Dr Steven F Komjathy MD

805-***-****

ad3kdf@r.postjobfree.com

https://www.linkedin.com/in/steven-komjathy-md-97b49314

●Licensed Physician in North Carolina since 1996

oLicense number 97-1440 current

●Global Drug Development Special Expert since 2009

●Global Development Lead for the following Rheumatology assets at various companie Janus Kinases inhibitors for Rheumatoid Arthritis and Psoriatic arthritis at Lilly and was Global Principal Investigator for Vertex's Janus Kinase inhibitor

●Monoclonal anti-body Ixekizumab an anti-IL 17 for Psoriatic Arthritis

●Real World Evidence Leader since 2009 while at Lilly, Amgen, Accorda, Pra International and Charles

●Key Leadership roles in Clinical Development include the following:

●Global Medical Director at Amgen, Lilly, Accorda, PRA International and St Andrews’ PharmaCom

●Over 250 global clinical development trials lead or supported from Phase 1 to phase 3 in Oncology, Hematology, Autoimmune, Virology, etc

●St Andrews’ PharmaCom 6/2004-10/2023

oGlobal Drug development with several (>250)completed and ongoing trials in phase 1,2,3 in Oncology, Hematology, Autoimmune, Virology, etc

●Amgen 8/2017-8/2021

oGlobal 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 3/2016-7/17

oLed the development of two global programs for Multiple sclerosis and Parkinson’s disease and multiple Advisory Board for MS with the most well known and published Professors and MS Investigators and Thought Leaders

●Eli Lilly and Co 3/2011- 7/2015

oLead Clinical Pharmacologist that led to the approval of Ixekizumab(Talz) for Psoriasis and Psoriatic Arthritis from Phase 1,2, 3, Lilly Clinical Pharmacology Physician representative for Lilly at multiple meetings

oHuman Factors Device development expert and in house expert for Lilly

●Charles 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 6/2005-3/2010

oOversaw 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 software

oAlso very experienced in Pharmacometrics

●Key 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 CRF

oAssessing severity and causality and ensuring follow up with site for patient safety outcomes

EXPERIENCE HIGHLIGHTS

St. Andrews Med and PharmaCom 2009 – Present

United States

●Helps 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 disease

Valor Hungariae, Ltd. 2017 – 2020

Senior Consultant to Hungarian government for medical innovation

Amgen 2017-2020

Global Medical Director, Thousand Oaks, CA

●Global Medical Lead for various inflammatory and autoimmune conditions including Tezepelumab in COPD and Asthma

●Worldwide clinical studies, Phases 1, 2, 3, 4

●Lead the Phase 2,3 studies for Tezepelumab for Amgen in partnership with AstraZeneca

●Part of the Pre-IND team

●Filed successful NDA for COPD Asthma; patent pending to anti-TSLP treatment

Acorda Therapeutics 2016 - 2017

Global Medical Director, Clinical Development, Ardsley, NY

●Early 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 – 2015

Global Clinical Pharmacology Medical Director, Indianapolis, Indiana

●Clinical 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 representative

Charles River Laboratories 2009 – 2011

Senior Principal Investigator II

●Specializing 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 - 2009

Senior Medical Director, international clinical pharmacology center, Lenexa, Kansas

●Phases 1, 2 human inpatient unit approximately 200 beds.

●200 studies as Principal Investigator and Senior Medical Director of Clinical

●Initially a 50-bed unit that grew into approximately 300

●Increased Revenue from $300,000 to $18 million

●Performed 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 leads

●Amended 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 authorities

●Guided 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 required

●Reviewed 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 submissions

VA Clinic, NC 2003 – 2005

Internal Medicine Physician,

University of North Carolina 1999 – 2003

Clinical Faculty for Internal Medicine

Licenses & Certifications

Active North Carolina medical license; North Carolina Medical Board since 1997

Education

University of Maryland, Doctor of Medicine, 1992 - 1996

Activities and Societies:

●Clinical and basic science research winner of Young Scientist Award

●Presenter at European Congress of Cardiology, Berlin, Germany, 1994

●Publications on circulation and thrombosis

Queens University Kingston, Ontario Canada, BSc honors Biochemistry

●Multiple scholarships from Medical Research Council of Canada and the Province of

Quebec

University of North Carolina at Chapel Hill, 1996 – 1999

Internal Medicine Residency Program

Activities and Societies:

●Research Scientist Award

●Several publications including those on Androgen deficiency in the adult male

and how to treat hyperlipidemia with Omega 3 fish oils

●Golf Champion at Echo Farms and several pro ams, TarHeel tour member

●Played in USGA qualifiers

●Deep Sea Tournament Fishing tournaments

●Triathlon Participant

Royal Informatory Edinburgh Scotland Dermatology Rotation 1996

Medical Student Rotation in Dermatology with Prof JAA Hunter

Selected 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.

Dudík B, Slimáková Ľ, Komjáthy Švecová M, Bundzelová A, Oboňová B, Šusterová A, Tóthová K.Eur J Hosp Pharm. 2021 Aug 23:ejhpharm-202*-******. doi: 10.1136/ejhpharm-202*-******. 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, Komjáthy 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.

Dudík B, Slimáková Ľ, Komjáthy Švecová M, Bundzelová A, Oboňová B, Šusterová A, Tóthová K.Eur J Hosp Pharm. 2021 Aug 23:ejhpharm-202*-******. doi: 10.1136/ejhpharm-202*-******. 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, Komjáthy, 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/s00228-012-1260-3. 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

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