|DAY 1: OCOBER 20, 2010
|8:30 am–9:00 am
|9:00 am–9:15 am
||Welcome and Introduction
Dr. Eric Green, Director, National Human Genome Research Institute
Dr.James Anderson, Director, Division of Program Coordination, Planning, and Strategic Initiatives
|9:15 am–9:30 am
||Background and Aims of Workshop
Dr. Adam Felsenfeld
|9:30 am–10:45 am
||Current technologies: What current technologies are being scaled now?
State-of-the-art, advantages/disadvantages; scalability, cost. What is the ideal approach if you had to start today? What are the critical elements of a pipeline capable of delivering renewable monoclonal affinity reagents for the entire human proteome?
Speakers and Moderators:
Dr. Aled Edwards
Dr. Mathias Uhlen
|10:45 am–11:00 am
|11:00 am–12:45 am
||Alternative/Future: The outlook for better or alternative approaches to developing affinity reagents. What advantages/disadvantages? What is their timeline? How will we know when they are ready to scale?
Moderator: Dr. Andrew Bradbury
Dr. Wayne Marasco
Dr. Larry Gold
Dr. Kenneth Shea
|12:45 am–2:00 pm
||Lunch (on own)
||Coordination and Resource Distribution: Other significant worldwide efforts. To what extent should NIH coordinate with these? How? What are the most important issue for resource distribution?
Speaker and Moderator:
Dr. Michael Taussig
|3:00 pm–3:30 pm
||Charge to Breakout sessions; any additional questions to address?
- What are the prime considerations in developing a resource now? (co-chairs: Dr. Aled Edwards, Dr. Henry Rodriguez)
- What technologies are really ready for a scaling pilot?
- What are the barriers to monoclonal antibody technologies (and their close variants) being a practical means to generate a comprehensive resource?
- How can NIH get the highest utility from a monoclonal antibody approach?
- What are the QA/validation needs? How integrated do they need to be with reagent production?
- Is there any other technology today that can be considered as mature, reliable, and with developed downstream applications, and therefore appropriate for immediate implementation toward the production of affinity capture reagents?
- Given the end-uses stated in the initial implementation (human transcription factors), what validation criteria should be requested for the antibodies generated?
- What factors should NIH consider in setting milestones for the initial implementation?
- What are reasonable user costs for obtaining reagents?
- If no new technology is ready for "production level" implementation in three years, should NIH still encourage a "monoclonal-only" approach? What practical trade-offs should be considered (for example in downstream validations, or breadth, or number of proteins, etc.)? What will be the likely overall cost?
- Technologies for the near future: a survey (Co-chairs: Dr. Michael Snyder, Dr. Salvatore Sechi)
What will be ready sooner vs. later? What technologies could be used in a production effort within the next three to five years? What are the advantages/disadvantages? What are the downstream applications?
- How can we stimulate the reduction-to-practice of "alternative" technologies that have already shown proof of principle?
- How should we assess if an "alternative" technology is mature for scaling it up to for the production of tens of thousands of reagents?
- How should we compare alternate approaches?
- What milestones should be set for the production of antigens (if applicable) and affinity capture reagents in the technology development phase of the program?
- What are the strengths and weaknesses of individual approaches? Will there be one optimum approach or will we need to consider multiple approaches? What are the main considerations in deciding the best mix of approaches (the portfolio)?
- What realistically could be done (how would the group construct a portfolio) with: $10M; $20M; $40M over five years?
- How should we encourage long-term technologies (e.g. five years or more)?
- Discussion: Strategic issues: Integrating with other worldwide efforts; also, maximizing resource accessibility and downstream utility (Co-chairs: Dr. Michael Taussig, Dr. Adam Felsenfeld)
There are a number of other efforts worldwide aimed at generating protein affinity reagents. How should NIH coordinate with those? NIH aims to create a community resource that is free of excessive intellectual property constraints that would inhibit a broad range of research applications.
- What other similar efforts are there that are of a reasonable scale and with whom we should seek to coordinate? Are there well-functioning mechanisms for coordination that currently exist? How should NIH’s efforts be designed to best complement other, ongoing efforts? Is there some value in overlap (e.g. between targets)? What is the right balance of coordination and competition?
- Given the NIH’s interest and current contemplated investment, what is likely to be the most effective way for NIH to productively interact with the community towards a comprehensive resource? At the level of individual projects? With funders? With other organizations? Which of these are the most significant?
- What are the minimum scientific requirements for acceptable terms for distribution of the resource? What downstream applications should NIH consider that may be affected by limitations that could be placed on distribution of the resources?
- Are there any IP issues in using some of the most promising "alternative technologies? Can they be accommodated and still fulfill the intent of the NIH to create a community resource?
- What are reasonable incentives for NIH to use to encourage the widest possible availability to the research community of the reagents it funds?
- How can NIH encourage a resource that can be distributed to the research community at minimal cost, for example so as not to discourage potential multiplexing applications?
||Adjourn for Dinner
||Executive Session Breakout Group Co-Chairs re-convene to make powerpoint summaries of breakout sessions
|DAY 2: OCTOBER 21, 2010
|8:00 am–8:30 am
|8:30 am–10:00 am
||Breakout Group Summaries (~20 minutes each, plus discussion) Breakout group co-chairs
|10:00 am–11:00 am
Moderator: Dr. Josh LaBaer
Some suggested overall topics:
- What are the essential elements of a successful production effort? What are the best metrics or benchmarks? If funds are limiting, what are the priorities (quality vs quantity, etc.).
- What is the right current balance that this program should try to achieve between "production ready" and "nearly ready" approaches? How soon should NIH be ready to consider encouraging "nearly ready" approaches to go into production?
- How should NIH measure success in 3-5 years? How will we know if this should be continued, scaled up, etc.?
- If funds are limiting, what are the priorities for adding additional elements (e.g., target more uses? More classes of protein? More "nearly ready" or alternate approaches?
||General Meeting Adjourn
|11:00 am–1:00 pm
||Breakout session chairs and General Discussion Moderator (LaBaer) meet with NIH staff to draft recommendations for program