Leaders in innovation

Louise Kearney is Head of Rare Disease, Pediatrics and Cell & Gene Therapy Strategy and Delivery at Fortrea. She has 25 years of experience across sites, biotech, pharmaceutical, and CRO companies. She has worked at Fortrea for 21 years, including 10 years in Project Management and 8 years as part of the Rare Disease, Advanced Therapies, and Pediatric team, where she established best practices for these complex studies. Her current role combines strategic leadership and delivery accountability for programs across the therapeutic areas within this portfolio at Fortrea. Louise acts as the central point of coordination for all CGT-related activities and workstreams.

Jinju Kim, MD, PhD, is a Medical Director of Oncology for Fortrea, based in Seoul, Korea. Dr. Kim has over 10 years of clinical development/clinical research experience in pharmaceutical industry and academia including a broad range of clinical drug development activities and cross functional collaboration. 

Dr. Kim earned her medical degree from Hanyang University and majored in Internal Medicine at Hanyang University Graduate School, Korea. In addition, she completed her internal medicine residency and fellowship training at Hanyang University Hospital and then worked as clinical physician and research professor. She has worked for various clinical and project-facing roles as a medical lead at both global pharmaceutical and innovative biotech companies since 2015. She joined our company in 2022.

Ryan Kirby has over two decades of industry experience, with more than 12 years at Fortrea. As a founding member of Fortrea’s Digital Health & Innovation group, he is recognized as a leader and subject matter expert within the Digital Health field. He has been instrumental in the organization’s advancement and adoption of digital solutions and works with industry partners to champion innovative strategies that enable Fortrea to deliver clinical trials. Ryan specializes in leveraging technology to create efficient digital strategies designed around optimized data workflows to enhance the trial experience for all stakeholders.

Tyler Knight, MS, is a Senior Director and real-world evidence (RWE) data scientist who co-leads the RWE & Analytics service within Fortrea’s Market Access Consulting and HEOR group. He has extensive experience writing protocols and statistical analysis plans for RWE studies and overseeing the analyses of primary and secondary data. He has over 25 years of experience using various types of data sources. He is well published with over 70 manuscripts and conference presentations in more than a dozen therapeutic areas.

Tyler’s experience with real-world data includes: administrative claims data from Medicare, Medicaid, and multiple commercial data sources; various electronic medical records sources; hospital administrative data; dialysis center data; various registries; ambulatory care survey files and NHANES from the National Center for Health Statistics; and SEER oncology data from the National Cancer Institute.

Prior to joining Fortrea (formerly Labcorp and Covance), Tyler was employed by Price Waterhouse, where he served as a lead SAS programmer and statistical analyst working with large real-world government datasets.

Tyler earned an MS in Mathematics with an option in Operations Research from Miami (Ohio) University and a BS in Applied Mathematics from Franklin College.

Michiel has over 21 years of drug development and clinical research experience in both pharma and CROs. He joined Fortrea in 2011 providing project management and delivery leadership oversight across many CVMER projects, from Phase I through Phase IV, including registrational and post-marketing programs. Michiel heads up the delivery team and overall accountable for the successful execution of the portfolio in cardiovascular, metabolic, endocrine and renal diseases. Michiel fosters relationships across the CVMER industry, including Fortrea’s sponsors and vendors, collaborating on their clinical development programs and understanding their key needs.

Marcin Koziej, MD, is a medical director of oncology for Fortrea based in Warsaw, Poland. Dr. Koziej has more than 33 years of experience in medical onco-pulmonary research centers, CROs and the pharmaceutical environment. His roles have included physician and investigator, clinical operations professional and project management leader of pan-European and global teams, medical monitor and advisor, clinical strategist, business advisor and mentor. 

Dr. Koziej earned his medical degree from the Warsaw Medical School, Warsaw, Poland and completed his internal medicine fellowship at the National Research Institute for Tb and Lung Disease in Warsaw, Poland. In 2016 he joined Chiltern, which then became part of Labcorp in 2020 and is now Fortrea.

Publications

• Neoadjuvant therapy in hormone Receptor-Positive/HER2-Negative breast cancer
• Intracellular DNA sensing by neutrophils and amplification of the innate immune response

Kah Leng is an Associate Director in Digital Health and Innovation. She has over 20 years of experience in clinical research including clinical operations, project management, and PMO. In her current role, Kah Leng focuses on leveraging digital health technology and innovation to transform the delivery of clinical studies

Chunyan Li, MD, is an associate medical director of oncology for Fortrea, based in China, Shanghai. Dr. Li has solid background and experience in Oncology, she is a board certified oncologist and has 7 years of clinical experience in Shanghai's top hospitals and has served as medical monitor in CROs since 2018 for studies that include solid tumors (non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, gastrointestinal stromal tumor, colon cancer, head and neck squamous cell carcinoma) as well as lymphomas (classical Hodgkin’s lymphoma, mantle cell lymphoma, non-Hodgkin’s lymphoma). 

Dr. Li received her bachelor degree of clinical medicine from Shanghai Jiao Tong University School of Medicine and master degree in oncology from Tongji University and Shanghai Jiao Tong University School of Medicine. She completed the standardized training for residents and standardized training for oncology specialist in Fudan University Shanghai Cancer Center and Shanghai 10th People’s Hospital. She joined our company in May 2021.

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.

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).

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.