Leaders in innovation

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.

Lingjuan Pang, MD, is a Medical Director of oncology for Fortrea Clinical Development Service, based in Guangzhou, Guang Dong Province, China. Dr. Pang as a member of our global team of Medical Monitors has significant medical and pharmaceutical expertise with 14 years in the industry. She has vast knowledge of oncology therapeutic experience across Phase I-III. She has built strong relationships with external research groups and Key Opinion Leaders (KOLs) to which our experience and success ensures optimal performance in clinical tirals. 

Dr. Pang earned her master degree from Sun Yet-sen University, Guangzhou, Guangdong, China, major in oncology in 2005. She joined our company in Jan, 2021.

Publications

• Biomarkers in head and neck squamous cell carcinoma: unraveling the path to precision immunotherapy

Martine Poelman, MD, is an Executive Medical Director, Oncology, for Fortrea, based in Brussels, Belgium. She provides medical and scientific support to help advance drug development in hematological malignancies for Fortrea clients. Dr. Poelman brings more than 30 years of experience in clinical research and development as a physician and medical director, specializing in pediatrics and oncology, to Fortrea. Before assuming her current position, she served more than 15 years as Global Head of Oncology Research for Fortrea, providing medical monitoring for more than 200 clinical trials. Before joining Fortrea, she served as Clinical Research Physician, Hemato-Oncology-Infectiology, for Eli Lilly in Brussels. Before going into research, she served as Bone Marrow Transplantation and Hemato-Oncology Physician for the Department of Pediatric Oncology, Wilhelmina Children’s Hospital, in The Netherlands. Martine joined our company in November 1996.

Publications

• The Evolving Landscape in Multiple Myeloma: From Risk Stratification to T Cell-Directed Advanced Therapies
• Mechanisms of immune modulation in the tumor microenvironment and implications for targeted therapy

Isabella Presch, MD, MBA, is a Senior Medical Director. She is a certified pediatric surgeon with more than 10 years of clinical experience across therapeutic areas in academia as well as private and public hospitals. Her pharmaceutical industry experience spans over 20 years across several indication, incl a focus on hematologic rare diseases across Phase I–IV.

Dr. Presch has broad experience in global clinical development developing and overseeing product developments collaborating with internal and external stakeholders, including the FDA, PMDA, EMA, PEI and reimbursement agencies. She also has supported global and local medical affairs leading launches of disruptive treatments in rare hematologic diseases and immunology and has significant experience in supporting due diligences.

Dr. Presch is a strategic, cross-functional global leader supporting rare disease, advanced therapies and pediatric clinical development activities across several therapeutic areas. She was recognized in 2022 with the prestigious Labcorp Chairman´s Award for her outstanding contributions.

Sonia Preston is a Senior Director in Strategic Delivery & Growth for Infectious Diseases and Critical Care and is based near Salt Lake City, Utah. Sonia has more than 25 years of clinical research experience including working as a study coordinator for the VA and in a university setting, in major pharma and for the CRO industry in senior positions of leadership in both project management and strategy. Her therapeutic focus within the last five years has been in infectious and immunological diseases, multiple therapeutic areas of rare diseases, renal, cardiovascular, and pulmonary indications. She has been in drug development in Phases I-IV with expertise in pediatric studies and hybrid study designs. 

Sonia is a certified Green Belt in Six Sigma and has been certified as a Project Management Professional (PMP) since 2003 and remains an active member of the Project Management Institute. She earned her master’s degree in operational management from the University of Washington. She joined our company in 2006.

Mala Puri, MD, is a Board-Certified Pediatric Endocrinologist and Senior Medical Director focused in the Cardiovascular, Metabolic, Endocrine and Renal therapeutic areas at Fortrea. Dr. Puri completed her residency training and fellowship in Pediatric Endocrinology at the Children's Hospital at Montefiore, New York and has over 20 years of combined clinical and research work in academia and industry including significant experience in global pediatric and rare disease studies.

Dr. Anna-Karina (Karina) Putineanu, MD, is a Senior Medical Director for Infectious Diseases and Critical Care and is based in Brussels, Belgium. Dr. Putineanu has more than 27 years of experience as an MD, with senior and extensive global pharmaceutical experience, in the medical, clinical, development and leadership fields. Her experience includes medical and operational leadership of multiple Phase I to IV clinical research programs in a multitude of indications, including pediatric, complex, and rare diseases as well as the development of both therapeutic (drugs and biologics) and vaccine products. Her therapeutic areas of interest and expertise include infectious diseases, immune-inflammation, vaccines, respiratory, non-malignant hematology and rare diseases. 

Dr. Putineanu has a strong record of team leadership at the global level, having built and led teams in Europe, U.S. and Asia. Besides the industry/CRO expertise, Dr. Putineanu collaborates with the European Commission in the evaluation of healthcare/medical projects. 

Dr. Putineanu earned her medical degree from Carol Davila University of Medicine & Pharmacy, Bucharest, Romania. Dr. Putineanu joined our company in 2017.

María García Requesens, MD, is a Medical Director at Fortrea based in Madrid, Spain. Dr. García has 5 years of experience in oncology clinical drug development clinical trials in pharma and CROs. She focuses on medical support of global oncology clinical trials for solid tumors. Dr. García earned her medical degree from Universidad Europea in Madrid. She also holds a Nursing Degree and is very patient-oriented, believing in the power of cross-functional communication. She joined Fortrea (formerly Labcorp) in January 2020.

Tanya has over 28 years of experience with Fortrea (formerly Labcorp, Covance and Chiltern), including monitoring, global project management, delivery director oversight and strategic planning and growth. Her clinical research experience includes a broad range of therapeutic experience with over 18 years in ophthalmology. Tanya’s ocular experience covers front and back of the eye indications, inherited retinal and ocular rare diseases across phase I-IV and medical device studies as well as ocular cell and gene therapies.

Her extensive delivery background, coupled with her ocular experience supports both internal and external stakeholders in the strategic development of a reduced burden approach, as well as an efficient and successfully executed ocular trial.

Tanya is passionate about ensuring the priorities of a clinical trial are 1) to reduce the burden across all stakeholders 2) a realistic, common-sense approach and 3) at the end of the day, we all do what we do for the patients.

Tanya is based in the US.

Dana Romano, MD, is a Senior Medical Director at Fortrea. In this position, she has the responsibility of leading the medical team working on global respiratory Phase I, II, III and IV studies, ensuring the Execution of the projects and direct communication with sponsors, including Medical Monitoring to support to Clinical Operations and Pharmacovigilance and ensure the development of compelling medical strategies and integrated solutions to meet sponsors’ needs. 

Dana started her pharmaceutical career as a Principal Investigator conducting Phase IV studies at her GP practice and Phase I and II studies at Richmond Pharmacology (Croydon University Hospital, UK), before moving to the Clinical Research Physician and Medical Monitor roles at Wyeth and Pfizer UK. 

Dana is board-certified in Family Medicine and has strong medical expertise gained through 11 years of clinical practice experience in Romania and the UK. She worked as a GP for 7 years at her own practice and with the largest private service providers. Dana has more than 21 years of experience in the pharmaceutical and CRO industry and managed successfully Phase I-IV clinical trials in biopharmaceutics, from the early protocol development through to medical oversight of enrolled adults, adolescents and children.

Kamal Saini, MD, executive medical director at Fortrea Inc., is a board-certified medical oncologist based in Cambridge, United Kingdom, where he also practices part-time at the Addenbrooke’s (Cambridge University) Hospital. He contributes to the scientific strategic leadership of the oncology therapeutic area at Fortrea and provides clinical and medical expertise to project teams and other Fortrea departments on clients’ drug development projects. He liaises with key opinion leaders and academic cooperative groups with regard to the design, setup, and execution of cancer trials, especially in the breast cancer subdomain. He manages a team of high-performing medical monitors who are a part of the European oncology team. He leads the Precision Medicine and Emerging Therapies Leadership Center at Fortrea, and is also our global Scientific Publications Lead (Oncology). He brings more than 15 years of experience in clinical research and development to Fortrea. He is the author or co-author of several peer-reviewed journal articles. He joined our company in 2015.

Publications

• The Evolving Landscape in Multiple Myeloma: From Risk Stratification to T Cell-Directed Advanced Therapies
• Unraveling the link between cholesterol and immune system in cancer: From biological mechanistic insights to clinical evidence. A narrative review
• CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2– early breast cancer
• Bladder Cancer, Loss of Y Chromosome, and New Opportunities for Immunotherapy
• The Convergence of Radiology and Genomics: Advancing Breast Cancer Diagnosis with Radiogenomics

Verena brings more than 25 years of clinical research experience, with 17 years in global project management across Phase I to Phase IV. She has more than 16 years of experience at Fortrea and offers extensive operational background in respiratory indications, including sinusitis, pharyngitis, bronchitis and pneumonia. 

In her previous role as Director of Project Management, Verena provided oversight for several international studies in Asthma and Chronic Obstructive Pulmonary Disease (COPD). She currently provides functional support from a strategic perspective to our teams.

Dr. Cheerag Shirodaria is the Vice President and Cardiovascular/Metabolic Therapeutic Area Head at Fortrea. He has over 25 years of clinical experience as an interventional and clinical cardiologist and remains on the Faculty at Oxford University Hospitals. He is an expert in cardiac imaging, having completed his doctoral thesis at the University of Oxford on the role of cardiovascular MRI in the evaluation of vascular function. He is also co-director of the coronary computed tomography angiography (CCTA) service in Oxford. He is also co-founder and Chief Development Officer of Caristo Diagnostics, an AI image analysis company that has developed proprietary AI image analysis technology that quantifies cardiometabolic risk associated with coronary inflammation plaque and adipose tissue characteristics. He has supported multiple companies through regulatory interactions, protocol development and Scientific Advisory Board interactions. 

Dr. Shirodaria received his medical degree from St. Bartholomew’s Hospital Medical College in London, his medical doctorate from the University of Oxford and his MBA from London Business School.

Hannah has more than 12 years industry experience focused on healthcare communications, patient insights and input, recruitment and retention solutions and patient support programs. Her experience spans Phase I-III global trials across range of therapeutic areas including neurodegenerative conditions with specific experience in Alzheimer’s Disease, ALS, Multiple Sclerosis, Parkinson’s disease, neuropathy and pain. 

She is driven by a strategic mindset to identify and understand the experiences, challenges and needs of patients and their families and build targeted data-driven recruitment strategies that enable truly patient-centric studies.

David (Dave) Simpson serves as Senior Vice President and Managing Director for Fortrea’s. Clinical Pharmacology Services (CPS). CPS oversees Phase I clinical trials which involves the study of investigational drugs in healthy volunteers. In his role, Dave provides executive leadership to the CPS organization including Project Management, Phase 1 Monitoring Services and Business Operations, as well as Early Clinical Biometrics (ECB) and was instrumental in the success of Fortrea’s recent investment in state-of-the-art facilities in Leeds.

Dave provides consistent strategic leadership to Fortrea with a demonstrable track record for driving growth and competitiveness in global operations across Europe and North America with significant expertise in developing high performance teams across organizational boundaries. Within his role, Dave works to maintain enterprise wide compliance of national and local legislation. Additionally, he is responsible for cultivating ideal workplace practices and routines among CPS to streamline workflow, facilitating an environment that supports innovation and improvement.

Dave is a Certified Management Accountant (CIMA) and has master’s degree in strategic business management from The Manchester Metropolitan University. Dave is a lifelong resident of Leeds, UK and an avid supporter of Leeds United FC. He has been with Fortrea and its previous incarnations for over 35 years.

Fortrea is a leading global contract research organization (CRO) with more than 30 years’ experience helping biotechnology, pharmaceutical, medical device and diagnostics companies advance healthcare innovation that accelerates life-changing therapies to patients.

Norberto Soto, MD, is Senior Medical Director for Infectious Diseases and Critical Care and is based in Philadelphia, USA. Norberto has more than 25 years of clinical research experience with academia, biopharma and CROs, focused on planning and execution of infectious disease, inflammation and general medicine clinical development from first in human to product registration. He has held regional and global positions of increasing responsibility in fields of infectious diseases, rheumatology, respiratory, gastroenterology, cardiovascular, hematology and urology. 

Norberto has co-authored three book chapters, and author/co-authored more than 30 papers in infectious diseases. Norberto earned his medical degree from the Escuela Colombiana De Medicina, Bogota, Colombia and completed his Internal Medicine residence and Infectious Diseases fellowship at Maimonides Medical Center in Brooklyn, NY. Prior to joining Fortrea, Norberto worked as Research Physician at National Institute of Allergy and Infectious Diseases (NIAID) in the National Institutes of Health (NIH) in Bethesda, MD, and held various clinical development positions in pharma and biotech companies. He has been with Fortrea and the legacy companies since 2013.

Dr Marcus Stavchansky PharmD, Executive Director, Global Head Pharmacy Services. Dr Stavchansky is Executive Director and Global Head of Pharmacy Services at Fortrea, based in Dallas, Texas. With over 20 years of experience in pharmacy practice—primarily in research and development—he leads global pharmacy operations across Fortrea’s Clinical Research Units in North America and the UK. As member of the Clinical Pharmacology Services leadership team, he provides strategic and scientific guidance for Phase I/Ib clinical trials, applying his specialist knowledge to drug development, GMP pharmacy services, On-Site Manufacture (OSM) of investigational drug product to clinic dose administration, and the transition from pre-clinical to first-in-human trials. He has therapeutic experience in cardiovascular disease, diabetes, obesity, asthma, and more. A registered pharmacist in Texas, Marcus also serves as adjunct faculty at the University of Texas and Texas Tech University.