Facet has always embraced novel scientific and regulatory approaches to products aimed at the treatment and prevention of disease. In the fight against cancer, we acknowledge the importance of early detection (see our expertise with diagnostic radiopharmaceuticals) and tools for patient management.
We also recognize that advances in the understanding of the molecular biology of cancer have led to significant innovations which have often triggered the need for novel regulatory approaches and interactive, collaborative discussions with FDA. Personalized/precision medicine has become a reality and one that Facet has embraced with our clients and with FDA.
Since our inception, Facet Life Sciences has partnered with small organizations to get their oncology products through regulated development for the prevention, detection, treatment, and management of cancer and related indications. We’ve helped our clients progress small molecules, targeted radiotherapeutics, antibody-based immunotherapies, and novel combination products, to name a few.
Contact us today to see how we might help you get your product to and through FDA!
Facet has experience:
- Providing stage-appropriate gap analyses for IND/NDA/BLA/device regulatory milestones
- Designing streamlined nonclinical programs to support research or commercial oncology INDs
- Providing strategic guidance and support to help satisfy FDA’s chemistry, manufacturing, and controls (CMC) requirements
- Championing the preparation, submission, and maintenance of IND/NDA/BLA/device applications for cancer and related indications
- Working effectively with all of FDA’s Office of Oncologic Diseases (OOD- DO1, DO2, DO3, DHM2, DHM2, and DHOT), as well as CBER, and CDRH
- Working on radiopharmaceuticals for the detection of local and metastatic disease as well as radiopharmaceuticals for use as biomarkers for disease staging/assessment of therapeutic benefit
Our oncology indication experience includes, but is not limited to:
- Acute lymphoblastic leukemia
- Basal cell carcinoma
- B cell lymphoma
- Bladder cancer
- Gorlin syndrome
- Head and Neck
- Liver cancer
- Mantle cell lymphoma
- Non-Small-Cell Lung Cancer
- Pancreatic cancer
- Primary and recurrent prostate cancer
- Ultra-rare cancers