Leaders in innovation

Dr Lomeli received her Medical Degree (MD) from the University of Kansas, Internship in Internal Medicine at the University of Iowa, and Residency in Emergency Medicine at the UMKC School of Medicine in Kansas City. UMKC Staff in Emergency Medicine for two years post graduate. Practiced ER Medicine as Board Certified in Emergency Medicine Physician from 1985- 2011. Principal Investigator at Quintiles Phase 1 Unit in Overland Park Kansas, 2011-1018.

Dr Mark Lovern is Executive Director of Medical Science Services at Fortrea, and has 25+ years of experience in the application of model-informed drug development (MIDD). Throughout his career, Mark has led and contributed to numerous projects involving quantitative pharmacology. Prior to his present position, Mark spent over 10 years at Certara in a variety of capacities. His work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Certara.) In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught over 50 technical training workshops on modeling tools and methodology. His most recent therapeutic area experience has been with therapies for infectious disease, metabolic, and autoimmune disorders.

Mark was awarded a Ph. D. in Biomathematics from North Carolina State University in 1997. His favorite leisure activities include hosting dinner parties, traveling, reading, and enjoying films.

Dr. Naidan Luo M.D Ph.D has over 28 years as a trained ophthalmologist and 23 years of clinical trial research experience in Phase I, II, III, IV in a wide variety of therapeutic areas, focusing on medical monitoring in ophthalmology indications including Glaucoma, Ocular hypertension, wet/dry AMD, Dry eye disease, Conjunctivitis, Blepharitis, Refractive error, Corneal Transplantation, NAION, LHON gene therapy, Stargardt disease, Ataxia, Parkinson Disease, AD, Woman health, COPD etc. Rare disease: Heriditary Spinocerebellar Ataxia (SCA), LHON.

Naidan is based in Beijing, China

Tanya Maltseva, Associate Medical Director is based in London, UK. She has over 25 years of experience in clinical research across academic, biopharma, and CRO settings. Board Certified in Internal Medicine, she also holds a PhD in Dermatovenereology and brings more than 8 years of clinical and academic expertise in dermatology and aesthetics.

Tanya currently oversees medical monitoring for Phase II–IV clinical trials and serves as Fortrea’s primary Therapeutic Area Expert in Dermatology and Aesthetics. Her therapeutic expertise includes acne, atopic dermatitis, hidradenitis suppurativa, psoriasis, melanoma, epidermolysis bullosa, aesthetic indications, and extends into COPD, asthma, IPF, allergy, vaccines, infectious diseases, and women’s health.

She began her pharmaceutical career at GSK in the sales department and later transitioned to marketing at TEVA, gaining first-hand experience in the competitive pharmaceutical environment. Her international experience spans US, UK, Europe, Middle East and Asia-Pacific with prior roles at global CROs where she held regional and global leadership positions of increasing responsibility.

Tanya is an active delegate at leading medical congresses such as EADV, AAD and ERS and is also a specialist member of the EADV.

Barbara Mascialino is a Senior Director who leads the Health Economic Modeling & HTA service within Fortrea’s Market Access Consulting and HEOR Consulting group. Her work encompasses health economic and other types of modeling across the product development cycle, as well as projects in health technology assessment (HTA), value demonstration, and real-world evidence (RWE) with over 25 years of experience in HEOR.

Barbara offers experience in cost-effectiveness, cost-benefit, cost-minimization, cost-utility, and other modeling, as well as country model adaptations. She is skilled in decision trees, Markov modeling, and Bayesian modeling. She also assists the European Commission in their evaluations to assign research fundings through the past FP7, Horizon 2020 and ongoing Horizon Europe schemes.

Before joining Fortrea, Barbara held roles in health economics, value demonstration and RWE, in industry and consulting. She has successfully implemented market access strategies globally, developing tailored health economic models, advising on evidence generation and value demonstration, and contributed to global value dossiers. With her deep experience and varied background, she brings a unique perspective, offering creative solutions to support client objectives.

Barbara earned an MSc in Physics, a PhD in Medicine, and multiple certificates in health economic modeling techniques. She also recently completed two advanced courses in artificial intelligence.

Board-certified medical oncologist and nuclear medicine physician with over 20 years of hands-on experience in medical oncology and nuclear medicine and 15 years in the pharma industry. Her expertise spans various domains, including clinical development, regulatory affairs, safety, and medical affairs. Orchestrated successful product launches across diverse therapeutic areas including immunotherapies, targeted therapies, and cellular therapies. 

As a medical affairs expert, she has collaborated with healthcare professionals, patients, and payers to optimize treatment outcomes. Her deep understanding of trial design, patient recruitment, and data analysis has been instrumental in bringing novel treatments to patients.

Patrick McLeroth, MD, is the Vice President and Global Therapeutic Area Head for Infectious Diseases and Critical Care and is based in Pennsylvania, U.S. Dr. McLeroth has more than 23 years of clinical trial experience including as a principal investigator and roles of increasing responsibility at Fortrea focused on planning and execution of infectious disease and critical care clinical development from first-in-human (FIH) to registration and post marketing trials. Dr. McLeroth has provided significant contribution to several approved antibiotics and has co-authored more than 20 papers in infectious disease. Since 2008, he has worked as the lead medical monitor on multiple protocols covering all aspects of infectious disease, including HIV, hepatitis B, hepatitis C, influenza, bacterial infections, fungal infections, tuberculosis and vaccines. 

Prior to joining Fortrea, he worked at Chase Brexton Health Services, Inc. in Baltimore, MD, as Director of HIV Medicine and Research, and was Principal Investigator on more than 30 protocols between 2002 and 2008. Dr. McLeroth completed his MBBCh degree at the University of the Witwatersrand in South Africa and his internship at the Baragwanath-Chris Hani Memorial Hospital in Johannesburg. Dr. McLeroth completed his fellowship in infectious disease and his residency in internal medicine at St. Luke’s-Roosevelt Hospital in New York City, one of Columbia University’s hospitals. Dr. McLeroth has been with Fortrea, formerly Labcorp, since July 2008.

Dr Som Menakuru, Medical Director and Principal Investigator. Dr Menakuru qualified in Hyderabad, India. He holds the Diploma in Pharmaceutical Medicine and the Certificate of Completion of Training in this discipline. He is on the Specialist Register of the General Medical Council for Pharmaceutical Medicine. Dr Menakuru is a Member of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians and a Member of the Royal College of Surgeons of Edinburgh. He has been working as an investigator in early phase clinical research for over a decade in a variety of therapeutic areas.

Dunja Mihajlovic, M.D, PhD is a board-certified anesthesiologist and intensive care specialist with more than 15 years of clinical and research experience. She joined Fortrea in 2022 and is currently involved with medical monitoring for respiratory studies. 

Prior to joining the industry, she worked in Clinical center of Vojvodina, Serbia, treating critically ill patients including patients with respiratory failure, through which she developed a strong expertise in respiratory medicine. She has been actively working on bronchial asthma (mild, moderate and severe) phase III and phase IV studies and COPD phase III studies, performing medical monitoring which includes review of eligibility and safety data, detection of safety trends/signals, detection and review of protocol deviations, providing medical and scientific expertise to sponsors, study sites and study teams. She is included in protocol development and reviews, development of case report forms and training materials. Her involvement also includes participation in Investigator and Sponsor meetings and discussing relevant study issues. She has established professional relationships with key opinion leaders and experts in the field of respiratory medicine.

Friedrich is a board-certified Endocrinologist and Internal Medicine specialist who has >25 years experience in clinical trials and medical practice. He was trained in clinical research and Internal Medicine while working at the Medical University Vienna (Austria) where he was Associate Professor for Clinical Pharmacology. In 2009 he gained an MSc in Public Health from the University of London. He published >50 research papers in peer reviewed journals. His clinical research focus is on Diabetes, Obesity, Endocrinology and Liver Disease (MASLD/MASH, cholestatic liver disease).

Dr Monaghan graduated from the University of Nottingham in 2015 (BMBS) and from the School of Pharmacy, University of London, in 2009 (MPharm). He is an affiliate member of the Faculty of Pharmaceutical Medicine and Certified Principal Investigator. Dr Monaghan brings to the team experience across all stages of drug development, from non-clinical pre-formulation, drug delivery, and safety pharmacology studies, through to conduct of both early and late phase clinical studies as principal investigator. He has been a clinical research physician with Fortrea’s Multiphase Clinical Research Unit since 2022.

Ken has over 30 years Clinical development experience across CROs, pharma & Biotech. He has significant experience from Pre-clinical validation, Global Clinical development planning, Program study execution and reporting, including licence application and approval to post registrational medical affairs activities.

With significant experience leading project management groups globally for over 20 years, through his 8 year tenure at FORTREA he transitioned from leading the PM group into a leadership role integrating the end to end solutions for Labcorp from preclinical through clinical & Laboratory services. In his current role he globally leads the Strategic Delivery and Growth team for Oncology, who are tasked with establishing compelling strategies aligned with our customers clinical development needs from FTIH Phase I to pre and post registrational study planning and delivery.

The primary focus for his team is leveraging the internal and external resources available to ensure a robust data driven study delivery strategy is established for clients needs and then working closely with the operational team to ensure delivery of that strategy. Although aligned to Oncology this team is truly cross therapeutic in background and experience from Cell and Gene therapy, immune-Oncology, radiotherapeutics, auto-immune disease and beyond to devices.

Makoto Nagaoka, PhD is a Senior Director and Head of Regulatory Affairs Japan at Fortrea, leading Regulatory Strategy Consulting and regulatory submissions in Japan. He oversees regulatory agency interactions, global RA/IRB/EC submissions and serves as a strategic regulatory advisor to support client‑focused development and execution in Japan.​

Makoto brings more than 20 years of experience across nonclinical regulatory science, clinical science, regulatory strategy and regulatory intelligence, covering therapeutic areas including oncology, neurology, ophthalmology, dermatology and inflammation. Prior to joining Fortrea, he held senior leadership roles in global and Japan regulatory affairs across major pharmaceutical and biotech organizations, leading PMDA and MHLW interactions through approval and shaping regional regulatory policy and development strategies in APAC and globally.​

He holds a BS, MSc and PhD in Pharmaceutical Sciences from Kyoto University and is a licensed pharmacist in Japan.​

Peter Neupert serves as Fortrea’s Chairman and Interim Chief Executive Officer.

Mr. Neupert served as an Operating Partner at Health Evolution Partners, a private equity fund, from February 2012 to July 2014. Prior to joining Health Evolution Partners, Mr. Neupert served as Corporate Vice President, Health Solutions Group at Microsoft from August 2005 to January 2012, and as the founding Chief Executive Officer and Chairman of the board of directors of drugstore.com, which he joined in July 1998. Since 2013, Mr. Neupert has served as a director of Labcorp and as a director of Adaptive Biotechnologies Corporation. Mr. Neupert previously served as a member of the board of directors of NextGen Healthcare, Inc., a public software company, and several private companies. Mr. Neupert served as a member of the Board of Trustees of Fred Hutchinson Cancer Research Center from June 2007 to June 2020.

Mr. Neupert holds an MBA from the Tuck School of Business at Dartmouth College and a BA in Philosophy from Colorado College. Mr. Neupert was selected to serve on our board of directors because of his extensive knowledge and experience in the field of healthcare information technology and his experience as a director and executive officer of several public companies.

Paulo Nunes, MD, is an Oncology Medical Director based in Porto Alegre, Brazil. Dr. Nunes is a medical oncologist and epidemiologist with more than 10 years of experience in oncology clinical and epidemiological research both as an investigator and medical monitor and has worked both in the academic setting as well as in cooperative oncology groups. His main areas of scientific interest are early-phase clinical trials, epidemiological studies, and gynecological cancers. 

Dr. Nunes earned his medical degree from the Federal University of Rio Grande and completed his internal medicine residency at the Hospital de Clínicas de Porto Alegre, medical oncology residency at Hospital São Lucas da PUCRS, and a fellowship in gynecological cancer and phase I clinical research at McGill University, Montreal, Canada. He holds a master's degree in Epidemiology from the Federal University of Rio Grande do Sul. He joined our company in March 2022.

Publications

• Immune Checkpoint Inhibitors in Breast Cancer: A Narrative Review

Maksym Novikov, MD, is a Senior Medical Director for Fortrea, based in Maidenhead, United Kingdom. He serves as global lead project physician on assigned projects, providing medical expertise and support in the development and conduct of clinical trials. This includes reviewing feasibility of investigator sites and recruitment of trial subjects and performing feasibility risk assessment and data safety monitoring, develops and reviews protocols, case report forms and other data and materials on assigned projects. 

Dr. Novikov has more than 20 years of experience as a physician (surgeon), clinical researcher and medical director. Before Fortrea, he was Senior Medical Officer for Chiltern International in the UK. He also has held clinical research and medical monitoring positions with Novartis, AstraZeneca and other drug development and health care organizations. He joined Fortrea in April 2019.

Teresa Oblak, PhD is an Executive Director in Regulatory Strategy Consulting at Fortrea, based in Michigan, where she focuses on clinical regulatory strategy to support global development programs and key regulatory milestones. She has nearly 20 years of drug development experience across regulatory affairs, medical writing, publication planning, and value demonstration.

Teresa regularly supports U.S. IND development, responses to clinical and non-hold issues, expedited program applications, special protocol assessments, pediatric plans, and diversity action plans. She has led FDA and EMA interactions across multiple therapeutic areas, including rare and orphan diseases, spanning small molecules, biologics, biosimilars, and combination products. She also serves as Head of Nonclinical Regulatory Writing.

Before Fortrea, Teresa was a scientific director and lead writer at a medical communications agency. She holds a PhD in Chemistry from Michigan State University and a BS in Chemistry from the University of Michigan–Dearborn.

Diane Ostang, Delivery Director, has a background in Biomedical Engineering and brings over 22 years of industry experience across various therapeutic areas, with over 18 years as part of Fortrea team. She supports project teams at portfolio level, escalates priority issues, and ensures delivery oversight. Diane prides herself in building strong relationships with sponsors and sites, recognizing how reducing patient burden and supporting site needs can make our program the study of choice even in competitive landscapes. ​

Diane is based in US (ET).