From Drug Discovery to Synthetic Biology
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1 The Future of Open Source: From Drug Discovery to Synthetic Biology Stephen M. Maurer Goldman School of Public Policy UC Berkeley
2 Introduction Why Open Source Matters The Open Source Biology Idea Analogy, Rhetoric, Reality Synaptic Leap: How Big is the Landscape?
3 A Rational Design Approach 1. Background Definitions Showstoppers OS Theory: Incentives & Social Welfare The Drug Discovery Landscape 2. Candidates 3. Synthetic Biology 4. A (Quick) Word About Licenses 5. Synaptic Leap - A Short Infomercial
4 1.Background: Definitions Definition: Goal-Oriented Collaboration + Donated Labor & Materials
5 1.Background: Showstoppers The Usual Suspects: Developing Drugs is Costly Drug Discovery is a Pipeline Competition With Patent Incentives A Neglected Disease Niche? Companies Might Fund Open Source
6 Incentives 1.Background: OS Theory Ideology Education and Signaling Own-Use For Hobbies For Work For Employer Complementary Goods & Services Standards Wars
7 1.Background: OS Theory Social Welfare Advantages (Donated Labor) Price of Information Agency Problems/Transparency Disadvantages Inadequate Incentives?
8 Basic Research Finding Targets Optimizing Targets Finding Lead Compounds Optimizing Lead Compounds Process Development Pre-Clinical Testing Phase I Tests Phase II Tests Phase III Tests Approval Manufacturing Phase IV Tests Marketing & Distribution 1.Background: The Drug Discovery Landscape
9 Basic Research Open Science Finding Targets Optimizing Targets Finding Lead Compounds Optimizing Lead Compounds Process Development Pre-Clinical Testing Phase I Tests Phase II Tests Phase III Tests Approval Manufacturing Phase IV Tests Marketing & Distribution 2. Candidates
10 2. Candidates: Examples Open Science BioPERL HGP, SNP Consortium, HapMap, AfCS. Traditional Academic Incentives Education, Signaling, Own-Use, Ideology. Showstoppers? Physics Precedents Big Science (cf. FermiLab) Virtual Experiments (PDG, TOI) Definitional Objection - Is It Open Source? HapMap License
11 2. Candidates Basic Research Finding Targets Optimizing Targets Finding Lead Compounds Optimizing Lead Compounds Process Development Pre-Clinical Testing Phase I Tests Phase II Tests Phase III Tests Approval Manufacturing Phase IV Tests Marketing & Distribution In Silico Biology
12 2. Candidates: In Silico Biology Social Analogy Biologists ~ Computer Scientists Incentives ~ Education, Signaling & Ideology A Social Experiment Science Analogy Doing Science With Databases In silico biology ~ software debugging A Scientific Experiment
13 2. Candidates: In Silico Biology Social Welfare Donated Labor Lower R&D Costs The SNP Consortium Problem Lower Manufacturing Costs Transparency
14 2. Candidates: In Silico Biology Example: Tropical Disease Initiative Mechanics On-Line Forums & Running Estimates Philosopher Kings? Bridging Institutions
15 2. Candidates: In Silico Biology Showstoppers Competition With Patents Are in silico methods good enough? Would it Work for Rich Nation Diseases?
16 2. Candidates Basic Research Finding Targets Optimizing Targets Finding Lead Compounds Optimizing Lead Compounds Process Development Pre-Clinical Testing Phase I Tests Phase II Tests Phase III Tests Approval Manufacturing Phase IV Tests Marketing & Distribution Wet Chemistry & Biology
17 2. Candidates: Wet Chemistry & Biology The Reagents Problem Big Science Grants Scrounging Strategies - TDI, Benkler Low Cost, High Ingenuity Problems - Mat Todd/Schistosomiasis Project What are the Limits?
18 2. Candidates Basic Research Finding Targets Optimizing Targets Finding Lead Compounds Optimizing Lead Compounds Process Development Pre-Clinical Testing Phase I Tests Phase II Tests Phase III Tests Approval Manufacturing Phase IV Tests Off Label Testing Marketing & Distribution
19 2. Candidates: Off-Label Testing Examples von Hippel Proposal Incentives Ideology, Education & Signaling Costs are Already Paid For Competition With Patents? Social Welfare Transparency
20 2. Candidates Basic Research Finding Targets Optimizing Targets Finding Lead Compounds Optimizing Lead Compounds Process Development Pre-Clinical Testing Phase I Tests Phase II Tests Phase III Tests Approval Manufacturing Phase IV Tests Marketing & Distribution Clinical Testing
21 Examples (None) Incentives Ideology, Education, Signaling, Complementary Goods Patents Would Support OS Advantages Transparency 2. Candidates: Clinical Testing
22 3. Synthetic Biology From Garage Science to Standard Parts Reading Tea Leaves A Chance to Intervene Incentives: Five Stories Ideology, Education and Signaling, Own-Use, Complementary Goods & Standards Wars
23 3. Synthetic Biology: Incentives Story 1: Ideology, Education, Signaling, Own-Use Story 2: Shared Costs Analogy: Operating Systems vs. Applications Programs
24 3. Synthetic Biology: Incentives Story 3: Shared Benefits Analogy: Game Theory & Embedded Linux Multiple Possible Equilibria Prodding the System Story 4: Appropriability May Not Be Valuable Analogy: Software Modules & LINUX
25 3. Synthetic Biology: Incentives Standards Wars? Parts Repository Strong Tipping Effects Private vs. Public Repositories An Unpredictable Process
26 3. Synthetic Biology: Social Welfare Open Standards, Competition, Antitrust National Security?
27 4. License Copyright vs. Patents The Licensing Fetish What s Wrong With the Public Domain? The Consumer Sovereignty Argument The Capturing Argument The Stability Argument
28 GPL ing Molecules Patents vs. Copyright Filing & Enforcement Costs Licensing & Waiver Law Issues Patent Misuse? Patents & Neglected Diseases Embargos Legal Holding Entities Patent Pools BIOS/Bioforge 4. Licenses
29 5. Infomercial Steve Maurer Computing & On-Line Collaboration: Ginger Taylor Biology: Marc Marti-Renom Chemical Engineering: Mat Todd Site:
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