1. Pharmaceutical and Biotech Company Practices and Strategies That Create Efficient Global Clinical Supply Logistics
BSMA Conference
Mary Jo Lamberti, PhD
Tufts CSDD
April 26, 2017

2. About Tufts CSDD
                      
An independent, academic, non-profit research group at Tufts University
Our mission is to develop strategic and actionable information to help stakeholders in the research-based drug development industry improve quality, efficiency and performance
Primary Objectives
To monitor and report on the development, regulation, and utilization of new drugs and biopharmaceuticals.
To explore the economic, legal, scientific, and public policy issues affecting pharmaceutical and biopharmaceutical innovation worldwide
To raise the level of national and international debate on issues related to new drug and biopharmaceutical product development and regulation.
To hold forums and educational programs that bring together the perspectives of  government, industry, academia, and the public health community.

3. Rationale for Study
Increasing pressure on clinical supply professionals as economics of supply chain management and distribution have grown substantially.
Little to no historical data on performance, measuring impact of new processes and solutions and identifying areas of improvement within clinical supply logistics.
Tufts CSDD study gathered data to examine current management practices and strategies that enhance efficiency and productivity within this area.

4. Overall Success Rates and Cycle Time in Years
Cycle Time in Years from
IND Filing to NDA Approval
Source: EvaluatePharma

5. Number of Unique FDA-Regulated Clinical Investigators
‘08-’15 CAGR
‘12-’15 CAGR
4.6%
5.5%
Source: Getz K, Brown C, Stergiopoulos S, Beltre C. Baseline assessment of a global clinical investigator landscape poised for structural change.
Therapeutic Innovation & Regulatory Science. Online publish date: March 30, 2017

6. Global Distribution of Unique FDA-Regulated Clinical Investigators
Source: Getz K, Brown C, Stergiopoulos S, Beltre C. Baseline assessment of a global clinical investigator landscape poised for structural change. Therapeutic Innovation & Regulatory Science. Online publish date: March 30, 2017

7. Study Overview
Tufts CSDD 2014/2015 global logistics study kick off meeting was held in London in October 2014 with 14 working group companies.
The study comprised both a comprehensive survey and study data gathered from working group companies.
Our survey was conducted across a diverse group of organizations including biopharmaceutical companies, clinical supply logistics providers and suppliers.

8. Executive Summary
A total of 17 respondents completed the logistics survey with three-quarters representing biopharmaceutical companies and one-quarter from clinical supply logistics providers and suppliers.
Over 2/3 of the respondents were managers or directors from large companies while the remainder worked in mid-sized companies.
Nine companies provided logistics data for 73 clinical studies across a diverse group of therapeutic areas including oncology, neuroscience/CNS, immunology and respiratory studies.

9. Executive Summary
What are the preferred distribution strategies among organizations and what are standard practices? How is distribution managed?
Companies manage their distribution by outsourcing nearly 40% of shipments, more than 25% are managed internally, and 20% use a mixed model.
Overall outsourced/external costs (72%) were reported as a proportion of total supply costs
Courier/depot (49%) and storage/distribution costs (40%)
Supply distribution is global and concentrated in North America (78%), Western Europe (66%) and Eastern Europe (63%). Distribution is nearly evenly spread across regions of Latin America (29%), Asia Pacific (22%),and Rest of World (18%).

10. Respondent Organization Type
Total Surveys
n:Total
Bio-pharmaceutical company
13:17
Clinical Supply Logistics Service Provider
3:17
Clinical Supply Logistics Product Supplier
1:17

11. Distribution Strategy and Execution

12. Key Performance Indicators of Distribution Success
*Respondents selected multiple items

13. Improved Efficiencies Resulting from Company Practices
*Respondents selected multiple items

14. Organizational Risk Assessment
Response
n=16
Yes 11 No 5
*Respondents selected multiple elements

15. Mean Percent Usage Per Method
Management of Returns
Mean Percent Usage Per Method
Destruction at Site
37%
Return to a Local Depot by Region
22%
Return to a Local Depot by Country
18%
Return to a Central Location
17%
n=16

16. Challenges to Managing Returns
N:Total
Reconciliation and Document Destruction
4:15
Complexity of Managing Returns
3:15
Regulatory Requirements
Costs
2:15
Highly Manual Process
Site Compliance
1:15
N=15
Respondents selected multiple options

17. Pooled Supply Management
Use Pooled Supplies
N=16
Yes 9 No 7

18. Top Challenges to Implementing Pooled Supplies
N:Total
Regulatory System
4:12
Labelling
2:12
Shipping Documentation
Other
System Planning Complexity
1:12
Reconciliation at Site
n=12

19. Key Distribution Metrics
Respondents selected multiple options

20. Product Waste/Overage- Average waste of packaged goods approximately 50%
Mean
Standard Deviation
CoV
Minimum
Maximum
Median
Range
Percent of Total Manufactured Product Packaged
89.9%
10.1% .1
70%
100%
90%
30%
Percent of the Total Packaged Product that was Shipped to Sites
74.1%
21.0% .3
19%
80%
81%
Percent of the Product Shipped that was Dispensed
67.8%
24.5% .4 5%
85%
N = 12 Companies, 57 Studies

21. Study Overage - Strategies
Accounting for Overage
N:Total
% is added into each study forecast
9:12
% is added into aggregated study forecast
2:12
% or actual used (based on historical use)
1:12
Respondents selected multiple options
Yes No
Overage Throughout Study 2 9

22. Organizational Training
Areas in Which Training Is Offered
N:Total
IMP Handling
11:12
Returns
10:12
Reconciliation/ Accountability
9:12
IRT
Inventory Management
4:12
Other
Technologies
GDP
3:12
Overage/ Waste
1:12
8 out of 12 of organizations train investigative staff on clinical supplies.
Respondents selected multiple options.

23. Measures to Improve Training Effectiveness
Visits to investigative site to capture feedback from site and pharmacy staff to enhance IP processes and identify areas for improvement.
Measure compliance improvement after training.
Examine trends and error rates in trip reports and address issues.
Use of blasts and newsletters to reinforce issues.
Requirement of training certificate as part of site initiation.
Close tracking of completion of required training by key study staff that manage IP.
Provide IP manual with information and surveys on IP processes and training.
Use of WebEx / Lync technologies to hold training sessions.

24. Study Update
Article published in Applied Clinical Trials, October 2016
Lamberti MJ, Hsia R, Mahon C, Milligan C, Getz KA. Assessing global clinical supply logistics. Applied Clinical Trials. 2016;25(10)26-34.
Plan to revisit metrics gathered on waste, shipping times, error rates (product impact) in a follow up study – Fall 2017

25. Thank You
Mary Jo Lamberti, PhD