Pre-Proposal Conference_Transcript.pdf

0:0:0.0 --> 0:0:0.350 Espinosa, Kimberly (NIH/NIDA) [E] All right.

0:0:0.360 --> 0:0:1.930 Espinosa, Kimberly (NIH/NIDA) [E] Well, it is 3:00 o'clock.

0:0:1.940 --> 0:0:4.0 Espinosa, Kimberly (NIH/NIDA) [E] So we will go ahead and get started.

0:0:4.320 --> 0:0:6.170 Espinosa, Kimberly (NIH/NIDA) [E] Uh, good afternoon everyone.

0:0:6.380 --> 0:0:19.10 Espinosa, Kimberly (NIH/NIDA) [E] We are here today to discuss the manufacturing and non clinical studies support for development of therapeutic biotechnology products, biologics for a neurological related disorders.

0:0:19.540 --> 0:0:27.270 Espinosa, Kimberly (NIH/NIDA) [E] I am Kimberly Espinosa, the contracting officer on this opportunity and joining me today are Lauren Friedman and Kelly Shepherd.

0:0:27.320 --> 0:0:44.390 Espinosa, Kimberly (NIH/NIDA) [E] To have nins technical experts in their space in this space, I'm sorry, although this is a pre proposal conference for this specific contract opportunity, we will spend some of our time today discussing an overview of the Nins Biologics therapies development programs.

0:0:44.460 --> 0:0:55.980 Espinosa, Kimberly (NIH/NIDA) [E] As additional background information and context for this opportunity, you should have all received a notification that this meeting is being recorded and transcribed.

0:0:56.170 --> 0:1:2.900 Espinosa, Kimberly (NIH/NIDA) [E] A transcription of the conference will be posted on sam.gov along with the slides after this conference.

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So first we will discuss an overview of the NIH programs.

0:1:9.190 --> 0:1:15.560 Espinosa, Kimberly (NIH/NIDA) [E] Then the proposal requirements, then a review of the questions received and ending with Q&A.

0:1:15.630 --> 0:1:18.810 Espinosa, Kimberly (NIH/NIDA) [E] As time permits, we will end at 4:00 PM today.

0:1:20.680 --> 0:1:26.260 Espinosa, Kimberly (NIH/NIDA) [E] So now I will turn it over to Kelly and Lauren for an overview of the NIH programs.

0:1:28.920 --> 0:1:30.130 Sheppard, Kelly (NIH/NINDS) [E] Thank you, Kimberly.

0:1:30.200 --> 0:1:31.270 Sheppard, Kelly (NIH/NINDS) [E] I'm Kelly shepherd.

0:1:31.280 --> 0:1:46.810 Sheppard, Kelly (NIH/NINDS) [E] I'm one of our scientific program managers at NINDS, and I'll go ahead and give this our overview of some of our programs and this is just hopefully to help Orient you to the kinds of support that we use with with contracts like this one.

0:1:46.820 --> 0:1:56.890 Sheppard, Kelly (NIH/NINDS) [E] So on some of the things that are are are true across all of our programs, is that for one thing, we support all large molecule therapies.

0:1:56.960 --> 0:2:9.360 Sheppard, Kelly (NIH/NINDS) [E] So we'll go into what each program does, but we are looking for contractors with the solicitation who are capable in House or through subcontractors of supporting all of our large molecule therapies.

0:2:9.370 --> 0:2:10.430 Sheppard, Kelly (NIH/NINDS) [E] Some examples are here.

0:2:10.440 --> 0:2:20.450 Sheppard, Kelly (NIH/NINDS) [E] The main examples that we see these days though of course there are always novel and emerging biologics coming out and we hope to be able to support the field as it grows.

0:2:21.120 --> 0:2:21.620 Sheppard, Kelly (NIH/NINDS) [E] Next slide.

0:2:24.440 --> 0:2:34.550 Sheppard, Kelly (NIH/NINDS) [E] Another element of our of our programs that's important to note is that these are projects that are milestone driven and they proceed in phases.

0:2:34.560 --> 0:2:41.150 Sheppard, Kelly (NIH/NINDS) [E] And so this diagram shows you our three programs and the different phases that they support.

0:2:41.160 --> 0:2:45.370 Sheppard, Kelly (NIH/NINDS) [E] Generally speaking, we divide our programs into discovery and development.

0:2:45.900 --> 0:2:58.860 Sheppard, Kelly (NIH/NINDS) [E] Discovery largely focused on lead optimization and of course development focusing on the island, enabling work and really turning our attention to that IMPD submission, which is a requirement within five years of all of our programs.

0:2:59.430 --> 0:3:8.880 Sheppard, Kelly (NIH/NINDS) [E] We also so we also support phase one trials though it's through a whole separate mechanism and is based on the project and where it is and everything.

0:3:8.890 --> 0:3:23.340 Sheppard, Kelly (NIH/NINDS) [E] So that's a little bit later in two of our programs we use, we divide everything into 2 phases and they have different names based on of course NIH is grant mechanisms, UG threes and U 44 is what's important.

0:3:23.350 --> 0:3:28.30 Sheppard, Kelly (NIH/NINDS) [E] Just to note here is that they generally correspond to our discovery and our development.

0:3:28.570 --> 0:3:36.370 Sheppard, Kelly (NIH/NINDS) [E] Uh pieces and there are time limits on how long they can really propose to be in them, so every one of our projects who comes in is a grantee.

0:3:37.390 --> 0:3:44.560 Sheppard, Kelly (NIH/NINDS) [E] They apply to one of these mechanisms and and they come in and they really start their process moving through again.

0:3:44.570 --> 0:4:2.720 Sheppard, Kelly (NIH/NINDS) [E] Discovery and development, or just development if they're already at that phase and we provide them with support to do whatever it is that they are capable of doing for these stages so they can come in and proposing to do any number of activities that their lab might be able to accomplish.

0:4:3.170 --> 0:4:13.880 Sheppard, Kelly (NIH/NINDS) [E] And then we follow up with contract support and the the goal of that contract support is to fill in all of the pieces that they cannot do in order to arrive at an Ind.

0:4:15.450 --> 0:4:16.310 Sheppard, Kelly (NIH/NINDS) [E] If you go to next slide.

0:4:19.600 --> 0:4:27.850 Sheppard, Kelly (NIH/NINDS) [E] And so each project team, when they come in, we surround them with what are called lead development teams or sometimes multidisciplinary project teams.

0:4:28.240 --> 0:4:41.90 Sheppard, Kelly (NIH/NINDS) [E] The idea is the same, which is that the principal investigator proposes their team of experts and what they're capable of doing, and they're all funded by grants to do their the Pi LED activity is kind of that purple section over to the side.

0:4:41.420 --> 0:4:48.550 Sheppard, Kelly (NIH/NINDS) [E] We then use contracts to support a number of other elements of what's required to really get to that Ind submission.

0:4:49.20 --> 0:4:53.880 Sheppard, Kelly (NIH/NINDS) [E] So we also we do bring in our own and uh consultants, we offer some data management.

0:4:54.70 --> 0:5:2.570 Sheppard, Kelly (NIH/NINDS) [E] What's most important for for this information in the solicitation that we're talking about today, provide the manufacturing and preclinical studies support.

0:5:2.990 --> 0:5:41.310 Sheppard, Kelly (NIH/NINDS) [E] So this is all manufacturing steps that might be required from early manufacturing just for lead optimization all the way through to GMP manufacturing and the production even if clinical supplies if a phase one study is something that we're going to support and for the preclinical studies, it's everything from the bioassays that need to be developed, all of their PKPD work, toxicology, anything again can be start with any of the non GLP work and work all the way through Ind enabling and depending again on the project that comes in if this this all looks different so some of.

0:5:41.390 --> 0:5:55.790 Sheppard, Kelly (NIH/NINDS) [E] Our API's come in and they they actually have manufacturing support either through their university, through their small business, through relationships they already have and we're largely focused on the preclinical studies and sometimes it's the reverse, sometimes they're well versed in the preclinical studies.

0:5:55.800 --> 0:6:1.730 Sheppard, Kelly (NIH/NINDS) [E] They have groups that they're coming in with and they need manufacturing support and sometimes it's a combination.

0:6:1.740 --> 0:6:7.790 Sheppard, Kelly (NIH/NINDS) [E] And so when we put out our contracted support for each of our projects, it is unique.

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It is tailored to the specific needs of each project and it can cover anything that you see in the statement of work on both the manufacturing and preclinical study side.

0:6:18.740 --> 0:6:19.290 Sheppard, Kelly (NIH/NINDS) [E] Next slide.

0:6:21.720 --> 0:6:38.420 Sheppard, Kelly (NIH/NINDS) [E] Alright, so right now you may have noticed in the solicitation that we mentioned that there are some specific programs, active programs that we support and that generally speaking we are capable of adding additional biologics therapy development programs that could be supported.

0:6:38.630 --> 0:6:41.680 Sheppard, Kelly (NIH/NINDS) [E] But right now these are the programs that we support.

0:6:41.730 --> 0:6:45.300 Sheppard, Kelly (NIH/NINDS) [E] The first one is the Blueprint Neurotherapeutics network for biologics.

0:6:45.610 --> 0:6:47.340 Sheppard, Kelly (NIH/NINDS) [E] So this is actually what we call a tree.

0:6:47.350 --> 0:6:55.80 Sheppard, Kelly (NIH/NINDS) [E] And the NIH program or a program that involves multiple institutes and centers at NIH and you can see the list of the institutes and centers at the bottom.

0:6:55.810 --> 0:6:59.640 Sheppard, Kelly (NIH/NINDS) [E] So this means that it really focuses more broadly on nervous system disorders.

0:7:0.90 --> 0:7:11.960 Sheppard, Kelly (NIH/NINDS) [E] Anything across the central nervous system disorder spectrum could be supported, and all of these institutes and centers could be the ultimate funding location for the grantee side.

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And so therapeutic modalities, this is just all large molecule platforms.

0:7:17.220 --> 0:7:36.630 Sheppard, Kelly (NIH/NINDS) [E] They can propose anything that's a large molecule and it would fall into this program and the indications really are all nervous system disorders we support in this one all the way lead optimization through the 1st in human trials, though again everything is limited to five years of support and they must be in a position to submit an Ind within five years.

0:7:37.800 --> 0:7:49.390 Sheppard, Kelly (NIH/NINDS) [E] It is important to note and you'll see this across all of our programs, all of our awarding organizations retain their rights to their intellectual property and are assigned rights to new IP developed within the program.

0:7:49.580 --> 0:7:54.660 Sheppard, Kelly (NIH/NINDS) [E] And that is an important element of our contract solicitation and something we need all of our contractors to understand.

0:7:55.840 --> 0:7:56.320 Sheppard, Kelly (NIH/NINDS) [E] Next slide.

0:7:59.370 --> 0:8:1.700 Sheppard, Kelly (NIH/NINDS) [E] We also support part of the HEAL initiative.

0:8:1.710 --> 0:8:3.390 Sheppard, Kelly (NIH/NINDS) [E] You might be familiar with the heel initiative.

0:8:3.400 --> 0:8:5.280 Sheppard, Kelly (NIH/NINDS) [E] This is helping and addiction long term.

0:8:5.510 --> 0:8:19.860 Sheppard, Kelly (NIH/NINDS) [E] This initiative was started with a large number of goals around helping people with opioid use disorder, actually beating opioid use disorder, but also developing nonaddictive therapies for pain.

0:8:19.910 --> 0:8:21.80 Sheppard, Kelly (NIH/NINDS) [E] And that's where we come in.

0:8:21.310 --> 0:8:31.770 Sheppard, Kelly (NIH/NINDS) [E] The pain Therapy Development program is part of the HEAL initiative and we want non addictive therapies to pain and so they will support projects that come in with ideas to do that.

0:8:32.180 --> 0:8:41.70 Sheppard, Kelly (NIH/NINDS) [E] They can actually support both biologics or small molecules, and our contract would only need to be in a position to support the biologics.

0:8:41.80 --> 0:8:43.530 Sheppard, Kelly (NIH/NINDS) [E] There are separate contracts that support small molecules.

0:8:44.750 --> 0:8:51.290 Sheppard, Kelly (NIH/NINDS) [E] Again, the grant itself features sort of the the lead development team and everything that we talked about.

0:8:51.300 --> 0:9:8.640 Sheppard, Kelly (NIH/NINDS) [E] It goes through the same the same steps and we they support both discovery and the development phase so they can come in needing some lead optimization and as long as they have a plan to reach their Ind submission within five years, it's a very similar structure to our VPN biologics program.

0:9:10.410 --> 0:9:10.890 Sheppard, Kelly (NIH/NINDS) [E] Next slide.

0:9:14.40 --> 0:9:15.290 Sheppard, Kelly (NIH/NINDS) [E] Yeah. Alright.

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And our last program is a little bit different.

0:9:17.460 --> 0:9:21.450 Sheppard, Kelly (NIH/NINDS) [E] So this is the urgent program or the ultra rare gene based therapy network.

0:9:21.930 --> 0:9:36.830 Sheppard, Kelly (NIH/NINDS) [E] Urgent is an NINDS only program, so these will only run through nine DDS and the goal is to support therapies for ultra rare neurological and neuromuscular diseases, and specifically gene based therapies.

0:9:37.100 --> 0:9:39.450 Sheppard, Kelly (NIH/NINDS) [E] So this falls into our biologics portfolio.

0:9:39.460 --> 0:9:51.350 Sheppard, Kelly (NIH/NINDS) [E] However, this program will only support gene based therapies and it will only support ultra rare indications they they officially support lead optimization through the 1st in human trials.

0:9:51.410 --> 0:10:0.460 Sheppard, Kelly (NIH/NINDS) [E] However, urgent is restricted to three years worth of funding, so generally speaking, they have to have a plan to have reached their ID within three years.

0:10:0.470 --> 0:10:6.400 Sheppard, Kelly (NIH/NINDS) [E] Most of the time these projects, uh, I come in at the development stage ready for Ind enabling.

0:10:6.570 --> 0:10:7.620 Sheppard, Kelly (NIH/NINDS) [E] They already have.

0:10:7.630 --> 0:10:15.580 Sheppard, Kelly (NIH/NINDS) [E] If not on pre Ind Ind meeting with the FDA, some decent FDA feedback on their plan to go forward.

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Next slide.

0:10:21.800 --> 0:10:25.150 Sheppard, Kelly (NIH/NINDS) [E] And this is just a look at our current biologics portfolio.

0:10:25.200 --> 0:10:35.10 Sheppard, Kelly (NIH/NINDS) [E] Uh, one of the things to highlight here is you can see that we do have a wide array of indications in each of the programs that's that are being supported as well as institutions.

0:10:35.140 --> 0:10:41.710 Sheppard, Kelly (NIH/NINDS) [E] We have several projects already in VPN, Biologics and urgent and a couple in heel that are actually large molecules.

0:10:42.20 --> 0:10:44.270 Sheppard, Kelly (NIH/NINDS) [E] However, all of these programs are growing.

0:10:44.280 --> 0:10:48.110 Sheppard, Kelly (NIH/NINDS) [E] None of them have reached their full steady state for the projects they can support.

0:10:48.300 --> 0:10:58.980 Sheppard, Kelly (NIH/NINDS) [E] And so we anticipate having more projects as these portfolios grow and therefore even more indications and possibly more modalities represented across these projects.

0:11:1.220 --> 0:11:1.790 Sheppard, Kelly (NIH/NINDS) [E] Next slide.

0:11:4.810 --> 0:11:8.740 Sheppard, Kelly (NIH/NINDS) [E] Alright, I'll hand it back to Kimberly to discuss some of the solicitation requirements.

0:11:10.280 --> 0:11:10.790 Espinosa, Kimberly (NIH/NIDA) [E] Thank you, Kelly.

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So I'm not going to go into detail about every requirement unless there are specific questions, but it would like to draw your attention to some important sections of the solicitation.

0:11:25.660 --> 0:11:29.510 Espinosa, Kimberly (NIH/NIDA) [E] First, the instructions to offers begins on page 69.

0:11:30.200 --> 0:11:35.130 Espinosa, Kimberly (NIH/NIDA) [E] This discusses the General Organization of the proposals and some of the required content.

0:11:36.430 --> 0:11:40.340 Espinosa, Kimberly (NIH/NIDA) [E] The technical proposal instructions began on page 75.

0:11:40.510 --> 0:11:56.0 Espinosa, Kimberly (NIH/NIDA) [E] This discusses the organization and content of the technical proposal Attachment 8 to the RFP provides additional information on some additional content that needs to be included in the technical proposal and the business proposal.

0:11:56.10 --> 0:11:58.140 Espinosa, Kimberly (NIH/NIDA) [E] Instructions began on page 82.

0:11:58.390 --> 0:12:1.550 Espinosa, Kimberly (NIH/NIDA) [E] This discusses the organization and content of the business proposal.

0:12:3.200 --> 0:12:16.520 Espinosa, Kimberly (NIH/NIDA) [E] Proposals must be submitted into the E CPS website I attachment, one of the RFP is all about the CPS website and walks you through the process of creating an creating an account.

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Now it can take some time to create an account as well as to fully upload proposals, so be sure to allow sufficient time to do those.

0:12:26.380 --> 0:12:31.140 Espinosa, Kimberly (NIH/NIDA) [E] This small business subcontracting plans must be submitted to SBC ex.

0:12:32.340 --> 0:12:50.870 Espinosa, Kimberly (NIH/NIDA) [E] This is discussed on page 86 of the RFP, which also discusses what the subcontracting plan needs to include the due date for for everything, the solicitation, the subcontracting plans must all be submitted by July 8th at 2:00 PM Eastern Time.

0:12:52.420 --> 0:12:57.670 Espinosa, Kimberly (NIH/NIDA) [E] Umm, the proposal intent response forms are requested by June 10th.

0:12:57.920 --> 0:12:59.500 Espinosa, Kimberly (NIH/NIDA) [E] Now those are not required.

0:12:59.510 --> 0:13:1.190 Espinosa, Kimberly (NIH/NIDA) [E] Those are not part of the proposal.

0:13:1.400 --> 0:13:11.230 Espinosa, Kimberly (NIH/NIDA) [E] Those are simply requested for the government's planning purposes, just so we can anticipate, you know, the interest and how many proposals we may receive.

0:13:16.340 --> 0:13:24.450 Espinosa, Kimberly (NIH/NIDA) [E] So questions that we received prior to the May 28th deadline were addressed in amendments one and two that were posted.

0:13:24.540 --> 0:13:31.950 Espinosa, Kimberly (NIH/NIDA) [E] We can go over those in more detail if anyone has any questions or would like to go over those shortly.

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Some questions that we received for this pre proposal conference were all about the page limitations and formatting requirements.

0:13:40.560 --> 0:13:42.630 Espinosa, Kimberly (NIH/NIDA) [E] So we'll we'll discuss that briefly.

0:13:43.160 --> 0:13:58.120 Espinosa, Kimberly (NIH/NIDA) [E] So there is no page limitation for either the technical or business proposal and we will leave it up to offers to use the amount of pages that they deem necessary to, you know, convey what they need to convey in their proposals.

0:13:59.410 --> 0:14:9.720 Espinosa, Kimberly (NIH/NIDA) [E] Proposals must be typewritten, paginated, reproduced on letter size, paper, printed copy, double sided on at least 30% postconsumer fiber paper as required by the far.

0:14:9.830 --> 0:14:13.560 Espinosa, Kimberly (NIH/NIDA) [E] So this is from the solicitation verbatim on page 69.

0:14:13.690 --> 0:14:18.620 Espinosa, Kimberly (NIH/NIDA) [E] Now, as we discussed, proposals will be submitted electronically, so there's no need to print anything.

0:14:18.730 --> 0:14:24.540 Espinosa, Kimberly (NIH/NIDA) [E] But I wanted to put that language here because that is part of the formatting requirements from this solicitation.

0:14:25.840 --> 0:14:33.250 Espinosa, Kimberly (NIH/NIDA) [E] So proposal should be created in a PDF format that enables word searches to the maximum extent practicable.

0:14:33.680 --> 0:14:36.950 Espinosa, Kimberly (NIH/NIDA) [E] That's from attachment one to the RFP.

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Now obviously that does not include like an Excel spreadsheet.

0:14:43.260 --> 0:14:57.750 Espinosa, Kimberly (NIH/NIDA) [E] For a breakdown of the budget and it would not include scanned documents, but the important thing is to just make them searchable to the maximum extent practicable.

0:15:0.510 --> 0:15:4.340 Espinosa, Kimberly (NIH/NIDA) [E] Now that is the end of our slides.

0:15:4.350 --> 0:15:10.680 Espinosa, Kimberly (NIH/NIDA) [E] And so we have a full 45 minutes for any additional questions that people may have.

0:15:11.150 --> 0:15:14.50 Espinosa, Kimberly (NIH/NIDA) [E] So I will now open the floor for any questions.

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Hi everyone.

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This is from .

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I do have one question.

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Is there an incumbent on this contract?

0:15:51.790 --> 0:15:54.180 Espinosa, Kimberly (NIH/NIDA) [E] Yes, there are incumbents on this contract.

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This solicitation is a ramp on of the original solicitation that was published on sam.gov.

0:16:3.530 --> 0:16:8.670 Espinosa, Kimberly (NIH/NIDA) [E] Give me just a moment and I will pull up that information from the solicitation.

0:16:52.620 --> 0:17:2.650 Espinosa, Kimberly (NIH/NIDA) [E] OK, so this solicitation is a ramp on of the original RFP, 75N95022R00013.

0:17:2.740 --> 0:17:6.730 Espinosa, Kimberly (NIH/NIDA) [E] That was issued in January of 2022.

0:17:7.700 --> 0:17:25.410 Espinosa, Kimberly (NIH/NIDA) [E] There were multiple awards made under that solicitation and I would be happy to provide a list of incumbents I will post that information to sam.gov along with the other information after this conference.

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Thank you for your reply.

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I have a second question.

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Is there any type of set aside for this, like for small business or?

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Or is it just open?

0:17:40.190 --> 0:17:41.400 Espinosa, Kimberly (NIH/NIDA) [E] This is full and open competition.

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OK. Thanks.

0:18:18.370 --> 0:18:24.270 Espinosa, Kimberly (NIH/NIDA) [E] Does anybody else have any questions about the programs or the solicitation or the proposal requirements today?

0:18:41.720 --> 0:18:47.370 Espinosa, Kimberly (NIH/NIDA) [E] OK, well, if not, I thank you all for your time and your participation in this pre proposal conference.

0:18:47.520 --> 0:18:54.250 Espinosa, Kimberly (NIH/NIDA) [E] I hope that you have found it helpful and I hope you all have a wonderful weekend.

0:18:54.260 --> 0:19:2.520 Espinosa, Kimberly (NIH/NIDA) [E] I understand it's Friday afternoon, so we're all looking forward to the weekend and yeah, thank you again.

0:19:4.70 --> 0:19:4.800 Sheppard, Kelly (NIH/NINDS) [E] Thanks everyone.

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Thank you all.

0:19:7.340 --> 0:19:7.700 Sheppard, Kelly (NIH/NINDS) [E] Kimberly.

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Thank you.

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0:19:8.670 --> 0:19:9.170 Espinosa, Kimberly (NIH/NIDA) [E]