Dr. Maher has 17 years of FDA clinical oncology review experience and joined DataRevive from FDA on July 1, 2019. Dr. Maher has been an oncology clinical team leader for 10 years in the CDER Office of Hematology and Oncology Products and for three years in the CBER Office of Cellular, Tissue, and Gene Therapies. Before that, Dr. Maher was a medical officer for biological oncology product review in the Office of Oncology Drug Products.

She also functioned as a clinical project director at Schering-Plough Research Institute and worked at NIH for four years at NCI. She was an assistant clinical professor in hematology and medical oncology in Tulane University Medical Center and oncology chief for four years.

She reviewed numerous efficacy supplements for both New Drug Applications and Biologics Licensing Applications, participated in FDA-Industry meetings, including advice to industry concerning their product development pathway, and reviewed of many Investigational New Drug applications for small molecules and biologics.

Dr. Maher reviewed numerous oncology products including:

  • Durvalumab
  • Avelumab
  • Atezolizumab
  • Radium-223
  • Enzalutamide
  • Vandetanib
  • Crizotinib
  • Pazopanib
  • Romidepsin
  • Bevacizumab
  • Sunitinib
  • Apaziquone
  • Tivozanib
  • Everolimus
  • Ridaforolimus
  • Vandetanib
  • Pixantrone
  • Pazopanib
  • Romidepsin