QPS-NL Respiratory Capabilities Presentation

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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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  • Good morning, thank you very much for inviting me here at ……………. today;
    It is a real pleasure to present to you the capabilities of QPS – helping you to navigate through your drug development program.
  • QPS is a full service early stage CRO – not only providing exceptional Phase I capabilities but also the full back and front services neccessary.
    These include the review of pre-clinical data, the design and preparation of the trial including study protocol, informed consent and case report forms.
    We undertake project and data management, clinical data management and biostatistics. Full bioanalysis at our own labs along with report writing, monitoring and pharmacovigilance.
  • In recent years, Respiratory Research has become an area of interest at QPS-NL;
    Our strategy is based on: (5 key elements)
  • ..our staff has been trained and/or experienced in the following methods, biomarker samplings and disease model:
    (mention training in spirometry by KN and sputum induction/analysis, principles of LPS challenge (inhaled/nasal) by Neil Alexis, sept 2012)
  • Overweeg deze erin te zetten
    Spirometrist – perhaps best translated as spirometry assistant – which implicates a training of approximately 6 months (2 days a week) with theory and clinical practice
  • QPS-NL Respiratory Capabilities Presentation

    1. 1. QPS Respiratory Capabilities
    2. 2. Early Phase Clinical Global Presence 31 maart 2015 Confidential 2
    3. 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 31 maart 2015 Confidential 3
    4. 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 31-03-15 Confidential 4
    5. 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 31-03-15 Confidential 5 EAR LAR
    6. 6. Current QPS Database Asthma & Allergy 03/31/15 Confidential 6 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. 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. 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 31-03-15 Confidential 8 Respiratory Team Members:
    9. 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 31-03-15 Confidential 9
    10. 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 31-03-15 Confidential 10 .

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