Transcript BIOTECH SUPPLY October 8-9, 2012 Crowne Plaza, Foster City, CA

BIOTECH SUPPLY
CHAIN ACADEMY
October 8-9, 2012
Crowne Plaza, Foster City, CA
Tufts CSDD Global Clinical Supply
Chain Market Study
Mary Jo Lamberti, PhD
Senior Project Manager
Tufts CSDD
Key Areas Explored in Study
•
•
•
•
•
Roles and responsibilities
Technology and use of resources
Management challenges & strategy
Outsourcing approaches
Future Outlook
Study Highlights Overview
• Timely study capturing major shift in sponsor clinical
supply chain management practices
• Transition of role from insulated, support function to a more
strategic, multi-disciplinary front-line function
» Increasing importance of forecasting and risk management
» Cross functional collaboration and coordination
• Growing receptivity to outsourcing
• Baseline measures of practices and key challenges
3
Methods
• Tufts CSDD developed online survey with input from
supply chain experts in industry and provider
organizations
• Survey distributed through contacts and mailing lists
in Jan-Feb 2011
• Roundtable Meeting of invited participating
companies held in mid-March
Survey Respondents
• 20 completed surveys
• Primarily large/mid-size biopharma companies
• Majority (80%) vice president/director level
• Median 20 years experience in biopharma industry
– Minimum of 3 years
• Median 3.5 years in current position
– Minimum of 1 year
Global Clinical Supply Chain
Market Roundtable
•
12 senior-level clinical supply management professionals from top
biopharma companies in March 2011 in Boston
•
Very participatory group – corroborated and added to survey findings and
interpretation; interest in forming an ongoing working group
•
Supply management role is evolving from insular/traditional role into a
strategic function with far more cross-functional coordination and
collaboration
•
Clinical supply management is becoming increasingly complex and
demanding—given time pressures and global logistics challenges
•
More sophisticated forecasting and risk-management becoming critical
capabilities
Primary Responsibilities
Responsibility
% of Respondents
Forecasting
95%
Manage supplier relationships
85%
Track supplier performance metrics
70%
Supplier assessment/selection
65%
Develop outsourcing strategy
60%
Develop contracts
50%
Negotiate contracts
40%
Other*
20%
* Other responsibilities include supply management and IVRS management
Technology Usage
Study Drug Forecasting
• Respondents use both manual approaches
(70%) and forecasting programs (75%)
• More than half reported using web-based
approaches
• Respondents indicated that the most
demanding resource requirement area is
forecasting supplies
Barriers to Implementing New
Technologies
• Cost (both dollars and resources)
• Difficulty integrating new and existing systems
• Lack of standards between systems
Most Demanding Resource
Requirement Areas
Top Ranked Clinical Supply Chain
Management Challenges
1.
Short lead times
2.
Operations-supply team communication
3.
Protocol readiness/accuracy
4.
Better forecasting
5.
Visibility
Top Factors Impacting Clinical
Supply Chain Strategy
1.
Increasing number of trials
2.
Globalization of trials
3.
Regulatory requirements
4.
Adaptive trial designs
5.
Mergers and acquisitions
Top Factors Impacting Clinical Supply
Chain Management Success
• Shorter study start-up timelines
• Study site locations
• Increasing number of study subjects
• Shorter development timelines
Factors Impacting Clinical Supply
Chain Management Success
Top Clinical Supply Priorities
in 2011
1.
Improve forecasting
2.
Establish Preferred Provider partnerships
3.
Reduce operating costs
Frequency of Activities
Outsourced
Strategies to Optimize Clinical
Supply Chain Management
% of Respondents
Functional outsourcing
60%
Tactical/study-specific outsourcing
60%
Regional hubs
65%
New technologies
40%
Investing in own capabilities,
such as adding owned depots
20%
Other*
20%
*Other strategies include drug pooling, IVR capabilities, and labeling
Outsourcing Relationships
Used
Strategy
% of Respondents
Individual clinical supply services for each trial
58%
A full range of clinical supply services to a
provider for each trial
16%
A service provider to manage the entire clinical
supply function across multiple clinical trials
16%
A combination of types depending on the trial
11%
Metrics Used to Assess Clinical
Supply Vendor Relationship Quality
Metrics Used to Assess Clinical
Supply Solution Success
Initiatives Underway
Comparator and Co-Therapy Sourcing Roundtables
• Follow up meetings held in Boston in October 2011 and London in March
2012
• 20 senior level managers from 15 top biopharma companies attended
each meeting
• Meeting focused on Issues and challenges in comparator and co-therapy
sourcing
• Next steps included plans for industry collaboration and dissemination of
best practices
Initiatives Underway
Comparator and Co-Therapy Working Group Study
• Tufts CSDD 2012 Study
• Multi-sponsor format; conducted between April/May and December 2012
• Key metrics:
• Growing proportion of comparator and co-therapy use in protocol designs
• Total amount spent on comparators and co-therapies between 2009 and 2012 (estimates)
• Comparative increase in cost relative to per patient costs per protocol, procedural costs per
protocol, other clinical supplies
• Total amount of comparator and co-therapy drug not used and estimated economic cost of
waste
Q&A and Thank You!
Mary Jo Lamberti
[email protected]