At QPS Netherlands (QPS-NL), we have expanded our early stage clinical research capabilities in 2012 to include respiratory clinical trials. To this end, QPS-NL is collaborating with Dr. Zuzana Diamant, research pulmonologist and clinical pharmacologist. Professor Diamant has over 20 years of experience in clinical respiratory trials, with a focus on phases 0, I and II proof-of-concept studies in respiratory allergy, asthma and COPD. Zuzana Diamant is Guest Professor at Skane University, Lund, Sweden; collaborating scientist at University Medical Centre Groningen, Dept. of General Practice; and a member of several international scientific networks including the ATS/ERS taskforce for bronchoprovocation testing (allergen challenge) and two editorial boards. Together with our dedicated research physician and epidemiologist Dr. Tjeert Mensinga, our well-trained research team, and onsite laboratory biomarker facilities, this collaboration now enables us to perform consultancy services. These include study design, study set up and the conduct of respiratory POC-studies combining clinical disease models (e.g. inhaled and nasal allergen and LPS challenges) with non-invasive airway samplings (e.g. nasal lavage, nasal brushings, sputum analysis, exhaled airway analysis) to test targeted therapies.

1. QPS Respiratory Capabilities

2. Early Phase Clinical Global Presence
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3. Global Early Stage Clinical Research
Full-Service Early Stage CRO
‘QPS is a full service early stage CRO that is not only capable of providing the clinical conduct of
your Phase 1 study but has the ability to provide the front and back end services as well’
Review of Preclinical Data
Design and Preparation of the Trial
Clinical Project Management
Preparation of the Study Protocol, Informed
Consent, and Case Report Forms
Clinical Data Management
Biostatistics
Bioanalysis/Biomarker Assays
Conduct PK/PD and/or Pop PK/PD Data
Analysis and Modeling
Prepare PK/PD Report
Prepare and Publish Fully Integrated
Clinical Study Reports
Monitoring
Pharmacovigilance
Bioanalysis
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4. QPS Respiratory Strategy – key elements:
Input in early drug development strategy, study design,
methods, medical writing, etc.
Implementation of disease models, validated (sampling)
methods and biomarkers to support Phase 0-II studies
Dedicated respiratory team, biomarker laboratory
Patient data bases (asthma, allergy) collaborating
partners on other respiratory indications (COPD,
fibrosis)
Networks and collaborations within Academia, Task
Forces & (Inter)national Networks of Excellence
Respiratory & Allergy
Respiratory & Allergy is an area of interest at QPS
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5. Disease models (upper/lower airways)
Allergen challenge (inhaled/nasal)
Virus inoculation (nasal)
LPS challenge (inhaled/nasal)
Spirometry & standard bronchoprovocation tests
Methacholine, histamine
Mannitol
Hypertonic saline
Airway biomarker sampling
Sputum induction & analysis
Nasal lavage/brush/scrapings
Exhaled air samplings (FeNO); eNose
Respiratory Capabilities
Disease Models, Methods & Biomarker Sampling
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EAR
LAR

6. Current QPS Database Asthma & Allergy
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Patient Age Range # Male/Female
Asthma 947 (384/560)
18-30 years 623 (235/385)
31-50 years 177 (71/106)
51+ years 147 (78/69)
Allergy 1410 (593/817)

7. Zuzana Diamant, MD PhD Professor
2014 GCP-Certified Principle Investigator, Amsterdam, NL
2002,2012 Board-certified Pulmonologist, Rotterdam, NL
2006,2011 Clinical Pharmacologist, Leiden, NL
Current Positions/Affiliations
Guest Professor Respiratory Allergy Research: Skane University, Dept
Respiratory Medicine & Allergology, Lund, Sweden;
Executive Medical Director/Director Respiratory & Allergy, QPS-NL/Expert in
Respiratory Clinical Trials/Principle Investigator;
Affiliated Scientist and Supervisor, Dept. of Pharmacy & Clinical
Pharmacology, University Medical Center, Groningen, Netherlands.
Research Experience
>20 year clinical trials; focus: asthma/allergy/(COPD)
10 years Research Director Respiratory Allergy (CRO); PI
Phase 0-II (human disease models, non-invasive biomarkers)
ERS TF member (Bronchoprovocation tests); EAACI TF chair (Biomarkers)
Editorial board member (3 international journals)
Several scientific advisory boards
>100 scientific publications
Scientific lectures, refereeships, chairs.
Head Respiratory Team

8. Respiratory Team
Tjeert Mensinga, Dedicated Research Physician
Manja Horstman, Research Nurse, Spirometry Assistant
Maaike Hogewoning, Research Nurse, Spirometry Assistant
Joke Oosterhof, Laboratory Technician
Jan Jaap van Melle, Respiratory Technician
Svitlana Tarasevych, Research Pulmonologist
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Respiratory Team Members:

9. UMCG - Dept of Respiratory Disease, Groningen
Professor D. Postma, Professor H. Kerstjens, Dr N. ten Hacken)
UMCG – Dept of Clinical Pharmacy & Pharmacology
Professor Dick de Zeeuw
Large Regional Hospitals (Assen, Delfzijl, Martini)
National Institute of Public Health, Utrecht (TM)
Skane University, Dept of Respiratory Allergy, Lund, Sweden
Professor Leif Bjermer; Dr Ellen Tufvesson; Dr Cecilia Ahlstrom-Emanuelsson
(Inter)national professional networks: NVALT, NVKFB, ATS, ERS, EAACI &
ATS/ERS/EAACI Task Forces (ZD)
Profess – Regulatory aspects to clinical trials & GCP:
Professor H. Pieterse
Respiratory Networks
Collaborations, Networks and Memberships
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10. Diamant Z, Singh D, O’Connor BJ, Zuiker R, Leaker BR, Silkey M, Dingemanse J, Sidharta PN. Setipiprant, a
selective CRTH2 antagonist, reduces allergen-induced airway responses in allergic asthmatics. Clin Exp Allergy
2014 Aug;44(8):1044-52.
Bjermer L, Alving K, Diamant Z, Magnussen H, Pavord I, Piacentini G, Price D, Roche N, Sastre J, Thomas M,
Usmani O. Current evidence and future research needs for FeNO measurement in respiratory diseases. Respir
Med 2014 Jun;108(6):830-841.
Diamant Z, Gauvreau GM, Cockcroft DW, Boulet LP, Sterk PJ, de Jongh FH, Dahlén B, O'Byrne PM. Inhaled
Allergen Bronchoprovocation Tests. J Allergy Clin Immunol 2013 Nov;132(5):1045-1055.e6.
Franciosi L, Diamant Z, Banner KH, et al. RPL554, a dual PDE3 and PDE4 inhibitor with bronchodilator and anti-
inflammatory properties: efficacy and safety in clinical trials in healthy subjects and in patients with asthma or
COPD. Lancet Respiratory Medicine 2013; 1(9):714-27.
Diamant Z, Tufvesson E, Bjermer L. Which Biomarkers Are Effective for Identifying Th2-Driven Inflammation in
Asthma? Curr Allergy Asthma Rep 2013 Aug 7.
Diamant Z, Boot JD, Mantzouranis E, Flohr R, Sterk PJ, Gerth van Wijk R. Biomarkers in asthma and allergic
rhinitis. Pulm Pharmacol Ther. 2010 Dec;23(6):468-81.
Boot JD, et al, Diamant Z. Applicability and reproducibility of measurements of biomarkers in allergic rhinitis. J
Investig Allergol Clin Immunol 2008;18(6):433-42.
Boot JD, et al. DiamantZ. Effect of an NK1/NK2 receptor antagonist on airway responses and inflammation to
allergen in asthma. Am J Respir Crit Care Med 2007;175(5):450-7.
Leckie MJ, ten Brinke A, Khan J, Diamant Z, et al, Holgate ST, Sterk PJ, Barnes PJ. Effects of an interleukin-5
blocking monoclonal antibody on eosinophils, airway hyperresponsiveness, and the late asthmatic response.
Lancet 2000;356:2144-8.
Key Publications
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