SBPWG:Discussion/Practices Bootcamp: Difference between revisions

From OpenWetWare
Jump to navigationJump to search
No edit summary
 
(20 intermediate revisions by the same user not shown)
Line 3: Line 3:
=Synthetic Biology 'Leaders in Practice' Bootcamp=
=Synthetic Biology 'Leaders in Practice' Bootcamp=


DISCLAIMER: THIS PAGE IS ONLY PERIODICALLY UPDATED AS A REPOSITORY FOR IDEAS. MORE DETAILED EDITING IS DONE VIA OUR COLLABORATIVE GOOGLE DOCUMENT, FOUND [[https://docs.google.com/document/d/1RfK0y5WdREWJgfY-gsseiB9p__xq7KcgR9nf1es9_vs/edit?hl=en_US HERE]] (protected; please ask permission)
DISCLAIMER: THIS PAGE IS ONLY PERIODICALLY UPDATED AS A REPOSITORY FOR IDEAS. MORE DETAILED AND UP-TO-DATE EDITING IS DONE VIA OUR COLLABORATIVE GOOGLE DOCUMENT, FOUND [[https://docs.google.com/document/d/1RfK0y5WdREWJgfY-gsseiB9p__xq7KcgR9nf1es9_vs/edit?hl=en_US HERE]] (protected; please ask permission)


==Description==
==Description==
Line 34: Line 34:
*  This workshop should provide practical, relevant and useful training to practitioners pursuing a diversity of professional paths - industry, academia, or otherwise
*  This workshop should provide practical, relevant and useful training to practitioners pursuing a diversity of professional paths - industry, academia, or otherwise


==Motivating Example==
===Motivating Example===


The OSTP recently issued a [[http://www.gpo.gov/fdsys/pkg/FR-2011-10-11/pdf/2011-26088.pdf Request for Information]] to "solicit input from all interested parties regarding recommendations for harnessing biological research innovations to meet national challenges in health, food, energy, and the environment...". '''How would we equip up-and-coming leaders in syn bio to work towards being able to make informed recommendations to the following requests for input?'''
* The OSTP recently issued a [[http://www.gpo.gov/fdsys/pkg/FR-2011-10-11/pdf/2011-26088.pdf Request for Information]] to "solicit input from all interested parties regarding recommendations for harnessing biological research innovations to meet national challenges in health, food, energy, and the environment...". '''How would we equip up-and-coming leaders in syn bio to work towards being able to make informed recommendations to the following requests for input, and hopefully take steps towards implementing those reccomendations?''' See the RFI questions [[SBPWG:Discussion/Practices_Bootcamp/OSTP_RFI | here]]


'''Grand Challenges'''
==Workshop Components==
*(1) Identify one or more grand challenges for the bioeconomy in areas such as health, energy, the environment, and agriculture, and suggest concrete steps that would need to be taken by the  Federal government, companies, nonprofit organizations, foundations, and other stakeholders to achieve this goal.


'''Research & Development'''
*(2) Constrained Federal budgets require a focus on high-impact research and innovation opportunities. With this in mind, what should be the Federal funding priorities in research, technologies, and infrastructure to provide the foundation for the bioeconomy?
* (3) What are the critical technical challenges that prevent high throughput approaches from accelerating bioeconomy-related research? What specific research priorities could address those challenges? Are there particular goals that the research community and industry could rally behind (e.g., NIH $1,000 genome initiative)?
* (4) The speed of DNA sequencing has outstripped advances in the ability to extract information from genomes given the large number of genes of unknown function in genomes; as many as 70% of genes in a genome have poorly or unknown functions. All areas of scientific inquiry that utilize genome information could benefit from advances in this area. What new multidisciplinary funding efforts could revolutionize predictions of protein function for genes?


'''Moving life sciences breakthroughs from lab to market'''
===Topic Brainstorming===
* (5) What are the barriers preventing biological research discoveries from moving from the lab to commercial markets? What specific steps can Federal agencies take to address these shortcomings? Please specify whether these changes apply to academic labs, government labs, or both.
 
* (6) What specific changes to Federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs would help accelerate commercialization of federally-funded bioeconomy-related research?
This is a space to list topics that might comprise a useful introduction to the broader societal context of biotechnology development - it's history, current practices, and ongoing/future challenges. This list will undoubtedly grow to include far more topics than could ever be covered in a week-long course. However, this is in itself useful as indication of the knowledge that we consider to be a valuable, if not essential, component of our education as responsible practitioners of synthetic biology that isn't being satisfactorily provided elsewhere, providing further motivation for the course.
* (7) What high-value data might the government release in the spirit of its open government agenda that could spur the development of new products and services in the bioeconomy?
 
* (8) What are the challenges associated with existing private-sector models (e.g. venture funding) for financing entrepreneurial bioeconomy firms and what specific steps can agencies take to address those challenges?
Once we have fleshed out potential topics, we can start to refine topics into essential and non-essential categories, match with speakers, case studies and/or activities.
 
'''(Bio)Technology and the Public Good: Introduction and Framing'''
* How do we think about technology and the ‘public good’? By which criteria do/can we evaluate how technologies enhance human and environmental flourishing?
* How and why are certain technologies adopted? What are the drivers of technology?
 
'''History of Biotechnology / Synthetic Biology'''
* What were the critical innovations? Actors? Institutions? Programs? Investments?


'''Workforce development'''
'''Current and Future Investments in Synthetic Biology'''
* (9) The majority of doctorate recipients will accept jobs outside of academia. What modifications should be made to professional training programs to better prepare scientists and engineers for private-sector bioeconomy jobs?
* The political economy of synthetic biology
* (10) What roles should community colleges play in training the bioeconomy workforce of the future?
* (11) What role should the private sector play in training future bioeconomy scientists and engineers?
* (12) What role might government, industry, and academia play in encouraging successful entrepreneurship by faculty, graduate students, and postdocs?


'''Reducing regulatory barriers to the bioeconomy'''
'''Synthetic Biology in the US'''
* (13) What specific regulations are unnecessarily slowing or preventing bioinnovation? Please cite evidence that the identified regulation(s) are a) slowing innovation, and b) could be reformed or streamlined while protecting public health, safety, and the environment.
 
* (14) What specific steps can Federal agencies take to improve the predictability and transparency of the regulatory system? (Please specify the relevant agency.)
Institutions
* (15) What specific improvements in the regulatory processes for drugs, diagnostics, medical devices, and agricultural biotechnology should federal agencies implement? What challenges do new or emerging technologies pose to the existing regulatory structure and what can agencies do to address those challenges?
*Academic
* (16) What are the highest impact opportunities for public-private partnerships related to the bioeconomy? What shared goals would these partnerships pursue, which stakeholders might participate, and what mutually reinforcing commitments might they make to support the partnership?
*Corporate
* (17) What are the highest impact opportunities for pre-competitive collaboration in the life sciences, and what role should the government play in developing them? What can be learned from existing models for precompetitive collaboration both inside and outside the life-sciences sector? What are the barriers to such collaborations and how might they be removed or overcome?
*Governmental
Funding Agencies
*SynBERC
*DARPA
*Sloan
 
'''Synthetic Biology in an International Context'''
* How is SB being developed/funded in other countries? How does this differ from the US strategy?
 
'''Synthetic Biology and the Innovation Landscape'''
* What types of things are we making: plug & play vs new application spaces?
* Investments in applications vs. tools/technology platforms?
* Who is interested (governments, existing companies, venture)?
 
'''Synthetic Biology, Intellectual Property and Open Innovation Systems'''
* Current practices in IP
* Theories/proposals for new systems
* Recent developments (e.g. Myriad) & their implications
 
'''Synthetic Biology as an ‘Emerging’ Technology'''
* What have we learnt from other contemporary emerging technologies (nanotech etc)?
 
'''Prudent Vigilance and Responsible Technology Development'''
* Interpretation and significance of the Presidential Bioethics Commission
 
'''Regulation and Oversight of Biotechnologies'''
* Which regulatory agencies current oversee syn bio products? What are the current/future gaps?
 
'''Synthetic Biology and Risk Governance'''
* What are different approaches to risk analysis?
 
'''Synthetic Biology & Biosafety'''
* What are the potential gaps in our current biosafety frameworks?
 
'''Synthetic Biology & Biosecurity'''
* What are the potential gaps in our current biosecurity frameworks?
 
'''Synthetic Biology as a Discipline: Education and Vocation'''
* How are we educating the next generation of synthetic biologists?
* Will there be jobs?
 
'''Synthetic Biology and the Public'''
* What do we know about the way the publics perceive biotechnology?
* How are we communicating and representing our work?
 
'''Open challenges: The next 5, 10, 15 years and beyond'''
* Gaps lists from different groups/meetings


==Workshop Components==


=== Workshop Topic Refinement and Structuring===
=== Workshop Topic Refinement and Structuring===
Line 74: Line 118:
'''Potential Workshop Title/Lens''': Developing Policy Frameworks for Advancing Synthetic Biology / Biotechnology
'''Potential Workshop Title/Lens''': Developing Policy Frameworks for Advancing Synthetic Biology / Biotechnology


* '''Application Package & Initial Presentation''': Write a letter in response to one or more of the questions posed in the OSTP RFI on Building the Bioeconomy Blueprint and list assumptions and pitfalls that could be addressed by this workshop.
* '''Application Package & Initial Presentation''': Write a letter in response to one or more of the questions posed in the OSTP RFI on Building the Bioeconomy Blueprint and list assumptions and pitfalls that could be addressed by the community of expert practitioners and stakeholders brought together by this workshop.


* '''Topic 1''': What is ‘new’ about synthetic biology?
* '''Topic 1''': What is ‘new’ about synthetic biology?
Line 82: Line 126:
* '''Topic 5''': How do we promote public trust and adoption of synthetic biology?
* '''Topic 5''': How do we promote public trust and adoption of synthetic biology?


* '''Penultimate Project:''' Teams use these tools to evaluate an existing development lifecycle for a genetic engineering technology
* '''Case Studies''' Teams use these tools to evaluate an existing development lifecycle (R&D through translation) for a genetic engineering technology and their broader societal impacts


* '''Final Project''': Teams use these tools to design an improved development lifecycle for future biotechnologies (which may use advanced synthetic biology techniques)
* '''Final Project''': Teams use these tools to design an improved development lifecycle for future biotechnologies (which may use advanced synthetic biology techniques) which lists recommendations on how to improve consideration of broader societal factors into research design.


====Breakdown====
====Breakdown====
Line 110: Line 154:
=====Topic 2: How do we identify and measure the potential benefits and pitfalls of synthetic biology?=====
=====Topic 2: How do we identify and measure the potential benefits and pitfalls of synthetic biology?=====


======Subtopics=======
======Subtopics======
* (Bio)Technology and the Public Good: Introduction and Framing
* (Bio)Technology and the Public Good: Introduction and Framing
* Synthetic Biology Application Spaces
* Synthetic Biology Application Spaces
* Synthetic Biology and Risk Givernance
* Synthetic Biology and Risk Governance
* Synthetic Biology and Ethics
* Synthetic Biology and Ethics


Line 121: Line 165:
* When is synthetic biology an appropriate approach to meet social needs?
* When is synthetic biology an appropriate approach to meet social needs?


=======Candidate Speakers=======
======Candidate Speakers======
* Risk Analysis & Emerging Tech  
* Risk Analysis & Emerging Tech  
* Ethics
* Ethics
Line 130: Line 174:


=====Topic 3: How do we optimize progress towards the benefits of synthetic biology?=====
=====Topic 3: How do we optimize progress towards the benefits of synthetic biology?=====
=====Topic 4: How do we minimize potential harms of synthetic biology?=====
=====Topic 5: How do we promote public trust and adoption of synthetic biology?=====


===Topic Brainstorming===
======Subtopics======
* Synthetic Biology and the Innovation Landscape: US & International
* Economics, Intellectual Property and Open Innovation Systems
* Synthetic Biology and Technology Standards


This is a space to list topics that might comprise a useful introduction to the broader societal context of biotechnology development - it's history, current practices, and ongoing/future challenges. This list will undoubtedly grow to include far more topics than could ever be covered in a week-long course. However, this is in itself useful as indication of the knowledge that we consider to be a valuable, if not essential, component of our education as responsible practitioners of synthetic biology that isn't being satisfactorily provided elsewhere, providing further motivation for the course.
======Driving Questions======
* What are the current private and public investments and activitities in synthetic biology in the US and Internationally?
* How do different research approaches (foundational technologies vs. new applications) contribute to (inter)national strategic goals?
* How should governments fund synthetic biology? What role does industry play?
* What is the current IP structure surrounding biotechnology? What are other possible IP structures and their merits?
* By which mechanisms do standards get set, what is their role, and who is responsible?


Once we have fleshed out potential topics, we can start to refine topics into essential and non-essential categories, match with speakers, case studies and/or activities.
======Candidate speakers======
* Govt Funding: Alicia Jackson (DARPA), Paula Oliewski (Sloan), Teresa Good (NSF)
* Private Funding: Biotech VCs
* Scholars on Economics of Syn Bio: Steve Maurer
* Standard Setting & Technology Development: Emma Frow
* Biotech Lobby Organizations: Brent Erickson (BIO)
* Legal Scholars: Mark Lemley, Arti Rai, Andrew Torrence


'''(Bio)Technology and the Public Good: Introduction and Framing'''
=====Topic 4: How do we minimize potential harms of synthetic biology?=====
* How do we think about technology and the ‘public good’?  By which criteria do/can we evaluate how technologies enhance human and environmental flourishing? 
* How and why are certain technologies adopted? What are the drivers of technology?


'''History of Biotechnology / Synthetic Biology'''
======Subtopics======
* What were the critical innovations? Actors? Institutions? Programs? Investments?
* Responsible Technology Development: Precaution, Proaction, and Prudent Vigilance
* Regulation and Oversight of Biotechnologies
* Synthetic Biology & Biosafety
* Synthetic Biology & Biosecurity


'''Current and Future Investments in Synthetic Biology'''
======Driving Questions======
* The political economy of synthetic biology
* What is our strategy for biosecurity (really) in a world in which we sustain incremental improvement in our capacity to engineer biology?
* How do we build trust regarding biosecurity across secrecy gaps due to private or classified work?
* How might we cultivate wisdom and leadership in biosecurity and biosafety within the next generation of practitioners?
* How do we responsibly address concerns about corrupting/overrunning nature?
* How should synthetic biology products and processes be regulated/monitored? What are current practices across applications?


'''Synthetic Biology in the US'''
======Candidate speakers======
* Biosecurity/Biosafety Experts: Ed You, DTRA, NSABB, Steven Maurer (Director of the Goldman School Project on Information Technology and Homeland Security)
* Bioethics: PCSBI -  Nita Farahany; Joyce Tait
* Regulatory Agencies: FDA, USDA etc


Institutions
======Relevant Case Studies======
*Academic
*Corporate
*Governmental
Funding Agencies
*SynBERC
*DARPA
*Sloan


'''Synthetic Biology in an International Context'''
=====Topic 5: How do we promote public trust and adoption of synthetic biology?=====
* How is SB being developed/funded in other countries? How does this differ from the US strategy?


'''Synthetic Biology and the Innovation Landscape'''
======Subtopics======
* What types of things are we making: plug & play vs new application spaces?
Synthetic Biology and the Publics
* Investments in applications vs. tools/technology platforms?
* Who is interested (governments, existing companies, venture)?


'''Synthetic Biology, Intellectual Property and Open Innovation Systems'''
======Driving Questions======
* Current practices in IP
* What do we know about the way the publics perceive (synthetic) biotechnology?
* Theories/proposals for new systems
* What can we learn from the adoption and perception of other technologies?
* Recent developments (e.g. Myriad) & their implications
* How do/should we communicate and represent our work?
 
* How do we facilitate understanding between practitioners and non-practitioners?
'''Synthetic Biology as an ‘Emerging’ Technology'''
* What have we learnt from other contemporary emerging technologies (nanotech etc)?  
 
'''Prudent Vigilance and Responsible Technology Development'''
* Interpretation and significance of the Presidential Bioethics Commission
 
'''Regulation and Oversight of Biotechnologies'''
* Which regulatory agencies current oversee syn bio products? What are the current/future gaps?
 
'''Synthetic Biology and Risk Governance'''
* What are different approaches to risk analysis?


'''Synthetic Biology & Biosafety'''
======Candidate speakers======
* What are the potential gaps in our current biosafety frameworks?
* Civil society reps
* Social Scientists expert in public perception of biotech: Joyce Tait, Claire Marris etc
* David Rejeski (Director of the Science and Technology Innovation Program at the Woodrow Wilson International Center for Scholars)


'''Synthetic Biology & Biosecurity'''
======Relevant Case Studies======
* What are the potential gaps in our current biosecurity frameworks?
 
'''Synthetic Biology as a Discipline: Education and Vocation'''
* How are we educating the next generation of synthetic biologists?
* Will there be jobs?
 
'''Synthetic Biology and the Public'''
* What do we know about the way the publics perceive biotechnology?
* How are we communicating and representing our work?
 
'''Open challenges: The next 5, 10, 15 years and beyond'''
* Gaps lists from different groups/meetings


==Application==
==Application==
Line 268: Line 301:
* Decreasing the barriers to innovation in syn bio  
* Decreasing the barriers to innovation in syn bio  
* Improvement to the process by which the benefits and risks of synthetic biology research can be assessed and reviewed.
* Improvement to the process by which the benefits and risks of synthetic biology research can be assessed and reviewed.
* Recommendations for how to promote learning and doing in Practices amongst the practitioner community  
* Recommendations for how to promote learning and doing in Practices amongst the practitioner community. For instance, how to incorporate considerations of societal context more meaningfully into early research design and execution,


2. Journal Article Summarizing the Meeting Outcomes
2. Journal Article Summarizing the Meeting Outcomes
Line 320: Line 353:


===Invited Guest Speakers/Tutors===
===Invited Guest Speakers/Tutors===
Invited guests and tutors could come from areas such as:
~10-15 Invited guests and tutors coming from areas such as:
* Industry
* Industry
* Funding Agencies (Program Managers)
* Funding Agencies (Program Managers)
Line 411: Line 444:
* I think that as long as participants in the boot camp come away with a certificate and a deliverable, a week or so of their time is fine for the first go around.  SB is big right now, so I don't see there being a lack of interest.  The public policy and biological threats workshop was a week long and it was very valuable.  Likewise for my program-mates, if not just because we all connected with one another, and made connections with the speakers.
* I think that as long as participants in the boot camp come away with a certificate and a deliverable, a week or so of their time is fine for the first go around.  SB is big right now, so I don't see there being a lack of interest.  The public policy and biological threats workshop was a week long and it was very valuable.  Likewise for my program-mates, if not just because we all connected with one another, and made connections with the speakers.
* I think a really good format would be seminars in the morning, interactive work/action in the afternoon, maybe a short summary meeting before or after dinner, and then more work/discussion over beer.
* I think a really good format would be seminars in the morning, interactive work/action in the afternoon, maybe a short summary meeting before or after dinner, and then more work/discussion over beer.
From Josh:
* something I would like the future practitioners of synthetic biology to consider is whether there are viable (distinct from practical) alternatives to implementing new technologies (reorganizing food distribution vs. GM crops; biofuels vs. conservation. If you have a hammer, every problem is a nail. As synthetic biologists, every problem can become defined through that lens.


==References==
==References==

Latest revision as of 17:48, 25 October 2011

Home        About        Members        Meetings        Gaps        Discussion        Resources       



Synthetic Biology 'Leaders in Practice' Bootcamp

DISCLAIMER: THIS PAGE IS ONLY PERIODICALLY UPDATED AS A REPOSITORY FOR IDEAS. MORE DETAILED AND UP-TO-DATE EDITING IS DONE VIA OUR COLLABORATIVE GOOGLE DOCUMENT, FOUND [HERE] (protected; please ask permission)

Description

An intensive week-long in-residence workshop for young investigators in the broader societal context of developments in synthetic biology designed to foster leadership in advancing responsible practices.

Broad Goals

  • Foster leadership among a community of practitioners working together with other partners and stakeholders to best advance synthetic biology.
  • Provide participants with an intensive, productive and fun introduction to the broader societal context in which synthetic biology is being developed which equips them with knowledge, skills, resources and connections to make well-informed choices about directing their future work.
  • Provide a venue for intensive discussion on how we might strategically direct synthetic biology development to best benefit the public good.


More simply put, this workshop would aim to translate prudent vigilance into practice by providing:

  • Knowledge/Resources: a curriculum in the past and current state of biotechnology practice
  • Community: connections with (i) peers who will become the next generation of leaders and (ii) leaders and stakeholders in synthetic biology.
  • Practice: engagement in envisioning and suggesting paths for best advancing the field towards public good
  • Productivity: production of deliverables which facilitate sharing of lessons and recommendations from the course

Motivation

Gaps

  • Graduate education offers very limited exposure to the practical realities of how biotechnology is being developed beyond the lab and its broad social and ethical dimensions. An awareness of the history, current practices and ongoing/future challenges facing the positive development of biotechnology is essential to being able to strategically direct individual and community efforts. We expect leadership from the next generation of practitioners of synthetic biology in developing policies and best practices around issues like safety, security, property rights and innovation frameworks etc. yet offer few opportunities for engagement (practice!) in these areas within early career development.
  • Current training in these topics is limited primarily to:
    • one-off seminars, which are piecemeal and offer little engagement
    • semester-long classes in other disciplines (policy, business etc), which are often not targeted to, and impractical to attend for, practicing researchers
    • entrepreneurial programs, which are primarily reach only a small subset of researchers developing commercial applications

Opportunities

  • SB has an opportunity to demonstrate new models for technology development whereby practitioners incorporate meaningful consideration of the social and ethical ramifications into their research design and practice.
  • This workshop should provide practical, relevant and useful training to practitioners pursuing a diversity of professional paths - industry, academia, or otherwise

Motivating Example

  • The OSTP recently issued a [Request for Information] to "solicit input from all interested parties regarding recommendations for harnessing biological research innovations to meet national challenges in health, food, energy, and the environment...". How would we equip up-and-coming leaders in syn bio to work towards being able to make informed recommendations to the following requests for input, and hopefully take steps towards implementing those reccomendations? See the RFI questions here

Workshop Components

Topic Brainstorming

This is a space to list topics that might comprise a useful introduction to the broader societal context of biotechnology development - it's history, current practices, and ongoing/future challenges. This list will undoubtedly grow to include far more topics than could ever be covered in a week-long course. However, this is in itself useful as indication of the knowledge that we consider to be a valuable, if not essential, component of our education as responsible practitioners of synthetic biology that isn't being satisfactorily provided elsewhere, providing further motivation for the course.

Once we have fleshed out potential topics, we can start to refine topics into essential and non-essential categories, match with speakers, case studies and/or activities.

(Bio)Technology and the Public Good: Introduction and Framing

  • How do we think about technology and the ‘public good’? By which criteria do/can we evaluate how technologies enhance human and environmental flourishing?
  • How and why are certain technologies adopted? What are the drivers of technology?

History of Biotechnology / Synthetic Biology

  • What were the critical innovations? Actors? Institutions? Programs? Investments?

Current and Future Investments in Synthetic Biology

  • The political economy of synthetic biology

Synthetic Biology in the US

Institutions

  • Academic
  • Corporate
  • Governmental

Funding Agencies

  • SynBERC
  • DARPA
  • Sloan

Synthetic Biology in an International Context

  • How is SB being developed/funded in other countries? How does this differ from the US strategy?

Synthetic Biology and the Innovation Landscape

  • What types of things are we making: plug & play vs new application spaces?
  • Investments in applications vs. tools/technology platforms?
  • Who is interested (governments, existing companies, venture)?

Synthetic Biology, Intellectual Property and Open Innovation Systems

  • Current practices in IP
  • Theories/proposals for new systems
  • Recent developments (e.g. Myriad) & their implications

Synthetic Biology as an ‘Emerging’ Technology

  • What have we learnt from other contemporary emerging technologies (nanotech etc)?

Prudent Vigilance and Responsible Technology Development

  • Interpretation and significance of the Presidential Bioethics Commission

Regulation and Oversight of Biotechnologies

  • Which regulatory agencies current oversee syn bio products? What are the current/future gaps?

Synthetic Biology and Risk Governance

  • What are different approaches to risk analysis?

Synthetic Biology & Biosafety

  • What are the potential gaps in our current biosafety frameworks?

Synthetic Biology & Biosecurity

  • What are the potential gaps in our current biosecurity frameworks?

Synthetic Biology as a Discipline: Education and Vocation

  • How are we educating the next generation of synthetic biologists?
  • Will there be jobs?

Synthetic Biology and the Public

  • What do we know about the way the publics perceive biotechnology?
  • How are we communicating and representing our work?

Open challenges: The next 5, 10, 15 years and beyond

  • Gaps lists from different groups/meetings


Workshop Topic Refinement and Structuring

Disclaimer: Work in Progress!

Overall Structure

Potential Workshop Title/Lens: Developing Policy Frameworks for Advancing Synthetic Biology / Biotechnology

  • Application Package & Initial Presentation: Write a letter in response to one or more of the questions posed in the OSTP RFI on Building the Bioeconomy Blueprint and list assumptions and pitfalls that could be addressed by the community of expert practitioners and stakeholders brought together by this workshop.
  • Topic 1: What is ‘new’ about synthetic biology?
  • Topic 2: How do we identify and measure the potential benefits and harms of synthetic biology?
  • Topic 3: How do we optimize progress towards the benefits of synthetic biology?
  • Topic 4: How do we minimize potential harms of synthetic biology?
  • Topic 5: How do we promote public trust and adoption of synthetic biology?
  • Case Studies Teams use these tools to evaluate an existing development lifecycle (R&D through translation) for a genetic engineering technology and their broader societal impacts
  • Final Project: Teams use these tools to design an improved development lifecycle for future biotechnologies (which may use advanced synthetic biology techniques) which lists recommendations on how to improve consideration of broader societal factors into research design.

Breakdown

Topic 1: What is ‘new’ about synthetic biology?
Subtopics
  • History of Biotechnology / Synthetic Biology
  • Synthetic Biology as a Platform Technology
  • Synthetic Biology as an ‘Emerging’ Technology
Driving Questions
  • What were the critical innovations? Actors? Institutions? Programs? Investments?
  • How have our capacities to engineer biology changed over time? What new capacities do synthetic biology techniques offer?
  • What lessons can we draw from previous experiences? What precedents exist that me must work within or overcome?
  • How is synthetic biology similar/distinct from other disciplines? What challenges are unique, which are common?
Candidate Speakers
  • History of (bio)technology scholar
  • Syn Bio Academic Leaders
  • Biotech Ind Veteran
Relevant Case Studies & Resources
Topic 2: How do we identify and measure the potential benefits and pitfalls of synthetic biology?
Subtopics
  • (Bio)Technology and the Public Good: Introduction and Framing
  • Synthetic Biology Application Spaces
  • Synthetic Biology and Risk Governance
  • Synthetic Biology and Ethics
Driving Questions
  • How do we think about technology and the public good?
  • By which criteria do/can/should we evaluate how technologies enhance human and environmental flourishing?
  • When is synthetic biology an appropriate approach to meet social needs?
Candidate Speakers
  • Risk Analysis & Emerging Tech
  • Ethics
  • Civil Society
  • Policy & Public Interactions
Relevant Case Studies and/or Resources
Topic 3: How do we optimize progress towards the benefits of synthetic biology?
Subtopics
  • Synthetic Biology and the Innovation Landscape: US & International
  • Economics, Intellectual Property and Open Innovation Systems
  • Synthetic Biology and Technology Standards
Driving Questions
  • What are the current private and public investments and activitities in synthetic biology in the US and Internationally?
  • How do different research approaches (foundational technologies vs. new applications) contribute to (inter)national strategic goals?
  • How should governments fund synthetic biology? What role does industry play?
  • What is the current IP structure surrounding biotechnology? What are other possible IP structures and their merits?
  • By which mechanisms do standards get set, what is their role, and who is responsible?
Candidate speakers
  • Govt Funding: Alicia Jackson (DARPA), Paula Oliewski (Sloan), Teresa Good (NSF)
  • Private Funding: Biotech VCs
  • Scholars on Economics of Syn Bio: Steve Maurer
  • Standard Setting & Technology Development: Emma Frow
  • Biotech Lobby Organizations: Brent Erickson (BIO)
  • Legal Scholars: Mark Lemley, Arti Rai, Andrew Torrence
Topic 4: How do we minimize potential harms of synthetic biology?
Subtopics
  • Responsible Technology Development: Precaution, Proaction, and Prudent Vigilance
  • Regulation and Oversight of Biotechnologies
  • Synthetic Biology & Biosafety
  • Synthetic Biology & Biosecurity
Driving Questions
  • What is our strategy for biosecurity (really) in a world in which we sustain incremental improvement in our capacity to engineer biology?
  • How do we build trust regarding biosecurity across secrecy gaps due to private or classified work?
  • How might we cultivate wisdom and leadership in biosecurity and biosafety within the next generation of practitioners?
  • How do we responsibly address concerns about corrupting/overrunning nature?
  • How should synthetic biology products and processes be regulated/monitored? What are current practices across applications?
Candidate speakers
  • Biosecurity/Biosafety Experts: Ed You, DTRA, NSABB, Steven Maurer (Director of the Goldman School Project on Information Technology and Homeland Security)
  • Bioethics: PCSBI - Nita Farahany; Joyce Tait
  • Regulatory Agencies: FDA, USDA etc
Relevant Case Studies
Topic 5: How do we promote public trust and adoption of synthetic biology?
Subtopics

Synthetic Biology and the Publics

Driving Questions
  • What do we know about the way the publics perceive (synthetic) biotechnology?
  • What can we learn from the adoption and perception of other technologies?
  • How do/should we communicate and represent our work?
  • How do we facilitate understanding between practitioners and non-practitioners?
Candidate speakers
  • Civil society reps
  • Social Scientists expert in public perception of biotech: Joyce Tait, Claire Marris etc
  • David Rejeski (Director of the Science and Technology Innovation Program at the Woodrow Wilson International Center for Scholars)
Relevant Case Studies

Application

The application package for the course is designed to engage participants in questions relating to the societal ramifications of their work prior to the workshop and facilitate conversations and group work during the week.

Potential Formats

Big Ideas for Building a Better Bio-Economy

How can synthetic biology be developed to best benefit people and the planet? Describe (in <500 words) a product, practice, policy or grand plan for, or from, synthetic biology that you believe could enable a better future. Give 3 reasons why it will succeed, and list 3 major assumptions, potential pitfalls, or uncertainties in your proposal. Lastly, briefly describe how participation in this workshop might help to explore the viability of your idea(s) and aid in your future work.

  • This could be modified to request a letter in response to the OSTP RFI

Better Broader Impacts

The NSF recently proposed changes to its merit review criteria, which includes refinement of the broader impacts statements: http://www.nsf.gov/nsb/publications/2011/06_mrtf.jsp. Write a broader impact statement for your current or proposed future research. List 3 major assumptions, potential pitfalls, or uncertainties in your claims. Lastly, briefly describe how participation in this workshop might help to craft a more accurate broader impacts statement or alter your research design.

Defining Prudent Vigilance in Practice

The Presidential Commission on the Study of Bioethical Issues recommended an on ongoing system of prudent vigilance for synthetic biology that carefully monitors, identifies and mitigates potential and realized harms over time. However, it remains unclear what prudent vigilance looks like in practice, and how this specifically relates to researcher responsibilities and activities. Describe an essential component of a prudent vigilance and how this might be translated into practice.

Framings

In order to guide and refine both the curriculum content and activities/output from the workshop, it may be helpful to have a central theme or framing.

Possible Framings

  • How do you promote learning and doing in Practices (w/in program grants, institutions etc?) For example, should the NSF mandate work/progress in Practices? How?
  • Beyond the Bioreactor: Considerations in the intentional and unintentional release of genetically engineered organisms
    • Curriculum and activities would center on proposals for (researching, evaluating, establishing) best practices for testing/demonstrating the safety and efficacy of engineered organisms in applications involving potential environmental release.

Case studies

Case studies and themes may be useful for grounding the conversation and navigating through curriculum elements.

Company/Institutional Profiles

Why are these companies/institutions betting on syn bio? what is their strategy?

  • synthetic genomics
  • amyris
  • life technologies
  • DSM
  • ginkgo
  • dna 2.0
  • could also profile new depts / institutions in syn bio like Berkeley
  • GEVO
  • LS9
  • Codexis
  • Agilent
  • Lumin

Technology Spaces

Examine deeply one or more particular application spaces

  • Chemical Synthesis; Biofuels
  • Health
  • Environmental Remediation

Problem/Issues

  • examine different approaches to an issues like safety/risk and biological containment

Activities / Projects / Deliverables

Deliverables

1. White Paper / Technology Roadmap

  • Decreasing the barriers to innovation in syn bio
  • Improvement to the process by which the benefits and risks of synthetic biology research can be assessed and reviewed.
  • Recommendations for how to promote learning and doing in Practices amongst the practitioner community. For instance, how to incorporate considerations of societal context more meaningfully into early research design and execution,

2. Journal Article Summarizing the Meeting Outcomes

3. Magazine/Newspaper Article or Op-Ed

4. New Research Proposal(s) around, for example, regulatory and risk science for synthetic biology

5. Revised Broader Impacts Statements (and secondary analysis thereof)

Follow-Up Events and Workshops

  • 'Graduates' from the bootcamp would be invited to participate in subsequent stakeholder workshops organized by the BBF focused more narrowly on topics such as IP, Standards, Ethics and Communications.


Formats and Logistics

Venue

  • Preferable venue is intimate and secluded to promote lots of interaction. Possibilities include Asilomar, Friday Harbor.
  • Could also hold somewhere like DC, for instance partnering with the Wilson Center. This facilitates interaction with a lot of the folks who will be local to the DC area.

Duration

  • 4-6 days

Timing

  • Summer 2012 - late June / early July most likely

General Format

  • Have mix of short expert presentations, discussions and small group projects
  • Lots of opportunities for extracurricular activities (mental processing time!) and off-line discussions to build community

Options

One Option:

5 days

  • Morning: seminar(s) from guest tutors
  • Afternoon: interactive activities (working through case studies) OR extra-curricular activity / outing (alternating days)
  • Pre-dinner: presentations/summary
  • Dinner
  • After-dinner conversations

Participants & Invited Guests

Participants

~25-35 young investigators (senior graduate students, postdocs and newPIs) who are (interested in) doing innovative work in various areas concerning the practice of synthetic biology:

  • Technologists / Natural Scientists
  • Social Scientists
  • Artists, Designers, Humanities Scholars

Invited Guest Speakers/Tutors

~10-15 Invited guests and tutors coming from areas such as:

  • Industry
  • Funding Agencies (Program Managers)
  • Government (Policy, Regulation)
  • Economics
  • Law
  • Risk Analysis
  • Social Science / STS
  • Experts on Teaching the Social and Ethical Implications of Research
  • Civil Society Organizations
  • Ethics
  • Media, Communications, Marketing
  • DIY/DIT community

Potential Invited Guests

  • Representatives from Syn Bio Companies (see case studies list)
    • Zach Serber (Amyris)
    • Jack Newman (Amyris)
  • Brent Erickson (BIO) : Corporate Biotechnology Innovation & Investment Landscape, Policy Lobby
  • Nita Farahany (Stanford) : Presidential Bioethics Commission - Law & Ethics
  • Anne-Maria Mazza (NAS): Policy, International Context
  • Steve Maurer (Berkeley): Economics of Syn Bio
  • Rob Carlson (Biodesic): Economics of Syn Bio
  • Ken Oye (MIT): IP, Biosecurity, Reg of Emerging Tech
  • David Rajeski (Wilson Center): Public Perceptions/Involvement, Policy, Regulation
  • Sheila Jasannof (Harvard): STS, Politics and History of Biotechnology in an International Context
  • David Mandell (MIT) - Emerging Tech
  • Arti Rai (Duke): policy, IP/patent law
  • Hank Greeley (Stanford): law, policy, ethics in the biosciences more generally
  • Mark Lemley (Stanford): IP/Patent Law
  • Michele Garfinkel (EMBO): policy
  • Non Freidman (Venter): policy
  • Rick Johnson (BBF): legal
  • Tom Khalil (OSTP): federal policy
  • Jane Evans-Ryan (worked w/ BBF): Communications
  • Ed You (FBI): Biosafety/Biosecurity
  • Jane Calvert (Edinburgh): Social & Ethical Dimensions; Collaboration w/ Social Science Community
  • Legal Counsel from small biotechs like LS9 (sugg by Ryan Ritterson)
  • Alicia Jackson (DARPA): Federal Agency agendas
  • Markus Schmidt (Biofaction)
  • folks from DTRA
  • folks from NSABB
  • Jim Thomas (ETC)

Partners, Sponsors

Confirmed:

SynBERC

BBF

Potential:

Bay Bio

QB3

Wilson Center Synthetic Biology Project

Siebel Scholars Foundation

Industrial Sponsors

Organizers

Team

Megan Palmer (Stanford)

Josh Wolf (Stanford)

Mike Fisher (Berkeley)

Ryan Ritterson (UCSF)

Jay Vowles (Stanford)

Stephanie Galanie (Stanford): Esp public communication, education, IP and international context.

Advisors

Drew Endy (Stanford)

Feedback

Megan Palmer presented some initial ideas for the workshop at the Sept 15th SPBWG meeting. A few comments:

From Mike Fisher:

  • I think that as long as participants in the boot camp come away with a certificate and a deliverable, a week or so of their time is fine for the first go around. SB is big right now, so I don't see there being a lack of interest. The public policy and biological threats workshop was a week long and it was very valuable. Likewise for my program-mates, if not just because we all connected with one another, and made connections with the speakers.
  • I think a really good format would be seminars in the morning, interactive work/action in the afternoon, maybe a short summary meeting before or after dinner, and then more work/discussion over beer.

From Josh:

  • something I would like the future practitioners of synthetic biology to consider is whether there are viable (distinct from practical) alternatives to implementing new technologies (reorganizing food distribution vs. GM crops; biofuels vs. conservation. If you have a hammer, every problem is a nail. As synthetic biologists, every problem can become defined through that lens.

References

JCVI's publication Synthetic Genomics: Options for Governance (found here) includes recommendations for improving practitioner training in the social and ethical dimensions of research in synthetic biology.

Other Workshops, Curriculum to Learn From

Leopold Leadership Program

Planning

TENTATIVE, needs development.

  • Sept:
    • Present Outline at SynBERC retreat for community feedback.
    • Recruit sponsors, partners, planning team.
  • October/November/December
    • Refine curriculum and choose tentative topics.
    • Set time/timing. Research Venues, determine budget.
    • Prioritize list of guests speakers. Contact/Confirm.
    • Contact additional sponsors.
  • January
    • Call for Applications
  • June/July
    • Workshop