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Serendipity, enthusiasm and openness for innovation in healthcare, Gouya Insights retains passion for innovation and the trust of our customer as its core values.
OUTLINE OF ACTIVITIES
References to our clients can be provided upon request

- Therapeutic Indication: gynecological Infections
Drug Class: Antifungal medication
Geographic Region: Austria
Role: Clinical Development Lead
Key Responsibilities: Creation of the clinical development program, seeking scientific advice from competent authorities, creation of clinical operations team and acting as main contact point between sponsor and clinical operation in providing oversight in the conduct of clinical studies and medical data review process, and supporting the finalization of clinical study reports, the publication and application process

- Therapeutic Indication: Slow healing foot ulcers
Drug Class: Biological wound dressing
Geographic Region: Austria / middle Europe
Role: Clinical Development Lead
Key Responsibilities: Creation of the clinical development program, seeking scientific advice from competent authorities, development of essential documents, creation of clinical operations team and acting as main contact point between sponsor and clinical operation.

- Therapeutic Indication: Endstage Renal Failure
Drug Class: patent-protected solution for peritoneal dialysis
Geographic Region: Austria
Role: Medical Data Review
Key responsibilities: Medical data review plan, medical data review of data listings, providing data query listings, confirmation of query resolution, participation in data monitoring board.

- Therapeutic Indication: fat graft
Drug Class: biological
Geographic Region: Austria
Role: medical Writing (protocol, informed consent form (ICF))
Key responsibilities: Literature search, developing final protocol and ICF for submission

- Therapeutic Indication: Hepatitis vaccination
Drug Class: biological
Geographic Region: Austria
Role: clinical project management, protocol development, medical writing, team structuring
Key responsibilities: Literature search, developing final protocol, and project plan, project management

- Therapeutic Indication: Inflammatory bowel disease
Class: medical device
Geographic Region: Austria / Germany
Role: clinical roadmap, Protocol development, third vendor outsourcing, medical writing,
Key responsibilities: Literature search, developing protocol, biomarker / endpoint selection

- Therapeutic Indication: functional bowel disease
Class: medical device
Geographic Region: Austria
Role: clinical roadmap, Protocol development, third vendor outsourcing, medical writing
Key responsibilities: Literature search, developing protocol, biomarker/ endpoint selection

- Therapeutic indication: infectious disease
Drug class: biological/combination product / vaccine
Geographic Region: EU
Role: Due Diligence for Investors for innovative Vaccine technology
Role: clinical project management, protocol development, medical writing, team structuring
Key responsibilities: sponsor oversight, literature search, developing final protocol, and project plan, project management, risk management

- Therapeutic indication: seasonal allergy vaccines
Drug Class: biological
Geographic Region: Europe
Role: clinical project management, protocol development, medical writing, team structuring, vendor selection
Key responsibilities: Literature search, developing final protocol, and project plan, sponsor oversight, risk management

- Therapeutic indication: aesthetics
Class: medical device
Geographic Region: Austria
Role: Literature research, medical writing, clinical evaluation report

- Therapeutic indication: nutritional toxins
Class: medical device
Role: project oversight, clinical project management, protocol development, medical writing, team structuring
Key responsibilities: Literature search, developing final protocol and project plan, project management

- Therapeutic indication: Arrhythmia
Drug Class: Small molecule
Role: Project oversight, clinical project management, protocol development, medical writing, team structuring
Key responsibilities: Sponsor oversight, literature search, developing final protocol, and project plan, project management
PUBLICATIONS

Publications
- Sheikh Rezaei S, Weisshaar S, Litschauer B, Gouya G, Ohrenberger G, Wolzt M. ADMA and NT pro-BNP are associated with overall mortality in elderly. Eur J Clin Invest. 2019 Jan;49(1):e13041.
- Rezaei SS, Litschauer B, Gouya G, Baumgartner-Parzer S, Stulnig T, Wolzt M. Cardiovascular Effects of Stress During Acutely Increased Free Fatty Acids in a Randomized, Double-Blind, Cross-Over Study in Humans. Horm Metab Res. 2018 Jun;50(6):478-484. doi: 10.1055/a-0620-8438. Epub 2018 Jun 8. PubMed PMID: 29883974.
- Simader E, Traxler D, Kasiri MM, Hofbauer H, Wolzt M, Glogner C, Storka A, Mildner M, Gouya G, Geusau A, Fuchs C, Eder C, Graf A, Schaden M, Golabi B, Aretin MB, Suessner S, Gabriel C, Klepetko W, Tschachler E, Ankersmit HJ. Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I). Sci Rep. 2017 Jul 24;7(1):6216.
- Mesgarpour B, Gouya G, Herkner H, Reichardt B, Wolzt M. A population-based analysis of the risk of drug interaction between clarithromycin and statins for hospitalisation or death. Lipids Health Dis. 2015 Oct 24;14:131.
- Wolzt M, Gouya G, Sator M, Hemetsberger T, Irps C, Rettenbacher M, Vcelar B. Comparison of pharmacokinetic and safety profiles between Bemfola(R) and Gonal-f (R) after subcutaneous application. Eur J Drug Metab Pharmacokinet. 2015 Jan 30.
- Told R, Schmidl D, Palkovits S, Boltz A, Gouya G, Wolzt M, WitkowskaKJ, Popa-Cherecheanu A, Werkmeister RM, Garhfer G, Schmetterer L. Antioxidative capacity of a dietary supplement on retinal hemodynamic function in a human lipopolysaccharide (LPS) model. Invest Ophthalmol Vis Sci. 2014 Dec 18;56(1):403-11.
- Storka A, Vcelar B, Klickovic U, Gouya G, Weisshaar S, Aschauer S, Bolger G, Helson L, Wolzt M. Safety, tolerability and pharmacokinetics of liposomal curcumin in healthy humans. Int J Clin Pharmacol Ther. 2015 Jan;53(1):54-65.
- Gouya G, Voithofer P, Neuhold S, Storka A, Vila G, Pacher R, Wolzt M, Huelsmann M. Association of Nutritional Risk Index with Metabolic Biomarkers, Appetite-Regulatory Hormones, and Inflammatory Biomarkers and Outcome in Patients with Chronic Heart Failure. IJCP 2014 Nov; 68(11):1293-300.
- Klickovic U, Doberer D, Gouya G, Aschauer S, Weisshaar S, Storka A, Bilban M, Wolzt M. Human Pharmacokinetics of High Dose Oral Curcumin and Its Effect on Heme Oxygenase-1 (Ho-1 Expression) in Healthy Male Subjects. Biomed Res Int. 2014;2014:458592.
- Told R, Palkovits S, Schmidl D, Boltz A, Gouya G, Wolzt M, Napora KJ, Werkmeister R, Popa-Cherecheanu A, Garhfer G, Schmetterer L. Retinal hemodynamic effects of antioxidant supplementation in an endotoxin-induced model of oxidative stress in humans. Invest Ophthalmol Vis Sci. 2014 Apr 7;55(4):2220-7.
- Aschauer S, Gouya G, Klickovic U, Storka A, Weisshaar S, Vollbracht C, Krick B, Weiss G, Wolzt M. Effect of systemic high dose vitamin C therapy on forearm blood flow reactivity during endotoxemia in healthy human subjects. Vascul Pharmacol. 2014 Apr;61(1):25-9.
- Gouya G, Arrich J, Wolzt M, Huber K, Verheugt FWA, Gurbel PA, Pirker-Kees A., Siller-Matula J. Antiplatelet treatment for prevention of cerebrovascular events in patients with vascular diseases: a systematic review and meta-analysis. Stroke. 2014 Feb;45(2):492-503.
- Gouya G., Siller-Matula J., Fritzer-Szekeres M., Neuhold S., Storka A., Neuhofer LM, Clodi M., Hlsmann M., Pacher R., Wolzt M. Association of Endostatin with Mortality in Patients with Chronic Heart Failure. Eur J Clin Invest. 2013 Nov 5.
- Storka A, Vcelar B, Klickovic U, Gouya G, Weisshaar S, Aschauer S, Helson L, Wolzt M. Effect of liposomal curcumin on red blood cells in vitro. Anticancer Res. 2013 Sep;33(9):3629-34.
- Wolzt M, Gouya G, Kapiotis S, BeckaM, Mueck W, Kubitza D. Open-label, randomized study of the effect of rivaroxaban with or without acetylsalicylic acid on thrombus formation in a perfusion chamber. Thromb Res. 2013 Aug;132(2):240-7.
- Weisshaar S, Gouya G, Nguyen D, Kapiotis S, Wolzt M. TheLPS-induced increase in circulating microparticles is not affected by vitamin C in humans. Eur J Clin Invest. 2013 Jul;43(7):708-15.
- Siller-Matula JM, Francesconi M, Dechant C, Jilma B, Maurer G, Delle-Karth G, Gouya G, Ruzicka K, Podczeck-Schweighofer A, Christ G. Personalized antiplatelet treatment after percutaneous coronary intervention: The MADONNA study. Int J Cardiol. 2013 Sep 1;167(5):2018-23.
- Schaller G, Dittrich P, Felizeter M, Gouya G, Leuchten N, Kapiotis S, Vcelar B, Vorauer-Uhl K, Wolzt M. Human pharmacokinetics of intravenous recombinant human Cu/Zn superoxide dismutase. Int J Clin Pharmacol Ther. 2012 May 22;Volume 50(June):413-417.
- Gouya G, Palkovits S, Kapiotis S, Madl C, Locker G, Stella A, Wolzt M, Heinz G. Comparative bioactivity of subcutaneous low molecular weight heparin in critically ill patients with normal renal function. Brit J Clin Pharm. 2012 2012 Nov;74(5):806-14.
- Wolzt M, Eriksson UG, Gouya G, Leuchten N, Kapiotis S, Elg M, Schtzer KM, Zetterstrand S, Holmberg M, Whlander K. Effect on perfusion chamber thrombus size in patients with atrial fibrillation during anticoagulant treatment with oral direct thrombin inhibitors, AZD0837 or ximelagatran, or with vitamin K antagonists. Thromb Res. 2012 Apr;129(4):e83-91.
- Gouya G, Sturm G, Lamina C, Zitt E, Freisttter O, Struck J, Wolzt M, Knoll F, Lins F, Lhotta K, Neyer U, and Kronenberg F. The association of mid-regional pro-adrenomedullin and mid-regional pro-atrial natriuretic peptide with mortality in an incident dialysis cohort.PLoS One. 2011 Mar 7;6(3):e17803.
- Gouya G, Hammer A, Elhenicky M, Neuhold S, Wolzt M, Hlsmann M, Pacher R. Benefit of specialized clinics for the treatment of patients with heart failure. Eur J Intern Med. 2011 Aug;22(4):428-31.
- Heinisch BB, Francesconi M, Mittermayer F, Schaller G, Gouya G, Wolzt M, Pleiner J. Alpha-lipoic acid improves vascular endothelial function in patients with type 2 diabetes: a placebo-controlled randomized trial. Eur J Clin Invest. 2010 Feb;40(2):148-54.
- Neuhold S, Huelsmann M, Strunk G, Struck J, Adlbrecht C, Gouya G, Elhenicky M, Pacher R. Prognostic Value of Emerging Neurohormones in Chronic Heart Failure during Optimization of Heart Failure-Specific Therapy. Clin Chem. 2010 Jan;56(1):121-6.
- Schaller G, Kretschmer S, Gouya G, Haider DG, Mittermayer F, Riedl M, Wagner O, Pacini G, Wolzt M, Ludvik B. Alcohol Acutely Increases Vascular Reactivity together with Insulin Sensitivity in Type 2 Diabetic Men. Exp Clin Endocrinol Diabetes. 2010 Jan;118(1):57-60.
- Siller-Matula JM, Gouya G, Wolzt M, Jilma B. Cross validation of the Multiple Electrode Aggregometry. A prospective trial in healthy volunteers. Thromb Haemost. 2009 Aug;102(2):397-403.
- Gouya G, Jilma B, Niel M, Eichelberger B, Wolzt M, Panzer S. Cross validation of aspirin effect ni healthy individuals by Impact-R and PFA-100: a double blind randomized placebo controlled trial. Platelets. 2009 May;20(3):171-6.
- Gouya G, Reichardt B, Bidner A, Weissenfels R, Wolzt M. [Partial reimbursement of prescription charges for generic drugs reduces costs for both health insurance and patients]. Wien Klin Wochenschr. 2008;120(3-4):89-95.
- Gouya G, Reichardt B, Ohrenberger G, Wolzt M. Survival of patients discharged after acute myocardial infarction and evidence-based drug therapy. Eur J Epidemiol. 2007;22(3):145-9.
- Risch L, Saely CH, Neyer U, Hoefle G, Gouya G, Zerlauth M, Risch GM, Risch M, Drexel H. Prevalence of decreased glomerular filtration rate in patients seeking non-nephrological medical care-an evaluation using IDMS-traceable creatinine based MDRD as well as Mayo Clinic quadratic equation estimates. Clin Chim Acta. 2007 Mar;378(1-2):71-7.
- Haider DG, Leuchten N, Schaller G, Gouya G, Kolodjaschna J, Schmetterer L, Kapiotis S, Wolzt M. C-reactive protein is expressed and secreted by peripheral blood mononuclear cells. Clin Exp Immunol. 2006 Dec; 146(3):533-9.
- Phringer P, Gouya G, Reichardt B, Wolzt M. Sex-specific antihypertensive drug therapy. Wien Med Wochenschr. 2006 Sep;156(17-18):498-500.
- Risch L, Saely C, Hoefle G, Rein P, Langer P, Gouya G, Marte T, Aczel S, Drexel H. Relationship between glomerular filtration rate and the adipokines adiponectin, resistin and leptin in coronary patients with predominantly normal or mildly impaired renal function. Clin Chim Acta.2007 Feb;376(1-2):108-13.
- Risch L, Hoefle G, Saely C, Berchthold S, Weber M, Gouya G, Rein P, Langer P, Marte T, Aczel S, Drexel H. Evaluation of two fully automated novel enzyme-linked immunosorbent assays for the determination of human adiponectin in serum. Clin Chim Acta. 2006 Nov;373(1-2):121-6.
- Hfle G, Holzmller H, Gouya G, Hergan K, Hubmann M, Langer P, Drexel H. Lower serum beta-CrossLaps in male cardiac transplant recipients treated without prednisolone. Transpl Int. 2003 Jul;16(7):523-8.
- Plzl G, Gouya G, Hgel H, Frick M, Ulmer H, Pachinger O. [Adaptation of guidelines for the treatment of chronic heart failure in a specialized heart failure clinic] Wien Klin Wochenschr. 2002 Oct 31;114(19-20):833-9.
- Schmetterer L, Krejcy K, Kastner J, Wolzt M, Gouya G, Findl O, Lexer F, Breiteneder H, Fercher AF, Eichler HG. The effect of systemic nitric oxide-synthase inhibition on ocular fundus pulsations in man. Exp Eye Res. 1997 Mar;64(3):305-12.
- Schmetterer L, Wolzt M, Lexer F, Alschinger C, Gouya G, Zanaschka G, Fassolt A, Eichler HG, Fercher AF. The effect of hyperoxia and hypercapnia on fundus pulsations in the macular and optic disc region in healthy young men. Exp Eye Res. 1995 Dec;61(6):685-90.
- Wolzt M, Schmetterer L, Gouya G, Zanaschka G, EichlerHG. Is the ECG measure RSh a promising technique for detecting class I antiarrhythmic drug action in men J Cardiovasc Pharmacol. 1995 Oct;26(4):660-5.
- Case reports, Editorials und Reviews:
- Gouya G, Hlsmann M. Die kardiale Kachexie. Eine Folge der chronischen Herzinsuffizienz. Wiener Klinisches Magazin. Volume 12, Number 3 / Juni 2009.
- Gouya G, Hartmann G, Fa P, Tauber M, Holzmller H, Benzer W, Lang A, Schuster A, Drexel H, Offner FA. A case of fulminant post-transplant lymphoproliferative disorder and septicemia. Clin Transplant. 2006 Mar-Apr;20(2):261-4.
- Book-chapters:
- Gouya G, Wolzt M: Cardiovascular disease and ocular manifestations. In: Schmetterer L (ed), Ocular Blood Flow. Springer, Berlin 2012.
- Gouya G. Current Topics in Clinical Pharmacology (Mller M. et al); Special situations, market fragmentation 2: sex – differences; Example: CHD. Springer Verlag 2010-revised 2016
- Gouya G, Wolzt M: Rationelle Abklrung des Hypertonikers und Risikostratifizierung. In: Auer J (ed), Hypertoniebehandlung in der Praxis. UNI-MED Verlag AG, ISBN 978-3-8374-1081-5, 2008.