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Oncology Expertise

From navigating evolving regulatory requirements, to building a strong clinical strategy, to understanding patient access and reimbursement, an oncology program requires the right expertise to accelerate development and reach patients faster. Our dedicated team of oncology experts is passionate about partnering to help clients navigate the path to approval and deliver better care to patients.

Recent projects include:

  • Pre-IND meeting support (request letter submission, package preparation, and attendance)
  • INTERACT meeting support (request letter submission, package preparation, and attendance)
  • Regulatory strategy development for accelerated BLA submission
  • Orphan designation preparation and submission (FDA & EMA)
  • CMC gap analysis

Indications include:

  • Hematologic cancer (leukemia and lymphoma)
  • Bladder/urothelial cancer
  • Brain cancer
  • Breast cancer
  • GI cancer (stomach and pancreatic)
  • Colorectal cancer
  • Prostate cancer
  • Lung cancer
  • Skin cancer/melanoma
  • Oral cancer
  • Ovarian cancer

Oncology Insights