Early phase studies

Léna PEREZ – Sanofi EDO Senior Global Study Manager

Margaux REZER – Sanofi EDO Leader (Clinical Project
Manager)

* Early Development Operations (EDO): department within Sanofi in charge of conducting Sanofi early phase studies
(Phase 1, Phase 2a)

October 25, 2023

AGENDA

01 Introduction (Quiz)

02 Early phase studies scope

03 Clinical Site Service Provider

Global Study Manager in

04 early phase studies

05 Conclusion and Q&A

session

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Early phase studies M1 Presentation – 25Oct2023
Quiz

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Introduction
Compound development
1 project = 1 compound = 1 or more indications
1 project team

Pre-clinical Clinical activities

CMC Others Commercial
activities (EDO Leader)

Ph1 Ph1 Ph1 Ph2 Ph2 Ph3 Ph3 Ph3

Ph4
study study study study study study study study
studies
1 2 x 1 x 1 2 x
(GSM)
(GSM) (GSM) (GSM) (GSM) (GSM) (GSM) (GSM) (GSM)

Early phase studies M1 Presentation – 25Oct2023 23

Clinical Research Development within Sanofi

CSO Platform (Clinical Sciences & Operations)

Phase Phase Phase

Phase 1
2 3 4
Early Phases Late Phases

EDO: Early Development TO: Trial Operations

Operations Department Department

Operational expertise
Global Study Manager (GSM) Study team coordinator GOAL = clinical trial realization
Operational expertise at (constraints: costs/quality/time)
EDO leader
project level
Early phase studies M1 Presentation – 25Oct2023 24
Clinical Trials organization
Global Project CoreTeam
Diabetes & Cardiovascular / Oncology /
Strategic Immunology & Inflammation / Rare Diseases & Rare Blood Disorders /
Neurology / Vaccines / Medical Affairs
Led by the EDO
leader for early
project
Responsible for the
Project Clinical Sub-Team operational strategy
for FIM studies to
POC
Ensure relevant risk
mitigation
Study Team (timelines, budget,
quality)

Local Led by the Global Study

Manager (GSM)
Study — Responsible for the planning,
Tactical Team set-up, initiation, conduct and
closure of the study
— Ensure compliance with the
established procedures and
timelines 25

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Early Phase studies scope
Clinical Sciences and Operations (CSO)
MISSION of the CSO Platform
Create value for Sanofi portfolio & patients through quality delivery of innovative, patient-centric,
clinical development solutions which leverage the distinct expertise of CSO teams, whatever clinical
operations, scientific and medical, as well as effective collaboration with partners

Early Phase I to
IIa study
management

Early Oncology
study management
up to PhII Phase IIb to III-IV study
management

Early phase studies M1 Presentation – 25Oct2023 27

 Departments within CSO

EDO (Early Development Operations) TO (Trial Operations)

Phase I Phase IIa Phase IIb/III

Population Healthy subjects Patients Patients Patients

Sample Size Generally, range from 5 to 250 Up to thousands

Duration Few days to several Can be several months to several years Several years
months

Country(ies) 1 country More than 1 if needed More than 1 Several

Center(s) Monocenter (Clinical Site Mono or multi center: academic sites and/or CSSP Several: academia, hospital,
Service Provider: CSSP) physician..

Primary endpoint PK/PD data, safety assessment, efficacy assessment Efficacy

All the early oncology studies are handled by another department: EDOO (Early Development Oncology Operations)

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Overview of studies managed by EDO (1/2)

Human Biology
studies

Proof of
Concept/Proof of
Mechanism studies
First administration
In Man (FIM)
Large scope of
studies with
studies

different objectives
and specificities
PharmacoKinetic
studies
PharmarcoDynamic
studies

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 Summary of studies managed by EDO (2/2)
Human Biology studies
In 2022
• For biomarker or methodology validation (ASY)

First administration In huMan (FIM)

• SAD (Single Ascending Dose) = TDU (Tolerance Dose Unique)
• MAD (Multiple Ascending Dose) = TDR (Tolerance Dose Repeated)

PharmacoKinetics studies
• BioEQuivalence (BEQ), Bioavailability (BDR) & others (e.g., PKM)...
• Drug-Drug INTeractions (INT), C14 Metabolism (BEX)
• POPulation (POP), PharmacoKinetics studies (e.g., hepatic and renal impairment, elderly)

PharmacoDYnamic studies (PDY), PET, Thorough QTc ECG (TES)

Proof of Concept studies (POC) - Proof of Mechanism studies (POC/POM) - Phase IIa
studies in patients (ACT/PDY)

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First administration In Man studies (1/2)
Combined protocols
SAD: Tolerance after Single Ascending Dose administration (SAD)
single ascending dose, randomized, double-blind study
5 dose levels (6 active / 2 placebo per group)-sequential
FED: Effect of food on pharmacokinetics during the SAD
preliminary food-effect, for oral formulations
2-period (fed vs fasted), cross-over, open study
1 dose level of the SAD (fasted) duplicated in fed conditions
MAD: Tolerance after repeated dose administration (MAD)
multiple ascending dose, randomized, double-blind study (14 days)
3 dose levels (9 active / 3 placebo per group)-sequential

Primary objectives: Safety & tolerability

• Evaluation of highest or Maximum Tolerated Dose (MTD) level after single or repeated ascending dose administration
• PK & Preliminary PD

Specificities:
• Dose escalation meetings with safety & PK data
• Investigational medicinal product bulk (non subject specific) packaging

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First administration In Man studies (2/2)
SEQUENTIAL DESIGN OVERLAP DESIGN
(

One cohort: 8 participants per dose cohort: 6 participants receiving active treatment and 2 participants receiving
placebo. Each dose level cohort in SAD part will be divided into 2 subgroups:

• The first subgroup (the “sentinel group”) will include 2 participants (1 receiving placebo and 1 receiving active
treatment) who will be dosed on the first day. For sentinel dosing, no restrictions for inter-participant dosing
time are defined (as one participant will receive placebo and the other active drug).

• The second subgroup (remaining participants: 6 in total) will be dosed on the following days after a safety
window internal of at least e.g., 48-96 hours later (depending on the product half-life) with inter-participant
dosing spaced at least 10 minutes apart.

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Proof of Concept/Mechanism studies (1/2)

Proof of Concept/Mechanism (POC/POM) studies : PDY, ACT (ACTivity)

Design
A randomized, double-blind, placebo-controlled, parallel group, Proof-of-Concept (PoC) study to
assess the efficacy, safety, and tolerability of IMP in a specific patients population
Sample size
Bigger sample size: up to 250 patients
Specific patient population
Go-No Go decision for further development in patients

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Proof of Concept/Mechanism studies (2/2)
*handled by EDO department

Fast to PoC/PoM
First administration in human Filing

Pharmaceutical Phase I/IIa Phase IIb Phase III Market

Life Cycle Management
development
PDY
TES
POP

INT
Healthy
Patients
Subjects
SAD
Clinical studies DRI EFC1
FED MAD PDY / ACT
EFC2
ASY

BEX
Clinical
PET
PK studies BEQ
BEQ (pivotal)
that support BDR/PKM
+ ALI
formulation
Early phase studies M1 Presentation – 25Oct2023 34
development
Clinical Site Service Provider
(CSSP) à Phase 1 site
Clinical Site Service Provider (CSSP)

Clinical site dedicated and specialized in Phase 1 studies

Clinical unit with

clinical staff, beds and
participants areas
Safety lab
• Cafeteria
for samples
• Recreation area (TV
(including Netflix), Video analysis
game, Outside excursions (or external • Close to Hospital
are also arranged for long Offices for administrative lab)
• Close to University
stay study tasks like
• Data management (data
entry), Pharmacy in
• Project management the clinical
(meetings room), building
• Monitor (CRA) dedicated (or external
pharmacy)
room
• Any other activities handled
by the CSSP (CSR, Biostat)

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Example of CSSP organization – Video

Example of CSSP organization (SGS in Belgium)

SGS Opens State-of-the-Art Site for Clinical Research in Antwerp, Belgium -
YouTube

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Participant Pre-screening can start before HA/EC approval, via
journey in a Site Database and/or Recruitment campaigns
CSSP (1/3)

01
Web registration
Registration
Dedicated web page à
With studies open for
recruitment.
After online
registration/phone call,
Healthy Volunteer (HV) will
receive a
call/confirmation email
explaining what happens
next.
02
Phone call to
check I/E criteria
CSSP will contact HV by
telephone to go through
their details and the
requirements of the
study.
Screening appointment
scheduling if pre-eligibility
confirmed
03 04
Before the Arrival at CSSP
screening visit for screening visit
Information pack sent to Reminder 1 WD before
HV with documents appointment.
including :
• a medical HV will visit the CSSP
questionnaire (medical screening center at the
history, ttt, participation agreed time and will report
to other trials) to the reception desk on
• ICF arrival.
• extensive information
about the study and
their stay at CSSP.

Read and understand the

information package and
notice any questions
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Participant For subjects eligible to participate in the study
journey in a
CSSP (2/3)
01
Medical screening
02
Day-1
03
Dosing day D1
04
Institutionalization &
ambulatory periods
~3 hours in total with: If eligibility confirmed • The results of the brief
• Appointment with a during screening, phone screening are available • Subject stays few days
Screening & doctor/nurse call 2WD before study • The doctor uses them to at the CSSP for regular
Participation • Covid check start to confirm start date decide who can check according to
• ICF check actually participate in study protocol.
• Explanation about the • HV will come at the the study (reserve • During this period,

clinical trial CSSP at the agreed subjects) subject is free to rest /

• Physical examination time. • Randomisation work / play / watch TV
and measurements • The study will be re- • Administration of the etc
(height and weight) explained to HV study compound by a
• Heart trace will be • They will be given a doctor or nurse in a • The subject return at
performed tour of the study dedicated room + home and will come
• Other center and meet the nurse/PI monitoring, back for Ambulatory
assessments/checks other participants. level depending on IMP visits as per the

according to study • Brief screening to see criticity. protocol

protocol. whether HV health has
changed at all
(according to protocol).
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Early phase studies M1 Presentation – 25Oct2023
Participant
journey in a After participation…
CSSP (3/3)

01 02 03
Follow-up & End Compensation Further trials participation
Follow up of the study
• Last day of the study • Payment compensation, • At least 30 days before
• Usually involves a separate including travel costs participating in a clinical
visit according to study • Within 21 days. trial again.
protocol • Four times a year for all
• It’s a short medical clinical trials.
examination to check that • In some countries Verified
HV are completely healthy Clinical Trial (VCT) check
and that the drug is used to prevent duplicate
completely out of subject.
his/her system.

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SAMPLES PROCESSING

How CSSP handle the samples processing?

VOLUNTEERS SAMPLES SAFETY LAB at REPORTS SAMPLES

• Samples collection PROCESSING at CSSP or external • Daily report with results STORAGE
site lab provided to the PI • A central refrigerator
• Available in the • Allow the PI to request
• Centrifugation • 1 area for all freezers &
fridge with temperature database for CSSP DM additional analysis if
• Aliquotage
• Dedicated area with : monitoring necessary
• Storage room • 1 area for machines : •Kept 1 week
• Bench • Samples analysis
(hematology,
biochemistry)
• 1 "conveyor belt" to
arrange the samples
(for big labs)

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 •Rooms dedicated •1 dedicated area
PHARMACY to store the IMP
received at the
for the pharmacist
to work on their
CSSP (cold or computer
ambient) •Labels printing
Pharmacy area organisation

2. Working
1. Storage area
area (administrative
offices)

4. From the
3. IMP
pharmacy to
preparation
the HV bed

• 1 room out of the •Areas dedicated to

pharmacy - for the prepare the IMP from
clinical team to NSSP* to SSP*
retrieve prepared packaging
*NSSP: Non subject specific packaging product or drop off •1 area dedicated to
*SSP: Subject specific packaging unused/used product radioactive IMP
• Locked by keys

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Clinical Site Service Provider (CSSP)
Main Specificities
• Avoid dosing of different studies or patients/HV studies at same time in same place

• Participant surveillance and emergency management:

• Nurses 24/24 to monitor the safety of the subjects during the institutionalization period and after each product
administration
• Emergency chart close to each bed
• Direct access to the Hospital (some CSSP have common corridor with the hospital)

• Nurse and site staff keep an eye on all participants especially:

• Right after drug administration (see above for safety monitoring)
• For protocol assessment (like Pharmacokinetics timepoint) to respect carefully the time of blood collection
• If any specific requirement of the study protocol e.g. specific forbidden beverage, doing sport etc. Otherwise
participants are free to go to the recreation room.
Doors are locked to avoid any intrusion from outside, and participants have dedicated access to where they are
allowed to go (badge and emergency automatic alert)

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Global Study Manager in
early phase studies : Role &
Responsibilities
GSM Job Summary

The Global Study Manager is

responsible for the overall
operational planning, management
and execution of a of Early
Development Operations clinical
trials (phase I studies and/or
complex patients’ studies) in
compliance with ICH, GCP’s, SOPs,
local requirements,
internal/departmental guidelines,
and established timelines.
The GSM is the leader of the
clinical study team and empowered
to drive the management &
delivery of the study team
operational objectives, ensuring all
trial deliverables are met according
to the study timelines, within
budget and having the highest
quality standards.

The GSM may be involved in

monitoring activities of his/her
own studies according to
workload/need and/or manages
local monitoring or outsourced
monitoring. The GSM may also
participate in intra or inter-
department Working Groups. The
job may include international
responsibilities.

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GSM Job Summary
The Global Study Manager is
responsible for the overall
operational planning, management
and execution of a of Early
Development Operations clinical
trials (phase I studies and/or
complex patients’ studies) in
compliance with ICH, GCP’s, SOPs,
local requirements,
internal/departmental guidelines,
and established timelines.
Key words:
Project management
Operational Expertise
International
The GSM is the leader of the Timelines
clinical study team and empowered
to drive the management & Quality
delivery of the study team Budget
operational objectives, ensuring all
trial deliverables are met according
to the study timelines, within
budget and having the highest
quality standards.

The GSM may be involved in

monitoring activities of his/her
own studies according to
workload/need and/or manages
local monitoring or outsourced
monitoring. The GSM may also
participate in intra or inter-
department Working Groups. The
job may include international
responsibilities.

Early phase studies M1 Presentation – 25Oct2023 46

 GSM Responsibilities
Provide management and oversight of clinical trials to ensure progress according to
study timelines:
• Lead, collaborate and build a strong collaboration with the Study Team including Data
representatives of all operational disciplines involved in the conduct of trial (i.e., Manager
Clinical Research Organizations, Data Management, Pharmacovigilance,
Study
Biostatist
Biostatistics, Pharmacokinetics, Clinical Supplies and other relevant departments, Medical
icien
platforms or units). Manager
• Provide regular study highlights for project team.
• Manage the study according to Good Clinical Practice(s) and local and/or national
regulations, with responsibilities on product and project level. Global
Study
• Develop the Study Risk Management Plan and anticipate bottlenecks in all steps Clinical Manager
Supply Sample
of the study and development/implementation of counteractive measures.
Study Manager
• Solve or coordinate the resolution of issues during conduct of the trial. Manager
• Develop and review specific study-related documents.
• Develop and coordinate the study budget, including invoice validation.
• Contribute to contract process.
Other Medical
• Oversight investigational product supplies (ordering, packaging, and shipment) members Writter
ensure Investigational Product supplies strategy is aligned with the overall study
timelines.
• Participate in and contribute to internal audits, if applicable STUDY TEAM
• Oversight local Monitoring activities with the affiliate

Early phase studies M1 Presentation – 25Oct2023 47

2 different types of operational model

TYPE OF STUDIES STUDY HANDLING MONITORING ACTIVITIES

With academic sites Involvement of A local study manager is handling

affiliate in each
Multi-country Multi-centric country (named local
study team)
Phase Ib, IIa, POC
With Clinical Site Service Providers (CSSPs) Hanlded directy by the
EDO Global Study
Mainly monocentric Manager (GSM) and
direct contact with the
By default, in Healthy Subjects (Phase I) CSSP
and/or in patients (Phase Ib/IIa/POC)
all operational activities and is
dealing with CRA (Clinical Research
Assistant)
The EDO GSM is handling all
operational activities and is dealing
with CRA (Clinical Research
Assistant

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 EXERCICE PAR GROUPE

Lister l’ensemble des

activités (du démarrage à la
fin de l’étude) dans lequel un
manager d’étude clinique est
impliqué
v Chronologiquement : du
démarrage à la fin de
l’étude
v Par domaine d’activités

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 Soumission du
protocole +
Consentement Gel de la Publication
éclairé Dernier base de
Signature du 1er Patient – Dernier du rapport
Approbation Patient – données de l’étude
protocole + 1ère Visite Patient – 1ère
du protocole Dernière
Kick off (FPFV) Visite (LPFV)
+ Visite (LPLV)
meeting
étude Consenteme
nt éclairé Réconciliation
Approbation budgétaire
Amendements
du budget Potentielle au protocole
Lancement demande de + soumission
de la base budget règlementaire Notification Soumission
de données complémentaire du rapport
Enquête de
et de l’eCRF
de fin
faisabilité + d’étude
Choix des
d’étude clinique
pays/sites
? ?

Mise en place Conduite Clôture

Visites de Visites d’initiation Activités de monitoring Visites de clôture des Archivage
qualification des des sites sites d’investigation électronique
sites d’investigation d’investigation Revue des données et des déviations au protocole (25ans)

Procédure liée à la sous-traitance : Transferts réguliers de données entre les sites/sous-traitants et la base Analyse statistiques des
de données données
Signature Développement Test et
des contrats du service lancement
Suivi des contrats et des factures

Ecriture des plans de l’étude:

Réunions de suivi avec les sites/sous traitants
- Plan de monitoring
- Plan de gestion des risques
- Plan de communication
- Manuel pharmacie
- Manuel de laboratoire

Réunions de suivi avec l’équipe clinique

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Légende:
Formes:

Etape continue
Etape Etape non
ponctuelle sur une
obligatoire
période
donnée
Couleurs:

Activités de
Activités Activités
Etapes clés Activités Activités data
liées au liées au
de l’étude opérationnelles règlementaires management
budget monitoring
et statistiques

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 Critical study steps

Milestones Healthy Subject Patient Study

Study (or specific
population)
Abbreviated Protocol to 1.5 months 2.3 months
Set-up phase Protocol approval
Protocol Approval to 1st ~3 months 4.5 months
subject/patient included
Conduct phase
Last Subject/Patient Last 1 month 1 month
Visit to database lock
Database Lock to Final 1 month 1.25 month
Statistical Result*
Closure phase
Final Statistical results to ~2 months 4 months
Clinical Study Report
*Key results are released just after the Database Lock to expedite GO/NO GO decision
for the development planned

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 Operational activities (1/4)
Study team management

help defining the

communication within
Set up of Clinical Prepare the different ST levels
Trial global planning
Management Communication
System and all Planning Plan
the tools used
for

Ensure the study Check what is on

team members critical path to
are aligned on
activities in case set up and adapt
activities (Reg,
Study team
of improvement
of timelines
(optimized
IMP, vendors
planning) activities)
organisation Adhoc meeting with
extended member :
patient network… Agenda
Meeting
meeting with each
Staffing plan core study team Regular GSM
document Sharing of tasks members communication in meetings
Minutes

the team
Role&Contact list with transition from one
all study team GSM to another Meeting with the affiliates (local
members involved in Effective meeting
representative) per country
the study

Early phase studies M1 Presentation – 25Oct2023 53

Operational activities (2/4)
Vendor management

Set up a vendor
Request For Proposal
Introduction call
Budget finalization and contract
Kick Off Meeting (KO) Example of vendors: central lab,
Specifications preparation and signature analytical lab, IRT System, eDiary,
eClinical Outcome Assessment
UAT (User Acceptance Testing) (COA) instruments , Patient travel
Go live reiumbursement, recruitement,
Data Management, Investigator
meetings, trainings, devices rental,
Ongoing basis home nursing services, central
reader… + CSSPs
The vendors are supposed to organize meetings + collect minutes
Depending on stage and the complexity of the service the GSM & Vendor Project Manager will decide the frequency of
required meetings
Invoices validation

Close out
Budget reconciliation
Quality check on the documentation

Early phase studies M1 Presentation – 25Oct2023 54

Operational activities (3/4)
Vendor management – FOCUS on Clinical Site Service Providers (CSSPs)

Phase I Unit/investigator site = Clinical Research Organization

Pool of qualified CSSPs (no site qualification to be performed)
Standard Study design
Small sample size / Heatlhy volunteers / mono-site study
Standard scope:
Review protocol
Prepare and translate in local language the ICF
Handle the preparation and translation of patient facing documents
Involve in the pharmacy manual preparation
Perform the EC Submission
Supply and prepare the samples labels (no central lab)
Regular communication / Study Sharepoint used for the sharing of documents (access restriction and role for the site
(CSSP) to a specific Sharepoint folder)
Other activities that can be handled by the CSSP: Data Management (eSource system or eCRF), statisitical activities,
CSR writing, Monitoring activities….

Early phase studies M1 Presentation – 25Oct2023 55

Operational activities (4/4)
Study documents and plans

Protocol
Informed Consent, Patient diary and patient facing document,
Questionnaires, Instructions For Use (IFU)
Pharmacy manual including, the investigational Product labels,
shipping/randomization/dispensation/accountability and destructions processes
Laboratory manual, samples labels, shipping material
Training support
Training matrix (to cover all trainings for the study and will indicate which are recommended and mandatory depending on the
role in the study)
Vendor documents
Lessons Learned
Clinical Study Report appendices: the list of the Principal investigators involved in the study, the list of all the names and
addresses of Services providers
Newsletters….

Communication Plan: to define how the communication will be performed within the study team
Study Risk Management Plan: to identify the study critical data and processes and assess the overall risk level
Monitoring Plan: study-specific procedures for the overall management of the study and site monitoring activities
Data Management Plan, Patient Recruitment and Retention Plan, Trial Master File Plan….

Early phase studies M1 Presentation – 25Oct2023 56

Budget activities

The
estimated At the end of
budget is the study, the
approved at GSM perform
project team Contracting the budget
level process reconciliation

Request For Ongoing basis : Monitor the

Proposal for budget throughout the
central services study and request
additional funds if needed
Grant Plan for
local services Validation of invoices in the
system regularly

Updated Contract

Early phase studies M1 Presentation – 25Oct2023 57

Regulatory

v GSM to make sure that the different study documents required for submission will be
available on time: Protocol, Informed Consent, patient facing documents,
Investigational Product study labels...
v GSM is also involved in the preparation and review of some regulatory document:
Clinical Trial Application From, Transfer of Responsibilities and Obligations (TORO)
form, Data Privacy documents including services providers information, Trial
Disclosure From (TDF)…

Submission/approval
(including questions
if any) Health
Authorities and Ethics End of study
committee notification

Amended protocol Clinical Study Report

submission during Submission
the study if any

Depending on the country the list of documents required for submission should be adapted

Early phase studies M1 Presentation – 25Oct2023 58

Data management

Study set-up
Participation to the design and set-up of the Case Report Form (CRF)
Study conduct
Data review and deviation review (manual and automatic)
Study close
Clean and lock of the Data Base
Data transfert from external data (e.g., coming from external lab) for statistical analysis et clinical study report release

Early phase studies M1 Presentation – 25Oct2023 59

Monitoring activities

Monosite study condcuted in CSSP

Site idenfication and allocation already Feasibility process (including
performed questionnaires and Site selection visits)

Study conducted in academic sites

GSM in direct contact with the CSSP for all GSM in contact with local study team per
operational activities (regular meetings) country (regular meetings). A Local study
and with the CRA manager is handling the CRA

GSM is handling the CRA training and the Local Study team is handling:
CSSP training (Site Initiation Visit), - Site Initiation Visit (following
monitoring visit reports review and

with different countries

Investigator Meetings)
approval
- Site contracts and payments
- EC Submission
- Monitoring activities
- All operational activities with sites

Early phase studies M1 Presentation – 25Oct2023 60

Conclusion
KEY MESSAGES

Organization
•Various activities
•Non redundant – always new
EARLY PHASE STUDIES challenges

• Phase I studies = not only early

phase I studies on Heathly volonteers •Leader of the clinical study

in clinical development: Communication

team
•Interaction with numerous

• Support to formulation development

GSM stackeholders within an
international environnement

• Regulatory registration support

• Fast to POC new mindset

• Phase IIa studies in patients – Proof of Operational
expertise •Clinical Trial knowledge
Concept •Project Management

Early phase studies M1 Presentation – 25Oct2023 62

Q&A session
THANK YOU