Leaders in innovation

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.

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.

Publications

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

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

Catherine Laing is a Senior Scientific Director at Fortrea with over 20 years of experience in Clinical Pharmacology. She brings extensive experience in First-in-Human, AME and Drug–Drug Interaction studies, supported by a strong background in pharmacokinetics and project management. Catherine provides strategic scientific leadership across study design.  She has led numerous dose escalation programs and conducts scientific review across all phases of study delivery, from protocol development to final clinical study reports

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 Lomeli received her Medical Degree (MD) from the University of Kansas, Internship in Internal Medicine at the University of Iowa, and Residency in Emergency Medicine at the UMKC School of Medicine in Kansas City. UMKC Staff in Emergency Medicine for two years post graduate. Practiced ER Medicine as Board Certified in Emergency Medicine Physician from 1985- 2011. Principal Investigator at Quintiles Phase 1 Unit in Overland Park Kansas, 2011-1018.