Investigational Drug Services

DEDICATED RESEARCH SUPPORT VERIFICATION AND PREPARATION  Aid in protocol development and the design of  Verify investigational product is ordered according investigator initiated trials protocol to protocol  Create randomization schemes  Compound or manufacture sterile dosage  Review protocols prior to PRMC and formulations PPHS approval  Prepare placebo formulations  Voting member of PPHS and PRMC  Prepare blinded preparations committees  Label and dispense investigational products in  Meet with study team, sponsors, and accordance with sponsor and government auditors to maintain trial integrity requirements  Comply with sponsor and government requirements COORDINATING CENTER ROLE  Maintain investigational products for multicenter PRODUCT PROCUREMENT AND MAINTENANCE trials  Facilitate procurement of investigational products  Package and ship products to participating sites  Receive investigational products directly from  Create protocol-specific investigational product sponsors request forms and shipment record  Provide secure storage location  Provide temperature-monitored drug storage STAFF SUPPORT AND EDUCATION  Maintain inventory accountability  Train pharmacy staff on protocol design,  Dispose/destroy investigational products objectives, and procedures according to regulations  Provide education to nursing and pharmacy staff regarding investigational products IDS Fees: Review Fee* $750 Protocol One-time cost incurred regardless of study enrollment Review *$375 for review of protocols involving only standard of care treatments For clinical trials involving more than one Mount Sinai site, a single review fee per study is incurred. Initiation Fee** $750 Study Initiation One-time cost incurred regardless of study enrollment; May include preparation of pharmacy study procedure, attending initiation meetings, providing in-services to staff, and set-up of electronic order entry records. **for primary site only; secondary sites waived Simple $50/dispensation Order verification and dispensation that involve minimal manipulation of final dosage Dispensation form, including oral dosage forms (capsules, tablets) and blinded kits. Moderate $80/dispensation Oral chemotherapy requiring Personal Protective Equipment; IV preparations with Dispensation minimal effort; Controlled substances; IVRS entry or Randomization of subjects required by pharmacy Complex $150/dispensation Labor intensive and/or hazardous preparations, including IV/SubQ chemotherapy, Dispensation biologics, antibodies, immunotherapy, virus/bacterial vectors; Advance notice not possible, including STAT preparations and poor stability preparations Special $90/hour Needs and requirements discussed with IDS coordinator. Compounding Storage/ $750 annually (billed Includes storage of study materials (e.g., inventory, recordkeeping, refrigerator, room Maintenance as $62.50 per temperature, freezer, temperature monitoring software); Quality assurance; Compliance Fee*** month) per site with Hospital, Joint Commission, state and federal standards; Site visits; Audits; Drug destruction; and Overall maintenance ***waived for federally funded studies Close-Out Fee $500 per site Includes return or destruction of remaining study materials; return of pharmacy records to Study Team as appropriate Coordinating $100/shipment to Includes receiving shipment requests, preparing shipments, and generating packing Center Services external sites****; list/transport records – Excludes the cost of courier service. Study Team must approve, $50/shipment to MS arrange, and provide airbill/courier service for each shipment. ****IND required to ship to sites external sites outside of NYS. Confirm plan with IDS coordinator. 1

Investigational Drug Service Contacts by Site

MOUNT SINAI HOSPITAL: CHELSEA MEDICAL CENTER AT MOUNT MOUNT SINAI UNION SQUARE: SINAI: Ivy Cohen, RPh (non-oncology) Tatyana Bazarova, Pharm.D., BCACP Mount Sinai Hospital Sheila Pierre, RPh Mount Sinai Union Square Department of Pharmacy Email: [email protected] Department of Pharmacy Investigational Drug Service 10 Union Square East 4B01 Pharmacy 1450 Madison Avenue Yolanda Rodriguez, RPh New York, New York 10003 Annenberg B2, Rm 204 Email: Tel.: (212) 844-8624 New York, NY 10029 [email protected] Email: [email protected] Tel.: (212) 241-2493 Email: [email protected] Chelsea Medical Center at Mount Sinai MOUNT SINAI WEST: Department of Pharmacy Grace Jiang, Pharm.D., BCOP (oncology) 325 West 15th Street Sheng-hsiu Lin, Pharm.D., BCOP, BCPS Mount Sinai Hospital New York, NY 10011 (oncology) Department of Pharmacy Tel.: (212) 604-6066 Mount Sinai West Investigational Drug Service Pharmacy Department 1470 Madison Ave. MOUNT SINAI MORNINGSIDE: 1000 – 10th Ave. Hess 4th Fl. Pharmacy, Rm 105 New York, NY 10019 New York, NY 10029 John Ugbogbo, RPh Tel.: (212) 523-8856 Tel.: (212) 824-8820 Mount Sinai St. Luke's Hospital Email: [email protected] Email: [email protected] Department of Pharmacy 1111 Amsterdam Ave Adewale Omoloju, B.S., Pharm.D. (non- MOUNT SINAI BETH ISRAEL: New York, NY 10025 oncology) Tel.: (212) 523-2582 Mount Sinai West Stephen Argiro, Pharm.D., BCGP Email: [email protected] Inpatient Pharmacy Department Mount Sinai Beth Israel 1000 – 10th Ave. Department of Pharmacy – Investigational MOUNT SINAI QUEENS: New York, NY 10019 Drug Services Tel.: (212) 523-6552 370 East 17th Street Vivian Leonard, RPh, BCSCP Email: [email protected] 3 Silver Pharmacy Mount Sinai Queens New York, NY 10003 25-10 30th Avenue NEW YORK EYE AND EAR INFIRMARY OF Tel.: (212) 844-5480 Pharmacy 5th Floor MOUNT SINAI: Email: [email protected] Long Island City, New York 11102 Tel.: (718) 906-6227 Samira Samarbakhsh, Pharm.D. MOUNT SINAI BROOKLYN Email: [email protected] New York Eye and Ear Infirmary of Mount Sinai Lucy Cannizzarro, RPh MOUNT SINAI SOUTH NASSAU Department of Pharmacy Email: [email protected] 310 East 14th street Theodore Vanikiotis, Pharm.D. New York, New York 10003 Alla Melamud Khaytin Pharm.D., BCPS, Mount Sinai South Nassau Tel.: (212) 979-4378 BCPPS Pharmacy Department Email: Email: One Healthy Way [email protected] [email protected] Oceanside, New York 11572 Tel.: (516-632-4545) Mount Sinai Brooklyn Pharmacy Department 3201 King Highway Brooklyn, New York 11234 Tel.: (718-951-2920)

https://icahn.mssm.edu/research/portal/resources/investigational-drug-service Updated April 2021 2