MarkMan v84 Group 4 - PTM and USP

Grifols Procleix Panther System
Latest Innovation in Blood Donor Screening
#GoingMolecular #SaferBloodisBetter
AGSB MarkMan v84 Group 3
Alves, Padua, Salvador, Santos

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Dr. Jose Alves
General Surgeon
Batangas Healthcare Specialist
Medical Center
Ace Padua
Business Development and
Private Sector Engagement
Specialist - FHI 360
Dr. Sarah Santos
General Pediatrician
Rizal Medical Center
Missions Hospital
Ryan Salvador
Senior Health Program Officer
Department of Health
Marketing Management v84 Group 3

1940
1818 1990 1999
First Successful
Patient Blood
Transfusion
1971 1985
History of Blood Transfusion and Safety
First National
Blood Collection
Program
HbSAg Testing and
Standardization of
Practices
Reference: https://givingblood.org/about-blood/history-of-blood-banking.aspx
First AIDS Blood-
Screening Test
First Hepatitis C
Donor Blood
Screening
First NAT Testing

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What, Why and How?
Outcome (Z)
4
Position Grifols Panther System
as the choice of our Primary
Target Market
Presenting to the PTM of Grifols
Panther System its, USP and
competitive positioning
To provide safer blood products
for transfusion to patients

#GoingMolecular
▷ What is Grifols Procleix Panther System?
▷ Who is the PTM of this system?
▷ Why does a Blood Bank need this system?
▷ How can we help Blood Bank solve his problem?
▷ What are Blood Bank’s choices?
▷ What are the USPs of his choices?
▷ Let’s recap
5

What is Grifols Procleix
Panther System?
6

▷ Blood Bank
○ Stand-alone blood banks
○ Tertiary Hospitals
○ Regional Hospitals
Who is the primary target market (PTM)?
7
○ Census of blood product screened
■ At least 800 screened blood units / month
○ Space Capacity of 85 sqm
○ Buying capacity of 1.2 Mio/month

Why does a Blood Bank need this system?
8
▷ To detect certain pathogens from the
donated blood products before they
are transfused to a patient
▷ To prevent transfusion-transmitted
infections (TTIs) brought about by
transfused blood products

How can we help Blood Bank
solve its problem?

Maslow’s Hierarchy of Needs
To Save Lives
To Protect Lives
Confidence
Institution

What are Blood Bank’s choices?
11

What parameters will Blood Bank use to
decide?
12
▷ FDA approved
▷ Highly sensitive and specific
▷ Detects HBV, HCV, HIV in blood products
▷ Provide patient confidence in blood product received

Difference in Testing Modality
Nucleic Acid Testing
13
▷ Technique used to directly
detect a particular nucleic acid
sequence present in a sample
Immunoassay
▷ Measures the presence or
concentration of an analyte
in a solution by using an
antibody or an antigen as a
biorecognition agent

Competitors
14
Direct Indirect
Cobas s201 Nucleic Acid Test
Architect i1000sr
Immunoassay Test

USP of Grifols Procleix Panther System
15
SMART DESIGN
SIMPLE OPERATION
VERSATILE CAPABILITIES

USP of Roche Cobas s201
16
▷ 1st multi-dye screening system
▷ High scalability
▷ Impressive flexibility

USP of Abbott Architect i1000sr
17
▷ High Productivity
▷ Seamless Consolidation

Criteria Low Sensitivity High Sensitivity
Low Price
High Price
Competitive Positioning
18

Points of Parity
19
Criteria
FDA Approval
TTI Detection
Market Availability

Points of Differences
20
Criteria
95% 99% 99%
98% 100% 100%
37 11 11
600 1,200 1,200
Sensitivity
Specificity
Window Period
(ave. days)
Price
(PhP/test)

Points of Differences
21
Criteria
Workflow 5 steps 11 steps
Turn-Around-Time 3.5 hours 8 hours
Footprint Fully Integrated Modular
Number of Tests
(in 12 hours)
500 results 325 results

#FullyIntegrated
#FullyAutomated
22
Procleix Panther System

45
35
25
15
5 NAT
IA
IA
55
NAT
IA
NAT
6
Days
HIV Detection HCV Detection HBV Detection
15
63% Risk
Reduction
92% Risk
Reduction
58
5
38
25
37% Risk
Reduction
Window Period of Detection

Analysis of NAT
▷ Nucleic Acid Testing can interdict 3,272 infectious donations
per year (5 Mio annual donations)

Analysis of NAT
▷ Transfusion risk without Nucleic Acid Testing can occur in
every 1400 transfusions

Grifols Workflow
Thaw calibrators at room temperature;
remove reagents from refrigerator and
freezer and prepare in reagent
preparation incubator (RPI)
Start Procleix Panther; load
consumables
as needed; manage lower bay as
needed
Rack samples
Load assay reagents and sample
racks
as needed . Testing starts
automatically.
Review results on Procleix Panther
• Discriminatory results on same
platform
• No deconvolution required as results
obtained in IDT

Roche Workflow Equilibrate reagents to
room temperature
Start Hamilton pipettor and pooling and data
management workstations
Uncap controls and load specimens, consumables, and
controls into Hamilton
Load reagent cassettes into AmpliPrep
Prepare sample processing unit (SPU)
Load SPU racks, K-tubes, and K-tip racks into AmpliPrep
if required
Create orders using AmpliLINK software at workstation
Cap S-tubes; transfer SK24 racks with
S-tubes containing specimens from
Hamilton to AmpliPrep
Check AmpliLINK software; press start
Docking station transfers K-tubes via
K-carrier from AmpliPrep to TaqMan®
Results automatically exported by AmpliLINK software;
review results on data management workstation
• If using MPX 1.0, separate
discriminatory platform and assay required; reactive
specimens require extra deconvolution steps in IDT
• Without docking station, manual
transfer required between AmpliPrep
and TaqMan; TaqMan starts
automatically

Releases first reportable result in
3.5 hours, then 5 results every
5 minutes
• 275 results in 8 hours
• 500 results in 12 hours
Results are released as a batch
test
First sample and last sample will
have the same time for release
Requires 8 hours for availability
of results
Turnaround Time

Innovations during the Pandemic
▷ FDA approved SARS-CoV-2 Test
▷ Plasma donor screening for COVID-
19 Treatment

Grifols’ USP for a niche PTM
▷ FDA approved, Highly sensitive and specific
▷ Detect TTIs - HBV, HCV, HIV
▷ Reduces the window period for TTI detection
▷ Prevents morbidity and mortality
▷ Increases confidence in accepting blood products for
transfusion
▷ Detects SARS-CoV 2
▷ Screens plasma donors for Covid treatment

SMART DESIGN
SIMPLE OPERATION
VERSATILE CAPABILITIES
Procleix Panther System
INNOVATIVE SOLUTIONS

Grifols Procleix Panther System
#SaferBloodisBetter
AGSB MarkMan v84 Group 3
Alves, Padua, Salvador, Santos

MarkMan v84 Group 4 - PTM and USP

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