Suzanne Demko, P.A.-C. has over 30 years of combined clinical, clinical trials, and regulatory experience in oncology, drug development, and regulatory review. She joined Data Revive on May 18, 2020. Prior to joining Data Revive, Ms. Demko was a clinical reviewer for four years and a clinical team leader for over ten years with the US FDA in the Office of Oncologic Diseases, Division of Oncology 2.

Initially, during her time at FDA, Ms. Demko was a full-time clinical reviewer responsible for a dossier of biologic products for all oncology indications. She subsequently led a clinical review team responsible for the review of drug and biologic products for indications involving neuro-oncology, pediatric oncology, and rare tumors. Before joining FDA, Ms. Demko spent 10 years as a clinician at NIH where she was involved in clinical care and research for inpatients enrolled in NCI Phases 0 – III clinical trials. Prior to joining NCI, she had a clinical role at Johns Hopkins University Medical Center, Oncology Center where she was responsible for the inpatient and outpatient care of adult and pediatric patients enrolled in bone marrow transplantation clinical trials.

In her role as clinical team leader with FDA, Ms. Demko provided leadership, supervision, and oversight of the review process for all phases of drug development. She also acted as cross-discipline team leader for NDA and BLA reviews, reviewed and responded to meeting dossiers, and provided development advice to industry.

She provided oversight and advice for expanded access programs and other FDA programs and initiatives; and she was involved in labeling negotiations, in the drafting of post-marketing requirements and commitments, ensuring product safety for drugs and biologics during their development programs, and in outreach to patient groups and other FDA stakeholders. In addition, Ms. Demko participated in Oncology Drug Advisory Committee meetings, Pediatric Oncology Drug Advisory Committee meetings, and she was a standing member of the Oncology Center for Excellence Subcommittee of the Pediatric Review Committee. Some of the new molecular entities and supplemental indications for drugs brought to market under her supervision are: everolimus (for renal angiomyolipoma and tuberous sclerosis complex), avelumab, cabozantinib, rasburicase, asparaginase Erwinia chrysanthemi, lenvatinib, cemiplimab-rwlc, lutetium Lu 177 dotatate, trametinib, sonidegib, regorafenib (for GIST), sunitinib, peginterferon alfa-2b, dabrafenib, pexidartinib, dinutuximab, denosumab, selumetinib, and selpercatinib.