Neuroscience 

Tanya has over 28 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 over 18 years in 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.

Tanya is based in the US.

Amber Burg is the Therapeutic Area Delivery Head for Neuroscience and Ophthalmology at Fortrea. She has more than 27 years of industry experience from a Clinical Trial Associate through CRA and Project Management across multiple therapeutic areas and joined our company in 2001. She develops strategy and provides delivery oversight for the Neuroscience and Ophthalmology portfolio at Fortrea. Amber’s passion for patients is demonstrated by the strategies she implements to reduce patient burden and getting new products to market by delivering studies quickly and with quality.

Amber 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.

Dr. Calabresi has more than 20 years of clinical experience and 16 years of industry experience with a strong track record of designing, conducting and reporting clinical studies in all phases of development in neuroscience. He has worked as a research physician and medical lead at CROs and major pharma companies across various neuroscience indications, including Acute (post-op) and Chronic (neuropathies: chemotherapy induced, diabetic peripheral, and post-herpetic) Pain, Multiple Sclerosis, Alzheimer’s Disease, Parkinson’s Disease, Spinal Cord Injury, Muscular Dystrophies, Mitochondrial Diseases and others across Phases I-IV.

Based in Siena, Italy.

Dr. Todorova is a board-certified neurologist with over 15 years of clinical and research experience in neurodegenerative disorders and demyelinating diseases. She obtained her PhD degree with a thesis on Quality of life in patients with Parkinson’s disease and was involved in academic and clinical research. Dr. Todorova worked as a Clinical Research Fellow at King's College Hospital, London and during this period she was involved in academic research focused on non-motor symptoms and continuous drug treatment in Parkinson's disease. She contributed to 14 publications in international medical journals, as well as 16 abstracts/ oral presentations in medical conferences.

She has been an Investigator in more than 20 clinical drug trials in Parkinson’s Disease, Alzheimer disease, Multiple Sclerosis and Migraine.

Her pharmaceutical industry expertise is focused on the neurosciences across Phase I-IV of clinical development, mainly in Parkinson’s disease, Alzheimer’s disease and Multiple sclerosis.

Based in Brussels, Belgium.

Dana has more than 25 years of experience in the pharmaceutical and CRO industry, with 9 years at Fortrea.

Her clinical research experience spans across global project management and drug development in a broad range of therapeutic areas including neuroscience, in which her expertise lay in several psychiatric indications such as ADHD and schizophrenia, as well as Alzheimer’s disease, and acute and chronic pain indications.

Her experience with Phase I to III studies includes pediatric and adult populations, DEA schedule II and III drugs, in-patient and emergency room/critical care settings, as well as with a variety of drug delivery devices (transdermal, sub-lingual, intranasal, etc.) and diagnostics.

Richard has more than 27 years of industry experience from Pre-Clinical work in the Pharmaceutical sector to Data Management, CRA & Project Management, in multiple therapeutic areas, focusing on Ophthalmology over the last 8 years, joining Fortrea in 2000. Richard provides delivery leadership to both his clients and project teams at portfolio & study level.

Richard prides himself in building strong relationships with sponsors and sites, recognizing how reducing patient burden and supporting site needs can make Fortrea the CRO of choice, in competitive landscapes, getting new products to market by delivering studies quickly and with quality.

Richard is based in the UK.

Dr. Chng has more than 18 years of drug development industry experience across broad indications including neuroscience.

She has extensive experience supporting small and medium sized biotech companies in Asia-Pac to develop their assets from early phase development to late clinical phases. With her project management skills, Dr. Chng is able to provide and advise operational strategy to Asia-Pac clients and help expand their drug development outside of the Asia-Pac region.

Her therapeutic knowledge encompasses neurodegenerative, rare neurology indications as well as psychiatry disease, with a particular focus on schizophrenia.

Dr. Fuller has more than 23 years drug discovery and development experience across neuroscience, immunology and inflammation indications. Her 17 years clinical research experience across Phase I-III studies includes 14 years at Fortrea (formerly Labcorp and Covance), where she has supported development and implementation of Phase I and II clinical trials in patients with neurodegenerative diseases including Alzheimer’s disease. Dr. Fuller earned her Doctorate of Pharmacology from Northwestern Feinberg School of Medicine with a focus on Alzheimer’s drug discovery and development.​

Diane Ostang, Delivery Director, has a background in Biomedical Engineering and brings over 22 years of industry experience across various therapeutic areas, with over 18 years as part of Fortrea team. She supports project teams at portfolio level, escalates priority issues, and ensures delivery oversight. Diane prides herself in building strong relationships with sponsors and sites, recognizing how reducing patient burden and supporting site needs can make our program the study of choice even in competitive landscapes. ​

Diane is based in US (ET).

Darby Thomas, PhD, is the Scientific Director of Cell & Gene Therapies. She earned her PhD in Molecular Virology from Baylor College of Medicine, performed postdoctoral training at the University of Pennsylvania, followed by 17 years in industry prior to joining Fortrea (formerly Labcorp) in 2021.

Dr. Thomas 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 with an emphasis on rare neurological and metabolic diseases and ophthalmology. She also has translational experience developing plasmid-based gene therapies, lentiviruses, as well as gene-modified cell therapies for the treatment of rare skin disorders.

Dr. Thomas provides specialized scientific expertise providing leadership and guidance to integrated global teams, as well as internal and external consultation and training on cell and gene therapy programs.

Dinesh has over 27 years of industry experience with over 26 years in EU/US regulatory strategy and submissions in in all phases of development (phases I-IV) in a variety of indications including orphan. He has led several meetings with FDA, EMA and MHRA.

Experienced with new chemical entities, biologicals and more recently cell & gene therapy products e.g., AAV2. Dinesh was the global regulatory lead for the early Pfizer pain portfolio up to proof of concept.

He has therapeutic and regulatory experience in Ophthalmology, Neurology, Pain, Rare Diseases, Respiratory, immunology, dermatology, diabetes type 1 and 2, biosimilars. Has supported and led strategic submissions such as IND, fast track, breakthrough, PRIME, orphan designations, pediatric plans.