Open Broad Agency Announcement (BAA) Virtual Proposers’ Day

good morning we're going to get started with this morning's uh composers day first thank you all for for joining us this is this is an exciting opportunity because this is going to be our inaugural but H open broad agency announcement or baa a critical concept behind the proposers day is to be authentic about the government's intent and to be able to really provide an opportunity for really an uploaded download uh with the health ecosystem so an exciting so we'll start the board with uh we're gonna have our vision from our director followed by a little bit more information about some of the technical areas and Mission office briefing by Dr Amy Jenkins and Dr Jennifer Roberts um followed by um we're going to be having acquisition details and next steps from myself I do want to point out we're going to be having a q a portion during this presentation and one of the key things that we're going to be having is we expected around 12 if you could uh please submit your questions in the in the Q a or the chat function and uh recommend you hold any questions until we've completed the presentation uh in case your question is covered by the presentation so again submit your around 12 o'clock submit your questions in the Q a chat function we're going to receive those questions collate them and we'll come back at 12 30 for the government's response a couple of logistical points uh the presentation will be reported and to the extent possible we will share the reporting and or the slides to everyone so if we're talking too quickly hopefully you'll be able to be able to catch up on the back end next I would like to introduce our inaugural director Dr Renee legerson to speak about her vision for herb h thanks everyone thanks Benjamin so it's really my best pleasure to be able to be here today and share with you a little bit about arpa H what we'll outline for you today is is what is arpa h where the newest arpa in the ecosystem we have the largest customer base of of any arpa all of the American people are part of our customer base and we recently announced our first solicitation which is an open broad agency announcement that's why you're here and uh what is that and we want to kind of introduce you to that concept you'll meet some of our technical leadership today to tell you a bit more about that share our initial Focus areas that we're interested in pursuing and then some more of the logistics around that Contracting and we'll have a little bit of time for Q a at the end but uh first I'd like to just kick off and tell you a little bit about what is arpa h and and where do we fit in this ecosystem and so first and foremost our mission above all else is to accelerate Better Health outcomes for everyone success for us really is an improved quality of life in the future for all Americans and so when we think about those outcomes we are very focused on deliverables on getting to an end goal we are less focused on things like great Publications which are important of course but we really want to change change lives going forward and so if you share that mission then you are absolutely in the right place and we launched just about a year ago um because of President Biden's Vision so of course President Biden wants cancer moonshot but also acknowledge that there needs to be an organization for moonshots for all diseases and and he said arpa H will pursue ideas that break the mold on how we normally support fundamental research and Commercial products in this country arpa H is going to provide funding and places where traditional Federal funding and the commercial sector who are can be risk-averse uh really aren't able to provide this is a place where ideas so audacious that people say that they just might work if and only if you try and so if you joined us a few minutes before our webinar started you saw QR codes that announced our H dash uh that is open to everyone from uh scientists down to your eighth grader that is really excited um about our page and what we're going to do that's a prize challenge we've announced um and those aren't r d dollars that this is really a 15K prize to launch but uh for us today it's really focused on uh the big research dollars for for the projects that are actually going to break the mold and how we do uh r d biomedical research in this country and the types of ideas uh are you know imagine if we could have personalized cancer vaccine that costs as little as a cup of coffee imagine if a damaged organ could be replaced by one 3D printed in a lab or imagine if a surgical nanobot could be delivered by a pill you no longer need to go to a surgical center of excellence you can have it delivered at home and so the these are Futures that are many years away but we want to be able to plant the seeds and catalyze the work uh really end to end that is going to enable this capability and these are the big shots that we want to take here at arpa h and we're here to augment the existing ecosystem this includes our customers I mentioned we are the the largest customer base for any arpa All American people this is the public health care providers and patient groups patient advocacy groups uh we really want to hear from those folks what will actually improve your quality of life our performers that's you so uh folks from Academia from industry from non-traditional players and then teams they're in we know that it takes a lot of players to get something across the Finish Line to commercialize and get things into the real world where we want to have that impact to accelerate Better Health outcomes for everyone our stakeholders our brothers and sisters at NIH are federal Partners like FDA The Regulators CMS the payers that need to be there from day one as we launch and organize these programs when you join our age and be a part of an rph funded opportunity what we bring to the table are these stakeholders we can move very quickly to be able to align and support your project but also help it graduate success for us is a transaction where we complete a project and move it out of arpa H and so uh as of uh the anniversary of our birthday on March 15th RPA H is open for business the first broad agency announcement this is now live on the street um I hope you all have had a chance to read it uh one theme that you will hear over and over today is read the baa we will definitely put FAQs we will just explain it but uh what if we are asking you to do something in the baa we mean it it's not open for interpretation uh and and for example having a mandatory three-pager um as a starting place for a conversation with RF we want to hear about your ideas um the rough order of magnitude of the time it's going to take to do those and the the funds it will cost we're not here we're not looking for lowest bidder we're looking for well-resourced projects to solve big problems in Health site selection so some of you may have come to our proposal today a couple weeks ago uh we are establishing three Hub site at HUB and spoke Network to reach all American people and our performers will be able to use this network as you set up a program if you want to set up a clinical trial that will that will bring in uh the the customers that are representative of the American population that may be impacted and serve to benefit from your Innovation uh we will be able to engage you with our Hub and spoke model as we establish that and then last but not least I've already mentioned the arpa H dash this is a bracket style challenge uh we are collecting ideas to seed into the first bracket which ends this Friday so please if you have a great big idea maybe you're going to submit a full proposal to the open baa good on you but also we want to hear about those ideas already in the arbor H dash to be part of this bracket challenge uh for for a cash prize and so um I do think it's important to just spend a moment and talk a little bit about the arborh organization within HHS and so my job when I was sworn in after on October 11th of last year was really focused on um protecting some of these authorities that allow arpa H to do the big audacious goals that that President Biden and the Congress have set out for us and so um our unique organizational structure we are the um first agency to ever be stood up inside of NIH we are not an Institute of Health we are an independent agency um so what that means is we can lean on a lot of the infrastructure that NIH provides the subject matter expertise helped us get running uh from day one but I report directly to secretary Becerra so he is the Secretary of HHS and that means we have a lot of autonomy and decision making um as we move forward you can really think about arpa ages almost two sides of the house we have our business team so the last five months we've been very busy establishing our team of contractors folks like Benjamin uh who going to be able to to help us manage contracts and launch those going forward our HR team our technical leadership has now joined and so it's very important to have that all in place I like to think of this as the minimum viable agency um as a startup in the federal government to get up and running for business and so so you're here with the latest startup in government and we're excited to be here and grow and build in this future for health um and we're doing this in service of the other side of our house which are the program managers these are folks that are term limited to come on board for a three-year initial contract uh to and they bring that on their great CV but their big idea and health that they want to pursue and so anyone who is funded under a project um even through the open ba will ultimately be connected to a program manager but we are still ramping up that team that they're a really important critical part of this and the urgency just to demonstrate this two weeks of time for a program manager and that three-year contract is one percent of their time already expense so every two weeks they're down their fuse is burning down by one percent this is the urgency that we need to create those Better Health outcomes some other points to just flag we're exclusively of funding agencies so we are not big Labs we're not intramural research we are an extramural funding agency Congress has provided Us in Appropriations it's two and a half billion dollars to start and this funding is actually independent of the NIH we we manage this uh directly with our with our federal funding counterparts um we have a lead and Nimble management structure so we're very flat organization allows us to move quickly and again the decision making is not by committee or consensus It Is by our program managers and so um that's going to be a really important part too to let us take on that risk um as you move forward really important for this group you'll hear this emphasized again but I'll mention it for the first time here we're not a grant based organization we're going to focus on Cooperative agreements OTA is this jargon for other transactional um uh agreements and then contracts and so what this means we're very focused on the end goal and for those of you that have been part of DARPA or other other archetype programs there's very active program management so you should expect that the technical team that will select your project and move forward with they'll have a seat at the table with you and they will make some of the decisions with you and they will they'll sit in your lab meetings of your laptop and so so just really think about this active program management going forward very different from other parts of the federal government and so um these authorities that we've now locked in uh as of last year really allow us to express our organizational attributes and so what makes us really unique is that the nucleus of our organization are those program managers I work for the program managers our technical leadership work for the program managers we want those big ideas and health to move forward but we know that you know this Bottoms Up approach isn't the only place where ideas come and that's really where the open baa uh comes into play so this is a place for Big Ideas to come from the scientific the technical the biotech uh the Health Medicine Community to come in through the open Bia um we are not looking for your failed proposals that have not worked in other traditional funding resources we are looking for revolutionary and radical change so evolutionary proposers need not apply if you've already de-risked your small molecule and it's ready for phase 3 clinical trial our page is not the place for your funding so we are we are looking to create new platforms uh to really revolutionize Health moving forward in terms of autonomy I've mentioned this already our programs our program manager directed and so if you become funded by arpa hob come uh how you'll be forming a really strong uh relationship with your program manager who is a steward of the taxpayer dollars but also wants you to be successful and bring those other stakeholders to the table for you and in hopes of transitioning and getting these capabilities out of our page and into the real world and then last but not least I mentioned this already but it's for emphasis I'm term limited our program managers are term limited and this is really to create this urgency that leverage the business team that's in place for the program managers to launch these Concepts and pick up ideas from the open baa that you'll be pursuing and giving to us for it and then the life cycle of any project you know starts with the design and organization one of the themes that you'll hear today is you may submit a project uh and if we decide to fund it we may uh mold it with you we may you may propose 10 tasks and we're really excited about seven of those tests and we're going to work on that with you negotiate um what is what is in best pursuit of your goals and our ph's goals as we move forward and so designing those programs Landing the team to do the work executing this making sure you're advancing against the very clear Milestones that you have proposed will be important we're going to learn for our failures we're going to be technically honest and we're going to try to give these capabilities the best shot of making it uh in the real world as we move forward this is my last slide before I hand it off but what I I really want to emphasize is just uh you know our age is a place that is here to be a catalyst for the entire Health ecosystem we are going to have program managers that are here for term employment our programs are typically on a two to four year timeline our open baa projects will likely be shorter than a program timeline so so think huge big ideas but where we can get across a proofs of concept um in a year in two years really after front so not only will the program managers bring in those ideas we want to hear these big ideas from you going forward again really excited uh for the group that's assembled here today I hope you learned a little bit about the vision of rbh and what our role is in this ecosystem um and with that I'm going to hand it off to our technical leadership and our mission offices uh Dr Amy Jenkins the director of our health science Futures office and Dr Jennifer Roberts the director of our resilience systems office over to you great thank you Renee I'm so excited to be here today and really excited to talk to everybody about our open broad agency announcement I do want to make just a couple quick announcements before I jump into the rationale for the open baa I know some folks joined a little late we will be posting these slides on sam.gov and we will also also post a version of the webinar so you can watch the webinar recording so let's jump in so what is the rationale for an open baa as you've heard several times already the goal of our our agency is to accelerate Better Health outcomes for everyone and our open baa is really serving three main functions in this towards this goal the first is that we want the opportunity to pursue novel ideas that are not currently covered by a program so ultimately at steady state our organization will have many programs led by those program managers that you heard Renee talk about in the previous couple slides however we may not always be covering every idea that exists out there we are a projects agency and we are an ideas agency and we want to ensure that we're not missing great novel ideas so our what we're having this open broad agency announcement out here for is so that you can submit those ideas even if they may not currently align with a program now many of you may be very astutely looking at our website we do not have current programs those will be launching soon and so that means that this open broad agency now is really an opportunity for you to submit those big revolutionary ideas right now I will talk about what makes something revolutionary in a couple slides I do want to point out that we have rolling submissions for one year so our this this announcement closes in March of 2024 not 2023 but you do not have to wait until 2024 to submit that um that abstract so please you can submit your abstracts at any time in the next year additionally revolutionary ideas are required here we are going to talk about what makes something revolutionary but the I word or incremental is is not a good word in um in an arbor like agency so let's move on to our next slide so what is the scope of what we're accepting in this open broad agency announcement we are looking at many different Scopes throughout this announcement but we are interested in things all the way from proof of concept all the way up to showing commercial viability things that have real world evaluation and are generating evidence and all encompassing Solutions particularly those disease agnostic approaches so I'm going to give an example of what a proof of concept a commercial viability may be you'll notice my bias and in my background here but a proof of concept may be an in-bitral demonstration that some technical goal is possible a very small uh demonstration what we may consider something that's a little bit more mid-range or slightly larger would be expanding that proof of concept study into animal studies or in Vivo studies and larger animals perhaps maybe even expanding that initial proof of concept into showing that it's maybe a bit more disease agnostic finally we are also considering a value or proposals that may be very large they may include proof of concept through a larger evaluation and validation perhaps even into some manufacturing capabilities and even into clinical evaluation I am going to come back to that clinical evaluation and you heard Renee talk about it previously but there are certain types of clinical evaluation that we would be interested in and certain types that we're not interested in now I want to say that while the scope can range from those proof of concept all the way through to commercial viability we do have proposal requirements and one of our biggest requirements is that the project should be scoped appropriately to achieve the technical goals of the proposal we are looking for a rigorous technical approach as well as cost realism so you've heard this before you're going to hear it a lot today we are not looking for the lowest bidder we are looking for the proposal that meets these broad audacious goals and has the most likely success most likelihood of succeeding recognizing that what we are trying to do is has a lot of high uncertainty high risk but the one way to buy down that risk is to have the right people and the right teams working working together on the on the proposed approach so what does that look like for many of you that may be familiar with other arbos many times people say that arpas are amazing and they can do wonderful and awesome things and that is true but what is this one of the secret sauce in my opinion one of the most secret sauces of an arba is our teaming and collaboration we really have an ability to bring together groups from disparate technical backgrounds to meet the goals the audacious goals that we set forth as an agency and we do those through days like our proposers day and through allowing people the time to submit an abstract where they have time to go and find those collaborators so we are really looking for people to put forward proposals that are very difficult technically that are really pushing the bar in a really quite revolutionary but you may not have all of the right groups to do that within your immediate circle of collaborators perhaps you need to bring folks together that have biology backgrounds and chemistry backgrounds bringing in engineers and Manufacturing experts maybe even bringing in uh people that have kind of cyber and data backgrounds might bring together all of these groups to try to meet the goals of the types of things that we're trying to do here at arpa h one thing that we want to point out is that there is the potential here to provide end-to-end Solutions but it's very rare that the same people that perform the discovery and work on the early phase pre-clinical are also the same people that are involved in clinical evaluation or production and Manufacturing therefore you want to provide an end-to-end approach or an end-to-end solution you often need to bring together a large team of collaborators and we very much anticipate large teams of collaborators um and and much teaming to achieve these goals it's very rare that one team can do it all now I do want to talk through what makes something evolutionary versus revolutionary you've heard us say this several times today so Define it what we are not is we are not funding something incremental and we want very audacious revolutionary goals but what does revolutionary actually mean it can be quite subjective and so we're going to give you a couple different examples of ways that we see things that are revolutionary so one way that you can do this is through reframing so leveraging insights from those different fields you heard me talk about it previously you may be a biologist or a biochemist or a chemist maybe bringing folks from electrical engineering backgrounds or data backgrounds that really take a new view on something to achieve some of these really novel goals you can certainly consider the idea of recasting a traditional problem often from first principles to reveal a new technical white space What haven't we thought of before to really challenge those technical assumptions and push the science forward we really want people to think what are the gaps and and be very creative about how those could be could be solved but more importantly what we don't want people to do is get bogged down in their traditional dogma and it's really important to be able to go out and find other people that think about problems in a different way and reframe those problems so that we can achieve goals that a lot of people say yeah that's impossible because I've been looking at that for 10 years maybe you need a new set of eyes um scaling so this is an opportunity to really think about some of the metrics that you may measure success by you made measure success by the speed the size of a device the power of the device the resolution if you think of a particular metric we want you to think of that metric and then we want you to multiply it by a hundred fold and that's the change that we're looking for so if you may say to yourself well I think we could do this discovery campaign in four months we're looking for solutions that allow you to do that Discovery campaign in under a day if we're looking at an instrument or a device or a manufacturing capability that fills a room we want you to think about how are we going to shrink that down to the size of my laptop so we want to think about these bold very large orders of magnitude of change in the scale and then finally we want to think about complexity one other way to think about a revolutionary idea maybe in the complexity of the disparate parts so oftentimes some of the integration of disparate components is actually what makes them quite revolutionary and when you combine those disparate components in a novel way it actually makes it revolutionary compared to the sum of those parts so if I'm going to talk about what's revolutionary and what we want I'll also talk about what we don't want some of these are stated explicitly in our baa on page four but I'll just talk through them a little bit so that first one we've now hit it many times we are not looking for incremental advances in the current state of the art we want you to think about what is possible in the next five years that's current state of the art what's possible in the next 35 years and bring that into the next five years those are the those are the types of advances we're looking for we want we do not want anything that directs towards policy change we are not a policy organization you're an r d funding organization the third one down maybe I'm quite importantly to this audience we are not looking to fund specific product development so if you have drug X that you've developed through pre-clinical development maybe you have some early clinical evaluations on that and you want to take it further into the clinic or evaluate that drug against disease Y in our further clinical study that's not appropriate for arpa H that is more appropriate for advanced development agencies not for the the type of r d organization that we are are funding now I will say that people ask Will you fund clinical trials we absolutely anticipate funding clinical studies but those clinical studies will be proof of concept that that an approach Works um that may be agnostic to several disease dates it may be an entirely new approach that we have to demonstrate and de-risk through clinical evaluation but what we are not doing is just one-on-one product development next we are not looking at traditional education or training we are not providing Center coordination and we will not construct physical infrastructure so we will not build brick and mortar um buildings and we will not build brick and Border Laboratories as part of our as part of our funding so with that I am going to stop talking about the open broad agency announcement rationale and I'm going to turn it over to my colleague Dr Jennifer Roberts to talk about some of the focus areas that we have at arpa h uh great thanks Amy great so I'm going to talk a little bit more about the technical Focus areas that we're interested in and before I get started I just want to highlight again that we are interested in accelerating the Improvement of Health outcomes for everyone so at a broad level we're interested in many different approaches that can ultimately improve health outcomes now that's very broad very multifaceted so we're going to break that down into four different areas the health science Futures scalable Solutions proactive health and resilience systems to give you a better sense of what types of things might be in scope um now before I jump into each of those Focus areas I also want to just highlight that there's a couple cross-cutting themes that we are interested across different application areas the first is quantitative measurement of Health outcomes our all our overall mission is to improve health outcomes the easiest way to do that is if we can measure whether Health outcomes are changing over time so anything with new sensors or new approaches to better measure um what's happening with outcomes is of Interest we're also interested in human-centered design we want to be designing approaches that uh help patient populations and help clinicians and the end user in a way that they find useful so that leads us to our third point we are interested in participatory research models so if you know that your technology is ultimately intended for a particular user Community it would be great to include those voices throughout the research process in order to not just push on the technical Innovation but also the way in which that technical Innovation will be packaged and meet the end user so that we're developing things that people want to use and then finally in a number of areas there might be ethical legal or societal implications so we're also interested in advances that take those considerations into account so that we can be developing new revolutionary technology in a way that is ethical and responsible so now talking a bit about the first Focus area before I dive into the technical aspects I want to just highlight that for each of these Focus areas I'll be talking about the overarching theme to give you a sense of what's in scope and on each slide there's a series of examples now in the open baa which I encourage you to read There is a longer set of examples and what's important to note about these these examples is that these are not comprehensive we are interested in ideas that are creative and maybe are not on the list as well so the um the scope and examples that I'll run through are intended to just get the juices flowing again we want revolutionary ideas that fit into that overarching mission of accelerating the Improvement of Health outcomes for everyone okay so now with that said moving into the first Focus area both Health Science Futures so this Focus area is all about core fundamental scientific advances in order to change our perception of what's possible as we treat disease and diagnose disease so one thrust is likely to be new tools Technologies and platforms that broadly apply to many different diseases we are also interested in new innovations that can help us better treat a disease or diagnose the disease that affects the large population so things like cancer or heart disease or diabetes or Alzheimer's likewise we're interested in innovations that can help us with rare diseases or diseases where we currently have limited treatment options so moving into the second area scalable Solutions this is one where we're really trying to make sure that the technologies that we have today can reach everyone who needs them so sometimes we might have an existing technology or treatment option that is really only available in an academic Medical Center but it would be great to have that available in a home health care setting so some of the thrusts here might look at how we miniaturize or repackage technology to help meet people where they are this area is also about access and affordability so uh perhaps we have a particular treatment that is at a high price point and we need to be thinking about new ways to approach distribution or manufacture Manufacturing in order to create economies of scale so instead of that treatment being available to perhaps five percent of the patient population it can really reach 100 percent but then the third area is proactive health so here we're interested in prolonging periods of health and well-being and when people do become sick we want to help them recover more quickly so proactive Health can include thrusts like preventative mess preventative medicine or uh early Diagnostics in order to be able to help people um avoid getting sick in the first place we're also interested in technologies that might help people age in place so how do we prolong those periods where people are healthy and active and maintain their independence and finally we're also interested in things that help accelerate recovery or perhaps provide new types of regenerative capabilities foreign systems and here we're trying to Foster the creation of robustness and adaptability inside systems that affect our health um and we want to Foster this um resilience and adaptability and systems from the molecular to the societal scale so a canonical example is how do we make our health and Public Health Systems more uh responsive and adaptable in the face of an adverse event like a pandemic so we can think about Supply chains we can think about electronic health record systems how do we make all of these things more resilient and reliable but within this resilience thrust we can also think about other things like the communication between a clinician and a patient are there innovations that could make that that communication which is very important for health outcomes more reliable more resilient to to different types of events um and um uh Community types so just to reiterate again these are just a few of the focus areas that that we are interested in for each of these we do have our examples in the baa and on the slides but these are not an exhaustive list so we are interested in Creative revolutionary ideas to help us improve patient outcomes for everyone and now I'd like to hand it over to my colleague Mr Ben Bryant in order to talk through acquisitions thank you Dr Jenkins um so I didn't introduce myself at the beginning my name is Benjamin Bryant and I'm the acting head of Contracting activity here at arba H as Dr Jenkins and Dr Robbins discussed the intent behind the open VA is is really over the next year to pursue novel revolutionary ideas not currently covered by the specific programs um I will sound like a broken record so just apologies in advance but I'm going to remind folks uh to read the baa this is the ultimate tool to guide you on how best to submit um so the broad agency announcement is a critical tool which allows for the government to um which allows for the government to invite novel approaches to tackle a range of challenges not associated with a common work statement so this is valuable considering the government will not evaluate submissions against one another but really on their own merits so the government will prioritize technical Merit over costs allowing our pH to explore the art of the hospital so so I promise you I've sounded like a broken record highly recommend you closely reading the baa again many of the questions that are that are posed uh can be found in the document itself so another key value of the baa is a capability to negotiate the award type so Dr wegerson talked about the fact that we're going to be using Cooperative agreements other transactions other transaction agreements or OTS and procurement contracts and I'll talk about those briefly um I do want to point out on that a typical an arch typically applies a fat fail fast model to its Vehicles so they're aggressively tackling performance against clearly defined Milestones considering the intent for our team to be heavily involved with the ultimate vehicle um this aligns more with the fail fast nature Parkway arpa and really gets to the fact that why we're not going to be using any types of Grants um for our type of rewards we anticipate timelines will vary uh so this is in the proposal process will vary from abstract to a proposal based on arpa H need however we will we do plan to aggressively pursue a 90-day clock pharmaceutical proposal to award now this is an ideal State we're going to be pushing this is our goal uh so we hope to attain that because we really want to make sure that there is a clear line of and clear communication and expectation management from the time you submit to the time you actually receive a response from the government as mentioned in the broad agency announcement the government reserves the right to award to some one or no responses and there's no ceiling on the overall vaa or individual so Cooperative agreements align very well so talking about these are the some of the vehicles we're talking about Cooperative agreements OTS and then procurement so Cooperative agreements align very well with an RFA H because of the collaborative partnership allowed with the easily aligned public benefit within the rph mission so as mentioned the arpa fail fast model runs itself to substantial involvement from the government as program staff will be providing guidance and oversight throughout the performance the value of Cooperative agreements is that partnership again between the government and the performer and Cooperative agreements lend themselves to providing greater customization than uh say procurement contracts so moving on to other transactions so for those folks that aren't familiar with OTS they began in the late 50s uh through NASA they're legally binding instruments or acquisition arrangements for uh customizable uh agreements so really the they're meant they're other than procurement contracts grants or cooperative agreements and the the intent of this was really demanded commercial acquisition practices uh similar to a Cooperative agreements uh OTS uh can be uh quite flexible to meet the dynamic challenge for a specific project they help you prioritize and focus on risk of an intent as opposed to regulation by removing that rigidity of traditional procurement business rules ultimately the OTS promote trust in the spirit of cooperation between the government and the health ecosystem so the last award type is a procurement contract this is kind of the bread and butter uh for for most kind of federal acquisition uh vehicles uh this type of vehicle is typically used when there's a direct benefit only really to the government these procurements follow a very linear set of business rules governed by a federal acquisition regulation and result in Greater transparency and accountability just to be clear this is likely kind of the least used vehicle uh for our for this upcoming broad agency announcement we're really going to be prioritizing Cooperative agreements and other transactions now that we've discussed the war types let's discuss the ba process the toothpaste process going from abstract submission and then if accepted uh being requested to receive uh provide a full proposal arpa H will submit a will conduct a scientific and Technical review of each conforming abstract proposal so the abstract process so just for those tracking on a VA which those nerds out there like myself probably have the ba open beside them if you look on page 11 this is a low barrier and the intent of the abstract process was really to create a low barrier of entry for applicants to participate in the process the intent is to create a minimal oops to jump through at the onset of the idea submission by only requiring this three-page submission rph will evaluate those submissions based on scientific and Technical Merit proposal capabilities and affordability so those are kind of the three primary areas that we're going to be evaluating if invited to submit a full proposal uh proposers must follow a more formal submission process in accordance with page 13 of the broad agency announcement providing a technical and management approach proposal in addition to a full cost proposal along with the state Network in addition to the abstract evaluation process the government will evaluate May evaluate cost realism and and um and contribute into the proposal's contribution uh and relevance to the our age Mission which we'll talk about in just the next slide so the next two slides as I mentioned we'll talk about the evaluation criteria uh so first you have overall scientific and Technical Merit uh the proposed technical approach should be Innovative feasible achievable and complete so these tax descriptions and and Technical elements really provide for really intended to provide a complete and logical sequence with all proposed liberals clearly defined such that the final outcome that achieves the goal can be expected as a result of the board so moving on to the second Factor proposers capabilities and related expertise uh the proposed technical team really are we're looking for an Ensure the proposed technical team has the expertise and experience to accomplish proposed tasks right so really looking at the key here is really describe similar efforts you've completed with a size and scope so that you can be able to understand and analyze that in more depth and detail because we want to make sure that your proposed a prior expertise and similar efforts clearly demonstrates an ability to deliver products that meet the proposed technical performance within the proposed budget and schedule moving on to our third Factor um really looking at a potential contribution and relevance to the rbh mission so uh potential future r d commercial and other clinical applications uh really looking at whether the systems uh the applications may have a potential to address current or unmet need within the biomedics and and improved Health outcomes again as I mentioned before and as I said before uh and the prior presenters are really looking for revolutionary and evolutionary impact to transform biomedicine and improving Health outcomes so moving on to our final final evaluation Factor um costs realism and price realism excuse me price of reducableness uh funding availability affordability so as mentioned during the abstract phrase the government will be focusing on affordability right and the proposal phase RP H will be performing a more exhaustive pricing cost of analysis at this at this juncture so price analysis really is performed to ensure each proposal uh to ensure that there's reasonabus and overall price making sure that it's not too high right on the Converse cost realism analysis is a tool to discern whether or not the proposed costs are too low right is this realistic to be able to perform the work and achieve the outcome most so in addition to the evaluation uh we'll take into consideration the extent to which the proposed intellectual property rights structure will impact the government's ability to transition the technology IP is a critical component and will be key aspect of negotiations so as Dr wipersen Dr Jenkins and Dr Roberts discussed the key to success is providing a revolutionary evolutionary idea these Concepts must be feasible with clear objectives and outcomes along with the personality strategy to execute submissions at both the abstract or proposed proposal phases should be clear logical and concise again clear logical and concise moving to other requirements I strongly encourage federally funded Development Centers so ffrdcs and government entities follow page nine of the broad agency announcement proposals are responsible for submitting abstracts and proposals to the electronic contract proposal submission or ecps website which I'll put in the chat shortly and ensure that received by the date and time specified so we need to make sure to follow these deadlines proposers must use the electronics transmission method nor the method for abstract or proposal will be permitted right for proposals of Cooperative agreements a reminder to submit form one and form two and four one is the sf4 24. uh this is research and related or RNR application for federal assistance along with form two the research and related senior key person personal profile which is the expanded form lastly please remember to review the baa as this will be the guiding principle for us for your submission and our evaluation process next Dr Jenkins will review a few frequently asked questions uh before we conduct our 30-minute q a thank you all wonderful thank you everybody so before I jump into some of the frequently Asked FAQs already I just want to really challenge the community to think about what those Innovative technological leaps may be we really want people to think about things that are maybe making slightly nervous that they may be difficult to achieve that's absolutely the right ground that we want to be in and we really want to challenge this community to think very big and bold and bring us some of those big and bold ideas so with that I'll move into some of the already received FAQs that we have those have been posted on sam.gov and you are able to see these a couple quick notes about our upcoming question and answer session so the first is I am reminding you there are almost 2 000 people on this webinar do not submit your very specific Tech topics so if you have a very specific technology that you would like arpa H to comment on we will not comment on those in this forum and we cannot obviously with 2 000 folks on this webinar offer one-on-one calls we are asking you to submit your feed your abstract to the open broad agency announcement so that we can give you uh feedback in that method um additionally for those who joined late the uh questions that we answer at 12 30 will be posted as part of a written FAQ and they will be posted on sam.gov as well the link to be able to

watch this webinar over again so with that I'm going to jump into some of the frequently asked questions that we've already had these may be some low-hanging fruit I'm not just going to read this um you know I know everybody's probably scribbling furiously I will leave these up for a few minutes but one thing I do want to point out we have had several questions require asking about um what the types of uh groups that can apply so applicants are open to universities businesses small businesses non-profits individuals and non-us entities as long as you're subject to the requirements that are included in the baa Section 3 dot a.2 so please read that section closely RFA H does not have a preference with respect to entity type or team size you did hear me talk about those teeming and collaborative projects we do not have a preference there and as you have heard already we are limiting our Awards to Cooperative agreements other transactions in procurement contracts foreign FAQs the baa does not have a funding limit for individual Awards it does not have a limit on the period of performance for individual Awards and it does not have a limit on the individual Focus area so groups can work across several of our Focus areas we do understand that efforts that may be submitted to the open broad agency announcement may actually you could probably make an argument for them being under one or two or maybe even more of our Focus areas and that is okay you can submit the one that is the most relevant um I will say that in the period of performance as you've heard Renee say in the very beginning are programs that are run by program managers and our larger efforts those will typically be anywhere from two to four maybe even five years we would anticipate that efforts that come in through our open broad agency announcement would be shorter than those as far as a period of performance um there are uh submission deadlines that I know that I've seen some questions in the Q a that are related to the submission deadline of March 14th 2024. that is for this open broad agency announcement and for submitting abstracts to this the April 7th deadline is for the DARPA the arpa dashed and that is a separate um that is a separate entity outside of the open broad agency announcement this open broad agency announcement is accepting applications for abstracts through March 20 March 14th of 2024. as you can see here and this will remain posted while we are correlating questions there is a questions mailbox if you are not able to get your questions submitted during this question and answer period you please feel free to send that information into that mailbox and then finally again we've talked about the scope we are looking for things all the way from proof of concept through fairly mid and in large scale efforts that would improve through a potential future Market or show that there may be a potential commercial Market um we are asking for uh a ROM in the uh in the abstract so that's a rough order of magnitude of the expected cost of an of an effort as part of that abstract to help us in that abstract reviewing so with that I just want to give we're going to we're going to end here we're gonna pause and we're gonna allow folks to submit questions and we are going to go off screen and we're going to work on preparing our answers to those questions um please submit your question through the Q a we will come back at 12 30 to answer as many of those questions as we can answer in 30 minutes so we do anticipate that we will be able to get through many of those questions and any that we do not will be posted as part of an FAQ on cm.gov so please submit your

questions now and we look forward to talking to everybody in about 30 minutes thank you all right uh good afternoon for those folks on the on the East Coast I still have been warning to those books on the west coast um quick shout out for the uh for interested individuals submitting to the dash challenge before we get into q a uh for the QR code that was on the screen responses are due this Friday at midnight so I'm very excited to see your response um so just a heads up we're going to spend the next 30 minutes so we'll do some of our questions in the room um we are going to be joined by our illustrious grants Cooperative agreements and uh a Contracting officer um Ryan Daniels who's going to be answering some of the acquisition questions um we reviewed a high volume of the technical questions ranging ranging from various technical Fields would you not plan to provide specific Direction during our responses we intentionally kept the bar low for our abstract process so we really just encourage you to submit that three-page abstract so that we can provide you our Dream from there so if we don't get to your question I apologize we will certainly be providing responses and the full FAQ along with this recording and slides at the conclusion of the uh or hopefully within the next couple of days actually all right so getting to our first couple questions um will the recording be available to our participants just to reiterate that um yes it will be available including this q a portion moving on to the next question our company has four white papers um of three pages each containing new technology medical breakthroughs how do we submit these papers and when can we expect a subsequent meeting to discuss our Technologies uh Dr Jenkins could you respond to that we are not going to provide one-on-one meetings as I mentioned during the um during the discussion that there's too many people to do that so abstracts for anything technical should be submitted through our open broad agency announcement and we will review them and provide feedback all right thank you uh the next question the VA is open for a year is there any Vision or advantage to submitting sooner rather than later meaning might the money run out in the mid-year or will all Awards be made after March 2024. uh Dr weberson could you respond to that one yeah so starting immediately submissions and awards will be made on a rolling basis so go ahead get your ideas in as soon as possible uh we'll be reviewing those and and you'll get that feedback again Awards and submissions on a rolling basis and when you uh if you are successful in your abstract we will let you know the submission date for your full proposal thank you all right next question are these funding opportunities are these funding opportunities more suitable for basic or clinical research how to how do we make basic research a better fit over to Dr Roberts yes our page will be developing a balanced portfolio across both basic and applied research categories including clinical research thank you next question who reviews The Open vaa submissions Dr Rodgers so generally speaking uh the reviews will be conducted by a team of government technical EX ports comprising mostly of arpa H staff that will bring in other U.S government experts but ultimately the rbh government employees will be the decision makers and we look to those subject matter experts for their perspective and recommendations all right don't go too far our next question is back over to you is the concept of ARP age similar to DARPA or run by the dod is our page run by the dodn well we've adopted the DARPA business model but we are not run by the Department of Defense we are under Health and Human Services and established within the National Institutes of Health all right thank you so after a pi submits an abstract an ecps can we then submit the full application via grants.gov workspace

like we would do for darba or IR Buzz submissions if we were requesting a course you know or if we're requesting a Cooperative agreement no grants.gov is not being utilized uh full proposals will be only be accepted by invitation and Abstract review all right next question um do Department of energy National Labs qualify for these proposals I'm going to kick it over to my colleague Mr Daniels uh yes they do but please see section 3a1 ffrdc's in the baa and ffrdc's have special rules they have contracts so uh make sure that whatever the rules are for doing research on behalf of government agencies that you work with your Contracting officer whomever else to figure that out all right moving on to the next question who are the program managers and their academic background Dr whiteerson for information about our H's program managers I want to direct you to our website when you can look at our base archive h.gov about our people um and but just a reminder that we are going to be hiring uh program managers on a rolling basis I hope uh to hire about 20 program managers this year um and they'll continue to grow over the next uh years as we go forward and if one of you would like to become a program manager look at our careers uh portion of our website where you can also see uh the the simple but intense program manager application thank you all right what is the expected turnaround time to get to a go no-go decision for an abstract VA submission so great question abstracts can be submitted and will be evaluated on a rolling basis uh abstract feedback is anticipated to be approximately four to six weeks from receipt uh depending on the volume of your submissions received rhb Reserve uh the right to adjust the expected evaluation timelines or to ensure the Integrity of the review process and more importantly there may be a time where we may be asking you to submit uh for a proposal letter at a downstream date to allow us an opportunity to be able to tackle uh evaluations in a timely basis if the timelines need to be adjusted updates will be posted on sam.gov to provide transparency moving on to the next question is one program manager taking responsibility for one project or multiple projects Dr markerson individual project will be managed by one program manager ultimately but HPM is expected to manage multiple programs and multiple projects awesome so next question how do we find out who is our assigned program manager uh Ryan um this will be communicated during contract negotiations perfect and I thank you for that uh next question is are the H looking just and only for projects focusing on clinical medicine cure diseases or highly focused on patients I.E people with diseases

already or public health preventative help help promotion Etc will those areas be considered the examples are usually very basic science EG molecules for new medicine or to cure diseases uh Jen could you help us answer that question that's a great list of options and we're interested in all of the above thank you for that next question are you looking for translational ideas basic science uh Amy could you help us over that one yeah the answer is both as it states in the in the baa we will Foster Innovations across the spectrum of Technology Readiness levels all the way from those foundational proof of concept experiments all the way through to prototypes that will enter into the marketplace awesome thank you very much for that when does the VA close Ryan it closes on March 14 2024. um so admission will be received on a rolling basis so please get them in as soon as you are ready now certainly uh excited to see your abstracts and I'm excited for uh the responses I will point out that the ba does not if we don't make a ward by the closed date of the VA that does not end the project we just need to be able in receipt of the of the abstract by that date uh next question are the proposers supposed to be U.S citizens or can they be green card holders as well Ryan Beck are you um please review Section 3 A2 page 10 um of the baa it describes the eligibility requirements that RP H does have some special uh eligibility requirements so uh please you read that carefully as uh the VA reflectors all right next question can an entity make multiple submissions aiming very easy yes you can make multiple submissions under one entity who are the program managers and where can I find a list Dr Ferguson yep once again just want to refer folks to our website under our people you'll steal on a as hired basis you'll start to see that program manager uh list grow uh during the course of the year all right next question where can I find in the instructions for submission form dates requirements I try to connect to Links uh from the ba but I got some several broken links which slowed a page not found so I will say that we tried to make it as clear as possible in the VA submission information and we can also put a link to that in the chat uh just because there was also the QR code that was posted on the screen so hopefully that will work out but the submission and instructions aren't clearly iterated.ba next question what is the April 8th deadline that I've heard people mention the webinar menti

2023-04-14 07:18

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