Cons of outsourcing Science AWS
A Perspective in Outsourcing Science Dan Mudra Ph.D. Eli Lilly and Company AAPS Annual Meeting Nov 14, 2017
Disclaimer… • The opinions expressed in the following slides are not the opinions of Eli Lilly and Company and not necessarily my personal opinion…. • Examples presented may or may not be “real”
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Scope API Manufacture
Clinical
Chemistry Outsourcing Pharmaceutical Discovery and Development
ADME
Biology
Toxicology
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Top 5 dilemmas in outsourcing Science 1. It’s too easy to outsource. 2. Even routine work can bite you. 3. You think you’re in control. 4. The productivity paradox. 5. Training the next generation.
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Outsourcing is too easy…… DO YOU WANT FRIES WITH THAT?
- Outsourced assays treated as a commodity
- Studies are “ordered up” with abbreviated designs - Studies become routine or check boxes - Protocol driven - Difficult to customize studies (time and cost ) - Changing direction is difficult or impossible 11/13/2017
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Even the routine can bite you! Compound X CYP inhibition Screen
Candidate selection
Definitive CYP inhibition
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You are not in control so bring it back home…. • Study lead times can be long. • CRO works towards the KPI. • CRO may not be working on “your” project exclusively. Think of Juggling…. • Lack expertise in technique may require to bring it back “in house” • Extremely difficult to troubleshoot assay problems without doing the work 11/13/2017
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Outsourcing increases productivity
• Dozens of studies are ongoing in parallel. • Oversite is burdensome and boring.
• How do you have a deep understanding of all the studies??? 11/13/2017
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The next Generation Supervisor to new hire: Have you ever seen a rat being dosed by gavage ? New hire: No, but in my back alley near the trash bin I’ve seen a rat down a package of “hot dogs” • No more “on the job hands on training” • How does one offer suggestions for troubleshooting and evaluate quality of work if one has never done it.
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Summary • Outsourcing sounds “easy” but it is a complex process that requires procurement, contracts, protocols, KPI’s, oversight, and patience. • Outsourcing has significant “overhead” involved. Taking scientists away from the bench. • Realize what can and cannot (or should not) be outsourced. • Remember we need to train the next generation of scientists 11/13/2017
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Disclaimer… • The opinions expressed in the following slides are not the opinions of Eli Lilly and Company and not necessarily my personal opinion…. • Examples presented may or may not be “real”
11/13/2017
2
Scope API Manufacture
Clinical
Chemistry Outsourcing Pharmaceutical Discovery and Development
ADME
Biology
Toxicology
11/13/2017
3
Top 5 dilemmas in outsourcing Science 1. It’s too easy to outsource. 2. Even routine work can bite you. 3. You think you’re in control. 4. The productivity paradox. 5. Training the next generation.
11/13/2017
4
Outsourcing is too easy…… DO YOU WANT FRIES WITH THAT?
- Outsourced assays treated as a commodity
- Studies are “ordered up” with abbreviated designs - Studies become routine or check boxes - Protocol driven - Difficult to customize studies (time and cost ) - Changing direction is difficult or impossible 11/13/2017
5
Even the routine can bite you! Compound X CYP inhibition Screen
Candidate selection
Definitive CYP inhibition
11/13/2017
6
You are not in control so bring it back home…. • Study lead times can be long. • CRO works towards the KPI. • CRO may not be working on “your” project exclusively. Think of Juggling…. • Lack expertise in technique may require to bring it back “in house” • Extremely difficult to troubleshoot assay problems without doing the work 11/13/2017
7
Outsourcing increases productivity
• Dozens of studies are ongoing in parallel. • Oversite is burdensome and boring.
• How do you have a deep understanding of all the studies??? 11/13/2017
8
The next Generation Supervisor to new hire: Have you ever seen a rat being dosed by gavage ? New hire: No, but in my back alley near the trash bin I’ve seen a rat down a package of “hot dogs” • No more “on the job hands on training” • How does one offer suggestions for troubleshooting and evaluate quality of work if one has never done it.
11/13/2017
9
Summary • Outsourcing sounds “easy” but it is a complex process that requires procurement, contracts, protocols, KPI’s, oversight, and patience. • Outsourcing has significant “overhead” involved. Taking scientists away from the bench. • Realize what can and cannot (or should not) be outsourced. • Remember we need to train the next generation of scientists 11/13/2017
10
