the future of open source: from drug discovery to

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Stephen M. Maurer Goldman School of Public Policy UC Berkeley The Future of Open Source: From Drug Discovery to Synthetic Biology

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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: Definitions

Definition:Goal-Oriented Collaboration

+Donated Labor & Materials

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

Open Standards, Competition, AntitrustNational Security?

3. Synthetic Biology: Social Welfare

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/