march 12 , 2015€¦ · 4 new paradigm – new challenges •fewer staff •tighter deadlines...
TRANSCRIPT
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March 12th, 2015
Dominique Gouty, Ph.D.
“New Trends in Bioanalytical Outsourcing: The Buyer’s Guide”
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2015 2010 2000 Outsourcing earlier in the drug development Process: What are the risks???
The Trend
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The Trend
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New Paradigm – New Challenges
• Fewer staff
• Tighter deadlines
• Quality standards
• The pharmaceutical and biotechnology industries are at a crossroads.
• Growing pressures from increased competition.
• New opportunities from recent patent expiries.
• Keep ahead of competitors with the right partners & strategy.
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Outsourcing - far from a panacea for pharma and biotech
Customer Pain Points
• Poor Quality
• Inadequate expertise
• Missed deadlines
• Poor communication
• Limited visibility
• Little collaboration
• Missed handoffs
• Budget overruns
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According to a recent study by the Economist Intelligence Unit, sponsors said the biggest challenges for a successful relationship with their CRO were2:
Recent Data - Your Timeline and Budget
2) Finding Alignment: Opportunities and Obstacles in the Pharma/CRO Relationship, Economist Intelligence Unit (2012)
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…..if it were only this obvious!
Choosing the Right Partner
• Poor Quality
• No visibility
• Delays
• Cost creep
• Deep expertise
• Transparency
• Quality results
• On-time
• On-budget
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• The sponsor/CRO relationship has traditionally been transactional in nature
• This model is quickly changing.
• Best-in-class organizations are seeking strategic input from CRO partners.
• A proactive and collaborative CRO partner will:
o Custom-tailor methods, optimizing for assay demands.
o Mitigate common challenges (communication break down, timeline creep, etc.)
Project Criteria Considerations
Will they offer consultative support?
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‘’As pharma companies rely more and more on CRO’s, the CRO business model is shifting from being task-oriented to offering value, input and problem solving.’’
o Oxbridge Roundtable Ltd1
1) Re-Thinking Outsourcing: The Power of the Contract Research Organization, Oxbridge BioTech (2013)
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• CRO’s vary greatly in their expertise.
• The key is finding a partner with the optimal breadth and depth of scientific skill in biologics.
• A specialized CRO partner will be more successful with complex and challenging assay demands.
Project Criteria Considerations
How specialized is the CRO’s large molecule focus?
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• Regulatory compliance is a critical concern when outsourcing large molecule bioanalysis.
• If standards are compromised, so is the discovery/drug development.
• A CRO partner must be well-versed in scientific aspects of compliance, data integrity, and reporting.
• Uphold all necessary requirements under GLP, GCP, or GMP.
Project Criteria Considerations
Level of Regulatory Need and Compliance
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• Your bioanalytical service provider must meet logistical & cost demands.
• How much will poor quality cost me?
o ‘’You get what you pay for’’
o Lack of specialized team/platforms costs in the long run
• Is the timeline put forth by the CRO realistic?
o Have record reflecting CRO’s proven ability to get projects done on time.
o Make sure CRO can be held accountable for deadlines and timeline creep.
Project Criteria Considerations
Your Timeline and Budget
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Project Manager
Customer
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Lost In Translation !!!
Scientific knowledge Information Details…
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• Project Oversight:
o Who is acting as project head?
o A biologic expert is wanted as main lead in the case of large molecule projects.
o Consider turnover; mid-study loss of project manager impacts project’s progress.
• Transparency and Responsiveness:
o ‘’They only call me when there is a problem’’.
o Consistent and continuous communication helps identify potential risks before becoming costly hurdles.
o Trust CROs that see their role as anticipating, communicating, and collaborating on all bioanalytical challenges.
Working Relationship Considerations
The Project Management Processes in Place
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Communication
The Main Problem
With Communication
Is The Illusion
That It Has
Taken Place.
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• Consider prospective CRO partner’s infrastructure dealing with project-specific constraints.
• Physical Location:
o Running a study within specific region consider a locally-based bioanalytical lab to streamline shipping and management.
o If study is global, location matters less.
• Capacity:
o Prospective partner’s workload plays a factor in ultimate project timeline.
o Understand broader picture: staff allocation, lab size, client base, etc.
o Assess CRO’s true ability to handle high volume projects.
Working Relationship Considerations
Location(s) and Capacity
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• Company Successes:
o How many drugs now on the market has the CRO helped support?
o Any prestigious awards?
o Any case studies or customer testimonials for validation?
• Staff-Level Recognition:
o Have the CRO’s scientists been published or recognized by industry?
o Are team members considered specialized experts or opinion leaders?
• A partner with proven experience can provide veteran insight for quickly navigating both scientific and regulatory demands.
Working Relationship Considerations
Success in Track Record
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March 12th, 2015
Case Studies
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• Phase I diabetes study
• ~8000 samples
• Needed analysis of 14 biomarkers
• IRB prohibits more than 5 x 1 ml blood/time point
• Sample turn around time of 1 week
Case Study #1
Providing a Solution
Multiplex Platforms + Multiplex Scientist + Automation
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• High %CV associated with an assay developed and validated for release of a product.
• FDA did not allow the release of the product until the %CV is at 25% or less.
• The assay required the use of live cells.
Case Study #2
Assay Quality Improvement
• Control of cell batches • Long term supply of cell batches (primary cells) • Standardization of cell culturing techniques and supplies:
• Dissociation reagents and incubations • Estimation of confluency • Plasticware matters
• Management of critical reagents: serum, growth factors
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• Assay in support of Alzheimer’s project
• Assay was run internally for 15 years
• Sponsor looking to outsource the assay to keep up with the sample analysis demand
• The assay was described as “dialed in and ready to go”.
Case Study #3
Accuracy of the Information Transfer from the Sponsor
Upon assay transfer, the following were observed: • There was only one analyst in the entire company that was running the assay for
almost 20 years. • The SOP did not match what the analyst was doing • Over time the analyst had changed many of the reagents without any assay validation • The analyst would run the assay enough times until see the results expected or the
group was happy with the results.
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Thanks for Your Attention and Not Falling Asleep!