the future of open source: from drug discovery to
TRANSCRIPT
Stephen M. MaurerGoldman School of Public PolicyUC Berkeley
The Future of Open Source:
From Drug Discovery to Synthetic
Biology
Why Open Source MattersThe “Open Source Biology” Idea
Analogy, Rhetoric, RealitySynaptic Leap: How Big is the Landscape?
Introduction
A Rational Design Approach
1. BackgroundDefinitionsShowstoppersOS Theory: Incentives & Social WelfareThe Drug Discovery Landscape
2. Candidates3. Synthetic Biology4. A (Quick) Word About Licenses 5. Synaptic Leap - A Short Infomercial
1.Background: Showstoppers
The Usual Suspects:Developing Drugs is Costly
Drug Discovery is a PipelineCompetition With Patent Incentives
A Neglected Disease Niche?Companies Might Fund Open Source
1.Background: OS Theory
IncentivesIdeologyEducation and SignalingOwn-Use
For HobbiesFor WorkFor Employer
Complementary Goods & ServicesStandards Wars
Social WelfareAdvantages
(Donated Labor)Price of InformationAgency Problems/Transparency
DisadvantagesInadequate Incentives?
1.Background: OS Theory
Basic ResearchFinding TargetsOptimizing TargetsFinding Lead CompoundsOptimizing Lead CompoundsProcess DevelopmentPre-Clinical TestingPhase I TestsPhase II TestsPhase III TestsApprovalManufacturingPhase IV TestsMarketing & Distribution
1.Background: The Drug Discovery Landscape
Basic ResearchFinding TargetsOptimizing TargetsFinding Lead CompoundsOptimizing Lead CompoundsProcess DevelopmentPre-Clinical TestingPhase I TestsPhase II TestsPhase III TestsApprovalManufacturingPhase IV TestsMarketing & Distribution
Open Science
2. Candidates
2. Candidates: Open ScienceExamples
BioPERLHGP, SNP Consortium, HapMap, AfCS.
Traditional Academic IncentivesEducation, Signaling, Own-Use, Ideology.
Showstoppers?Physics Precedents
Big Science (cf. FermiLab)Virtual Experiments (PDG, TOI)
Definitional Objection - Is It Open Source?HapMap License
Basic ResearchFinding TargetsOptimizing TargetsFinding Lead CompoundsOptimizing Lead CompoundsProcess DevelopmentPre-Clinical TestingPhase I TestsPhase II TestsPhase III TestsApprovalManufacturingPhase IV TestsMarketing & Distribution
In Silico Biology
2. Candidates
2. Candidates:In Silico Biology
Social AnalogyBiologists ~ Computer ScientistsIncentives ~ Education, Signaling
& IdeologyA Social Experiment
Science Analogy Doing Science With DatabasesIn silico biology ~ software debuggingA Scientific Experiment
Social WelfareDonated LaborLower R&D Costs
The SNP Consortium ProblemLower Manufacturing CostsTransparency
2. Candidates:In Silico Biology
2. Candidates:In Silico Biology
Example: Tropical Disease InitiativeMechanics
On-Line Forums & Running EstimatesPhilosopher Kings?Bridging Institutions
ShowstoppersCompetition With PatentsAre in silico methods good enough?
Would it Work for Rich Nation Diseases?
2. Candidates:In Silico Biology
Basic ResearchFinding TargetsOptimizing TargetsFinding Lead CompoundsOptimizing Lead CompoundsProcess DevelopmentPre-Clinical TestingPhase I TestsPhase II TestsPhase III TestsApprovalManufacturingPhase IV TestsMarketing & Distribution
“Wet” Chemistry & Biology
2. Candidates
2. Candidates:Wet Chemistry
& BiologyThe Reagents Problem
Big Science Grants“Scrounging Strategies”
- TDI, BenklerLow Cost, High Ingenuity Problems
- Mat Todd/Schistosomiasis ProjectWhat are the Limits?
Basic ResearchFinding TargetsOptimizing TargetsFinding Lead CompoundsOptimizing Lead CompoundsProcess DevelopmentPre-Clinical TestingPhase I TestsPhase II TestsPhase III TestsApprovalManufacturingPhase IV TestsMarketing & Distribution
Off Label Testing
2. Candidates
2. Candidates: Off-Label Testing
Examplesvon Hippel Proposal
Incentives Ideology, Education & SignalingCosts are Already Paid ForCompetition With Patents?
Social WelfareTransparency
Basic ResearchFinding TargetsOptimizing TargetsFinding Lead CompoundsOptimizing Lead CompoundsProcess DevelopmentPre-Clinical TestingPhase I TestsPhase II TestsPhase III TestsApprovalManufacturingPhase IV TestsMarketing & Distribution
2. Candidates
Clinical Testing
2. Candidates: Clinical Testing
Examples(None)
IncentivesIdeology, Education, Signaling, Complementary Goods
Patents Would Support OSAdvantages
Transparency
3. Synthetic Biology
From Garage Science to Standard PartsReading Tea Leaves A Chance to InterveneIncentives: Five Stories
Ideology, Education and Signaling, Own-Use, Complementary Goods & Standards Wars
Story 1: Ideology, Education, Signaling, Own-Use
Story 2: Shared CostsAnalogy: “Operating Systems vs. Applications Programs”
3. Synthetic Biology: Incentives
Story 3: Shared BenefitsAnalogy: Game Theory
& Embedded LinuxMultiple Possible EquilibriaProdding the System
Story 4: Appropriability May Not Be ValuableAnalogy: Software Modules & LINUX
3. Synthetic Biology: Incentives
Standards Wars?Parts Repository – Strong Tipping EffectsPrivate vs. Public RepositoriesAn Unpredictable Process
3. Synthetic Biology: Incentives
4. License
“Copyright vs. Patents”The Licensing FetishWhat’s Wrong With the Public Domain?
The Consumer Sovereignty ArgumentThe Capturing ArgumentThe Stability Argument
GPL’ing MoleculesPatents vs. Copyright
Filing & Enforcement CostsLicensing & Waiver Law IssuesPatent Misuse?
Patents & Neglected DiseasesEmbargosLegal Holding EntitiesPatent Pools
BIOS/Bioforge
4. Licenses
5. Infomercial
Steve Maurer [email protected] & On-Line Collaboration:Ginger Taylor [email protected]:Marc Marti-Renom [email protected] Engineering:Mat Todd [email protected]: http://www.thesynapticleap.org/