ADVANCED CLINICAL RESEARCH SOLUTIONS

RESPIRATORY DRUG DEVELOPMENT

LIFE SCIENCES

For over 40 years, SGS has built up unique expertise in early phase clinical trials including First-In-Human studies, QT/QTc prolongation, human challenge

testing, biosimilars and complex PK/PD studies.

52 respiratory clinical trials have been conducted in the past five years,

including 17 multi-center clinical trials in respiratory and pulmonary diseases (Phase I-IIb) in the following diseases:

OVERVIEW

• Rhinitis

• Asthma

• Bronchiolitis Obliterans Syndrome (BOS)

• Chronic Obstructive Pulmonary Disease (COPD)

• Cystic fibrosis

• Pulmonary Arterial Hypertension

FROM PROOF OF CONCEPT TO FIRST IDENTIFICATION OF PROOF OF EFFICACY

Respiratory clinical research requires a broad range of experience, multidisciplinary support and resources. As an international mid-size CRO, supporting bio/pharma clients in Europe and North America, we provide clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. SGS is recognized as the benchmark R&D partner for quality, reliability, flexibility and customer care. Our comprehensive early and late phase expertise in pulmonary diseases includes asthma, COPD and cystic fibrosis.

Benefits of SGS’s early respiratory drug development expertise:

• Defining the best regulatory and scientific approach for compound development

• Enrolling patients quickly through our early phase respiratory network

• Testing classic and new pathways, including biologicals and different administration routes

• Using non-invasive, invasive and pharmacodynamics challenge methods

RESPIRATORY CLINICAL TRIAL EXPERIENCE

PULMONARY EXPERTISE WITH CLINICAL PHARMACOLOGY EXPERIENCE

HV: Healthy Volunteers

2013-2018 experience

INDICATIONS ADMINISTRATION ROUTES

PATI

ENTS

10

COPD

HV, 7

ASTHMA

HV, 11

CYSTIC

FIBROSIS

HV, 9

PATIENTS 2

OTHER

HV, 8

RSV

HV, 4

DPI18

MDI

13

INHALA-

TIONORAL 18 ORAL

PARENTERAL

IV 2

SC 3

SUBLINGUAL

For a faster, targeted clinical trial execution and patient recruitment, clients can rely on SGS’s:

EARLY CLINICAL TRIALS EXPERTISE

CLINICAL TRIAL OPERATIONS EFFICACY

• Extensive database of investigators and key opinion leaders with therapeutic experience in

respiratory diseases

• Specific skill-sets to successfully execute studies in respiratory and infectious diseases

• Favorable regulatory environment in Belgium with very short phase I trial approval timelines

(14 working days)

To ensure proper recruitment and organization, SGS has developed a hybrid hospital network model which encompasses our historical and main clinical pharmacology unit in Belgium, supported by a satellite phase I unit in a major regional hospital, and several partnering hospitals with respiratory departments.

SGS’s clinical pharmacology unit is located in Antwerp with a total of 88 hospitalization beds. For optimized early phase clinical trials, the unit features:

• A biosafety Level 2 quarantine facility

• A GMP pharmacy for on-site formulation

• Full eSource clinic automation (EDC) including sample tracking for safety lab data

The Clinical Pharmacology Unit (CPU) has successfully passed several US FDA inspections during recent years.

MULTI-SITE RESPIRATORY NETWORK FOR EARLY PHASE CLINICAL TRIALS

The clinical sites bring the infrastructure and a group of referring pulmonologists and general practitioners (GP) who are highly motivated to carry out early phase studies. It guarantees a secured access to the targeted patient population. SGS staff within the network ensures an efficient, harmonized training and study execution level for complex evaluations required in respiratory trials.

Overall, the multi-site hospital partnership network enables:

• A flexible and tailored approach to meet sponsor timelines

• Faster study start-up and sites activation through established Clinical Trial Agreements

• A high rate and qualitative recruitment level: access to large and diverse patient populations for respiratory indications. Having a dedicated patient recruitment expert within the CRO team allows reliable and predictable patient recruitment, and the wider the network, the greater the hospitals’ databases are, including newly diagnosed patients or referrals from the established physician network.

BENEFITS OF THE SITES NETWORK CONCEPT

Key Pharmacodynamic Methods

SGS has a full-time team of Investigators, Research Physicians, Study Nurses, Clinical Research Coordinators and Clinical Project Managers who are trained and experienced in various kinds of evaluations. They are also present to support hospital staff, and can provide specific equipment (eg. body box) to properly carry out the necessary measurements such as: • Mechanisms of action

■ SABA, LABA, LAMA, ICS, LTB4 + PDE4 inhibitors, mast cell stabilizers and methylxanthines

■ New CRTH2 inhibitors and Monoclonal Ab, involving the TLR3 target

• Methods

■ Spirometry

■ Whole body plethysmography

■ FeNO

■ Arterial blood gases

■ Capnography

■ Sputum induction

■ Bronchoalveolar lavage

■ Bronchial challenge techniques like metacholine and LPS

At SGS we have implemented different ‘customized’ or ‘on-demand’ bronchial challenge models depending on the study/sponsor specific requirements.

KEY CHALLENGES• Identify the proper location in the site for overnight stay and spirometry assessment

• Establish an efficient project management and site coordination

• Competitive enrolment

STUDY DESIGN• Design: phase IIb, multi-centre, placebo-controlled 3-period cross-over study

• Population: mild to moderate male and female asthma patients

• Drug and administration: long-acting muscarinic antagonist (LAMA) by inhalation

• Objective: safety and bronchodilator effects

• Assessments: spirometry and pharmacokinetic sampling during 24 h with overnight stay

OUTCOMES• Hybrid model with local (Investigator, administrative support, pharmacy) and CRO (PD assessments, trial

coordination, sponsor contact, staff training) services

• All tasks and evaluations executed per same high-quality standards: on-time delivery, high data quality and integrity, high staff reactivity

• Highly satisfied sponsor, site and CRO staff

SGS IS THE WORLD’S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY

A PHASE IIB STUDY IN ASTHMA

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CONTACT US

EUROPE

+ 32 15 27 32 45

clinicalresearch@sgs.com

NORTH AMERICA

+ 1 877 677 2667

www.sgs.com/cro

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