Clinical Resources: LLUMC Investigational Drug Service 5/14/2018 Clinical Resources: LLUMC Investigational Drug Service Desiree Wallace, Pharm.D. Objectives: To describe the availability of the IDS for research on campus To discuss how one can collaborate and access the IDS to enhance research activities 2016 Research Affairs Symposium October 21, 2016 LLUMC Department of PharmacyTrial Center

5/14/2018 IDS Overview Activities centralized in UH Central Hospital Pharmacy, 2nd floor IDS Coverage M-F 8-4:30 (1FT Pharmacist & 1FT tech), Pharmacist Supervisor on duty after hours & weekends Assist Coordinator (s) and Site Investigator(s) with conducting an ID protocol InPatient: all study drugs administer in UH, CH, SH, EC must be processed through the IDS Pharmacy OutPatient: as requested by sponsor/investigator Any Type of Study: Open-Label, Randomized, Placebo-Controlled, Single/Double-Blind, Investigator Initiated Adhere to Regulations/Policies: E6 (ICH)-Good Clinical Practice Food & Drug Administration (FDA): Title 21 CFR Part 50, 56, 210 & 312 DHHS Title 45 CFR Part 46 State of CA Requirements CA Board of Pharmacy Law Institutional Policies & Procedures (421-R2, R1, Q29) LLU IRB Board Member Investigational Drugs---refers to drugs used in human research that are Approved or those Not yet approved by the FDA IDS staff: 17 yrs experience with over 500 ID studies; educate pharmacists to cover weekends/nights GCP Consolidated Guidelines from International Conference on Harmonisation CFR Part 50/DHHS Part 46-Protection of Human Subjects: PI is responsible for protecting subjects from harm while they are participating in their research protocol. Part 56: IRB (Institutional Review Board) Part 210 & 211 cGMP (current Good Manfacturing Practice) Part 312-IND may be required if research on the use of a marketed drug intended to support sponsor’s change in labeling, advertising, or indications for use, a significant increase in risk, or change in dosage level or route of administration. Part 314 NDA (New Drug Applications) The most stringent of the laws should govern the conduct of use of the investigational drug…. >for the most part they are additive; GCP and CFR set the minimum standards to follow & your local laws and SOPs help define the details at your site

IDS Protocol Evaluation: review feasibility of IDS participation, budget, letter of agreement, EPIC requirements, staff education Routes of Administration: intravenous, oral, topical, hazardous/chemotherapy, controlled substances Storage: in Separate area from commercially available drugs, Secured Location with Limited Access Temperature Monitoring: daily with certified calibrated device @ room-temperature, refrigerated, frozen, excursion reporting; preferably continuous with excursion alarms & procedures established Storage Equipment: refrigerator/freezer maintained/inspected by clinical engineering Transport: Chain of Custody/Cold Chain documentation & temperature monitoring during transport Packaging/Labeling: OL or Blinded; per CA Rx Law (“Caution: New Drug—Limited by Federal law to investigational use.”); special precautions; child proof Preparation: non-aseptic, aseptic in ISO class 5 (hazardous/chemo) or laminar flow hood in USP 797 compliant facility All records shall contain accurate reporting, verification and retrieval after archiving. Labeling to Ensure Safe Use: (21 CFR Part 312.6) “Caution: New Drug—Limited by Federal law to investigational use.” USP 800 compliant by July 1st, 2018

IDS Randomization: experience with many IVRS/IWRS systems, manually, Rx generated lists Dispensing: Inpatient/Outpt EPIC/Willow/BEACON formulary build requests or treatment plan build Drug Accountability: manual paper forms or electronically; all study drug must be reconcilable Inventory: ordering, receipt, transfer, returns/compliance by subject, expiration dating Disposal: on site per SOP T-9 or return to sponsor Regulatory: maintain current Protocol/IB, IRB approval, ICD, amendments, investigator/sub-I’s, billing Monitoring, Audits and Closeout (Sponsor/CRO, FDA, DEA) Record Retention: 21 CFR 312.57c: 2 yrs after the date of approval for the indication (NDA) being investigated or not approved

5/14/2018 IDS Collaboration Investigator may contact IDS directly for ?’s (see contact info) CTC feasibility analysis: will help determine the need for IDS ancillary department IDS works with CTC on LOA to Participate & Financial support IDS will determine feasibility based on information provided by the investigator from the Sponsor & SEV (Protocol, IB, Pharmacy Manual, Operating Manual, IWRS/EDC) EDC-electronic data capture

Conclusion IDS resource is available to help the PI with the responsibility of Managing Investigational Drugs IDS will collaborate with CTC, the Investigator, Coordinator & Sponsor to assure that the protocol, regulations, laws & P&P’s are followed to ensure the safety of human subjects. IDS will ensure that all Investigational Drugs are fully managed and accounted for.

Questions?

5/14/2018 Contact Information: Desiree Wallace, Pharm.D.,RPh, Investigational Drug Pharmacist Mayra L. Gonzalez, CPhT, IDS Pharmacy Technician SHIPPING ADDRESS: Loma Linda University Medical Center Investigational Drug Service, Department of Pharmacy 11223 Campus Street, DOCK B Loma Linda, CA 92354 Office: LLU School of Pharmacy, Shyrock Hall Rm 228 (909) 558-4000, ext.83773 Pager (909)558-1717,1505 or dwallace@my2way.com Fax (909)558-0323 email: dwallace@llu.edu Backup: Norm Hamada, PharmD, RPh-Director of Clinical Pharmacy Services; x47386