Leaders in innovation

María Elvira Parellada, MD, is part of the Oncology Medical Directors at Fortrea, based in Buenos Aires, Argentina. Dr. Parellada joined us in 2021. Her area of expertise is the Medical Monitoring of Onco-Hematology trials, through Phase I to III with special focus on Cell and Gene Therapy and small molecules, and their development through early phase trials. Previously, Dr. Parellada served as an investigator in multiple clinical trials related to the area of Onco-Hematology; and served as an MSL in large pharmaceutical companies. 

Dr. Parellada earned her medical degree from the National University of Tucuman (Tucumán, Argentina) and completed her Hematology residency at the Hospital Ramos Mejía and at the Argentinian Society of Hematology (Buenos Aires, Argentina).

Plamen Penev, MD, PhD, is a Board-Certified endocrinologist and Executive Medical Director leading a group of five other endocrinologists in the Cardiovascular, Metabolic, Endocrine and Renal therapeutic areas at Fortrea. 

Dr. Penev completed his PhD training at Northwestern University, followed by residency in Internal Medicine at Saint Louis University and fellowship in Endocrinology at the University of Chicago and has over 25 years of combined patient care and clinical research experience in academia and industry.

As a member of our global team of Medical Monitors, Dr. Yi Pi has significant medical and pharmaceutical expertise with more than 15 years in the industry and academia. He was certificated for specialized clinical practice in Cardiac Surgery and internal Medicine of Cardiology and had performed as the Principal Investigator and Medical Monitor, fully engaged in both designing and implementing clinical research in China National Center for Cardiovascular Diseases, Fuwai hospital and Duke Clinical Research Institute. 

After joining our company in 2021, Dr. Pi has been working as lead/regional physician on multiply early phase studies, as well as confirmatory trials in treatment areas including Oncology, as well as Cardiology, Endocrinology, Respirology, Neurology, Dermatology and Rare Diseases. Dr. Pi earned his medical degree from Xiangya School of Medicine and Master of Health Science degree from Duke University School of Medicine.

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. 研究職に転身する前は、オランダのウィルヘルミナ小児病院で小児腫瘍科の骨髄移植、血液腫瘍専門医として勤務しました。 Martine joined our company in November 1996.

Isabella Presch, MD, MBA, is a Senior Medical Director of Fortrea's Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). 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 includes more than 15 years supporting 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 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.

Suning Qian, MD, has eight years of pharmaceutical experience in oncology area and has built strong relationships with external research groups and Key Opinion Leaders. She has medical monitoring experience in all phases of oncology trials, focused on planning and execution of oncology clinical development projects. Dr. Qian earned her medical degree from Peking Union Medical College, Tsinghua University, and completed her internal medicine residency and fellowship training at Nanjing Drum Tower Hospital. She joined our company in July 2021.

Gong Qing, MD, is Associate Medical Director for Fortrea Clinical Development Services, based in Shanghai, China. She has over 16 years of academia and clinical practice experience and more than 4 years of early and late clinical development research experience covering oncology and other therapeutic area. Her industry experience includes global trials in solid tumors, including breast cancer, NSCLC, pancreatic cancer etc., for products including biologics, targeted therapy and chemotherapy. Dr. Gong served as Associate Chief Physician before joining in industry and held medical responsibility in Pharma since 2018. She joined our company in March 2020.

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 26 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 the last 15 years specifically focused on 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!

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.

Irina Savina, MD, PhD, is a Medical Director for Fortrea Medical Services, based in Saint-Petersburg, Russian Federation. Dr. Savina has more than 13 years of experience in oncology clinical drug development from medium-sized to large-size CROs, focused on medical support of global oncology clinical development projects for solid tumors. 

Dr. Savina earned her medical degree from Medical University of Saint-Petersburg and Philosophy Degree from Oncology Institute in Saint-Petersburg. Dr. Savina has an experience as Lower Gastrointestinal Surgeon and Medical Oncologist. She joined our company in 2019.

Susanne Schmidt, MD, PhD, is a Senior Medical Director of Fortrea's Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). She is a Board-Certified pediatrician with more than 14 years of clinical experience across multiple therapeutic areas including pediatric gastroenterology and rare diseases. 

Dr. Schmidt has 10 years of industry experience in the CRO environment, which includes projects in pediatrics, rare diseases and advanced therapies (gene therapy, RNAi) across many indications and all phases of development. She also has broad experience supporting projects across all pediatric age groups including premature neonates.

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.

Vikas Mohan Sharma, MD, joined Fortrea in December 2023 and serves as its Global Head of Neuroscience and Ophthalmology therapeutic areas. ヘルスケアと臨床開発において 23 年以上の経験を持ち、業界のリーダーとして高く評価され、研究倫理と患者様の安全における専門家として名立たる存在です。 

ヘルスケア、CRO、バイオ医薬品業界でさまざまな指導的役割を果たし、医薬品開発分野の重要なオピニオンリーダー（KOL）とみなされています。精密精神医学、デジタルバイオマーカー、医療サービスの利用や、いわゆる「ラストワンマイル」の課題に対処するためのテクノロジー活用などの推進を図るため、さまざまな産業界、コンソーシアム、非政府組織の取り組みを主導し、コラボレーションを促しています。 

直近では、Boehringer Ingelheim 社で、エンドツーエンドの臨床開発戦略と、初期および後期段階の製品の研究開発を担当し、複数の治療領域にわたるグローバルな臨床開発、医療業務、科学専門チームを率いました。精神医学と中枢神経系（CNS）臨床試験の治験責任医師として 16 年の臨床経験を有し、薬理学的、さらにはデジタル資産のファースト・イン・クラス、「ブルーオーシャン」、「ビヨンド・ザ・ピル」製品戦略の策定と実行を成功に導いた実績を持っています。バイオマーカー開発への早期投資の支持者として知られ、適切な利害関係者の仲介役となることに尽力しています。 

また、欧州研究評議会やその他の非政府組織で、独立した倫理専門家としても活躍しています。特別な支援を必要とする子どもたちを助けることに情熱を注ぐ彼は、ボランティアとして自らの時間と専門知識を分かち合い、その目標を達成するため尽力しています。インドのムンバイにある Seth Gordhandas Sunderdas Medical College（GSMC）と King Edward Memorial（KEM）病院で心理医学の医学博士号を取得しています。