Respiratory Drug Development
Health Inspired, Quality Driven.
Respiratory Expertise
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
Indications
Administration Routes
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. 158 respiratory clinical trials have been conducted in the past five years, including 45 multi-center clinical trials in respiratory and pulmonary diseases (Phase 1-IV) in the following diseases:
*Other: Smoking cessation, IPF, BOS, Cough, Rhinitis, 16
Intravenous (IV) 2%
Othe r 6%
Subcutaneo us ( SC) 3 %
Tuberculosis , 6
RSV, 2 8
Intranasal 4%
, 7
Lung Cancer
• Respiratory Syncytial Viral Infection (RSV) • COPD • Influenza • Asthma • Cystic fibrosis (CF) • COVID-19 • Pulmonary arterial hypertension (PAH)
• Lung cancer • Tuberculosis • Smoking Cessation/Addiction • Idiopathic pulmonary fibrosis (IPF) • Bronchiolitis obliterans syndrome (BOS)
Intramuscular/Injectio n 5%
PAH, 1 0
COPD, 25
Inhalation ( DPI) 8%
COVID-19, 1 0
Oral 52%
Inhalation
• Cough • Rhinitis
9%
Inhalation ( MDI) 11%
, 23
Asthma, 21
SGS Phase I-IV Clinical Trials Experience (Last 5 years)
Early Clinical Trials Expertise
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 At SGS we have implemented different ‘customized’ or ‘on-demand’ bronchial challenge models depending on the study/sponsor specific requirements.
METHODS • Spirometry • Whole body plethysmography • FeNO • Arterial blood gases • Capnography • Sputum induction • Bronchoalveolar lavage Bronchial challenge techniques like metacholine and LPS
Clinical Trial Management Efficacy
Multi-Site Respiratory Network for Early Phase Clinical Trials 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, Edegem with a total of 110 hospitalization beds.
For a faster, targeted clinical trial execution and patient recruitment, clients can rely on SGS’s: • Extensive database of investigators and key opinion leaders with therapeutic experience in respiratory diseases. • Specific skill-sets to successfully execute studies in respiratory and respiratory diseases. • Favorable regulatory environment in Belgium with very short phase I trial approval timelines (14 working days).
For optimized early phase clinical trials, the unit features: • A biosafety Level 2 quarantine facility
ensures an efficient, harmonized training and study execution level for complex evaluations required in respiratory diseases 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.
• A GMP production facility 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. Benefits of The Sites Network Concept The clinical sites bring the infrastructure and a group of referring respiratory disease specialists 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
Health Science Health Inspired, Quality Driven.
Contact us
healthscience@sgs.com sgs.com/healthscience sgs.com/healthcommunity
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