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Temperature Intelligence ™ Solutions DCVMN VVM Overview Webinar July 2018

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Page 1: DCVMN VVM Overview Webinar July 2018...d u µ / v o o ] P v ¡ ^ } o µ ] } v s ] v d u µ ^ v ] ] À ] Ç, v ] ] À ] Ç Ç ï ó £ & Ì v ] ] À ] Ç & Ì v ] ] À ] Ç 5RWDYLUXV

Temperature Intelligence™ Solutions

DCVMN VVM Overview Webinar

July 2018

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Temperature Intelligence™ Solutions

Temptime Vision and Mission

Vision: “Temptime elevates the quality of global health”

Mission: “We innovate cost-effective monitoring solutions for environmentally sensitive products to ensure supply chain integrity, protect patients and benefit communities globally”

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Temperature Intelligence™ Solutions

Driving Principles

• “Sometimes it’s the simple ideas that make all the difference. Making it super easy for a rural health worker to know whether a vial of vaccine is still effective by scaling up the VVMs has saved hundreds of thousands of lives.”

Bill Gates - February 21st, 2017

• “I have always been struck by the brilliance of the VVM approach: a marker that changes color to reflect the state of the vaccine. Now, with electronics and imaging entering a new regime of cost-to-performance, it is exciting to see Temptime add fine-grain recording and geo-tracking in the supply chain, and innovative 2D barcodes which can be read with smartphones.”

Sanjay Sarma, Vice President Open Learning, MIT - April 13th, 2017

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Temperature Intelligence™ Solutions

The Challenge: Develop a low-cost, highly reliable, easy-to-interpret, unit-level temperature sensor that improves product quality and

patient confidence and safety, reduces wastage, and spares product that is still viable for administration – at the very end of the very last

mile of the most challenging supply/cold-chains…

to assist:

• the World Health Organization• UNICEF• PATH• Gavi (the Global Alliance for Vaccines & Immunisations)• The Bill & Melinda Gates Foundation

with…

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Üm

itKa

rtoğ

lu

Improving vaccine effectiveness…

PATHD. Kristensen

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Enabling vaccine outreach…

Üm

itKa

rtoğ

lu-W

HO

D. KristensenPATH

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PATH

/Joh

nny

Alim

an

Expanding vaccine coverage…

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Preventing vaccine wastage…Yogyakarta, Indonesia earthquake - 2006

D. KristensenPATH

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Wor

ld H

ealth

Org

aniza

tion

Facilitating stock management…

D. KristensenPATH

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Helping to eradicate diseases…

Save

The

Chi

ldre

n U

K

D. KristensenPATH

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“Time temperature indicator known as vaccine vial monitor (VVM) absolutely vital to eradication effort, allowing health workers to know vaccine has not been exposed to excessive heat.”

And helping to save lives!

D. KristensenPATH

Üm

itKa

rtoğ

lu-W

HO

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Temperature Intelligence™ Solutions

Time-Temperature Indicator/ VVM Arrhenius

• Color change based on Arrhenius curves/equationsk rate coefficientA0 frequency factorEa activation energy (J mol–1)R universal gas constant (8.314 x 10-3 kJ mol-

1K-1 )T Kelvin temperature (K)

Gradual Predictable Cumulative Irreversible

Measure of MKT

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The Vaccine Vial Monitor (VVM) – Cornerstone of Portfolio

Technology:• The principle of operation is based on the solid-state polymerization of substituted diacetylene monomers• The combined effects of time and temperature cause a gradual, predictable, cumulative and irreversible color

change from clear to dark• The white square is the active color changing reactive portion• End point is reached when the color of the Active Square area is equal or darker than to the Reference Circle

Scale: Temptime manufactures and sells more than 600 million VVM’s per year

USE USE DO NOT

USEDO NOT

USE

13

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Temperature Intelligence™ Solutions

(Colorless)

R C C C C R

R C C C C R

R C C C C R

(Colorless)

R C C C C RR C C C C R

R C C C C RR C C C C R

R C C C C RR C C C C R

Polymerization Reaction

• The principle of operation is based on the solid-state polymerization of substituted diacetylenicmonomers

• The combined effects of time and temperature cause a gradual, predictable, cumulative and irreversible color change from clear to dark

Polymerization

C C C C R

C R

C

C C C C R

R

C C C C R

R(Black)

The Chemistry of the HEATmarker TTI

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Temperature Intelligence™ Solutions

Vaccine Temperature Sensitivity

Heat sensitivity

Daysat 37°C

Freeze sensitivity

Freeze sensitivity

2

7

14

30

Rotavirus

Pneumo conj

IPV

DTP DTP-HepB

DTaP +combos

Hep A

HPVCholera/TyphoidKilled

DT/TT/Td

Hib Liq

Influenza

OPVInfluenza

Varicella

MeaslesRubellaJE PHK MMR

Yellow Fever

Cholera/Typhoid

Live

Men conj

Men conjBCG

RabiesMen PSJE mouse

brainHib Lyo

Principles and considerations for adding a vaccine to a national immunization programme FROM DECISION TO IMPLEMENTATION AND MONITORING http://apps.who.int/iris/bitstream/10665/111548/1/9789241506892_eng.pdf?ua=1 World Health Organization

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Temperature Intelligence™ Solutions

VVM category chosen is correlated to vaccine stability

World Health Organization

Four WHO VVM categories

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Temperature Intelligence™ Solutions

WHO Prequalified and FDA 510k Clearance

• Temptime's quality management system is consistent with FDA’s Quality SystemRegulations (QSR) 21 CFR 820 (GMP for medical devices)

• ISO 9001:2008 ISO 13485:2003 WHO Prequalified Device

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Temperature Intelligence™ Solutions

PharmaceuticalProduct

Indication Customer TemptimeProduct

ValueDelivered

Children’s ImmunizationCampaigns for a range of contagious diseases: • BCG• Diphtheria• Tetanus• Pertussis• DTP• Hep B• HiB• Meningococcal A and C• Measles• Mumps, Pneumococcal• OPV• Rotavirus• Rubella• Tetanus Toxoid• Yellow Fever

Other Campaigns:• HPV• IPV• Rabies• Typhoid

GSK, Sanofi Pasteur, Merck, Crucell, Pfizer, Novartis, Serum Institute of India, Biofarma, Japan BCG, BB-NCIPD, Bharat Biotech, Statens Serum Institute, Biological E, Bharat Serums and Vaccines, Haffkine, Bio-Manghuinos, plus others

VVM2, VVM7, VVM14, VVM30

• Prevents immunization with heat damaged vaccines

• Expands reach of immunization programsto remote populations

• Increases immunization programs efficiency

HEATmarker VVM for use on vaccinesOver 650 million VVMs used last year

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Temperature Intelligence™ Solutions

2011 Honduras Technical and Operational Guidelines for Pneumococcal Conjugate

http://www.bvs.hn/Honduras/PAI/LTOVNC2011.pdf

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• Single use threshold indicators.• Multiple unit secondary packages or shipping boxes.• Ability to customize temperature thresholds.

Window

Peak Threshold Indicators

USE DO NOT USE

LIMITmarker F/LTM

Formulated to signal short excursions above the set response temperatures: 9°C, 17°C, 21°C, 25°C (all +/- 1°C).

LIMITmarker I™

Formulated to immediately signal upon excursions above the set response temperatures: 40°C ±1ºC, 44°C ± 1ºC, and 50°C ±2°C

Before Exposure to 40°C After Exposure to 40°C

USE DO NOT USE

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Temptime Continues to Invest in Product Innovations

• VVM: new categories

• CTC & VVM+®: combined VVM and peak threshold indicator

• Hybrid 2D Bar Codes with embedded VVM active area or threshold indicator: improve patient safety and address evolving international anti-counterfeiting/track & trace and serialization requirements

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Temperature Intelligence™ Solutions

Four WHO VVM Types to Monitor Vaccines with Different Heat Sensitivities

VVM11 and VVM250 added on 18 May 2018 for six VVM types

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VVM Line Extensions to Address Programmatic Needs: VVM11

• Why VVM11• Some vaccines have stability > VVM7 but < VVM14

• Some vaccines have moved to 3 year expiry date but with < 14 days at 37°C

• Change to statistical modeling of vaccine stability can possibly lead to use of a lower VVM type

• e.g., VVM14 now would revert to VVM7

• VVM11 fills the gap between VVM7 and VVM14• Provides ≥ 2.5 years at 5°C

• Project initiated based initially on potential IPV stability

• Status• Included in newly published VVM spec

• No premium charge for VVM11

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Temperature Intelligence™ Solutions

Four Five WHO VVM Categories – VVM11 is now approved

VVM11

VVM11

VVM11

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•Allowing specific vaccines to be kept and administered at ambient temperatures, up to 40oC

• For one, limited period of time (length of time will vary by antigen and setting) immediately preceding administration

• For vaccines meeting a number of pre-determined conditions

►Up until this excursion, the vaccine should continue to be kept in the traditional 2oC-8oC cold chain.

Current focus: vaccines administered during campaigns and special strategies, in ‘single antigen’ settings.

Current definition of CTC

The Next Challenge –Controlled Temperature Chain (CTC)

25

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26

Temptime’s Peak Threshold Indicators used in WHO pilot to spare new heat-stable Meningococcal vaccine (stable up to 40°C)

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New Product Innovations Address High Temperature Excursions and CTC Requirements

VVM+TM

• Combined VVM response and high temperature threshold in a single indicator

VVM+

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Temperature Intelligence™ Solutions

HEATmarker VVM+VVM Plus Peak Indicator in Same Device

• VVM+ reacts like a VVM up to 37°C

• At 40°C, VVM+ reaches the end point rapidly to show exposure to critical peak temperature

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Temperature Intelligence™ Solutions

Over 5 years and $5 Million Dollars Invested

• What are the next steps to launch VVM+?• HPV• Oral cholera• Hep B• Rotasiil lyophilized• Others?

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Temperature Intelligence™ Solutions

VVM Challenge – Highly Stable Rotavirus Vaccine540 days at 37°C

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Temperature Intelligence™ Solutions

VVM Line Extensions to Address Programmatic NeedsVVM250 – Technology Capability

Temptime has supplied TTIs for use by US Military with 3 year life at 26°C for more than 20 years and a more stable category for use on Rapid Skin Decontamination Lotion

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Temperature Intelligence™ Solutions

Rotasiil Team was Concerned with Exposures Above 40°C

VVM+250

VVM11 VVM250+

VVM+250 confirmed by WHO and SII

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VVM 250 Specifications

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The Challenge: Cold Chain Problems are Global

Category # of IncidencesLoss

(dollars)

Refrigeration Problems 16 $42,958

Shipping/Receiving 4 $34,772

ImproperStorage 6 $187,133

ExpiredVaccines 51 $127,289

TotalLosses 77 $392,717

Extrapolation to state$2,352,426

Howard Backer, MD, MPH

Vaccines – US San Francisco Bay Area 10 County Region (2006)

Source: California Department of Public Health

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US Vaccines for Children ProgramVulnerabilities in Vaccine Management1

Howard Backer, MD, MPH

1 https://oig.hhs.gov/oei/reports/oei-04-10-00430.pdf

Office of Inspector GeneralJune 2012

• Vaccines for Children (VFC) program provides free vaccines to eligible children

• 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost of $3.6 billion in 2010

Study• Vaccine storage unit temperatures were monitored in

45 providers for a 2-week period

Finding• 76 percent of the 45 selected providers were exposed to

inappropriate temperatures for at least 5 cumulative hours during that period

Impact• Exposure to inappropriate temperatures can reduce

vaccine potency and efficacy, increasing the risk that children are not provided with maximum protection against preventable diseases.

Ice on box of

influenza vaccine

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Global Temp-Monitoring Requirements – 2018Last Updated: April 2018

National requirements for VVM on all public sector vaccines (3: Pakistan, India, Indonesia)

Gavi requirements for VVM on all public sector vaccines (54 Gavi-eligible countries in 2017)

Provincial requirements for VVM on all private sector vaccines (9 – Beijing, Shanghai, Fujian, Anhui, Jiangsu, Shandong, Hebei, Heilongjiang, Zhejiang)

Regional requirements for VVM on all public sector vax (6 GCC countries - unimplemented )

Argentina – 2009 law requiring

temp-monitoring of all temp-sensitive

human/animal medical products; gradual implementation in 2017

on vaccines/carton-level

Brazil – 2016 policy requiring

Nat’l Mail Service to distribute all

temp-sensitive medicines, vaccines,

diagnostic kits, and medical supplies for Nat’l Health Agency

Peru – 2015 law requiring documentation

of all temp-excursions during distribution,

resulting remediation plans, and empowerment

of MoH to enforce remediation plans

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Temperature Intelligence™ Solutions

The Solution: Add Another Dimension to 2D Barcodes with Embedded Temperature Sensors

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Temperature Intelligence™ Solutions

The solution: 2D Barcode with Embedded Temperature Sensor -Digitization of Chemical Indicators & Unit Level Data Connection

What it is; how it works…

• Specific area has indicator ink – e.g. cumulative (VVM) or threshold printed as part of barcode

• Rapid reading with phone or scanner• Connect with cloud or web-based

databases• Use on primary, secondary and

tertiary packaging

Enhance the value of 2D barcodes (for patient safety and anti-counterfeiting) by incorporating temperature integrity

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Temperature Intelligence™ Solutions

GS1 2D Data Matrix with Threshold Sensor

• Threshold Indicator – rapid, irreversible color change when peak temperature threshold is exceeded

Exceed Threshold

Temperature

Below threshold temperature

Exceed threshold temperature

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Temperature Intelligence™ Solutions

GS1 2D Data Matrix with Time Temperature Indicator (TTI)

Time and temperature

exposure

• Time temperature indicator – gradual, irreversible color change from light to dark develops with cumulative time and temperature exposure

Before heatexposure

After excessive heat

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Temperature Intelligence™ Solutions

GS1 2D Data Matrix with Other Potential Indicators

Reversible Threshold 2D Barcode Anti-Counterfeiting 2D Barcode

Dual 2D Barcode(any combination)

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Temperature Intelligence™ Solutions

Dynamic 2D Barcode Indicator

• GS1 compliant 2D barcode with temperature-sensitive monitor to provide machine-readable, variable, environmental information that supplements other static data

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Temperature Intelligence™ Solutions

New Technology Development:2D Barcodes w/Integrated Temperature Indicators

• Serialized barcodes on individual saleable units provide enabling technology for global identification and tracking regulations

• Merges unit serialization and temperature-monitoring in a single scan

• Technology adaptable for anti-counterfeiting applications

• Significantly enhances product integrity, patient safety, supply security and temperature compliance from point of manufacture to point of use

End-to-end unique identifier and unique temperature monitor

What it is; how it works – continued

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Temperature Intelligence™ Solutions

Dynamic Barcodes Allow Unit Level Data Connection from Manufacture to End Use

Monitoring DeviceProduct Flow Package Level Data Capture Information

Flow

Manufacturer

National Distributor

Local Distributor

Health Provider

Patient

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