2015-11 mary syto cts socal challenges in global supply mgmt in small biotech
TRANSCRIPT
Overcoming the Challenges of Global Supply Chain
Management at a Small Biotech
Mary SytoSr. Global Project Manager
Disclaimer
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Receptos, Celgene, its directors, officers, employees, partners, investors, or any organization with which the presenter is employed or affiliated.
Who am I?
18+ years of pharmaceutical development
Key experience Global CRO in clinical operations and
project management for 8+ years Strategic clinical development/operations
in virtual and emerging pharmaceutical companies All phases and across a broad range of
therapeutic areas
Who are you?
Overcoming the Challenges of Global Supply Chain Management at a Small Biotech
Agenda
Clinical Supply Chain Process
Industry Trends and Challenges
Challenges at a Small Biotech
Tips for Selecting your Dream Team
Relationship Management and Communication Strategies
Key Takeaways
Typical Clinical Supply Chain Process
• Schedule drug product shipments to depot or sites
Manufacturer
• Store drug product until ready to ship to site
Depot• Receive drug
product• Record
quantities used and unused
Site
• Send unused drug product to sponsor for destruction
Sponsor
Looks simple!
You make the clinical supplies
Slap a label on the bottle
You put it in a box
Ship to the site
Patient takes the drug
Looks simple. What could go wrong?
Patient doesn’t get drug
Drug product expires
Label is incorrect
Not enough API or
comparator drug
Delays in customs
IP sent to wrong site
IRT does not work and drug
not shipped
Critical Step: Clinical Supply Management
The final leg of this process presents endless opportunities for missteps and delays
to patients being treated.
Industry Trends in Clinical Supply Management
Globalization of Clinical TrialsMore trialsMore regionsMore resources
Clinical Supply Challenges: • Regulatory requirements – import/export
regs, QP release, country-specific labeling• Logistics of distribution• More contract service providers needed
Industry Trends in Clinical Supply Management
Complexity of Trials Adaptive trials, multiple arms, double-blind, triple-blind, crossover trials, more comparator drugs Targeted therapies
Clinical Supply Challenges:• Accurate supply forecasting dosage and
quantity • Track of expiry dating of all supplies• Increase in cold-chain storage
Industry Trends in Clinical Supply Management
Tighter Drug Development BudgetsTargeted therapies and comparators – more $$$
Start-up Trials FasterLess time for API production and stability testing
Birth of New and Evolving Technologies - IRT, IVRS/IWRS
Clinical Supply Challenges:• Tightly manage quantities and minimize
overages• Search for more efficient and lower cost
solutions• Time for evaluation of new technologies
Challenges for a Small Biotech
Unique compound or
product
Crazy timelines
Limited in-house staff and internal
expertise
High Reliance on partners, 3rd parties,
and vendors
Cost Constraints
Study outcome may determine the company’s future.
Risk Management
Risk Mitigations at a Small Biotech
Get involved early with your clinical operations teamPlanning needed at the protocol development stageChoose vendors that will work together
Request regular status updates: Enrollment, CTA submissions
During the StudyRequest regular status updates
Enrollment projections vs. Actual real-time patient enrollmentIMPD updates
Be a part of the Protocol Amendment discussionExtending length of study? Adding another arm? Adding more patients?
Finding Your Dream Team
Skilled expertiseFaster, smarter, more efficientTrack record of quality and excellenceAbility to meet or beat timelinesAccess to world-class connections and solutionsCommon culture and commitment to quality
How do you find your Dream Team?
First Step: Research the Outsourcing MarketplaceSubscribe to newsletters, webinars, blogsReview “white papers” and articles from CROsAttend a conferencePublic info – Annual ReportsEvaluate Contract Service Provider’s (CSP) key existing (and most recent) alliances and partnershipsAsk your peers
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How do you find your Dream Team?
Next Step: Reach out!Contact BD people
Phone chatCoffee/lunch
Request a demo session and “play” with their systemIs it user-friendly?Ability to customize further?
Ask your current CSPDo they plan to add new services or capabilities?Who did they enjoy partnering with and why?
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CSP Evaluation: What to Request in the Request for Proposal (RFP)?Team Structure Processes and Communication PathwaysKnowledge and Expertise
Import/Export requirements – what documentation is needed?Cold chain requirementsProvide a problem/scenario and ask them for their solution or strategy on how to tackle the issues
World-wide connections and partners (i.e., depots, suppliers)Quality Control and Management ProcessesProven Track Record
Request metrics from previous studies (similar to yours), case studies
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CSP Evaluation: RFP Process
Send same specifications and be clear with what you need
if you don’t know what you need, do your homework and schedule F2F meetings with people who do
Request same format back so you can compareto to Be transparent about other service providers being usedProvide them your timeline for review and evaluation
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Tip: Have conversations with BD people prior to sending out the RFP and encourage that they send questions before sending the proposal
CSP Evaluation: Proposal Review
Who in your company should be involved in proposal review? Further evaluation of the systems needed? Face to Face meeting needed?
You should have thought about this before sending out your RFP!
Will you select based on:Price (This should not be the determining factor!)ExperienceResponses to your questions?
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You’ve selected your Dream Team. Now What?
Relationship Management: F2F KOM
Schedule Face to Face Kick-off MeetingInvite other service providers (if they will need to interact)Define roles and responsibilities (i.e., RACI)Define tasks, owners, deadlinesDiscuss logistics, communication pathways
Tip:• Schedule an annual “Refresher” meeting to
re-visit (and re-evaluate) topics discussed at KOM.
Relationship Management: KPIs
Establish clear timeframes and metrics
Establish key performance indicators
Performance metrics are a good way to measure study activities and recognize accomplishments or determine when things are going off track
Define success
Finalize plans prior to study start
Communication Tips/Strategies
Lead by ExampleSpeed: turnaround yourself as quickly as you demandQuality: demonstrate that your team is reviewing carefully, tooCommunication: Be direct, open, timely – considerate of timeFollow-through: Do what you say you will do
Key Takeaways
Clinical supply chain management is not simple.
The industry is changing and the clinical supply function needs to adapt to the challenges.
This critical function is vital to the success of the clinical trial and should be involved early in the study-planning process.
It is essential to take the time to find your “Dream Team” and once identified, keep them motivated and performing
References
D. Dreifke. “Clinical Trial Supplies 101,” ContractPharma (Sept 2015)
M. Lamberti. “Global Supply Chain Management,” Applied Clinical Trials, 21 (9)
M. Lamberti. “Trends and Novel Approaches to Clinical Supply Outsourcing,” ContractPharma, (Jan 2012)
P. Singh. “Clinical Supply Management with Siebel Clinical,” Slideshare, April 2013 R.S. Kumar, "Clinical Trial Supply Chain Management," ContractPharma, 6, 74-75 (2008).
