Challenges and Solutions in Clinical Supply Management. Pamela Osborne Sr. Clinical Supply Chain Mgr

Transcription

1 01 Challenges and Solutions in Clinical Supply Management Pamela Osborne Sr. Clinical Supply Chain Mgr

2 02 Session Objectives Key Takeaways: Aspects to consider when supply planning Influence of early decisions and impact on outcome as trial progresses How decisions may/may not put patients and the trial at risk Interactive review of key factors that affect supply planning: Package Design Dispensing Plan Label Grouping Crisis management

3 03 The Velocity of Clinical Trials COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE BREADTH and SCOPE FEW NEW DRUG APPROVALS

4 04 Breadth and Scope of Clinical Trials COSTS 120,000 Number of Registered Studies Over Time 119,470 COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE 100, ,370 BREADTH and SCOPE FEW NEW DRUG APPROVALS Number of Trials 80,000 60,000 40,000 83,650 66,462 49,407 35,989 20, ,648 7,001 8,599 10,281 25,045 12, Year Source:

5 05 Approvals of Medicines 800 COSTS Number of New Drug Approvals COMPLEXITY OF TRIALS BREADTH and SCOPE SENSE OF URGENCY FEW NEW DRUG APPROVALS LOW SUCCESS RATE Medicines Approved Since New Medicine Approval Note: New medicines include New Drug Applications and Biologics License Applications Sources: Pharmaceutical Research and Manufacturers of America, New Drug Approvals, (Washington DC: PhRMA, ); U.S. Food and Drug Administration, 2011 Biological License Application Approvals, 2 March 2012, (accessed 10 February 2012); U.S. Food and Drug Administration, New Molecular Entity Approvals for 2011, 31 January 2012, (accessed 10 February 2012) Many examples exist of major therapeutic gains achieved by the industry in recent years anecdotal and statistical evidence suggests that the rapid increases that have been observed in drugrelated R&D spending have been accompanied by major therapeutic gains in available drug treatments. 2 Congressional Budget Office

6 06 Probability of Success for Investigational Drugs COSTS Number of Trials GI/Metabolism CNS Cardiovascular Clinical Approval Success Rates by Therapeutic Area Only Approximately 20% of new drugs that enter clinical testing will receive U.S. marketing approval. 1 COMPLEXITY OF TRIALS BREADTH and SCOPE SENSE OF URGENCY FEW NEW DRUG APPROVALS LOW SUCCESS RATE Respiratory Onc/Immunologic Sys Anti-Infective 0% 10% 20% 30% 40% 50% Success Rate Source: The Tufts Center for the Study of Drug Development, New drugs entering clinical testing in top 10 firms jumped 52% in , Impact Report, 2006.

7 07 Increased Cost of Developing New Drugs COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE $ 1.4 Billions (Constant Dollars, Year 2000) $ 1.2 $ 1.0 $ 0.8 $ 0.6 $ 0.4 $ 0.2 $ 0.3 $ 0.8 $ 1.3 BREADTH and SCOPE FEW NEW DRUG APPROVALS $ 0.0 $ Sources: 1 J. DiMasi and H. Grabowski, "The Cost of Biopharmaceutical R&D: Is Biotech Different?," Managerial and Decision Economics, 2007; J. DiMasi et al., The Price of Innovation: New Estimates of Drug Development Costs, Journal of Health Economics, 2003.

8 08 Operational and Strategic Challenges According to research done by Tufts Center for the Study of Drug Development: Clinical supply professionals are faced with greater operational and strategic challenges. COMPLEXITY OF TRIALS BREADTH and SCOPE COSTS SENSE OF URGENCY FEW NEW DRUG APPROVALS LOW SUCCESS RATE Factors contributing to these challenges include: Rising volume of global clinical trial activity Logistical complexity Regulatory pressures Shorter study start-up timelines Study site locations Increasing number of study subjects Shorter development timelines

9 09 Top Five Challenges in Clinical Supply Chain Short lead times Operations-supply team communication Protocol readiness/accuracy Better forecasting Visibility Source: Tufts Center for the Study of Drug Development

10 010 It s so easy Just use the standard formula for planning & forecasting IP: NUMBER OF SUBJECTS PER SITE NUMBER OF SITES FOR ALL COUNTRIES NUMBER OF DISPENSING DOSES QUANTITY OF IP TO MAKE FOR TRIAL Maybe it s not so easy Enrollment speed Milestone attainment Dating and Extensions Material Availability Blinding Distribution Systems Numerous Dosages, Forms, Sizes, Shapes Measure twice, cut once. Repeat as necessary

11 011 The following challenges will demonstrate: The importance of critically thinking through key decisions to be made when building a supply plan and their impact on; Forecasting Operational communications Lead times and ultimately influence the success of the trial

12 012 Information overload?! Protocol Study Summary Planned Duration of Treatment Study Drug Dosage and Administration Study Milestones Titration and Stratification rules Bulk Drug Information Allowable fill range Dating and possibility for dating extension Which countries accept what dating Temperature Storage conditions Cost to manufacture Quantities Available Source for Commercial Material Supply Chain Label, Packaging & Distribution Timelines Manufacturer -> Packager ->Distributor ->Site

13 013 Challenge : Dispensing Plans & Package Design Patient Compliant Packaging Bottles vs Blisters Patient Focused Packaging Indication Disease state Flexibility of Supply 1x vs 10x cartons Blinding Reduce the number of package types

14 014 Impact of Package Design and Dispensing Decisions on the IP Supply Chain Decision Impact Supply Chain Challenge Patient Compliant & Focused Packaging Flexibility of Supply & Low Number of Package Types Helps achieve more accurate study results. Helps patients adhere to complex dosing regimens requiring several combinations of drug Protection from damage and environment Easier returns and drug accountability Retention of patients because of ease of use Method of administration in trial impacts commercial administration Decreased demand forecasting complexity Increased flexibility in supply management Decreased overages Decreased packaging lead times and/or instances More efficient use of storage space (warehouses and site) Less complex IRT forecasting and set up Fewer number of site shipments Operational Communications Forecasting Complexity Operational Communications Lead Times Forecasting Complexity

15 015 Challenge : Determining IP Label Groups Facts: Global Trial in 25 countries: US + EU + ROW US has FPV first All countries accept the maximum dating 3 weeks to get a Single Panel label 7-10 weeks to get a booklet Choose one of the options below: a) US Single Panel and OUS/ROW Booklet b) Regional Booklets NA, EU, AP c) Other - come up with your own solution! -

16 016 Impact of Label Grouping Decisions on the IP Supply Chain Decision Impact Supply Chain Challenge Low number of label groups Grouping countries with like dating acceptance Decreased packaging cost/instances Decreased overages Increased supply flexibility Fewer forecasting instances and decreased forecasting complexity Maximized use of material: decreased waste Decreased number of resupplies: decreased packaging cost Fewer dating extensions Forecasting Complexity Operational Communications Forecasting Complexity Operational Communications

17 017 Massive tornado has hit several Cities in the Midwest...

18 018 Challenge Emergency! A tornado has hit the US warehouse and all of the IP was lost or damaged Considering that: US is on it s own label Patients actively on drug Enrollment is ahead of plan No resupplies planned because there was sufficient quantity and dating on current supplies What are your next steps? What could you have done differently?

19 019 Life Happens there Goes Your Forecasting!

20 020 What could you do? Push out the patients to the maximum visit window Micro Manage IP Redistribution Hold Enrollment Expedite unplanned resupply

21 021 It all comes back to QUALITY DISPENSING LABEL IRT PLAN DESIGN SITE INVENTORY MGMT EFFECTIVE COMPARATOR SUPPLY PLANNING & REGULATORY COLD CHAIN FORECASTING DATING MGMT MGMT PACKAGE DESIGN DISTRIBUTION CRISIS MANAGEMENT

22 022 Efficient Supply Planning CONTROLLED COSTS SIMPLIFIED PACKAGING & DISPENSING EFFECTIVE SUPPLY PLANNING & FORECASTING IMPROVED PATIENT OUTCOME ACCELERATED MILESTONE ATTAINMENT BREADTH & SCOPE

23 023 Questions? Pamela Osborne

24 024 Thank you!

25 025 COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE BREADTH and SCOPE FEW NEW DRUG APPROVALS

26 026 COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE BREADTH and SCOPE FEW NEW DRUG APPROVALS

27 027 COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE BREADTH and SCOPE FEW NEW DRUG APPROVALS

28 028 COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE BREADTH and SCOPE FEW NEW DRUG APPROVALS

29 029 COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE BREADTH and SCOPE FEW NEW DRUG APPROVALS

30 030 COSTS COMPLEXITY OF TRIALS SENSE OF URGENCY LOW SUCCESS RATE BREADTH and SCOPE FEW NEW DRUG APPROVALS