Avatar

Laszlo D. Molnar MD PhD

Biostatistics, Statistical programming, Medical, Clinical research, Phase I-IV studies, Analysis of Clinical Studies, Veterinary and Social research

1204 Budapest, HU
Szent Imre herceg utca 52.

molnardl@hotmail.com

+36 20 9552782


Research Activity

Medical research, Clinical research, Phase I-IV studies, Animal studies

Social Science research

Consulting

Technical Skills

Data management

Biostatistics

Social statistics

Multivariate statistics

Computer intensive methods

Bayesian statistics

Deep learning

Data science

GIS development, Geodemography, Disease mapping

Statistical Programming

SAS programming (Enterprise Guide, Data Integration Studio, Enterprise Miner, Predictive Modeling, Visual Analytics)

Stata programming (Stata 16)

R programming

Python programming

Languages

English

German

Hungarian



CLINICAL STUDY DESIGN AND ANALYSIS EXPERIENCE

Pre-clinical / Design and analysis of experiments, shelf-life stability

I / SmPC, SOP, protocol, CSR, SAP, design, analysis, reporting of safety, tolerability, bioavailability, PK/PD, bioequivalence, efficacy, noninferiority; TQT studies

IIa,b / PoC, dose-finding, communication with authorities

IIIa,b / Design, analysis, reporting of pivotal studies, safety and efficacy analysis, submission of documents, medical writing, publications

IV / Design, analysis, reporting of PMSs, IISs, PIL, medical writing, publications

Other / Epidemiology, technology assessment, medical devices, HEOR, RWE

Regulatory affairs / Development of MAA/NDA for EMA, pre-IND and IND to ND for FDA, submissions including DCP, MRP, CP, and national applications; PIL, generics and OMPs

Drug safety, Pharmaco-vigilance / Data capture for drug safety, AEs, SAEs, ADRs, SUSARs, assess causality, benefit and risk. Evaluate Case Safety Reports. Participate in signal detection, signal prioritization, risk analysis. Use ICD-10, MedDRA, WHO, TNM, Recist 1.1 classification for NSCLC

Medical writing / SmPC, eCSR, TOC, assigned protocol, granular eCTD, eCRF, Informed Consent, Randomization Scheme, SAP, PK/PD, Appendices, papers

SELECTED THERAPEUTIC AREA EXPERIENCE

Cardiology / ECG analysis, atherosclerosis, MI, arrhythmias. Cardiac safety, TQT studies

CNS / Addictions, genetic polymorphism, multiple sclerosis, stroke; pain scales, VAS, EQ-5D, SF36

Endocrinology / Oxytocin, vasopressin, renin-angiotensin-aldosterone system, diabetes mellitus

Immunology / RA, ITP with a recombinant mAB. Safety and efficacy of mAB targeting CD20, ACR20 resp.

Oncology / Breast, colorectal, kidney, skin cancer, leukaemia, NSCLC. Cancer registry

Pulmonology / Asthma, COPD, NSCLC

Medical devices / Embryo development using media

Translational Medicine / Vasopressin V1/V1a, V3/V1b and V2 receptors and oxytocin receptor ligands. Tumor marker utility of cathepsin B, cathepsin L, CEA and CA 19-9 in colorectal cancer. Pathways in RA. T cells, B cells and interaction of pro-inflammatory cytokines, esp. TNF-α, IL-6 and IL-1; CRP

Urology / Ureteric stones. Renal transplantation. Number of potential donors from vital stats

Selected references

2019 / Lendvai et al. Cardiometabolic correlates of sleep-disordered breathing in renal transplant children. Pediatric Transplantation. 2019;00:e13529.; 1 of 8. DOI: 10.1111/petr.13529

2019 / Dinya et al. Biometrics in clinical practice. Bayesian Solutions. Medicina Kiadó. (In Hung.). 306 pp.

2017 / Abdelmegeid et al. Radiographic assessment of pulmonary fluid clearance and lung aeration in newborn calves delivered by elective Caesarean section. Reprod Domest Anim. Dec;52(6):939-944. Epub 2017 May 30. PMID: 28560819, DOI: 10.1111/rda.12998

2016 / Molnar Bayesian methods in medical science. (In Hung.) Lege Artis Medicinae, 26(1-2):33-47.

2015 / Hardarson et al. Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup. Fertil Steril. Dec;104(6):1452-9.e1-4. doi: 10.1016/j.fertnstert.2015.08.037. Epub 2015 Sep 25.

2015 / Szenci et al. Co-infection with Bovine Herpesvirus 4 and Histophilus somni Significantly Extends the Service Period in Dairy Cattle with Purulent Vaginal Discharge. Reproduction of Domestic Animals. Article first published online: 21 DEC 2015. DOI: 10.1111/rda.12658

2008 / Herszenyi et al. Tumor marker utility and prognostic relevance of cathepsin B, cathepsin L, urokinase-type plasminogen activator, plasminogen activator inhibitor type-1, CEA and CA 19-9 in colorectal cancer. BMC Cancer, 8:194.

2003 / Romics et al. The effect of drotaverine hydrochloride in acute colicky pain caused by renal and ureteric stones. British Journal of Urology International (92):92-96. Blackwell Publ.