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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!