RNAi Questions and Answers

Question:  What is the purpose of the RFI meeting on RNAi?
Answer:  A Request for Information (RFI) Meeting is used when the Government does not presently intend to make awards but wants to obtain market information for planning purposes.  Responses to an RFI are not offers and cannot be accepted by the Government to form a binding agreement.  We have received several emails describing RNAi platforms, screening efforts and projects, vectors, instrument platforms for transaction of cells, and so forth. We encourage all interested parties in academia, government, and industry to attend this meeting. 

Question:  Will the NIH be able to include non-U.S. service providers in this project?
Answer:  Yes.

Question:  Please clarify the scope of the pricing agreements.  Are the pricing agreements sought for all Institutes or NIDDK only?
Answer:  Pricing agreements will be sought for all Institutes.

Question:  Will the selected contractor(s) be required to extend the pricing agreements to NIH Grantees and Principal Investigators (private entities)?
Answer:  The Government (NIH) cannot require the extension of pricing agreements to NIH Grantees and Principal Investigators (private entities).

Question:  More detailed specifications are required to extend the most favorable pricing agreement.  Can (a) more detailed specification(s) be provided at this time that would be beneficial to prospective bidders prior to the presolicitation meeting?
Answer:  Detailed specifications are not available at this time.  NIH Researchers will discuss the research that is under way and planned in their laboratories.  The primary focus of this meeting is to provide industry and academia with an overview of the research planned in the NIH Intramural Laboratories.  NIH Intramural Researchers will make presentations on their research at the meeting.

Question:  Will multiple preferred vendors be selected from the proposals, or is it the NIH’s intent to select individual vendors for each type of RNAi technology under consideration?
Answer:  The NIH has not made a decision on this question.  Proposals are not being requested at this time.  The NIH will make a decision on the acquisition methodology(ies) to be employed after the meeting.  A discussion of acquisition methodologies will be on the Agenda.

Question:  What is the anticipated volume of each type of RNAi technology?
Answer:  Information on the volume of each type of RNAi technology is not available at this time.

Question:  What materials and what format will companies need to submit for this conference?  Is it going to be a roundtable discussion of company presentations?
Answer:  Companies will be given the opportunity to present information at the meeting. Companies should contact Mr. John Hare of The Scientific Consulting Group, Inc. to inform him of their intent to make a presentation. Companies should plan on a 10-minute presentation.  Electronic copies of the presentation should be sent to Mr. Hare no later than 3:00 p.m. on December 10, 2007.  The order of the presentations will be determined by the order in which companies register with Mr. Hare.  In the event that the electronic copies of the presentation are not sent to Mr. Hare by December 10, the company(ies) will not be able to make a presentation. 

Question:  Have you already experienced the challenges of co-transfection using lipid-mediated or viral delivery?
Answer:  The NIH recognizes that delivery is a significant challenge and expense.  Viral, transfection, lipofection, and other RNAi reagent vehicles are important components and should be discussed.

Question:  Is the NIH interested in high-throughput (adaptable to medium-throughput) instrument platform(s) for transfection of cells?
Answer:  The NIH is very interested in integrated platforms for high-throughput RNAi screens.  The NIH options include in-house development, cooperative research, and development or outsourcing.

Question:  Is the NIH interested in generating a systematic database of phenotypic effects of RNAi in transfected cells?
Answer:  Yes.  Database development is essential for high-throughput aspects.

Question:  If so, how many phenotypes per RNAi per cell type?
Answer:  This is unknown and will be developed during pilot work and based on the assays developed by NIH scientists.  We will seek a balance between completeness of phenotypic descriptors, feasibility, and cost.

Question:  How many cell types would phenotypes be scored in?
Answer:  Hundreds of NIH users use particular cell types where they can best address specific scientific and/or medical questions.  Cell type flexibility is important.

Question:  How many different media conditions or environments would phenotypes be scored in?
Answer:  This depends on the questions being addressed by researchers at any of 27 different NIH institutes.

Question:  What price point per phenotype would be acceptable?
Answer:  The NIH is seeking the most favorable pricing an organization can offer.

Question:  What sorts of phenotypes would be highest priority?
Answer:  Low-to moderate-throughput use will be wholly investigator driven.  A mechanism for prioritizing high-throughput screening will be developed.
Question:  Would phenotypic assays of metabolite utilization and chemosensitivity be of interest?
Answer:  This is one of many potential uses.  Phenotypes are part of assay development, which will be investigator driven.

Question:  Would cell-based assays that require no reporter gene engineering or target-specific reagents (antibodies or nucleic acids) receive priority consideration?
Answer:  Research priorities have not been determined.

Question:  Would all phenotypes be scored in all cell types under all media conditions?
Answer:  It is unlikely that all phenotypes will be scored in all cell types under all media conditions.

Question:  Is the NIH planning on developing and supporting the database and associated bioinformatics or outsourcing these activities?
Answer:  Both options will be considered.

Question:  How many centers within the NIH will be doing high-throughput and moderate-throughput screening, respectively?
Answer:  The number of centers has not been determined at this time.  The objective is to establish a trans-NIH research project.

Question: If an instrument was available for moderate-to high-throughput screening of RNAi phenotypes, would purchasing have to wait for capital budget appropriation and approval?
Answer:  Yes, equipment purchase(s) are subject to internal approval at the NIH Institute level.

Question:  Could a reagent rental program accelerate purchase and implementation of moderate-to high-throughput instrumentation for screening?
Answer:  An analysis of rental costs would have to be prepared as reagents are depleted during the course of an experiment.

Question:  Would a two-tier system of uniform pricing (standing order for reagents and consumables alone vs. reagent rental for reagents/consumables and instrument lease to own) be acceptable?
Answer:  An analysis comparing purchase cost versus rental cost for reagents and consumables and instrument lease to own cost would have to be prepared to determine which approach is most advantageous and cost effective.

Question: How long would the NIH envisage a typical standing order or reagent rental program to last?
Answer: A minimum of 1 to 5 years with pricing subject to renegotiation on an annual basis.