Who's Who In The New OHOP

FDA has reorganized its Office of Oncology Drug Products and renamed it the Office of Hematology and Oncology Products. The leadership team remains intact under the head of OHOP Richard Pazdur. Rather than separate applications by small versus large molecules, the new structure breaks down reviews by disease type. If there are multiple indications for one drug, applications will be filed separately to different divisions, based on the tumor type targeted.
Current Structure
Division of Oncology Products 1 (DOP1)	Division of Oncology Products 2 (DOP2)	Division of Hematology Products (DHP)		Division of Hematology Oncology Toxicology
Division Director Robert Justice	Division Director Patricia Keegan	Division Director Ann Farrell		Division Director John Leighton, formerly associate director of the Office of New Drugs’ pharmacology toxicology staff
Review Coverage Areas Breast, gynecologic, genitourinary, supportive care (non-hematologic)	Review Coverage Areas Gastrointestinal, lung, head & neck, neuro-oncology, rare cancers/pediatric, solid tumor, melanoma sarcoma	Review Coverage Areas Benign hematology, hematologic malignancies, hematology support, pediatric hematology		Review Coverage Areas Non-clinical review division for hematology/oncology products
Previous Structure
Division of Drug Oncology Products (DDOP)	Division of Biologic Oncology Products (DBOP)		Division of Hematology Products (DHP)
Division Director Robert Justice	Division Director Patricia Keegan		Acting Division Director Ann Farrell
Review Coverage Areas Traditional cytotoxic compounds and small molecules, hormones and metabolic factors, synthetic peptides, oligonuclotides and siRNA, small molecules conjugated to antibodies.	Review Coverage Areas Large molecules (e.g. monoclonal antibodies, recombinant proteins, cytokines, growth factors, enzymes, non-vaccine therapeutic immunotherapies)		Review Coverage Areas Benign hematology, hematologic malignancies, hematology support, pediatric hematology