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Click here or scroll down to respond to this candidateDr Steven F Komjathy MDPHONE NUMBER AVAILABLEEMAIL AVAILABLEhttps://LINKEDIN LINK AVAILABLELicensed Physician in North Carolina since Street Address
oLicense number Street Address -1440 currentOver 350 global clinical development trials lead or supported from Phase 1 to phase 3 in Oncology, Hematology, Autoimmune, Virology, etcKey Leadership roles in Clinical Development include the following:Global Medical Director at Amgen, Lilly, Accorda, PRA International and St Andrews PharmaComGlobal Drug Development Special Expert since 2009Real World Evidence Leader since 2009 while at Lilly, Amgen, Accorda, Pra International and CharlesActively practicing physician( actively seeing patients since completing medical school in 1996 and I am skilled at Outpatient and in-patient medicine and Emergency Medicine and Acute Care, ICU, Cardiology, and can do several procedures like EGD, Colonoscopies, Swan-Gantz, Intubation etc, ALS and BSL) since 1996, Prescription Fraud investigation Expert since 1997St Andrews PharmaCom 6/2004-10/2023oGlobal Drug development with several (>250)completed and ongoing trials in phase 1,2,3 in Oncology, Hematology, Autoimmune, Virology, etcAmgen 8/2017-8/2021oGlobal Medical Director overseeing the Global phase 2,3 programs for Tezepelumab (an Anti-TSLP) monoclonal antibody for COPD and asthma and approval Globally (i.e. USA, Canada, European Union, South America, Japan, China, Middle east, Israel, Australasia)Accorda 3/2016-7/17oLed the development of two global programs for Multiple sclerosis and Parkinsons disease and multiple Advisory Board for MS with the most well known and published Professors and MS Investigators and Thought LeadersEli Lilly and Co 3/2011- 7/2015oLead Clinical Pharmacologist that led to the approval of Ixekizumab(Talz) for Psoriasis from Phase 1,2, 3, Lilly Clinical Pharmacology Physician representative for Lilly at multiple meetingsoHuman Factors Device development expert and in house expert for LillyCharles River Laboratories, Phase 1-unit, Senior Medical Director,oCompleted over 21 phase 1,2 studies complete between 3/2010-3/2011 from First in Human, SAD/MAD, Food Effect, TQT studies, Drug Drug Interaction studies, Abuse Liability Studies to assess the potential addictive potential for non-opiod compounds if they had some off site binding to mu receptors etc.{only a few sites in the USA and Canada offer this very important labelling and to Manage Abuse Potential for non opiate compounds.Pra International 6/2005-3/2010oOversaw and was the Senior Medical Director and Principal Investigator for Clinical Pharmacology Center for Pra International in Lenexa, KS wherein we ran and complete over 300 Phase 1,II studies from First in Human, to single ascending dose to /multiple ascending dose, drug drug interaction, TQT, Bioequivalence, Drug Food interaction, ADME, and I am well versed in using WinNoLin and various other clinical pharmacology softwareoAlso very experienced in PharmacometricsKey Pharmacovigilance roles include the following:oAt Amgen, Accorda, Eli Lilly, Pra International and Charles River I was responsible interpreting all the aggregate safety data for the AE and SAE reports thru medical review and along writing the formal regulatory report and writing the report then after colleague review was responsible for the final signature on the CSR and CRFoAssessing severity and causality and ensuring follow up with site for patient safety outcomesEXPERIENCE HIGHLIGHTSSt. Andrews Med and PharmaCom 2009 PresentUnited StatesHelps support on multiple platforms in Pharma, Biotech, Medical Device, Human Factors, small molecule, large molecule monoclonal antibody, transdermal patches, etc.Global consulting services for all medical and worldwide drug development expertise.Global Regulatory support from clinical development to CMC to Regulatory Affairs, Orphan diseaseValor Hungariae, Ltd. 2017 2020Senior Consultant to Hungarian government for medical innovationAmgen 2017-2020Global Medical Director, Thousand Oaks, CAGlobal Medical Lead for various inflammatory and autoimmune conditions including Tezepelumab in COPD and AsthmaWorldwide clinical studies, Phases 1, 2, 3, 4Lead the Phase 2,3 studies for Tezepelumab for Amgen in partnership with AstraZenecaPart of the Pre-IND teamFiled successful NDA for COPD Asthma; patent pending to anti-TSLP treatmentAcorda Therapeutics 2016 - 2017Global Medical Director, Clinical Development, Ardsley, NYEarly and late phase drug development worked on heart failure, relapsing multiple sclerosing, oncology, asthma.Late phase development of unique inhaler levodopa for the acute treatment of OFF times in Parkinson's disease.Lead the development and wrote as well as getting approved all protocols from preclinical to Phase 1, 2 and 3, as well as investigator initiate protocols.Review AEs and SAEs as well as visits to all clinical sites to help with patient recruitment.Developed strategies to motivate PIs and their teams.Eli Lilly and Company 2011 2015Global Clinical Pharmacology Medical Director, Indianapolis, IndianaClinical pharmacology, early thru late phase support for registration from candidate selection to first in human, proof of concept, dose selection for phase 3 and design and implement of clinical pharmacology package thru life cycle.Medical Device support in design and oversight of Human Factor development. Used clinical pharmacology skillsets combined with quantitative analytical skills and leadership skills to foster strong relationships between teams.Provided a medium for successful discussions that led to approval of Ixekizumab for Psoriasis.Served as the clinical pharmacology & pharmacometrics leader on compounds in both early and late stages of development as well as small and large molecules.Contributed to the design of development strategies, collaborated with business development and other cross functional teams.Appeared before the FDA, BMA, and European regulatory agency to answer all questions regarding the phase 1,2,3 plans and protocols,CP&P on cross-functional drug development teams, contributed to design drug development strategies, regulatory submissions.Bioethics committee member for Clinical Pharmacology Center. Member of Drug Abuse and Liability committee, IQ clinical pharmacology representativeCharles River Laboratories 2009 2011Senior Principal Investigator IISpecializing in Early Drug Development, First in Human, Proof of concept, Radioactive Materials Studies, Thorough QTc studies and other Phase I thru Phase III studies.PRA 2005 - 2009Senior Medical Director, international clinical pharmacology center, Lenexa, KansasPhases 1, 2 human inpatient unit approximately 200 beds.200 studies as Principal Investigator and Senior Medical Director of ClinicalInitially a 50-bed unit that grew into approximately 300Increased Revenue from $300,000 to $18 millionPerformed routine Pharmacovigilance (PV) activities including, but not limited to daily adverse event processing (AE/SAE), medical review of various drug safety deliverables (e.g. ICSRs), running reports from safety database, creating quarterly safety data overview reports, and developing PowerPoint presentations for safety review meetings in collaboration with global safety leadsAmended standard operating procedures (SOPs) and protocols as necessary for Phase II and III trials to mitigate risks found in drug safety procedures; requires writing Protocols (SOPs), Clinical Study Reports (CSRs), and Institutional Brochures (IBs) before submission to local and global regulatory authoritiesGuided regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, Development Safety Update Reports (DSURs), and Periodic Safety Update Reports (PSURs)Reviewed all Serious Adverse Event (SAE) reports, including Individual Case Safety Reports (ICSRs)Reviewed all reported SAEs for completeness of information, IRB/EC notification, Individual Case Safety Reports (ICSRs), and FDA MedWatch or CIOMS form submission/local reporting, if requiredReviewed Individual Case Safety Reports (ICSRs) for approximately 20 US and global clinical trials including adverse events of special interest for neuroscience therapeutic indications in support of regulatory submissionsVA Clinic, NC 2003 2005Internal Medicine Physician,University of North Carolina 1999 2003Clinical Faculty for Internal MedicineLicenses & CertificationsActive North Carolina medical license; North Carolina Medical Board since 1997EducationUniversity of Maryland, Doctor of Medicine, 1992 - 1996Activities and Societies:Clinical and basic science research winner of Young Scientist AwardPresenter at European Congress of Cardiology, Berlin, Germany, 1994Publications on circulation and thrombosisQueens University Kingston, Ontario Canada, BSc honors BiochemistryMultiple scholarships from Medical Research Council of Canada and the Province ofQuebecUniversity of North Carolina at Chapel Hill, 1996 1999Internal Medicine Residency ProgramActivities and Societies:Research Scientist AwardSeveral publications including those on Androgen deficiency in the adult maleand how to treat hyperlipidemia with Omega 3 fish oilsGolf Champion at Echo Farms and several pro ams, TarHeel tour memberPlayed in USGA qualifiersDeep Sea Tournament Fishing tournamentsTriathlon ParticipantRoyal Informatory Edinburgh Scotland Dermatology Rotation 1996Medical Student Rotation in Dermatology with Prof JAA HunterSelected Publications:Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies.Liu L, Bello A, Dresser MJ, Heald D, Komjathy SF, O'Mara E, Rogge M, Stoch SA, Robertson SM.J Clin Pharmacol. 2016 Feb;56(2):143-51. doi: 10.1002/jcph.562. Epub 2015 Jul 29.PMID: 26044116 Review.Preparation of COVID-19 vaccines in hospital pharmacies: a half-year report from Slovakia.Dudk B, Slimkov , Komjthy vecov M, Bundzelov A, Oboov B, usterov A, Tthov K.Eur J Hosp Pharm. 2021 Aug 23:ejhpharm-PHONE NUMBER AVAILABLE doi: 10.1136/ejhpharm-PHONE NUMBER AVAILABLE Online ahead of print. PMID: 34426489 No abstract available.Increasing efficacy of contact-tracing applications by user referrals and stricter quarantining.Goldberg LA, Jorritsma J, Komjthy J, Lapinskas J.PLoS One. 2021 May 19;16(5):e0250435. doi: 10.1371/journal.pone.0250435. eCollection 2021.PMID: 34010333 Free PMC article.Orally inhaled levodopa (CVT-301) for early morning OFF periods in Parkinson's disease.Hauser RA, Isaacson SH, Ellenbogen A, Safirstein BE, Truong DD, Komjathy SF, Kegler-Ebo DM, Zhao P, Oh C.Parkinsonism Relat Disord. 2019 Jul;64:175-180. doi: 10.1016/j.parkreldis.2019.03.026. Epub 2019 Mar 30.PMID: 30992235 Free article. Clinical Trial.Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies.Liu L, Bello A, Dresser MJ, Heald D, Komjathy SF, O'Mara E, Rogge M, Stoch SA, Robertson SM.J Clin Pharmacol. 2016 Feb;56(2):143-51. doi: 10.1002/jcph.562. Epub 2015 Jul 29.PMID: 26044116 Review.Preparation of COVID-19 vaccines in hospital pharmacies: a half-year report from Slovakia.Dudk B, Slimkov , Komjthy vecov M, Bundzelov A, Oboov B, usterov A, Tthov K.Eur J Hosp Pharm. 2021 Aug 23:ejhpharm-PHONE NUMBER AVAILABLE doi: 10.1136/ejhpharm-PHONE NUMBER AVAILABLE Online ahead of print.PMID: 34426489 No abstract available.Increasing efficacy of contact-tracing applications by user referrals and stricter quarantining.Goldberg LA, Jorritsma J, Komjthy, Lapinskas J.PLoS One. 2021 May 19;16(5):e0250435. doi: 10.1371/journal.pone.0250435. eCollection 2021.PMID: 34010333 Free PMC article.Orally inhaled levodopa (CVT-301) for early morning OFF periods in Parkinson's disease.Hauser RA, Isaacson SH, Ellenbogen A, Safirstein BE, Truong DD, Komjathy SF, Kegler-Ebo DM, Zhao P, Oh C.Parkinsonism Relat Disord. 2019 Jul;64:175-180. doi: 10.1016/j.parkreldis.2019.03.026. Epub 2019 Mar 30.PMID: 30992235 Free article. Clinical Trial.Pharmacokinetics, pharmacodynamics, and safety of clevidipine after prolonged continuous infusion in subjects with mild to moderate essential hypertension.Smith WB, Marbury TC, Komjathy SF, Sumeray MS, Williams GC, Hu MY, Mould DR.Eur J Clin Pharmacol. 2012 Oct;68(10):1385-94. doi: 10.1007/sPHONE NUMBER AVAILABLE Epub 2012 Mar 29.PMID: 22457015 Free PMC article. Clinical Trial.Arterial diastolic pressure augmentation by intra-aortic balloon counterpulsation enhances the onset of coronary artery reperfusion by thrombolytic therapy.Gurbel PA, Anderson RD, MacCord CS, Scott H, Komjathy SF, Poulton J, Stafford JL, Godard J.Circulation. 1994 Jan;89(1):361-5. doi: 10.1161/01.cir.89.1.361.PMID: 8281671 |
