Katharine Nicholson

About Katharine Nicholson

Katharine Nicholson is Clinical Research Director in Neurology Development at Sanofi and an ALS Clinician Researcher at MGH with over 10 years of experience in clinical research and drug development at MGH, Biogen, and Sanofi. She currently serves as Clinical Research Director in Neurology Development at Sanofi, where she leads cross-functional teams in clinical trial design and conduct as Study Director and Medical Monitor for neurological clinical trials, working closely with operational, biostatistical, pharmacovigilance, data management, and regulatory colleagues. In this role, she has gained submission strategy and dossier experience, and also provides relevant medical input and support to medical and commercial colleagues across stages of clinical development.Dr. Nicholson is well-published with experience presenting her work at both international and national conferences. She served as Principal Investigator on multicenter clinical trials and natural history research studies. She led the design and conduct of several multicenter, industry-sponsored ALS clinical trials, overseeing MGH NCRI CRO and CTO activities for these programs. In addition to fellowship training in Neuromuscular/Neurodegenerative disorders at MGH, she completed additional training in ALS therapeutic development at Biogen as part of the two-year Anne B. Young in Translational Neuroscience Fellowship. Her clinical expertise and innovative work in academia have focused on familial ALS, while her investigation has centered on the identification of early markers of disease and those at risk for developing ALS. She led the ALS component of the Mass General Brain Health Clinic to provide sub-specialty clinical evaluation/genetic counseling for asymptomatic family members of people with ALS. By pairing this clinical program with her research initiatives at the Healey Center for ALS at MGH, she spearheaded an innovative platform to provide both clinical support and access to research for the ALS gene carrier population. Before joining Sanofi, she co-led a multicenter natural history program called the Dominant Inherited ALS (DIALS) Network, evaluating over 200 pre-symptomatic ALS gene carriers over time to investigate leading candidate biofluid markers and novel outcome measures in the symptom conversion period. By studying a population directly at risk for developing ALS, this research has the potential to further our understanding of underlying early disease pathophysiology and improve the diagnostic delay in ALS.

Experience

1. Clinical Research Director

   Sanofi

   Feb 2022 — Present · Cambridge, MA, US

Education

• The George Washington University School of Medicine and Health Sciences

  Doctor of Medicine (M.D.)

  2005 — 2009

• University of Pennsylvania

  Bachelor’s Degree

  2000 — 2004

Skills

• Neurology
• Clinical Research