Leaders in innovation

Ileana Guerschman is an MD and Sr Director in Project Management, with 25 years CRO drug development experience. She has strong expertise in the management and oversight of complex global studies across various therapeutic areas and different phases. Ileana supports a culture of project management excellence, ensuring assigned staff perform consistently according to defined operational, financial and quality performance and process standards. Ileana acts as a senior point of contact for clients and serves as a liaison supporting the core team throughout the study duration, as needed, to ensure all study deliverables are achieved.

Where are you located? What geographical region(s) do you cover? 
I am based in Wenzhou, China. 

How long have you been working in the area of clinical research? 
I began my career in clinical research in 2016 and have spent nearly a decade supporting clinical development and healthcare innovation. During that time, I have witnessed remarkable changes across China's clinical research landscape, from increasingly complex studies and higher quality expectations to faster innovation and evolving regulatory standards. I joined Covance in 2018 and have had the opportunity to grow alongside the organization through its transition from Covance to Labcorp Drug Development and now Fortrea. Looking back, I feel grateful to have developed both professionally and personally throughout this journey. 

What is the best part of your job? 
What I enjoy most about my role is the people. Throughout my career, I have been fortunate to work alongside talented colleagues who are always willing to share knowledge, offer support and learn from one another. I have benefited from the guidance of experienced teammates and managers who have supported not only my professional development but also my well-being outside of work. As my life evolved from a young professional starting out in the industry to becoming a wife and mother, I have greatly appreciated the flexibility, understanding and encouragement I have received. Those experiences have made Fortrea feel like more than just a workplace. 

What has been interesting about your work in clinical research? Did anything surprise you about the patient population? 
One of the most rewarding aspects of clinical research is the opportunity to learn from people with different perspectives. Every day, I collaborate with a diverse range of professionals, including CRAs, Clinical Research Coordinators, Clinical Team Leads, Project Managers, sponsors, site staff and data management teams. What fascinates me is how each person approaches challenges in a unique way. These conversations often help me see situations from new angles, deepen my understanding of clinical trial operations and inspire creative solutions to complex problems. Continuous learning through collaboration is one of the reasons I remain so passionate about this field. 

What are you most proud of in your work? 
What I am most proud of is being part of a culture that truly values collaboration, growth and people. Throughout my journey I have experienced a strong sense of teamwork and a genuine commitment to helping one another succeed. I particularly appreciate the supportive relationships I have built along the way and the opportunities I have had to continue developing my skills through programmes such as the SCRA Development Program and CQCV Observation. These experiences have broadened my perspective and contributed significantly to my growth as a clinical research professional. 
As I approach my tenth year in clinical research, I remain inspired by the impact our work can have on advancing medicine and improving patient outcomes. I am proud of the journey so far, grateful for the opportunities I have been given, and excited to continue learning, growing, and contributing alongside my colleagues in the years ahead.

Brian has over 20 years clinical research experience, having worked at biotech companies, a global CRO and GlobalCare Clinical Trials. Brian joined Fortrea in 2020. He has hands-on experience in clinical operations, data management, medical writing, project management, portfolio management, line management, business development, contract execution, FDA/regulatory submissions and working with advisory boards. He has therapeutic experience in Ophthalmology, Neurology, Rare Disease, Oncology, Cardiovascular, Women’s Health and Trauma research and has spent the last 4 years dedicated to 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.

Brian is based in the US.

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 28 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.

Based in Germany.

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 has more than 15 years of experience in clinical research as a medical director and physician/oncologist. 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 has 26 years of CRO industry experience in a wide variety of therapeutic areas, most recently in the past 16 years focusing on medical monitoring in ophthalmology indications including: Retinal: dry/wet AMD, Non-infectious Uveitis, DME, Macular edema in uveitis, Vitreomacular traction, Proliferative/non-proliferative diabetic retinopathy. Anterior indications: dry eye, Glaucoma/POAG. Gene therapy: wet AMD, Batten’s disease. Rare disease: Batten’s disease, choroideremia, Stargardt’s disease, Retinitis Pigmentosa, Leber’s amaurosis.

While in medical school, he participated in Parkland Hospital’s “Mavericks in Ophthalmology” program, leading to a long fascination with research and the clinical practice of vision care.

Dr. Hoelscher is based in Austin, Texas.

Alison Howell, PhD, is a Senior Director who leads the Value Demonstration service within Fortrea’s Market Access Consulting and HEOR group. She has over 18 years of experience in market access consulting.

Alison provides strategic direction to projects, specializing in partnering with clients to develop and validate impactful value messages for their products. She delivers the value messages through tactical value communication tools in a variety of formats for use with internal stakeholder and external decision makers. She is well published in medical and health economic journals across many therapeutic areas and has delivered education symposia at international congresses.

Before joining Fortrea (formerly Labcorp and Covance), Alison worked for seven years at Medaxial, a specialist value communications consultancy. Prior to that she worked as a researcher at the University of Edinburgh, studying molecular mechanisms of learning and memory.

Alison earned a PhD in Neuroscience and a BSc in Pharmacology from the University of Edinburgh. She is a Fellow of the Royal Society of Biology (UK).

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.

Sanjay Jain is an Executive Director in Global Regulatory Affairs Strategy with nearly 30 years of experience in product development and regulation. He has deep experience in CMC and leads CMC writing teams, working across small and large molecules, including advanced therapies, biosimilars and combination products. Sanjay advises on global development and regulatory strategies, regulatory pathways, agency interactions and lifecycle management, covering development from preclinical stages through clinical authorization, expedited programs and due diligence.

Before joining Fortrea (formerly Labcorp, Covance, and Envigo), he held senior roles in biotechnology and pharmaceutical companies and previously served as a university lecturer in pharmaceutical sciences. He completed postdoctoral training in Drug Delivery at UCL and holds a PhD in Pharmaceutical Sciences, an MPharm (Gold Medalist) and an MBA in Pharmaceutical Management.

James Joyce is a Delivery Director within the Biopharma group of Global Project Delivery, specializing in Phase Ib through Phase III studies in Obesity as well as Liver Disease including MASH/MASLD (metabolic dysfunction-associated steatohepatitis and metabolic dysfunction-associated steatotic liver disease), Primary Sclerosing Cholangitis and Primary Biliary Cholangitis and Cirrhosis indications. James brings extensive core lab imaging experience, biopsy histology and pathology management, sponsor portfolio oversight and governance. He has worked for 25 years in the pharmaceutical industry, 15 years of which have been at Fortrea (formerly Labcorp and Covance) in Project Management and Director roles. He is based in Atlanta, Georgia, USA.

Dr. Kam is a trained OB/GYN with more than a decade of CRU early drug development experience across multiple indications. As a Certified Physician Investigator (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 and currently is one of the Senior Medical Director at Fortrea. Her expertise in Women’s Reproductive Health includes 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.

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.

Soo-Kiang Cheah, MTM (Biotechnology), BSc (Pharmacy) is a Senior Director at Fortrea, leading Consulting regulatory submissions across the Asia Pacific region. She specializes in regulatory strategy and execution and brings more than 28 years of experience in regulatory affairs, with deep experience in managing regulatory registration activities across Asia Pacific countries.

Prior to joining Fortrea (formerly Labcorp and Covance), Soo-Kiang held senior regulatory roles in the biopharmaceutical and clinical research industries, leading clinical trial and drug registration activities as well as regulatory consulting efforts across the region. She has successfully managed numerous new drug applications across multiple therapeutic areas throughout her career.

Soo-Kiang holds a Bachelor of Science in Pharmacy and is a licensed pharmacist in Singapore. She also earned a master’s in technology (Biotechnology) Management and a Graduate Certificate in medical device regulatory affairs.

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 more than 21 years of drug development and clinical research experience in both pharma and CROs. He joined Fortrea (then Covance) in 2011 as a lead CRA on global trials and moved into project management and delivery leadership positions. He serves as an accountable executive responsible for Fortrea’s liver portfolio (MASH, PSC, PBC), as well as several other metabolic and cardiovascular indications. Michiel has provided oversight across a portfolio of five T2DM studies from start-up through regulatory filing and marketing approval.

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