Rare Diseases

Leone Atkinson, MD, PhD, is the Executive Medical Director of Fortrea’s Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). She has more than 22 years of industry experience across pharmaceutical, biotechnological and CRO environments with a primary focus on rare disease drug development in Phase I-IV studies across a variety of platforms, including small molecules, biologics, RNA therapies, and gene therapies. 

Dr. Atkinson has extensive protocol design and endpoint development expertise. Her interests include expanding the role of genetic counselors in clinical trials and improving partnerships with specialized site networks and patient advocacy groups. 

She was trained as a Neurologist at Mount Sinai Medical Center, New York City and earned her Doctorate in Medical Genetics.

Marlene Brown is the Director, Operational Strategy of Fortrea’s Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) and Co-Chair of Cell, Gene and Advanced Therapies Tiger Team. She has more than 30 years in pharmaceutical drug development spanning large pharma, emerging biotechs and CROs. 

Within the Project Management realm, Marlene has more than 20 years of supporting end-to-end drug development, clinical, regulatory solutions with Phase I–IV clinical and regulatory expertise across multiple therapeutic areas as well as working as a product development team leader. Before she joined Fortrea, Marlene held various roles at Merck, including basic research, QA, regulatory, product-level project management. She has worked in basic research at Sandoz, BOC Group and W. Alton Joes Cell Science Center.

Frederick Derosier, DO, is the Head of Fortrea’s Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). He has 22 years of experience in the pharma/biotech industry and 10 years of clinical practice in Internal Medicine. He has focused broadly on neurosciences and concentrated exclusively within rare diseases for more than 12 years. 

His Phase I–IV expertise spans small molecules, combination products, biologics, RNA and gene therapies and he has experience leading global clinical development programs including clinical development strategy and planning, protocol development, regulatory and patient advocacy group interactions.

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.

Julie Maher is a Senior Director of Fortrea’s Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). She has more than 27 years of clinical research experience, which includes 26 years of industry experience at Labcorp (now Fortrea). She has extensive project management expertise in late phase oncology as well as operational, strategy and planning expertise across complex Phase I-IV oncology, rare disease and pediatric trials. 

Julie started her career in pediatrics at Sheffield Children's Hospital as a respiratory laboratory technician, where her duties included the study coordinator role for all pediatric asthma trials before she joined the industry side as a CRA for pediatric asthma trials. Her treatment experience includes immunotherapy, cell and gene therapy, vaccines and radiopharmaceuticals.

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.

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.

Darby Thomas, PhD, is the Scientific Director of Fortrea’s Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT). She has more than 20 years of experience in virology, cell and molecular biology, gene and cell therapy and biotechnology. 

She also has broad experience in adeno-associated virus (AAV) gene therapy with roles in CMC, discovery, translational development and patient advocacy for several AAV-focused companies including AGTC, StrideBio, and Sio Gene Therapies with an emphasis on rare neurological diseases and ophthalmology. 

Before the formation of Fortrea, Dr. Thomas was the Director of the Labcorp Enterprise Cell and Gene Therapy team. She also worked as the Director of Rare Diseases at Intrexon, where she gained translational experience developing AAV and plasmid-based gene therapies as well as gene-modified cell therapies for the treatment of rare skin disorders.