Response_to_Questions.pdf

QUESTIONS RECEIVED FOR HHS-NIH-NIDA(AG)-RFP-19-048

Question 1: Can you clarify the total amount of iPSCs for the project period? In one section it says 200-600, and in another it says 20-50 per month (which would add up to 720-

1800 over the 3 years).

Answer 1: The total of iPSCs for the project is 200 to 600, limited by our overall budget for this project and hence on the vendor supplied price per cell line. Our expectation is that for FY19 we will likely be nearer 200 lines.

Question 2: Should our pricing be submitted as a range with the low end capturing 200 iPSCs and the high end capturing 600?

Answer 2: Pricing should be submitted per cell line.

Question 3: Is there a page limit to the proposal submitted?

Answer 3: No page limit

Question 4: Do you have any more information regarding the genetic / epigenetic profiling?

We are unsure if this is DNA methylation, targeted genotyping, etc. Any insight into the assays required would help inform our pricing.

Answer 4: We would like a reliable pluripotency test to be completed for each line. We expect these will likely be based on gene expression of pluripotency markers.

Question 5: Is there an idea of when we would begin to receive PBMCs and when the first clones would be expected? In planning our resourcing, we want to figure out if production would start immediately after award, or if there will be some sort of ramp up period to meeting the 20-50 per month deliverable.

Answer 5: We plan to start sending PBMCs as soon as possible after award, likely with an initial smaller number to establish capability. Therefore, some ramp up period could be tolerated.

Question 6: Does the project requires tube-level tracking?

Answer 6: Tube level tracking is not required, although clearly each provided IPSC line must be accurately labeled in a manner that would allow NIH staff to be able to link back to the original anonymized donor ID.