Leaders in innovation

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

Carlo Lanza, MD, PhD, is Executive Medical Officer for Fortrea, based in Lugano, Switzerland. Dr. Lanza performs medical monitoring and safety assessments on Phase I-IV clinical trials for Fortrea clients. He leads early phase and translational research early development programs with targeted therapies, small molecules, biologics and gene therapy. Dr. Lanza also oversees development of late-stage development strategies, delivery and approval of registrational programs. He brings more than 20 years of experience in clinical research and development as a physician and medical director, specializing in pediatrics and oncology. 

Before joining Fortrea, he served as Medical Director for Medicines for Malaria Venture in Geneva, Switzerland. Dr. Lanza has also held leadership positions with Novartis Oncology, Pfizer Global R&D, and AstraZeneca UK. Carlo joined our company in 2012.

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 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.

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.

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.

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).

Ines Pagel-Langenickel, MD, is an Executive Medical Director of CVMER (cardiovascular, metabolic, endocrine and renal) at Fortrea. As a cardiologist, she has over 18 years of clinical research experience and has served as a principal investigator and co-investigator in several Phase II and III CV trials. Dr. Pagel-Langenickel’s areas of expertise include heart failure, myocardial infarction, CV outcomes, atrial fibrillation, cardiac amyloidosis, stem cell therapy as well as extensive experience with CV outcomes trials and endpoint adjudication. 

Dr. Pagel-Langenickel has an MD from Humboldt University of Berlin, completed a postdoctoral fellowship at NHLBI/NIH and earned an MBA from Mannheim Business School.

Zehra Nurgul Pamuklar, MD, PhD, is a Senior Medical Director of Oncology for Fortrea, based in Cary, North Carolina. Dr. Pamuklar has more than 20 years of experience in oncology clinical drug development in biotechnology companies and CROs. She has supported planning and execution of global oncology clinical development projects from early phase to post approval, within medical affairs and clinical development organizations, and management of pharmaceutical, academic and regulatory interactions. 

Dr. Pamuklar graduated in medicine from the Ankara University School of Medicine, Ankara, Turkey; she has a PhD in Physiology/Immunophysiology and a Master of Science Degree in Clinical Research Management from Duke University, Durham, NC. 

Before joining our company in 2019, Dr. Pamuklar provided medical management of Phase I to Phase III immuno-oncology/oncology clinical trials in non-small cell lung cancer, hepatocellular carcinoma, bladder cancer, esophageal carcinoma, melanoma, pancreatic cancer, prostate cancer, urothelial cancer, colorectal cancer and head and neck cancer.