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QPS-NL Respiratory Capabilities Presentation


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 …

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.

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  • 1. Respiratory Capabilities Professor Zuzana Diamant, MD PhD Pulmonologist – Clinical Pharmacologist 6 November 2013 Confidential 1
  • 2. Introduction Zuzana Diamant MD PhD Professor Qualifications • 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 • Expert in Respiratory Clinical Trials/Principle investigator, QPS-Netherlands. • Quest lecturer GCP, Netherlands. Research Experience • >20 years clinical trials; focus: asthma/allergy/(COPD) • 10 Years Research Director Respiratory Allergy (CRO); PI • Phase 0-II (human disease models, non-invasive biomarkers) • ATS/ERS Task Force member; EAACI Task force member; • Associate Editor (2 international journals) • Several scientific advisory boards • >80 Scientific publications • Lectures, refereeships, chairs.
  • 3. Respiratory & Allergy at QPS NL Respiratory Research is an area of interest at QPS-NL QPS Respiratory Strategy – key elements: Input in early drug development strategy, study design, methods, medical writing, etc. Implementation of validated methods and disease models to support Phase 0-II studies Dedicated, qualified & experienced respiratory team Patient data bases (asthma, allergy, COPD) Network and collaborations with Academia & (Inter)national Networks of Excellence 11/6/2013 Confidential 3
  • 4. Respiratory Capabilities at QPS NL Methods, Disease Models & Biomarker Sampling Spirometry & standard bronchoprovocation tests Methacholine Histamine Mannitol Disease models (upper/lower airways) Allergen challenge (inhaled/nasal) Virus inoculation (nasal) LPS challenge (inhaled/nasal) EAR LAR Airway biomarker sampling Sputum induction & analysis Nasal lavage/brush/scrapings Exhaled air samplings (FeNO) 11/6/2013 Confidential 4
  • 5. Respiratory Team at QPS-NL Tjeert Mensinga, MD PhD, Dedicated Research Physician Manja Horstman, Research Nurse, Spirometry Assistant Maaike Hogewoning, Research Nurse, Spirometry Assistant Helen Schuitemaker, Laboratory Technician Zuzana Diamant, MD PhD Prof, Pulmonologist/Clinical Pharmacologist, Director Respiratory & Allergy Karin Nietzman, Lung Technician 11/6/2013 Confidential 5
  • 6. Respiratory Networks Collaborations, Networks and Memberships UMCG - Dept of Respiratory Disease, Groningen Professor D. Postma, Professor H. Kerstjens, Dr N. ten Hacken) UMCG – Pulmonology & Allergy Laboratory Professor A. van Oosterhout UMCG – Dept of General Practice Professor T. van der Molen Large Regional Hospitals (Assen, Delfzijl) National Institute of Public Health, Utrecht (TM) Skane University, Dept of Respiratory Allergy, Lund, Sweden (Inter)national professional networks: NVALT, NVKFB, NVvA, ATS, ERS, EAACI & ATS/ERS Task Forces (ZD) Profess – Good Clinical Practice: Professor H. Pieterse 11/6/2013 Confidential 6
  • 7. Recruitment Tools Databases with Asthma Patients Our own patients database (e.g. 500-750 asthmatics) Database of another external medical professional (e.g. 350-400 asthmatics) Patient databases from collaborating pulmonologists in nearby peripheral hospitals (some thousands of patients)
  • 8. Recruitment Tools Online Recruitment Tools Our very visible and well-visited volunteers website ( Targeted advertising (social media such as Facebook and internet bannering) Other external volunteer websites/specialized recruitment agencies Patient forums
  • 9. Recruitment Tools Offline Recruitment Tools Collaboration with a call center, daily telephone screenings Selective direct mailing in certain zip code areas with high asthma rates Advertising through flyers (e.g. at pharmacies) Advertising in local/national papers
  • 10. Respiratory Science Key Publications Franciosi L, Diamant Z, Banner KH, et al. RPL554, a dual PDE3 and PDE4 inhibitor with bronchodilator and antiinflammatory properties: efficacy and safety in clinical trials in healthy subjects and in patients with asthma or COPD. [Lancet Respiratory Medicine, in press]. 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 in press. Diamant Z, Tufvesson E, Bjermer L. Which Biomarkers Are Effective for Identifying Th2-Driven Inflammation in Asthma? Curr Allergy Asthma Rep 2013 Aug 7. Bjermer L, Dihal A, Diamant Z. Fine Particles Inhaled Corticosteroids and Systemic Therapeutic Options for the Treatment of Small Airways Inflammation in Asthma. Treatment Strategies Respiratory 2011, pp 34-41– online book. 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. Diamant Z. 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. 11/6/2013 Confidential 10