Investigational Drug Services (IDS ) Pharmacy

1. Investigational Drug Services (IDS) Pharmacy

2. Overview • What is an IDS Pharmacy? • About Us • Role of IDS in Clinical Trials • Workflow for New Studies • Industry • Consortium • Investigator Initiated • Common Pitfalls & Limitations

3. What is USC IDS Pharmacy? • Retail Licensed Pharmacy dedicated for research • Approximately ~300 studies • Study Sites • LAC+USC Medical Center • Norris Cancer Hospital • Keck Outpatient – Healthcare Clinics • Beverly Hills – USC Norris Westside Cancer Center • Satellite Sites • Keck Hospital • Newport Beach - USC Oncology/Hematology Infusion Center (OCOH)

4. About Us Travis Rock Pharmacy Technician David Bateshansky, Pharm.D. IDS Pharmacist - Norris Charlene Chiu, Pharm.D. IDS Pharmacist Edward Hill Pharmacy Courier

5. Upcoming for December Current Location: Keck HC3 1516 San Pablo St. Suite 3403 (4th floor) Los Angeles, CA 90033 Permanent Location: Norris Cancer Center currently under construction 1441 Eastlake Ave (2nd Floor), Los Angeles CA 90033 Hours of Operation: 8:00AM to 4:30PM

6. IDS Work Space – HC3

7. IDS Work Space – HC3

8. Storage – Refrigerator

9. Storage – Ambient Temperature

10. Role of IDS in Clinical Trials • Preliminary • Site Qualification Visit • IRB, CIC Review - Feasibility • Protocol Review / Scope of Service for IIT • Regulatory Compliance • Drug Procurement / Storage • Prescription Processing / Dispensing • Drug Destruction / Return • Sponsored Visits

11. Regulatory Compliance • Good Clinical Practice • Human Subjects Research • Board of Pharmacy, DEA Licensure • Protocol and Amendment Training • Unblinded Staff

12. Drug Procurement / Storage • Drug Requests – Initial & Resupply • Auto-Resupply • Form • Electronic request – NCI, DAIDS • Drug Receipt • TempTaledocumentation • Temperature Excursion Reporting • Drug Accountability Record Forms • Interactive Web Response System

13. Drug Procurement / Storage (cont) • Refrigerators (7) • Ambient Temperature – 20°C to 25°C • Freezer • -20°C (-15°C to -25°C) • -80°C(-70°C to -90°C) • Temperature Monitoring • FreshLoc – continuous monitoring • Min/Max Thermometer (Back up)

14. Prescription Processing / Dispensing • Prescription Review for Appropriateness • Initial Enrollment • Informed Consent • Protocol Registration • Kit allocations • Prescription Labels • Compounding Verification • IVPB – PVC (DEHP) vs non-PVC • Tubing • Filters • Maintenance of DARFs and Inventory Checks

15. Accountability – Oral Agents

16. Accountability – Non Oral Agents

17. Drug Destruction / Return • On-site destruction of unused and used investigational products (IP) • Returns to sponsor • IP Return / Reconciliation • Responsibility of Study Coordinator (SC) to document count (CISO – Double count) • IDS will destroy used upon reconciliation by SC and Sponsor

18. Drug Destruction / Return

19. Regulatory Visits • Site Qualification • Site Initiation Visits • Monitoring Visits • Audits (Sponsor, Federal) • Close out visits • Please remind Sponsor to schedule at least 6 weeks in advance for any visits. • Will be adding an FTE to assist with SIVs

20. Workflow for New Studies

21. Industry-Sponsored Study • Budget – Completed by CTO • Pharmacy Fees (Fixed/Dispensing) • Drug purchases • Refer to Budget/Research Order Form • Site Initiation Visit • Schedule ~6 weeks in advance • Prior to enrollment, confirm IP available in IDS

22. Consortium Study • Federal/Government and University sponsored studies • National Institutes of Health (NIH) • National Cancer Institute • Budget – Mixed with or without industry support • Site Initiation Visit – Generally internal (unless sponsored by industry)

23. Investigator-Initiated Trials • Internal USC study • Budget – Need to contact IDS for Scope of Service Agreement • Please email idspharmacy@med.usc.edu for all IIT inquiries • Please include: • PI, IRB #, and a copy of the protocol • Location(s) of drug administration • Number of subjects to be treated • IP information (i.e. IP name, dosage form and frequency/duration of dispensation or administration • Procurement of drugs (IDS to provide or supplied by sponsor) • Afterwards and internal SIV or Workflow meeting

24. After the SIV… • Work on the prescription/order template & submit to IDS for review • Patient info (Name, MRN, DOB, Sex, Allergies, Subject ID) • Drug info (Drug name, Dose, Sig, Kit) • Prescriber info (Original Signature, Date, Name) • Misc (Delivery Location, Coordinator Contact, Protocol Name) • Come up with a workflow (new coordinator) • When a study starts screening, prospective enrollment: confirm IP in stock

25. Cycle 1 Day 1 • Order submission - Ensure it is complete with an original signature & date by the prescriber • IDS or Keck – Fax paper order and call to confirm receipt • Norris (Ambulatory and Inpatient) - Upload paper order in Cerner • HC3 - Upload initial order into Cerner. On day of, either fax or hand deliver final order • Include the 1st and last signed page of ICF • Copy of protocol enrollment / randomization • Note: Paper orders for all investigationals. SOC drugs should be ordered as normal via Cerner as non-investigational

26. Subsequent Visits • Send completed order to respective pharmacy • Include any necessary kit numbers or randomization visit information

27. Common Pitfalls & Limitations

28. Common Pitfalls & Limitations • Preliminary • SIV / MV scheduling (or not including IDS) • Drugs that are supplied by sponsor vs IDS-supplied and reimbursed by sponsor • No Pharmacy Fees incorporated for IIT • During the study • No IP available for the first patient enrolled • Shipments sent to the incorrect address • Incomplete orders (not signed, dose missing, kit #s, visit reg) • Limited compounding space/availability • Drug transfer to Norris • Hours of Operation

29. Contacts Norris HealthCare Center Pharmacy Attn: Charlene Chiu, PharmD. (IDS) 1516 San Pablo St. Suite 3403 (4th floor) Los Angeles, CA 90033 Office (323) – 865 – 3538 | Fax (323) – 865 – 0857 Email: idspharmacy@med.usc.edu Hours of Operation: 8:00AM to 4:30PM

30. Contacts • Norris (David Bateshansky, Pharm.D) • Ambulatory Pharmacy (323-865-3613) • HC3 Pharmacy (323-276-3737) • Keck Hospital (323-442-8800) • Akiko (Hattori) Maloney, Pharm.D. • Mira Bakas, Pharm.D.

31. Former/Future Location USC IDS Pharmacy 1441 Eastlake Ave Suite 2407 Los Angeles, CA 90033 • Permanent Move: • Planned for December 2019 • Will provide updated SOP • Will provide Note To File documenting transit • Update sponsors / 1572

32. Questions?