Leaders in innovation

Franklin Gaylis, MD, FACS, ist als Consultant im Bereich Urologie bei Fortrea beschäftigt. Darüber hinaus ist er als Executive Medical Director von Unio Health Partners (UHP), der größten urologischen Unternehmensgruppe in Kalifornien, und als ehrenamtlicher Professor für Urologie an der University of California in San Diego beschäftigt. 

Er ist außerdem als wissenschaftlicher Mitarbeiter am American College of Surgeons, Mitglied der American Urological Association und Botschafter des American Board of Urology tätig. Er hält im In- und Ausland Vorlesungen zu Themen der medizinischen Qualität und Implementierung wissenschaftlicher Erkenntnisse und gilt in diesen Bereich als führender Fachmann. His research has been published in clinical journals such as Urology, Journal of Urology, Urology Practice, American Journal of Medical Quality, and the New England Journal of Medicine. Dr. Gaylis konzentriert sich seit mehr als 30 Jahren auf die Behandlung von Prostata- und Nierenkrebs in der Früh- und Spätphase, einschließlich chirurgischer Eingriffe und klinischer Studien in den Phasen I bis IV. Er hat in den vergangenen 30 Jahren an zahlreichen klinischen Studien teilgenommen, an vielen von diesen als leitender Wissenschaftler. Außerdem hat er 40 Publikationen veröffentlicht, bei 30 dieser Publikationen war er Erstautor. Dr. Gaylis hegt ein enormes Interesse an Data-Mining aus dem EMR und überwacht das Programm für Gesundheitsinformatik von UHP. Er verfügt über eine einzigartige Erfahrung im Bereich Big-Data-Analysen und führt bei Fortrea Durchführbarkeitsstudien zur Entwicklung synthetischer/externer Kontrolllösungen für den Bereich Urologie durch. Dr. Gaylis bietet urologische Beratung für Therapien, Diagnostik und klinische Biomarker-Studien und hat bereits zahlreiche Beratungsveranstaltungen für Sponsoren organisiert, die Beratung bezüglich Protokollen in der Entwicklungsphase benötigten.

Michael George, MBBS, MRCP, MFPM, is the Global Therapeutic Area Head at Fortrea. 

His areas of expertise include global strategic clinical drug development and portfolio and program management across multiple therapeutic areas, including immune-mediated inflammatory diseases (IMIDs), cardiovascular and metabolic diseases and women’s health. 

He has more than 25 years of experience in the pharmaceutical and CRO industry, having held numerous posts of increasing seniority across all phases of clinical drug development in various therapeutic areas and pharmacovigilance with both regional and global responsibility. At Fortrea, Michael is responsible for medical portfolio oversight, executive governance and clinical business development. He has authored several articles in the areas of IMID development, hypertension, heart failure, diabetic retinopathy and neuro-endocrine modulation.

Maria Paula Ghirardi, MD, is Medical Director of Oncology for Fortrea Clinical Development Services, based in Buenos Aires, Argentina. Dr. Ghirardi has 6 years of Oncology clinical research experience in both pharmaceutical and CRO industry. She provides clinical and medical expertise to project team and other Fortrea departments to advance clients' drug development programs and contributes to the scientific strategic leadership of the Oncology therapeutic area. She has experience leading important launches of hematology-oncology compounds for multiple myeloma, AL amyloidosis, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. 

Dr. Ghirardi earned her medical degree from the University of Buenos Aires and completed her internal medicine residency at the Hospital Ramos Mejia in Buenos Aires and Hematology residency at the Hospital de Clinicas in Buenos Aires and Sociedad Argentina de Hematologia. She joined our company in October 2022.

Susan Gilchrist, MD, is a Medical Director of CVMER (cardiovascular, metabolic, endocrine and renal) at Fortrea. Dr. Gilchrist is a board-certified cardiologist with more than 15 years of experience treating cardiovascular patients and has formally trained in epidemiology and clinical trial design. As a clinician scientist, she has extensive experience in cardiovascular cohort and clinical trial development and execution and has contributed to over 100 peer-reviewed publications in cardiovascular clinical research. 

Dr. Gilchrist has an MD from the University of Texas Health Science Center in San Antonio (UTHSCSA) and completed a cardiology fellowship at Wake Forest University School of Medicine and an internal medicine residency program at UTHSCSA. She earned an MS in Epidemiology and Clinical Research from Wake Forest University Graduate School and a BA from the University of Texas at Austin.

Vice President & Therapeutic Strategy Leader at Fortrea, Board Certified Nephrologist, Adjunct Professor at University of North Carolina, Division of Nephrology & Hypertension and past Associate Medical Director at local dialysis units. 

Board of Directors (2018-2023) for the Kidney Health Initiative (a public-private collaboration between the FDA and the American Society of Nephrology). Co-chair of Steering Committee for APOL1 Kidney Disease; work group member (and publication co-author) for Endpoints in IgAN, FSGS, C3G, Peds IgAN and CVO Trial challenges in CKD patients. Steering Committee for NFK CKD Patient Registry (Patient Network) and serves on multiple Advisory Boards and Stakeholder Committees (e.g., NephCure and International Society of Glomerular Disease's PARASOL for FSGS Endpoints; PREPARE-NS for PROs; NKF Scientific Workshops for Renal Endpoints in Early CKD; Medical Ad Board for Regional NKF, NephCure MN Consensus Group, PCORI, SONG) and invited faculty speaker at many global nephrology conferences. 

Collaborating with sponsors since 2006 on renal clinical development programs across 20+ indications in both CKD and End Stage Kidney Disease and associated complications

• Senior Medical Director at Fortrea.  Board certified internist and nephrologist
• 15 years clinical experience as internist and renal physician including serving as in-house nephrologist at dialysis centers.
• Clinical trial industry related experience since 2009.   Collaborating with sponsors serving as project medical lead and scientific advisor on various therapeutic indications including CKD and End Stage Kidney Disease, Lupus Nephritis, hemodialysis study and associated complications

Brian is based in Chicago, Illinois, USA and has over 19 years clinical research experience, having worked at several biotech companies, a global CRO and GlobalCare Clinical Trials (acquired by Covance/Labcorp). Brian joined Fortrea in 2020 as a part of the GlobalCare acquisition. He has worn many hats in those years and has hands-on experience in clinical operations, strategic planning and growth, data management, medical writing, project management, portfolio management, line management, business development, contract execution, FDA submissions and working with advisory boards. He has therapeutic experience in Ophthalmology, Women's Health, Neurology, Rare Disease, Oncology, Cardiovascular and Trauma research and has spent the last 3 years solely focused on Ophthalmology. 

Brian is passionate about patient centric clinical trials and finding creative solutions to reduce site and patient burden in a space filled with complex and debilitating disorders.

Dr. Gutiu is a board-certified neurologist with more than 15 years of clinical experience in a hospital setting across a wide range of neurological and psychiatric indications. He spent 10 years in academia as Assistant Professor of Neurology and attended doctoral courses in neuropharmacology. His 25 years of clinical research experience includes roles as an investigator, medical monitor and medical leadership positions spanning Phase I-IV studies. 

He has broad range of experience across product modalities, including biologics and cell and gene therapies as well as medical expertise in neuro and psychiatric diseases, including, but not limited to, neurodegenerative, pain, neuromuscular and demyelinating.

Brian Hamilton, MD, PhD, is Senior Medical Director for Fortrea, based in Newton, Massachusetts. He serves as Fortrea Subject Matter Expert for cellular immune-oncology, CAR-T and gene therapy. Er ist außerdem als globaler leitender Projektarzt bei Wirkstoffentwicklungsprojekten von Kunden tätig. Dr. Hamilton hat mehr als 35 Jahre Erfahrung in der pädiatrischen Medizin, Immunologie, hämatopoetischen Stammzelltransplantation und klinischen Forschung und Entwicklung. Before joining Fortrea, he served as Executive Medical Monitor for Chiltern International. Er hatte außerdem leitende Positionen als medizinischer Direktor, ärztlicher Direktor für regulatorische Angelegenheiten und klinische Forschung bei Galena Biopharma, AstraZeneca, Onyx Pharmaceuticals, Wyeth Oncology und anderen Pharma- und Biotech-Unternehmen inne. Dr. Hamilton joined our company in August 2018.

Konstantin Haradinov, MD, is a Medical Director, Oncology for Fortrea, based in Sofia, Bulgaria. He contributes to the development of Fortrea policies involving medical, safety and therapeutics; serves as global lead project physician and provides medical and safety monitoring on assigned projects; reviews medical data and provides clinical and medical expertise to project teams and other Fortrea departments, and performs safety trend analyses. 

Dr. Haradinov hat mehr als 15 Jahre Erfahrung in der klinischen Forschung als medizinischer Leiter und Arzt/Onkologe. Before joining Fortrea he served as Medical Officer, Oncology, for Chiltern International in Sofia, Bulgaria. Dr. Haradinov joined our company in April 2019.

Dr. Hoelscher ist in Austin, Texas, ansässig und verfügt über 24 Jahre Erfahrung in der CRO-Branche in zahlreichen Therapiebereichen. In den letzten 16 Jahren konzentrierte er sich insbesondere auf die medizinische Überwachung unter anderem folgender ophthalmologischer Indikationen: 

• Retinal: trockene/feuchte AMD, nicht infektiöse Uveitis, DME, Makulaödem bei Uveitis, vitreomakuläres Traktionssyndrom, Proliferative/ Nicht proliferative diabetische Retinopathie 
• Hinterer Abschnitt, z. B.: Trockenes Auge, Glaukome/POAG 
• Gentherapie: feuchte AMD, Spielmeyer-Vogt-Krankheit 
• Seltene Erkrankungen: Spielmeyer-Vogt-Krankheit, Choroideremie, Morbus Stargardt, Retinitis pigmentosa, Lebersche kongenitale Amaurose 

Während seiner Ausbildung nahm er an dem Programm „Mavericks in Ophthalmology“ des Parkland Memorial Hospital teil, das seine bis heute bestehende Faszination für Forschung und die klinische Praxis der Augenheilkunde weckte.

Jingjun (Eric) Huang, MD, is Senior Medical Manager in Fortrea, based in Guangzhou, China. He has 10 years of experience in clinical practice and clinical study in oncology, especially in hepatobiliary cancer. He was a principal investigator and expert reviewer of the National Natural Science Foundation of China and Medical Science Research Foundation of Guangdong Province. He published nine studies as the first/co-first author. 

Dr. Huang earned his doctorate degree and bachelors degree in an eight-year program in Clinical Medicine at Sun Yat-sen University. He completed his residency in the Third Affiliated Hospital of Sun Yat-sen University and worked as attending physician in the Department of Interventional Radiology and Minimally Invasive and Interventional Cancer Center and the Second Affiliated Hospital of Guangzhou Medical University. He joined our company in January 2022.

Krane Huang, MD, is a Senior Medical Director, China Regional Head of Oncology for Fortrea, based in Shanghai, China. Dr. Krane has nearly 20 years of experience as medical oncologist in cancer hospitals, global pharmaceutical industries and CROs, focused on planning and execution of global oncology clinical development projects in all phases (I-III), different drug types and classes. 

Dr. Krane earned his medical degree from Tongji Medical College, Huazhong University of Science & Technology and completed his internal medicine degree and medical oncology fellowship training at Wu Union Hospital. He joined our company in September 2019.

Kazuya Iwamoto, MD, PhD, MBA, FACP, is Senior Medical Director for Fortrea in Osaka, Japan. He provides medical and scientific expertise to oncology study teams on clients' drug development projects and contributes to the development of medical strategies and execution of clinical trials. Dr. Iwamoto has more than 25 years of experience as a physician, research clinician and medical director. 

Before joining Fortrea, he was Head of the Medical Division, including Clinical Development and Medical Affairs, for Hospira Japan in Osaka. He previously served as Head of the Medical Division for Biogen Idec, Head of Medical Affairs for Bayer Yakuhin, and Clinical Research Physician for Eli Lilly in Japan. Currently President and Fellow of the Japanese Association of Pharmaceutical Medicine, Dr. Iwamoto joined our company in May 2016.

Juan Jure, MD, is a Medical Director based in Buenos Aires, Argentina at Fortrea, where he serves as project physician. Dr. Jure brings extensive experience in medical and safety oversight of clinical trials, with a strong therapeutic experience in oncology (solid tumors Phases I-III) and cancer supportive care as well as developing, reviewing, and revising protocols and project-specific tools. 

Prior to his current position, Dr. Jure held positions where he gained expertise in medical monitoring demonstrating a commitment to ensuring the safety and well-being of study participants, as well as maintaining high standards of data quality and site compliance.

 Dr. Jure holds an MD degree from Universidad Nacional de Córdoba, Argentina, and completed his postgraduate degree in Clinical Oncology at Municipalidad de San Isidro. Furthermore, he has completed a Master's in Business Administration from Universidad del Salvador, Argentina. 

Dr. Juan Jure's diverse experience and commitment to patient care, make him a valuable asset in the field of clinical research and drug development. He joined our company in March 2023.

Jeanelle Kam, MD, is a trained OB/GYN with more than a decade of CRU drug development experience across multiple indications. As a CPI and Medical Director at the Phase I Dallas CRU, Dr. Kam conducted over 200 trials in BE, DDI, FE, FIH, Japanese Bridging and TQT studies. In 2022, she joined the CPS Medical Scientific Team as a Phase I Medical Monitor. Her expertise in Women's Reproductive Health include serving as PI on OC-DDI studies, consultation of endometriosis, lactation and post-menopausal studies. She was the lead author for Fortrea's birth control guidance, "Evidence-Based Guidance for Contraceptive Use in Phase I and Clinical Pharmacology Trials Including Women of Child-Bearing Potential" and presentation of the guidance at the 2015 Annual Meeting for ACCP poster session.

Geoffrey Kannan, PhD, MD, is an Executive Medical Director in the Oncology Therapeutic Area, Head of the Americas Oncology Team, and Lead for the Pediatric Oncology Medical Science Leadership Center. Dr. Kannan also provides medical and scientific governance to Sponsors, supporting development and execution of oncology clinical trials. Dr. Kannan brings more than 25 years of oncology scientific and medical experience to Fortrea. Dr. Kannan trained as a pediatric hematologist/oncologist and pediatric neuro-oncologist and has served at the University of Miami Miller School of Medicine, the University of Texas M. D. Anderson Cancer Center, Dana-Farber Cancer Institute/Boston Children's Hospital, and on faculty at Harvard Medical School. Dr. Kannan joined Fortrea out of practice as a pediatric neuro-oncologist affiliated with Inova Children's Hospital and Children's National Medical Center. At Fortrea Dr. Kannan leads medical and scientific oncology therapeutic expertise and strategic endeavors for Fortrea's Americas-based oncology physicians, and leads Fortrea's pediatric oncology initiatives, lending an experienced voice to guide industry partners to bring life-saving therapies to children afflicted with cancer.

Louise Kearney is an Executive Director of Fortrea's Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) and Chair of Fortrea's Cell and Gene Therapy Long-term Follow-up Workstream. She has 23 years of experience, across sites, biotech, pharmaceutical and CRO companies. She has worked at Labcorp (now Fortrea) for 19 years, including 10 years within Project Management. Her operational expertise spans a wide variety of complex rare disease and pediatric trials including leading a rare, pediatric program.