain.

Chief Business Strategist- Igwe Daniels

Chief Scientific Officer- Helena Gwani

Operating Manager- Priyesh Waghmare

Marketing Manager- Ayo Awosusi.

Contento Introduction

o Company Profile

o Salary Distribution

o Gantt Chart

o Quality Control

o IP status

o Internal Management Systems policy

o Registration for ISO 13485

o CE marking 7rocessNow is the future… lol.

IntroductionPre- Eclampsia

Globally,

• 10% of all pregnancies

• 12% of maternal deaths

• 1/3rd of pre mature births

Causes:

• Damage to the blood vessels

• Insufficient blood flow to the uterus

Symptoms:

• Rising High blood pressure

• High protein levels in the urine

• Severe headache

• Visual Disturbances

G7 DIAGNOSTICS

Market need

12% of maternal deaths

Our market research reveals:There is no clinically useful screening test to predict the development of preeclampsia in either low-risk or high-

risk populations.

Global prevalence of pre-eclampsia

G7 DIAGNOSTICS

Company profile

Research and Development

• Chief Scientific Officer

• Scientists (PhD, B.Sc)

Operations(Process Development)

• Scientists (PhD, B.Sc)

• General Manager

• Assistant

Business Development

• Market Research analyst

• Business development analyst

Administration and Finance

• Chief Executive Officer

• Finance Manager

Quality Systems• Quality

Assurance engineer

• Quality Control engineer

• Documentation specialist

• Validation engineer

Salary Distribution (pre-clinical trials)Role Number Work Status Salary (GBP p.a.)

1.DevelopmentChief Scientific Officer 1 1 day/ week 15,000Scientists (PhD) 2 Full-time 30,000

2. Operations (Process Development)Scientists (PhD) same as above _ _Scientists (B.Sc) 1 Full-time 25,000General Manager 1 Full-time 60,000

3. Business DevelopmentBusiness Development analyst 1 2 days/ week 30,000Market Research analyst 1 2days/ week 12,000

4. Administration and FinanceChief Executive Officer 1 1 day/week 18,000Finance Manager 1 1 day/week 12,000

5. Quality SystemsQuality Assurance engineer Scientist (B.Sc.) _ _Quality Control engineer 1 1 day/ week 17,500Documentation specialist 1 1 day/ week 12,500Validation engineer 1 1 day/ week 15,000

PRODUCT DEVELOPMENT - GANTT CHART

Planning

ManufacturingSpecification

Process designProduct design

Production of 2040 stripsProduction of 50 meters

Quality ControlVerification

ValidationFeedback

Legal

20-Jan-11 11-Mar-11 30-Apr-11 19-Jun-11 08-Aug-11 27-Sep-11 16-Nov-11 05-Jan-12

30

30

60

60

30

30

20

30

30

365

File Patent PCT

Development phase: Gantt chart

G7 DIAGNOSTICS

S.No. Tasks Start Date Duration (days) End Date Cost involved (£'000) 1 Planning 20/01/2011 30 19/02/2011 10 2 Manufacturing Specification 20/02/2011 30 22/03/2011

350 Process design 23/03/2011 60 22/05/2011 Product design 23/05/2011 60 22/07/2011 86 Production of 2040 strips 13/10/2011 30 12/11/2011 51 Production of 50 meters 13/11/2011 30 13/12/2011 400 3 Quality Control Verification 22/07/2011 20 11/08/2011

80 Validation 12/08/2011 30 11/09/2011 Feedback 12/09/2011 30 12/10/2011 4 Legal 20/01/2011 365 20/01/2012 80 filing a patent licencing liability

therapeutical consequences reliability of results 5 Salary 247 Total 1,304

Gantt chart

• The research phase is not considered

• Production of equipment and strips subcontracted

• The respective subcontractors follow standard procedures and are ISO13485 registered

G7 DIAGNOSTICS

Quality Control System(Validation and Verification)

G7 DIAGNOSTICS.COM

Selectivity 95%

Specificity 95%

Reproducibility 91%

Storage conditions 20°C

Heat stability 15°C – 30°C

Being spot-on at quality is always an issue at G7…

IP StatusPatent No. Title Inventor Applicant

GB 2464222 Analysis method and device.

Bolbot, J. A. (2010)

Inverness Medical Switzerland Gmbh

EP 1175940 Diagnostic devices and apparatus for the controlled movement of reagents without membranes.

Beuchler, K. A. (2002)

Biosite Diagnostics Inc.

G7 DIAGNOSTICS.COM

G7 Diagnostics internal management system policy

“…policy shows the commitment of the company as it encompasses quality, environmental management and safety measures which the company holds in high esteem.”

Registration for ISO 13485

Review of Internal Quality Management system policy

Hold meetings within Quality System team:•Objectives of ISO 13485•Medical Device regulations•Coach members across functional departments

Conduct internal audits and spot checks

Audit by (external) notified body

CE Marking Process

G7 pre-Eclampsia strip and meter

Full quality assurance system (Annex II)

The notifying body will assess and monitor our quality system

“ … acquisition of the CE Marking is very important in boosting our chances of increasing sales especially considering the stringent rules by which hospitals (our target market) operates…”

Technical file

• Intended use of the test: early detection of pre-eclempsia

• Indication for use: Week 12 and week 19 of gestation period

Quality Management Systems certification

Product Classification: Annex II List B (non-self testing)

Declaration of conformity (Annex III)

Aiming at European Market Acceptance:– ISO 13485– CE marking

Technical file: Equipment specification1- Power Button

2- LCD (liquid crystal display)

3- Thermal Printer

4- Printer Cover

5- Diagnostic Device Insertion Point

6- Power Supply Connection

7- Data Connection

8- Printer

9- Battery Cover

10- Code Chip Port

Meter specifications Physical

Size Diameter 8.5" , Weight 6.25", Height 2.75"

Weight1.5 pounds without batteries; 1.6 lbs with batteries

Keypad 12 numeric keys, 10 function keys

Electrical 6 volt DC @ 1 amp.

AC / DC converter or 4 AA batteries

Printer Panasonic Thermal Printer

Interface RS-232 Computer Serial Port

Environmental

Temp 15 C - 30 C

Humidity 10% - 85%

Location Dry, flat, horizontal surface away from direct sunlight

Optical

Laser Laser Diode - 1 milliwatt

Detector Silicone Photodiode

Memory capacity

User ID's 600

Patient Diagnostics 750

ZONES SPECIFICATIONS

Main Body

1. Sample addition zone

2. Sample addition Reservoir

3. Sample-reaction barrier

4. Reaction chamber

5. Time gate

6. Fluid control means

7. Diagnostic element

8. Used reagent reservoir •.

12

45

3

6

7

8

Technical file: Strip specification

Plastic material: length 10cm, width 3cm.

Round shape

•Open trough. •Filter – PA 66, Polyamide ( mesh count: 93mesh/inch, diameter 0.10nm, thickness 0.18mm).

•Narrow capillary: diameter 0.05mm

•Depth 5mm, width 0.3mm.•Nanoparticle based antibody with fluorophore: powder 1.4nm, fluorophore: Alexa488.

•Polystyrene latex: diameter 2µm, length 1mm. •Binding component: Bovine serum albumin.

•Trapezoid shaped gap.

•Two opposing surfaces a capillary distance apart•Antibodies array:

•Soluble fms-like tyrosine kinase (sflt)•Soluble Endoglin (sEng)•Placental growth factor (PlGF) antibodies.

• Nitrocellulose material.•Capillary space: width 2mm, depth 1mm.•Capillary grooves: depth 0.3mm, density 40 grooves/cm

Risk management

Will the end user be harmed at any point?

YES

NO

What necessary steps to be taken to minimize risk?

Implementation of corrective

actions

Continue monitoring

• Careful sample collection,

labeling and storage

• Storage of strips at proper

temperature• Periodic

(monthly) calibration of

meter• Bar code

validation

Summary:

• Detailed description of Gantt Chart

• Time period for Product development estimated as ~ 1 year

• Conclusion:• Long term vision- G7 as global company• Immediate goal: to attain the ISO 13485 and

fulfill regulatory requirements

a G7 Diagnostics Inc. Production.

THANK YOU FOR LISTENING