industrial development clinical supply chain

From specific

approaches

to global standards

Industrial Development

Clinical Supply Chain

Once upon a time

From the product

to the Patient

The sponsor

The IRT/IVRS

The site & the patient

Why ?

What’s next ?

The journey through Next steps

The sponsor

Primary packagingMolecule Bulk

Once upon a timeThe sponsor

Secondary packaging

Patient kit

The patient kit

Patient kit

The patient kitPackaging design

1. Contain and protect the

product

2. Ensure that the kit has not

been tampered

Drivers

SAR123456 4mg/Placebo

Prot.#

Treat.#

Lot#

Exp.

EFC98765

1132659

6544795

10/2020

The patient kitClinical labelling


Prot.#

Treat.#

Lot#

Exp.

EFC98765

1132659

6544795

10/2020

The patient kitClinical labelling

1. Answer to regulatory

constraints

2. Make it readable....?

Drivers

Secondary packagingLeaflet/Booklet design

1. Answer to regulatory

constraints

2. Make it readable....?

Drivers

Secondary packagingThe result

Secondary packagingSum up

Compliant

Usable

Cheap

The IRT

IRT / IVRSThe big picture

Sponsor IRT Hospital

IRT Tria l EFC332245


Sponsors IRT Hospital



Sponsors IRTs Hospital


The site & the patient

Site interactionsPhysical world – Information Systems - Patients

Patient kit


The site and the KitBecause size maters…

Patient kit

The site and the KitCold chain

Patient kit

*smart packaging trial conclusions

*

The patient and the KitUsability

Patient kit

From a child resistant kit To a patient resistant kit

The patient and the KitLeaflet / Booklet

Patient kit

Hard to read

Lack of interest

Only 20% of the

patients are

using it

Sponsor: sanofi

Trial: EFC98765

Treatment #: 1132659

Lot: 6544795

Exp: 10/2020

Kit1


Prot.#

Treat.#

Lot#

Exp.

EFC98765

1132659

6544795

10/2020

The kit identificationDeciphering the label

Patient kit


Prot.#

Treat.#

Lot#

Exp.

EFC98765

1132659

6544795

10/2020

Drug Name 4mg/Placebo

(1)

(2)

(3)

(4)

1132659

EFC98765

6544795

10/2020

Sponsor A Sponsor B Sponsor C

The kit identificationDeciphering the labels

Patient kit


Trt:

Stud:

Batch:

Exp:

1132659

EFC98765

6544795

10/2020

The kit identificationBarcode - Extra labelling

Patient kit


The kit identificationBarcodes


(1)

(2)

(3)

(4)

1132659

EFC98765

6544795

10/2020

EFC98765

(01)321654(240)1132659

6547896

Patient kit

IRT Trial EFC332245

Sponsor

Trial

Treatment

Lot.

Exp

sanofi

EFC98765

1132659

6544795

10/2020

Sponsor: sanofi

Trial: EFC98765

Treatment #: 1132659

Lot: 6544795

Exp: 10/2020

Kit1


Prot.#

Treat.#

Lot#

Exp.

EFC98765

1132659

6544795

10/2020

The kit identificationUp to the IRT


Scaling effectYes but for how many different trials ?

10 100 750 !5

Number of trials per site


































Information SystemsToo many of them (simplified view ☺)

eCRFs

Third parties

Internal appsIRTs

Consequences

ConsequencesExtreme complexity for the site

As many adresses/url, credentials

(login/password) and processes as

sponsors, systems and or trials….

Most of it done by hand

ConsequencesTime spent with the patient is lower than it should be

“Overall, we are spending twice the

time to manage the trial and its data

than with the patient”

Time with

the patient

Time to manage

the trial

ConsequencesRisk !

Risk Quality

Why ?

Lot of different countries & rules

Competitive advantage

R&D secrecies

Complexity

History

Conservatism – Lack of will

What’s next ?

Kit identification

Kit identificationGS1 standard for clinical trials

Unique, common & standard

Readable by everyone

First step, long journey

A common kit identificationFor digitalization & seamless communication (incl. track & trace)

Sanofi, Pfizer &

Paris Hospitals

Co-leader on

GS1 standard for

clinical tirals

Q1

2019

FDAOk for

next step

Benefits and Challenges along the Supply Chain

• Standardization of Clinical Labels and information

• Ease In line Controls,• Identification of kits /

batches

• Shipments preparation are more reliable• Supply Chain stakeholders are sharing

and exchanging information

Distribution

Patient

Packaging OperationsLabel & Pack Design

Ease Study Management activities at site level

Hospital

Sub-Contractors

• Connectivity to Patient’s ecosystem (smartphones, diaries…)

• Innovative Solutions (eLabeling…)

Sub-Contractors

Pharma B

Pharma C

eProduct Information – Track & TraceBuilding block for the future

GS1 Digital Link

The journey

1 A unique standard to

identify IMP

UN/EDIFACT

working group

2 A unique format to

share data around

IMP

Done On going (Q4)

3 A common

way to

exchange data

Starting

Human readable kit information

The future of clinical packaging

IP7531642

9012346

12-2018

EFC63076

2°C(36°F)

8°C(46°F)

Optimized packaging conception

(compacity, usability)

Standard GS1

Identification

The kit information & usabilityExample of what we should have

9012346

EFC63076

Packaging

differenciation

Universal label

Storage conditions

Side informations

SAR123456 - 4mg/Placebo

Other initiativesShy and slow ?

Welcome to the SIPThe Shared Investigator Platform (SIP) is a single platformthat facilitates investigative site collaboration with multipleclinical trial sponsors. The SIP has been designed to lessenthe administrative burden on site staff by reducingredundant requests for information and training andincreasing automation and the re-use of data.

Pictograms

group

Treating the consequence Slow and difficult

Patient

centricity

Site

centricity

Let’s push harder altogether

to make it happen !

Thank you

Contacts

Sylvain Alberola

Head Of Industrial Development

Clinical Supply Chain Operations

www.sanofi.com

[email protected]

Sanofi - Montpellier - France

+33 (0)6 76 74 90 17M

E

Pierre Fernandez-Barbereau

Project Management

Clinical Supply Chain Operations

Sanofi - Montpellier - France

E [email protected]

industrial development clinical supply chain

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