the pre-approval inspection of new technologies such as a continuous manufacturing in some of the facilities. Next slide, please. With regard to advanced innovative mechanisms for evaluating technology outside product approvals, the academies will command the following opportunities. Create new mechanisms and evaluate, expand and consolidate existing pilot programs that allow consideration of innovative technology outside individual product submission. In response to these recommendations, first, I would like to point out that ETP or emerging technology program is not a pilot program. We approve products, not technologies, and FDA will continue to approve application based on the drop products because we all know that we need to account for product specific risk and understand and evaluate interactions between the product characteristic and manufacturing technologies, as well as looking into some of the control strategy elements as well. However, I do want to point out that the emerging technology program already offers a long product specific track that allows feedback on a proposed technology without the need for a sponsor to identify a product or molecule associated with the new technology. So let me just re-emphasize this point. Under the emerging technology program, you can talk about innovative platform technology. Now, because I do want to emphasize this point again because I have presented in many conference about this is the key feature, but it seems like I think there's a communication gap we need to adjust because most of it still seems to me the industry think emerging technology only talking about the product specific technology, which is not correct. Throughout the emerging technology program, OPQ has adopted risk based approach to help streamline implementation of technologies over multiple products using the existing regulatory framework. Let me just give you one example. We have a user suggested using a group submissions to implement a novel container cultural system for multiple products as post-approval changes. Next slide please. With regard to the to expand the scope and capacity of the emerging technology program, the Academy will command the following opportunities for the emerging technology program. Delegate independent funding, increase number of dedicated full-time employees, broaden criteria for entry, increase transparency of the program capacity. In response to this recommendation, FDA thanks to Congress as well as other funding sources. FDA has received funding to support advanced manufacturing, including the emerging technology program. So we do appreciate for those sponsors. And I do also want to emphasize that emerging technology program, even though we have a core member, this program utilize all 1000 employees in OPQ in the Office of Pharmaceutical Quality and select appropriate subject matter experts to evaluate a new technology. And therefore we believe that having dedicated staff could limit the agility of this emerging technology program, especially we anticipate there are wide range of emerging technology we need to deal with in the future. And then this experience, the way we operate in this way because we also had an experience during our PAT initiative, we have a very dedicated group, but we receive a lot of complaints from the industry to say that there's a disconnection between the review staff and the PAT staff. And the criteria for entry into the emerging technology program, I want to emphasize abroad and high level. And it is really up to the sponsors to justify why their proposed technology is novel and has positive impact on product quality, which warrants acceptance into the emerging technology program. We say it up in this way because we want to provide feasibility for the industry to propose the new technology, because if we do have a too prescriptive criteria that may preclude some of the new technology like AI and some other like innovative approach from joining this program. But however, we do recognize that from this, the Academy report, we have communication gap here. So this ETP will increase external communication to educate industry regarding the criteria for acceptance into the program. With regard to the next slide please, with regard to increase external engagement to facilitate innovation and increase awareness of Cedar readiness to evaluate innovative technology in response to Academy's recommendation on the left hand side. First, I want to point out that consortia can apply to the emerging technology program to discuss and get recommendation from OPQ. I also want to emphasize that this is already happening. The thing about this, we will allow them to do it and also as I mentioned before, ETP does not have to discuss the technology associated with particular products. So together you can see that we are already doing it. So I just want to take the opportunity here to clarify this point. As mentioned by Joe, we have a plan under the emerging technology program 2.0 to further enhance communication with external stakeholders to share our learning and exchange information. We are also planning to update our ETP website to make sure to provide the latest update on this program. OPQ already also support the extramural research and training in advanced manufacturing area, as I mentioned before, through a very strong partnership with external stakeholders such as academia like Purdue and Rutgers University. We are currently considering additional opportunities, including further improving knowledge transfer from internal as well as external research to aim quality assessment of new technologies and offering more training opportunities to our assessors and investigators. And next slide please. And finally, with regard to expand the leadership role in global regulatory harmonization efforts. In response to Academy's recommendations on the left hand side, I want to point out several things we have been doing and we will be doing. OPQ already worked on ISH several ISH to develop several guidelines on continuous manufacturing and electrical procedure validation and development and also viral safety of evaluation of biotechnology products. OPQ already shared its learning and expertise in advanced manufacturing with international regulators, such as a PMDA. And I also want to emphasize that we already have a couple of meetings with a PMDA to discuss about what we should do together to advance, for example, the technology like continuous manufacturing. And we actually did plan to reach out with our other regulatory agency like MISA as well as EMA. Unfortunately, at this moment that put on hold because of COVID-19. The reason is that because we do want to travel have a face to face meeting to have a very meaningful discussion with other regulatory agency. So we will definitely continue to do this type of outreach and collaboration. We will continue to work with other regulatory agencies to move toward global regulatory conversion through a variety additional values such as PICS as well as ICMRA in addition to the ISH. So with this, I would like to conclude my presentation. And once again, I really appreciate the Academy to put a lot of effort to put this report together. And I also want to emphasize that this is very in line when we actually plan our program enhancement for emerging technology program and also really help us to identify some of the communication gap. We need to adjust in order to make the industry as well as other external stakeholders to be aware of some of the work we are doing right now. Thank you so much. Thank you, Larry and Joel. I know that the community really appreciates that description of what's happening with ETP 2.0. That's exciting. I would encourage the community to use the Slido to post questions for Larry and Joel and others and to capture some themes for community discussion later. But we're going to hold questions until the end of this, the talks. And so I'd like to at this time introduce our next speaker, who is Rohan Mahathre. Rohan has worked in the pharma biotech industry for the past 30 years, the last 25 of it with with Biogen, where he is senior vice president of product and technology development. His department is responsible for the processing process and product development of all the Biogen products, including associated devices and digital tools. Prior to this role, he's also headed the global engineering and manufacturing science departments. Rohan has also managed the regulatory CMC department and has been involved in the approval of over a dozen products. He has several publications and patents in the area of biopharmaceutical development and analytics. So we welcome Rohan. Thank you very much. And we look forward to your talk. Thank you. Thanks for the invitation to speak. Just a few slides to share. But I just wanted to maybe highlight, you know, things mechanisms for innovation that have worked at Biogen and just my overall experience and just kind of share with you sort of specific examples. And my idea was to really talk about what the outcome has been, and then maybe go back and probably discuss a bit in terms of how we actually got there what were all the tools available and so on. So, you know, so let's start there if you can have the next slide. I think many of you folks have that know Biogen, the company that's been focused in neuroscience for quite some time now and for the foreseeable future as well. And these are disease, you know, fortunately with rather devastating outcomes really isn't anything out there. That's effective enough. And if you can just click one more. And the outcomes here the numbers that you see are rather disheartening in terms of leading cause of disability. Just the number of patients. So seeing all these things I think this sort of, you know, dawned on us, thankfully, number of years ago at this point probably close to 10 years ago just looking at where the portfolio was going. We talked specifically about how we developed our processes in this case the biological processes, and how all that came together. So roughly about, I would say close to 10 years ago. What we were looking at is sort of anticipating how the portfolio is evolving and how do we really stay ahead of what the needs were going to be. At this stage, believe it or not, you know, the platform itself biologics end to end I would say was fairly robust. We had very good success rates in manufacturing and you know the facilities were fully utilized and so on. And I think it's really at that time we said that this in fact is a good time to step up that effort. Really the did the objective was figuring out how do we significantly improve productivity from where we were we are roughly three to four grams per liter at that stage in antibodies and didn't have as much. We had a lot of automation, as many predictive tools and so on so we sort of decided to kind of really take a holistic view and say let's put out what we believe would really sort of change the whole game, and enable us to better serve the patients that we were developing all these drugs for. So we can go to the next slide. I think the key for this. I mean this is sort of existing now organization for a while and something this is not just put up because it's a good thing to show but we've actually really held ourselves accountable for this for both through management, including folks at the plant that it really was was key that innovation had to be the core of everything that we did and by innovation I don't just mean developing technology where it was just the ability to look at how we were doing things and how one could sort of think about constantly sort of keep them back on mind how could you do this differently. How could you bring efficiency in the overall operation. And that's really how we looked at innovation rather than just a fancy tool to be evaluated or some such thing it was really an end to end holistic view of how one could evolve our whole way of working interacting and so on. And for many years, you know, there's something I've appreciated, you know, working at Biogen is that we've enabled this and there's been an expectation really, whether that goes through, you know, the kinds of goals we expect individuals to set, and so on is really really empowering across the board, you know, this is not sort of a top down view in terms of how, you know, things should evolve, but really getting everybody into this and actually measuring this I mean for some years now we have a whole system and I'll talk about that a little bit more. There's a separate office looking at sort of continuous improvement, evaluating all the processes that we have, and trying to sort of figure out and into a large extent looking at investments returns on investments and so on so it's a, it's a fairly sort of involved process and I think on hindsight, thankfully so. And one thing that we've kind of really believed in is if we feel that there is the right science and we feel that that actually is going to help us out. We have been willing to take those risks and really accepting the consequences I don't I don't try to kind of use the word use the term failure because in a way when we are in this particular space. Any kind of learning that comes out of it I look at that as an outcome rather than a failure. So a large part we've we've embarked on several projects over the years, and the outcome hasn't been as expected, but what's been very important is a lot of learning that's come out of it and that's something that has really helped us navigate through where we wanted to go. As I said earlier, the core for innovation here was not necessarily putting out tools, but more importantly to be able to anticipate business needs, and figuring out how one could stay ahead of those business needs so that's, that's really in a nutshell is how we've been evaluating clearly is a, is a, you know, process which one has to look at and figure out how does one, you know, possibly change or, or, you know, bring about certain different approaches. So next slide please. So this is, this is what I wanted to show you, you know, we've been talking I've been talking about at conferences and all for a while on this but this this is really one can call it been the outcome of this particular one aspect of this innovation led us and this is our new manufacturing facility that's up and running in Switzerland, and also most of these tools have been in another facility which is in North Carolina as well these are large scale manufacturing facilities 15 to 18,000 liter reactors and so on. You know. So what what I'm trying to get at here is with the 10 plus years that we have been in the space. We had looked at it truly as an end to end piece where I don't want to go through every every unit operation here, but sort of looking at sort of raw materials, spending a lot of time on initial modeling work and complex raw materials, trying to be able to decipher how changes could impact product quality figuring out real time, you know, supplementation strategies. And as I said, utilizing even some of the predictive models looking at sort of a bulk analysis rather than looking at it and you know in in a more sort of a granular way, and trying to correlate those two product outcomes. And I've talked about this at other conferences before in terms of upstream and downstream controls, where in at least two of these facilities, we have sort of a whole automated loop, looking in within the bioreactor using simple probes like one but looking at a multitude multiple attributes in this particular case what we've shown is glucose could be lactate so on, but being able to figure out when the feeding has to occur based on what the conditions are rather than sort of fixed feeds. And this is all done through control loops feedback loops. And this is something that's been working. Likewise, when you look at downstream. In particular case what we have talked about is control of aggregation, where you're in fact measuring levels of aggregates and changing loading conditions accordingly all this happening real time, something we didn't quite have in our facilities in one could call the previous generation. And likewise using things like refractive index figure out you know concentrations using all kinds of modeling the idea that we've got to hear and which is what we're implementing is understanding what the product looks like at all times. And this is not necessarily by measurements initially it could start with measurements, but then moving into truly predictive models looking at some in some cases maybe random associations to be able to figure out what the product quality looks like. And this is sort of what I want to show you is the outcome and talk a little bit in terms of what tools we had and how we've approached this and other innovation as well as if you can go to the next slide. So there are new way of working that has that has emerged is, you know, as I said, we are going into, you know, previous is really high productivity processes intensifying the culture. And this is just sort of, I'm just showing you what the current stages, we are already looking at what it will be in the next five to seven years. And it could be maybe even four to five four higher than whatever the 10 to 12 grams that we are today. I could easily see it being much much higher than that. It doesn't have to be in the million systems. And since we are we are also ready even as things are settling in into the second stage, looking at what it could be in another five to seven years or so. Something I have strongly believed in and fortunately, sort of many many in the organization is in order to get the kind of control that we're trying to do is we need, we need to have to in order to get the consistent output is to be able to self correct as processes are running. And particularly what I talked about in the upstream is getting to a state where you can have consistent cell growth with the with the understanding of that would lead to consistent product quality. And through all of this, the, the operations have changed there's a lot of localized testing testing happening where it needs to happen. Technology available everywhere simplifying more recipes driven operations and so on. So this is, it's an whole integration of technology processes and people in shift to the next slide please. So this really goes through the mechanism one of the one of the pieces that has been very very effective is the early stage. So what we have is a program called technology investment it's been around for for a long time now. And it's very little money, it's a few million dollars that I have in my budget. And we, every year, we, we have a sort of proposals being presented by anyone, anyone in the organization doesn't even have to be in my group. It's a committee that looks over it. And these can be proposals I'm not something that is needed now but in many cases it could be very blue sky approaches. And, you know, we fund about 2030 projects depending. And these are all short terms fun is just seed money, seed money, either if you want to form academic collaborations if you want to get a postdoc in there, or you want to get interns or co ops or whatever to do some of the work so it frees you to do other things. Many of this funding can go anywhere from a few months to probably up to a year but it's just basic funding for an initial proof of concept doesn't even have to be where everything is sorted out because if something looks promising, we then take it to the next phase where now it becomes more part of our budgets are annual operating plan, and based on the promise we would then then funded. But along the way, I just want to go back where we found it very very effective for all this work is little investment at the early stage has led to a lot of very productive outcomes. And a program against speaking of academia that's also been very helpful as we have sort of a formal PhD program whereby anyone in the organization if they want to pursue a PhD, we will fund that entire thing you know where they will be working on a full salary. But what we do is they will write proposals we would appoint an internal committee member, any one of this, the staff, and then they will work with universities we've had about multiple students go through that, and it doesn't always have to be completely associated with what we are doing at Biogen at that time it could be some forward looking thing it could be maybe some tangential association will be trying to do. But the idea here is we create the time and the facilities, most of the students work at one of our campuses, they will go to universities off and on, depending on whatever arrangements that they have but it's been extremely extremely productive in some years and it's a great sort of a value for people that are going through this. But then going through the next stage, as we start, you know where more of the funding comes in, as things come up, we've engaged several you know speaking at meetings obviously but through, you know, programs at the agency is what we just heard of that has been very productive. And this is really where we then start in some ways, I wouldn't say operationalized but bringing a system to innovation because this is at sort of the myth to late stage, or maybe it's like a phase two of this development is where we have organizations in the company trying to put a business case around it, looking at what the investment is what the outcomes are, trying to sort of figure out, you know, where this would be implemented and what some of the implications would be, and this goes on. And interestingly, you know, even as I showed the previous slide I've been talking about where we want to take a manufacturing which has now been implemented for a couple of years. There was quite a bit of, I mean, you know, there were questions asked like, you know, is the agency going to buy into this, because you're really trying to kind of move things that they may not have seen before. And is it really likely or is it just for a good presentation that you guys are coming to these meetings. And interestingly, at least through my experience and I would like to hear what others may have to say during our discussion. I, through all the innovations that we put together, I actually have had, in my experience, very little resistance from agencies, particularly if the science has been strong. A lot of the anxiety, I feel, has come from within the company or through the industry in terms of what this would mean and you know how could these be perceived but to a large part, when science has been on our side. It's I, I have actually not encountered much resistance at all doesn't mean that there hasn't been discussions or questions, but that's just my opinion here. So you can go to the next slide. And this is what I was talking about earlier, something that we've really been very, very aware of that innovation by itself, you know, can happen randomly. But there have to be pieces come that have to come together one is the overall strategy so clearly, you know, we try to tie where we're going, once we know what the strategy is to a large part we try to also stay ahead of where things are going. The people have to come together and to a large part, where this has helped is management needs to be completely on board to be willing to accept risk. And more importantly, as I said, being willing to accept the consequences, you know, to a point where over the past many years we've actually rewarded and acknowledged the effort irrespective of what the outcomes have been, you know, even the less than ideal outcomes, we have rewarded those efforts. So that's something that that is very important, the people aspect which includes the management as well. Then you also need to have systems, you know, you can't have things getting in the way of progress. And maybe it's the size of our organization or what have you, you try to kind of navigate around that systems technology and processes all coming together. And I think it's really when all these things work is when things start to happen. So next slide. This just gives you, you know, something that we've introduced in our in my apartment. It's called the technology hub, because you know we realized, you know, I mean there's a lot of, a lot of good ideas things moving around, it's very hard to keep track of those things. So it's not necessarily to say that we want to operationalize it but some extent bring some kind of a oversight if one can call it that. So that there's awareness with the multitude of things going on, where things are, you know, what have what the learnings have been. And so it's the idea being that at some point if you park something, we don't sort of restarted go back to square one. You know, bringing a continuous improvement program again which is a formalized program through the entire organization, things like the innovation hub and so on, are important as much as one may think that you know they may be getting in the way of creating too many systems. They do enable in our experience, things to be sort of coordinated better. So that's probably one of my last slides and go to the next one. So just really I just want to end by saying that this is the facility I was talking about our new facility in Switzerland. It's an up and running for the last year or so. And all the things that I talked about have been implemented there and likewise another facility that's been running for a while, using all these for late stage and commercial programs. So I just want to thank a few people, Dan and Aona were on this call today. They've been heading, you know, Dan heading the technology investment investment initiative in us heading up the innovation hub, and large number of people process analytics protein development regulatory manufacturing sciences made this happen. So thank you for your attention and thanks again for this invitation. Looking forward to any questions. Thank you, Rohan. You can hear me now. We appreciated that fascinating view into how by biogen views innovation and values innovation. So I think we're going to hold talks until our community discussion. We'll be following the next talk, which will be by Sarah Arden. Sarah is director of global regulatory affairs at GSK. She serves as well for the discovery and early development of projects in that unit at GSK. She has 15 years of combined experience and regulatory affairs, intellectual property pharmaceutical and vaccines development and research. Dr. Arden previously served at the US FDA as a regulatory reviewer and facility inspector and directed emergence emerging technology research policy and development programs. Prior to joining the FDA Dr Arden founded an AI based technology startup served as a life sciences consultant and IP advisor to startups, law firms and government clients. She received her PhD from Johns Hopkins University and her BS from the University of California San Diego. So look forward to hearing your talk, Sarah. So if you'd like to take the podium. Thank you so much for that kind introduction Kelly and hi everyone. I'm, I've been asked, along with my colleagues Ben Stevens and Jean new primer to present on some of these existing mechanisms as well. And we've put some slides together to go over what we've identified as some currently existing mechanisms that are in use today and provide ways to collaborate early on with regulators and the next slide please. And I mentioned Jean new primer and Ben Stevens and myself put these slides together we're all at glass of Smith climb. Next slide please. In looking for existing mechanisms we identified several different categories that we could parse out the ways in which sponsors firms industry can engage quite early with regulators and other stakeholders. And the first category we identified where these direct sponsor interactions. So the first thing that came to mind, and Larry and Joel gave a really nice presentation earlier on the emerging technology program of course, you know, they, they are the first program that came to mind we have engaged with them ourselves at GSK and in a little bit to that. The next one is seabirds advanced technologies teams the ATT and we've, you know, we've had kind of mixed reviews about about that particular program. The Center for devices also has its innovation group, which is also developing and moving quite rapidly to get to some of that as well to provide other platforms that enable industry and other stakeholders to engage particularly on and have joint learning with the regulator as well. So other national regulatory agencies, the MAs innovation task force, the UK's MHRA and Japan's PMD all have their own innovation offices that enable early engagement for sponsors. Next slide please. In this category we identified where these guidance is. And these, these are interesting because they provide some thought leadership that comes together by dealing with what knowing what the agency is dealing with industry and what are some of the pain points that industry is having in areas that they want to move forward in. And so some of these guidances that have come out recently are the PT guidance, the continuous manufacturing guidance which came out before Q 13 the ICH community had just recently put the Q 13 and of course the advancement of emerging tech application which is kind of the backbone of the ETT Q 12 and then divide additive manufacturing for medical devices so all these guidances are providing this framework that industry can certainly go to when they are at a crossroads and trying to determine how best to move forward, but they are just, you know, information that's provided it's one directional. So it doesn't provide that engagement but at least there's a framework to work from next slide please. The next category we identified with these innovation initiatives.  They may not all be well publicized but they nonetheless are ways that the public and stakeholders can engage quite early and have a say in the direction of how and how the regulator, the regulator can innovate its own regulatory policy. As well as how the industry can move forward in terms of their innovation and commercial strategy. Some examples of these are using the documents that CD CDR and CDRH are using for public comment here's an example in the federal register for quality management maturity which you might spoke about earlier. And so these provide this opportunity for public to engage early on and comment. There are also initiatives such as this one right this is a platform that is a really nice platform that brings various stakeholders together academia industry regulatory and the Duke Margolis Center for health policies another one such platform. Recently, for instance the FDA had one workshop there on establishing high quality real world data ecosystems. And these are really nice meetings because there there's a really kind of mutual discussion and hopefully some ideation that can happen that these venues. Another interesting one is really looking at within the agency, different various offices have their own annual reports they publish annually. This is an example of one annual report there's also other reports that are published regularly. And, you know, going through these you can identify some of the initiatives that are being developed yet to come, and also observe and monitor some of those that have already been in place and see where the, how they're impacting industry and innovation. And there's also an interesting initiative coming out of the digital health center of excellence, which is actually part of CDRH Center for devices so this is the center of excellence that was recently organized and launched as a platform that enables all stakeholders to kind of come in and interact with the center. And as it's, it's, you know, you know exactly where you need to go if you have some particular questions. And the process allows both the agency as well as the stakeholders to grow, learn together and really allow the community to move forward. Next slide please. Another area we identified are these FDA external funding opportunities that exist. These are in the form of contracts and grants CDRH has its own BA and grant opportunities so to see her and throughout the agency there it's not at the level of course of NIH, but you know the funds that exist for funding and supporting new technology development. Here we have a certain priority areas that we've looked at such as supporting new approaches to improve product manufacturing quality. And then the other priority area ensuring FDA readiness to evaluate emerging technologies. These are some examples of where funding goes. CBER CBER had an RFA out recently for enhancing innovations and advance manufacturing technologies for vaccines against influenza and emerging infectious diseases is another interesting area. So these provide an opportunity where oftentimes academia comes in and submits a proposal, the agency reviews those proposals and determines how best to distribute funds and also meet some of the mutual learning goals that can advance both regulatory reviews side policy side as well as of course the commercial side and just generally moving innovation forward. Next slide please. And lastly we we also look to public private partnerships. You know these are great platforms where multiple stakeholders that are at the forefront of innovation can be engaged in discussions together. The MEP National Network, NIMBL, BioFab, BioMaid and the Medical Device Innovation Consortium come to mind of course manufacturing USA as well. And NIST is of course it's another sort of it's an agency that can provide a role as an independent party when different industry members need to meet and discuss a particular topic and move that particular area forward. So NIST is also engaged in a lot of that. And next slide please. So, I want to speak a little bit to the recent experience that GSK has had with ETT. Some of this was discussed earlier. This is a high level overview. And we did find that the engaging with ETT was really useful pathway to integrating the novel manufacturing and testing platforms that we presented. We submitted a meeting request to discuss the novel microbiological testing platforms with ETT. We had discussions that were centered on leveraging prior knowledge for method validation approaches for product specific method validation and verification following method transfer, sample prep and bracketing of the evaluated species and comparability to compendial methods. In the process, subject matter experts from the different FDA divisions were assembled into the meeting package review, which is also really unique way to engage very early with the agency, and get the multi discipline perspective and identifying those early risks that can impact how you are going to move forward in terms of your go to market strategy. So prior to getting to that IND stage so we found this to be very useful. The feedback was robust and the agency provided us with actionable responses and encouraged us to seek additional interaction as we continue to develop the technology with that feedback that they had given us in mind. Next slide please. So here, you know we sat down and we thought about well what works, and you know what can be improved or enhanced to maybe make things a little bit easier and more efficient for the community and all stakeholders. And the first, going back to that first category of sponsor direct sponsor interactions. We looked at those centers and the different mechanisms that are in place for engaging early with industry. You know, one of the areas that we thought could be an area to look at to improve is the consistency across the centers and maybe using something like a pre pre IND sort of situation type C process that could enable all the centers to have a similar approach, depending on the product type that the sponsor is working on. For instance, some of the, some of the, I guess, mixed reviews that have come in about the Ctt or that those informal interactions with them may not. That's presenting a new technology and that's one area is that consistency. Another is really having a somebody who is a well publicized clear champion point of contact, or an office that has that is directly associated within the centers to facilitate sponsoring our actions we thought that that could also be beneficial to to the industry. And another thing that has come up and I think this has come up in the past as well is kind of considering a technology master file. You know, is that something that could be considered as a mechanism that we can review the technology in the absence of an application cross referencing and this is something that potentially manufacturing equipment vendors they might be able to do something of this sort. Those are the three areas we thought about for opportunities to to improve on the sponsor interactions. The next area is global alignment. And not there yet. Global alignment. So that, you know, we thought just like the consistency across centers. I think that would be really helpful to have more global alignment and one of the barriers to and concerns I think many industry members feel with innovation is, if we take something to one agency versus another it's going to have with the different different perspectives different risk assessments on how we approach the bringing something to market what is the commercial strategy going to look like and it's not consistent across the board. We're having, you know, MOUs between the agency and counterpart innovation task forces at other national regulatory authorities that enable parallel scientific advice consultations for example to achieve more alignment on regulatory risk and and and particular technology we think that could be very useful. And we've just recently seen something like that come out of the Center for devices just this week, where they jointly published a best practices for machine learning in digital health with the UK's MHRA and Health Canada. So we know that there's precedent for that and that could certainly facilitate some of the concerns with bringing something to market across different regions. And then lastly we have innovation centers and test beds. So the agency does support academia and maybe some smaller companies that come in through the form of those contracts and grants, but we really were, you know, questioning how impactful some of these contracts and grants are when it comes to commercializing a new technology and how does that impact really the private sector so something to think about there. And then lastly here, the agency can also consider more collaboration with private sector R&D that's in that pre competitive space with craters or using test beds. These are already in place in some cases but it's not something that's widely done or really publicized. So that covers some of the areas that my colleagues and I had come up with that, you know, could potentially improve what's currently out there and make things more efficient for the community. And with that, I would like to thank you all. The next slide is the last slide and I'm happy to take questions and engage in the follow up discussions. Thank you Sarah that was really helpful and I, it was a terrific summary of all the different mechanisms, you know that that you can see from your perspective. So with that, I would like to invite the speakers from Penn and Joel and Larry to join us in the spotlighted part of the discussion and I would also like to encourage all the participants in the workshop to use the Slido function to pose questions or ideas for discussion in this thread. So, one of the things, you know, to start us off, one of the observations that I've had that I think is, you know, Larry mentioned the communication problem right there's so much going on, and it's difficult for external stakeholders to have insight into all those different mechanisms what is currently being done. And so, I would suspect that part of that challenge is that when you hear, you know, when you consider from Sarah's perspective as preventive presented and that everyone have presented about all of the different mechanisms that are on the table. It seems that often FDA defaults are cedar defaults to the ETT right as the mechanism. And while that's certainly an important daykeeper for it. Well, I don't want to use the word daykeeper enabler right and it's a very important program, it is not the only program that is there and shouldn't be the only one that should be considered I would imagine at this stage in the game, even though that might be the intention to grow that program to sort of be the all encompassing face of cedar for innovation. I just wondered if the community would like to react to that if any of you would like to share your perspectives on sort of the sufficiency of the FDA because it does appear that it's very much of the ETT, excuse me. It does appear that it's a very appreciated mechanism, but is it a sufficient mechanism, and I recognize that I'm bleeding over into session three. So, just just a flavor of that. And I'm happy to start. So, you know, default into ETT you know I think part of part of what we've had success in the past and part of what we're continuing to build is, you know, robust, not just engagement processes for intake and that's something you know we highlighted in our presentation and I think a lot of the implications that rejected it's because it's not quite a right fit for ETT so I feel like a lot of a lot of the important logistical things that happen on the back end is really finding those things the right home so I guess I would push back on the idea that we're, we're defaulting to ETT I think we're really being thoughtful about what's included and we're where there's an interesting development program that ETT is not the right fit for for a variety of reasons trying to steer it in the right direction. I think so I think when ETT establish is really to give people about the clear point of contact if you do want to develop technology for future regulatory submission right. So, I think we really need to think about, like this is the scope of that program, because like in the past like people have no idea where to go. So, so but I agree with you, with you that I think it depends on the purpose like what type of innovation you want to communicate, but the purpose of the way of you want to communicate with the agency. Other other platform maybe is a suitable like let's say if you do want to advance regulatory science, then like you start going, this will not be go will not go to ETT we have the BAA and also grant processes I think Sarah actually did a very nice job to organize to do a lot of stuff and then also I think at Adams and Tom will actually also talk a little bit more about the regulatory framework and also regulatory science. So they will actually also let you know like how do we communicate those because I already mentioned we want your input on the regulatory framework part. So, so far. Thank you. I think we have one question that I believe you can quickly clarify. Is the emerging technologies team ETT part of the emergency emerging technology program or is this a separate team and FDA so I know Larry Joel would like to just clear up any confusion on that point. Yeah, I can clarify that Joe please. Yeah, I guess it's my apology. I think they are the same thing. I think we have emerging technology program but mainly is driven by the emerging technology team. As I mentioned before, like this team is the core team but we can have an ability to recruit any subject matter expert within the OPQ, as well as outside OPQ, depending on the nature of the new technologies. Yeah, no I think we sometimes use the terms of that interchangeably but it's it's really the difference between the individuals who are the team and then kind of the thematic program which is you know the entity to himself but obviously there's there's a lot of overlap there between the two. So, we have one question in the slido that I think it's more more general, but I suppose this, this community, or the speakers could respond to this what's the primary part of the process that by manufacturers would like to see more innovation introduced and why. So, that perspective on where it would be most useful to see an innovation appear, I suppose. So you're asking what area is that right. I believe that's what the question is asking. Yeah, I mean it's, it's necessarily it's hard to generalize it also depends on where your current platforms are where your network is and so on, I mean manufacturing network. I mean, I mean you saw from the poll I mean there is a good amount of effort on improving you know intensification improving productivity and so on. And this is where things like continuous come in because the other idea being is how long do you want to build larger and larger facilities, you know so many of these ways in which you can optimize that. I think there's, you know sciences and advanced enough, where we can start thinking beyond just the traditional choke platforms and so on so I feel that's where it is. But the other piece I do think I mean at least in our organization we believe that, whether you call that digital or what have you is really around process predictability. Because there's just so much advance been made there. You know whether that be through predictive modeling and so on. But I do think that that has very, very big value, because if you're producing at the rate at which we are, and at the productivity that we are a batch going down is is a large expense and you know without all these predictive tools, you could have many batches go down the drain before you actually assess it. Yeah, if I could add to that I would second, certainly what Rohan said. You know I think some of the considerations that of course they're related to do risking earlier. You know if that's related to applying models, and I think the agency has recently been more endorsing of using models earlier on. So apply those models early so that you can reduce time, you know, or fail early, the risk stepwise. I think that that's an area of course process intensification is related to that because you know you. There are specific areas that could be more streamlined and then in consideration of that are also, you know how ai plays into this how digitization of processes and systems that can become that are that are mature enough to handle data rich, you know, process technologies and understanding how the data is handled versus just collecting all of it. And, you know, putting together systems and mechanisms in which you know exactly how that data can become meaningful and useful for your process to apply it towards process intensification or de risking and also being able to skill much earlier without all that risk so those are clearly high priority. Thank you Sarah. So I'd like to loop back to a question I believe it was john Erickson that asked and I'd like to invite john if he's willing to come and elaborate on that it was effectively what are the characteristics of successful FDA collaborations with external partners. And believe it was that question was posed in the Slido during my conscious talk. And he suggested it would be good to punt it into this, this discussion. So, let's see, if it was john Erickson who posed the question I'd like to invite john, or really any in the community who'd like to raise their hands and give a perspective on that but first I'd like to ask our speakers for their perspective on that. So you think external program that has been successful with the agency that I I think it's more if you, if you view one mechanism for fostering innovation as an external collaboration of what are the elements that make that collaboration successful. You might say that he will pun the question to Joe or to me. I think it was both of you. Okay. Joe why don't you go first. I mean, it's kind of a hard question right what makes what makes it successful so I think, you know, and I think you know Tom and Adam will I think speak a little bit to these kind of concepts to later and later in the program. I think, you know, there are a variety of processes and I think Sarah did a nice job highlighting that so I think, you know, it's hard to hard to generalize what makes one successful I think certainly having having the processes we do that that try to identify up front what what success factors, you know should be considered and making making sure we're making informed decisions where we make investments I think I think the process itself is part of what drives that success. And you know, I think, sometimes these product projects you know there's always uncertainty about you know where the industry is going so I don't know that I'm able to generalize much more than that. Larry do you have any thoughts it's kind of a challenging but interesting question. I do have some thought to that based on the interaction we have with industry, many experience. I think the key for the successful collaboration is really be direct, be honest and be transparent. I think this to me will be a key success factor because so far I think the program we have is successful in a way that because I think there's a lot of contribution I have to acknowledge a lot of contribution from industry because they came in. They came here, the result with us right and, and really transparent because like remember FDA is not the one who do a product development right so sometimes I have to say that's like, we can only make a good decision, or we space decision based on the information provided by the industry or by the manufacturers. I think be really transparent. And then also from our end I think Joe, like, and I always try to make sure that if we disagree with you or we agree with you with you we give a very clear reasons. And then we do so not just like call the regulation, because of regulation we cannot do this, we try to be scientific and risk based. So I think those are really important factor is based on my experience. And then if I could add something I think from from the industry side I think it's really helpful to know what kind of questions you need you want to get answers for from the agency. I think that you're asking the right questions, and that you have. If you do have some supportive data to kind of go in with those questions, or if it's early in concept you still have some kinds of questions that the agency can really provide feedback for. That's, that's very helpful. Sarah, anyone in the community who would like to join this row and I forgot to give you an opportunity to answer that question. I mean, I think I agree with what everyone has said, you know in this particular instance what I showed you are manufacturing, whatever the reframing. One of the most discussions is that when we were proposing new things we weren't saying we'll do this. As a result of this we won't do that. You know and I think that's sort of where a lot of sort of maybe one debate or friction has come in the past where proposals go forth, say that you know if we do this this is what we don't want to do. And many times when it comes to control strategy changes from the norm is when issues come up. This isn't much of the technologies not like that we would just want to keep doing everything. But the way we had approached it was that we want to do this to get a better outcome of a process and a product, and just left it there, and that actually enabled for a much better engagement. We have another question from Tim Charlewa in the Slido and Tim's question is, could consortia bring forward non proprietary archetype products with detailed data sets to collectively de-risk technology and I think that's for you and the emerging technologies program and team Larry and Joel. Larry would you like to start or should I I think Larry highlighted you know that there are different tracks for engagements in his talk and I think you know there is there is the possibility of having I think engagement on, you know, if not a specific product at least some data to have some meaningful back and forth in terms of providing some specific feedback I think one challenge anytime you move outside of having a specific program a specific molecule, a specific set of questions a specific use case, you know, the questions become more general but then the feedback has to become more general to and there's that's just scientific reality so I do think there are places where we can engage in a different way on this you know obviously it still needs to have enough meet there for I think discussion, but I think you know there are there are different groups that we have engaged in this pathway as Larry mentioned so I think you know that's that's certainly a tool but again it's it's still going to be I think driven based on you know the type of engagements and questions we need to discuss and also how much data and how much specificity we can bring to the conversation. Yeah, I think I agree with Joe. I think we definitely have no problem to entertain this type of a meeting terms, even under emerging technology. Right, but Joey is correct. Right, a certain point. I think we can talk a little bit share my experience with you. We have a lot of this type of a discussion already, right. Very productive. I mean, like some of these are very, very early technology development. And, but we give a high level feedback and also like the company did a very good job to provide high level background information. Right, but I do want to point out that some of the specific like you really cannot assess the risk until you identify certain product and molecule due to the interaction with the specific technology like for example I can give you the direct compression continuous manufacturing process, your high dose drug low and low dose drug low the risk would be very different. So if we talk about the technology platform is very difficult to get into those area. So I just want to solve a share this to point out some of the limit quotation, we may have, but if you start to suggest some like in the things can still provide information about certain product characteristics not naming the product but certain product characteristics you are interested using this type of a technology I think that will also help help where we helpful to but I think in the emerging technology program. That's a lot of facility really depends on what type of feedback you want from from the from the agency. Thank you for that Larry and Joel, any, anyone else and again I'd like to make sure that anyone in the community that would like to contribute to the discussion knows that they are welcome to do so they just need to raise their hand or enter through the slide or chat or the ideas in the slide or chat, so that we know to call on you and and highlight that idea. And to see if anything, if anyone raises their hands, we had another question for Rohan in the chat from Tim Charlebaugh. And that was a question as to whether your phases of innovation that you showed on your slide a track with clinical development of a product, or are they also applicable to introduction of technology for approved products. Tim, where have you been haven't seen you in a while. But no. So, when it's associated with a product, right, I mean, if we time it we do time it with the clinical which is the idea being that whatever new technology or platforms we put in to make sure that product for pivotal trials is made accordingly. But there are a number of cases where in fact we've used it for commercial products, including a, you know, including some of the modeling work that I've shown me and we've, we've used it for a product that's been in the market, what about seven years or so. Thank you. And we have just a minute, a few minutes left before we go to lunch, and I don't want to slow us down but I thought Sally answered asked a really important question. And so I'd like to ask Sally. If you'd like to to pose the question yourself or bring that up for discussion. I think I'm sorry if you can be on camera and we can spotlight you. It's also wonderful. Can you guys hear me right. Okay, awesome. Yeah, so I, it's just a general question. And I think that, you know, sometimes, um, you know, there are changes and when we talk about certain things and we because we think that we understand them then we don't take enough time to really digest and harmonize the point that everybody's going to be aligned with what we are really intending to do. So this is, this is again goes back to change management. My question is, you know, I have I have worked with multiple filings and we talk about science based and risk based. Um, but in particular, I, you know, I think that people understand a little bit more about what risk based means. But I have seen in multiple occasions when when folks talk about science based. You know, many occasions I have seen folks talking about just the data right if you do an analysis and well I calculate a p value for that or I calculate some sort of like statistics on that and they assume that is because it's the science of statistics is science based. So, and then I haven't seen in other cases where people try to use you know like the understandings of the process itself and the engineering and concepts of mass balance and just fundamentals of the process to define what science based is. So, I might be not I don't know if it's completely out there I have seen it in multiple guidances that we talk about science based. I just don't know if folks are still if we have made some sort of agreement of how we're defining science based for people. That's more towards the folks from the FDA because I think that I think that there's I have seen that gap and and I have seen that gap trying to put a filing myself working with other colleagues are helping out. Yeah, I can address this question first and then Joe to me a little bit. I think in terms of you are talking about the consistency in the post approval, even like let's say the evaluation right. Yeah, I agree sometimes like, like, I just want to let you know the amount of work we are dealing with is more than like, a supplement per year as well as, as well as even for the original is the number I don't really remember the number. Right. I think a certain type of inconsistency I think definitely from from our, from our end is expected. And I process also considering that we have quite a lot of large pool of quality assessor, some of them are with a little bit background those also can may contribute this as well. But we do actually tried our best to ensure consistency apply the risk and science based approach in our assessment. So what we are doing like, like we, I'm not saying that we finish in this area. But what we are doing is that we start to, we have already incorporate more like a team based approach based on different discipline to evaluate those type of application. So really the science based approach. And then to your point Sally, I think some of the things is that even though for the individual, they may have a different type of risk assessment framework they use vary from one reviewer to the other reviewer. As I mentioned in my talk little bit about the program like the castle program we are going to develop and basically really to develop more formalized with base algorithm using the latest scientists and then this system is going to be maintained and continues to improve based on the best practice we have here is not, it's not there yet is still in the development and initial implementation but that's where we try to get to that will actually help us to improve our consistency in the near future. But Joe also is the person who developed this type of system for biology so he may be able to give you a little bit more granular level information. Yeah, I think, I think a lot of this always, you know, turns back to communication and we have you know training really, you know, good, good understanding of what we're talking about but I think all the tools that we're developing I think aren't necessarily either even technology specific but really are at the core trying to address this this communication and this back and forth, you know, challenge I would throw besides costs you know PQC MC and how we think about information being submitted I would throw in, you know q 12 where we talked about trying to identify, you know concepts data expectations shared understanding of risk up front. But I think all this is, is driving towards a better shared understanding of that and you know the idea of what's new data what's existing understanding right the definition of prior knowledge we've all agreed on for a long time and I CH as it is so I think all those, all those tools are our neighbors for us to continue to move forward in terms of sharing this vocabulary. Thank you. It is time for lunch break, but Sally, yes, do you have one more question. Yeah, very quick. I, you know, just, I just wanted to say thank you to, you know, both gentlemen for answering that to that question now. One thing that I would like to add is, you know, like sometimes we think about this consortium that we tend to work with and there's other groups that are, you know, apart from the regulatory as in like sharing data and doing things that are very ambitious right, I think that I have found that some of these consortiums are very effective just sitting down and having everybody in the room and just saying hey this is what we're going to be agreeing to, to call this one moving forward like what we did with the APC workshop right. So I think that that's, you know, one recommendation that I can give that I don't know if I, you know, the committee gave it during our document is, you know, using this consortium just to find alignment with regards to some of the new terminology that it's coming, because we're going to be able that we're going to be enable enabling folks to share best practices way better if we align with the same, you know, concepts at least. So just just was thinking about that while you guys were talking thank you so much. Thank you Sally for the, for the suggestion. And thank you. Now, the only thing we have left for lunch is to say thanks again to our speaker Sarah Joel Larry and Rohan, you know, for the time and the thoughtfulness that you put into your presentations I think it'll set us up really well for our next session on where the gaps and and opportunities live in building these mechanisms. So thank you all very much I think Linda wants us back at 145. Thanks, thanks everyone welcome back from lunch and welcome to session three. Linda, do you want to display the results for a minute. Yes, we are going to pull that up in a bit. I think there's some interesting poll questions there will just let people look at them are we able to see these I look back and find out and it's, I couldn't I could see that I have responded but I couldn't see the results in the, in the video app so I just wondering if people had, were able other than when we display them on the screen, if they'll be able to see them. It's just on the main screen here. Everyone else has a participant participants. Yeah. Okay so this is probably the right time to quickly look at and reflect on these poll questions and thanks to folks that have responded. These are just to stimulate a little bit of thought and I think we can certainly come back to this and the community discussion at the end of this session as well as in the other sessions. This question about the extent that changes in regulatory policy procedures practices or culture could could affect innovation and pharmaceutical manufacturing as you see some extent. Or to a large extent. So that's still still, you know, some some opportunity, you know, at least reflected by the community there, moving on to number six, which, which sort of focuses on the how part of that question and it's kind of split regulations review practices, workforce training and and guidance with emphasis you know a little bit higher on the on the last two. Thanks for those responses. Number seven moves over to industry practices and here there's even larger louder voice I think to a large extent innovation can be enabled by practices and industry. I think that's kind of a strong vote there. I think in that direction which not surprising based on the conversations we've had earlier, and looking on to number eight. Greater greater this was sort of split vote but greater willingness to accept risk, not at all shocking based on what you know the perceptions of the pharmaceutical industry are. I think seeing increased pre competitive collaboration to substantially do risk implementation, and you know something that I think certainly been enhanced and accelerated by the pandemic increased recognition of manufacturing as a value driver, and also, you know a lot of votes for for greater transparency regarding innovation activities, which is something maybe we can come back to talk about. At the end of our questions area we have one more. Okay, great thank you. Some extent academic practices could also enhance and is that the end there Linda. Yes. Yes, thank you for that so thanks to folks for responding and this is to get people thinking and we're hoping to stimulate some discussion there so welcome to to session three, and I just wanted to take a second. I would like to thank all of the speakers and participants in sessions one and two this morning I thought it was thought provoking and and very useful those sessions. I appreciate the engagement and for those that are hanging in with us for this afternoon. I really look forward to continuing and enhancing that discussion and on into tomorrow and so as we look at the overall flow of the agenda. That's kind of a pivot point in the agenda so this morning. We wanted to have the opportunity to basically disseminate awareness of the report itself, and to talk about reflect on the technologies that were emphasized in the report, as being those that are impactful in the near future, and then to reflect on the existing mechanisms for accelerating and enhancing and enabling manufacturing innovation, and to give FDA a chance to give visibility to what they're doing, which was very, very useful. And at this point we wanted to pivot a bit toward what gaps do we see this is Kelly mentioned this earlier what gaps. Do we see in the community as a whole for enabling innovation and that's what this session is intended to be and as we move toward the flow we're trying to use this session and the discussion to say well these are the real problems in front of us. You know, as it relates to the hurdles that we face and really hear from people the report did weigh in on this affair amount but we want to hear from the community and draw energy out of that. And, and, and then, as we move through into tomorrow's agenda will be talking about solutions that should address these gaps, and then the path forward so I really urge you to continue to stay with us and participate because as I mentioned earlier this morning. So we're really looking for community engagement and ownership over this problem statement and very much appreciate your, your attention to this workshop and ongoing attention to the issues that we face as a community. And at the introduction to this session specifically we have a series of four short talks, you see on the screen. These are intended to be approximately 10 minute short talks, and they're there to provide some opportunity for additional reflection on the topic of what gaps challenges communities do we see in enhancing and advancing innovation. And, and also to use these talks as a springboard to stimulate the discussion. So we will have the four 10 minute talks serially I'll introduce them in turn. And then we will hold questions until the community discussion at the end. I think we have 45 minutes for that at the end which will. Please continue to use slide out to input your questions to speakers and your ideas for discussion. I use the upvoting feature for that. And, you know, remember, you know, raise your hand if you want to speak as well and we'll try to recognize that and the extent possible we're going to try to get voices in out here and really hear from people and try to stimulate some discussion. So, with with that as an intro and I hope I haven't forgotten any of the ground rules there. First, our first speaker is Tom ran so off, who is is co head of the biological franchise at resilience of manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Tom. Thanks Tim. Can you hear me can everybody hear me. Great. Okay, well, I think we can advance the next slide I'd like to just start by saying it's it's a real pleasure for me to be here I really enjoyed this discussion and, and I really appreciate the opportunity to provide just some brief thoughts on some of the challenges related to new technology adoption and in our industry. And because we're all products of our experience.  I don't have any comments on that but my my career has been primarily focused in the recombinant protein and monoclonal antibody field. You know, over 30 years in bioprocessing and, and I have worked on a number of new technologies that have, you know, been successfully introduced at some level to the industry. So, you know, the bioprocessing processing area, and, and obviously, all focused on bioprocessor bio pharmaceutical manufacturing. And I'll start by dating myself by acknowledging that one of the first new technologies I worked on which is now obviously considered a conventional accepted technology is protein a, but at one point, when I entered the industry in the in the mid 80s. Conventional accepted approaches for purifying proteins from complex mixtures were primarily ion exchange chromatography and precipitation. And the idea of using a coat protein from a pathogenic organism as an affinity like and to purify a therapeutic injectable was viewed by some as a radical and risky new technology but obviously now we'll you know know and appreciate the value of affinity technologies and I was involved in some of the early evaluation of protein a and antibody processes and later in the development of recombinant forms of protein a and obviously that field has continued to evolve. As we now have, you know, base stable protein a like ligands that have been successfully adopted by industry. And a little bit of a theme here also involved in novel affinity lagging discovery. In particular, you know, collaboration between DIAX one of my former employers and why discovery of a novel affinity lagging for purification of a factor factor eight products. And as well in single use technologies, prepack column technologies and more recently in continuous chromatography. In all of these cases, you know, my role was, you know, a role in combination with many, many, many other people, obviously, and so one of the points I think that I want to make is that it really does take I think a community. And to develop a and successfully introduced, you know, a new technology or a new way of operating into our industry and that theme I think has, you know, been shared by many of the speakers. And the importance of communication of standards of, you know, developing strong communities of practice and, you know, common language and common guidance is I think is really critical to this process. So, these types of, you know, forums are important to that process. And I think it's important also to stress that these are my own personal perspectives but I think they're aligned with, you know, my current employer resilience who's really focused on leveraging innovation and new technologies to develop the fault and new platforms for production of techniques. So, you know, bottom line up front my overall conclusions are that we can as an industry introduce new technologies, we have demonstrated that ability, but there are some challenges to the process. And I think one of the things I've learned is that the benefit really needs to be consistent with a level of effort. So, talking about a technology that's going to require a lot of work and effort to implement. We're unlikely to do that for a modest benefit so that's part of the evaluation I think of of new technologies as as we as we look at where we might implement them in our processes and our product development programs. The timelines for adoption of innovation are long compared to other industries I think that's been true throughout my career I think it's, it's still true although I do think we're getting better at it, but I do think, you know, this is in part due to the timelines for our product development. You know, my friends in the software industry talk about, you know, being disappointed that they don't launch a new product a year from when they start obviously we think in terms of decades and I, I think it's hard for the new technology introduction process to move at a very different cadence from the product development process so to some extent, I think that is part of the, the recognition of those long timelines needs to be part of our approach to new technology introduction. So if you could go to the next slide please. I just have a few slides here but this I thought was one useful example that I've been tracking. And I'm sure many of you have is the adoption of single use by reactor technology in our industry, but just thought it's a useful example in reflecting on how long it does take to really truly adopt a new technology and thinking into the first introductions of single use by reactors in the late 1990s with the wave by reactors which, you know, obviously, those of you that are rocking motion by reactor, not really representative of the stir tank by reactors that are used in the process. So, you know, that led to enough interest and excitement that the first CSDR stir tank type by reactors single use by reactors were introduced a little less than a decade later, and then the first 2000 single use by reactor which is sort of our current most commonly adopted production scale for single use right now was introduced about 12 years after after the wave introduction and then finally about 15 years later. The first FDA approval of a biopharm, a commercial biopharmaceutical manufactured in a single use production by reactor was was successfully accomplished and and even now the slides up here show, you know, sort of a 15 year view of the installed single use by reactors compared to stainless steel both in volume on the left and in number of bioreactors on the right. This is from a database trending supply and demand trends for biomanufacturing capacity that helped develop a consulting company called BC which is now part of the video and still a database that I find useful. You know, it shows that even now we're continuing to adopt at a greater rate single use by reactors compared to stainless steel but this is 20 years later so adoption cycle of a you know very successful new technology in this case. This is somewhere in the order of one to two decades but depending on your perspective. So finally next slide. And we'll get to my last slide which is really just an overview of the challenges as I see them to new technology adoption and the opportunities and things that we can do as an industry to to improve our ability to do this. One of the most important challenges is the risk associated with technology adoption and this has been highlighted well in the, in the NASA report and also in the discussions this morning. You know, they're there penalties for delays and setbacks and any pharmaceutical development program and these are significant. And as a result, you know, the perceived risks for new technology adoption are. You know, perceived in the context of what if it delays a important, you know, biopharma development program. As a result, you know if we can develop a product with conventional technologies were more likely to do that nobody wants to be the first to develop a new technology and as was highlighted in the report and before the first person to go through that approval process, you know, faces the double burden of, you know, justifying and supporting the new technology as well as their own product, which is a heavy lift. Second challenge is that there's there's no good time to implement new technologies and I think Todd mentioned this at the very beginning, you know, as as our timelines get compressed this becomes maybe even more and more true. It's it's hard to find a time to slot in, you know, the time that's required to implement a new technology when it may require more time to qualify new equipment to train operators on a new way of operating. And this this inherently will slow down the first few times a new technology is adopted. So how do we manage that. I do think has been highlighted before our industry has invest relatively little compared to our revenues in new technology compared to other industries and, and I think that's also perhaps re action to the fact that our manufacturing costs are quite low compared to the sales price of our product so you know I think we are seeing that improve and you know the Rohan and that Norendra's talk today, I gave some great examples of, you know, the potential impact that proactive investment can provide as companies, you know, really do develop exciting new technologies. As I was highlighted this morning, I think, you know, part of being better at this is is being more proactive at investing in new technologies as an industry. And part of that is, you know, justifying the value and I think the benefits are often underappreciated we we focus too much I think on the cost and timeline benefits only while under appreciating the potential to add real value to our programs and products and, and to the supply chain as we've all, you know, you know, experienced within COVID the, the impact of fragile supply chain on on everybody is significant and part of the value that we can bring with new and new technologies is, is the ability to, to have a more robust supply chain across our industry. And finally, I think IP uncertainty can be a challenge that people face when when looking at new technology is obviously freedom to operate is paramount to the ability to supply. And, you know, but fortunately, there are many opportunities to improve our ability to innovate and I think some of the strategies that that I think are most important have already been highlighted really today. And those include consortia to allow for pre competitive collaboration and groups such as nimble and, you know, others are certainly important, I think to that objective regulatory engagement to provide mechanisms for feedback to innovators so the ETP, which is highlighted today I think is a great example of that and there are others that Sarah talked about in her presentation I think those those are those are tremendously important and finally standards and guidance documents to provide common understanding and vocabulary. With, you know, my focus and interest and continuous recently I've spent a lot of time with ICH Q 13 the recent draft and think it's a really great example of a document that provides a good insight and the use of the annexes to, you know, provide even more granular perspective without, maybe as rigid, you know format as the the actual guidance I think is also very helpful and that was, you know, I think done well with Q 13. And then finally, as I mentioned earlier proactive investment by industry I think greater willingness to do that across the industry will is important as well. Well, I had done, you know, without it just like thank you for your attention and pass it on to the next speaker apologize for probably going over a little bit. Thank you very much Tom, appreciate that and our next speaker moving right along is Dolores Hernan, who was a quality specialist in the human medicines evaluation division at the EMA where she focuses on the development and characterization of control release delivery systems based on micro and nano technologies. Thanks Dolores and welcome. Hello, good morning everyone. First of all, we would like to thank the National Academy of Science and the FDA for inviting us to share with you our perspectives. We believe we are very much aligned we are all on the same boat on this, and I would like to share with you our perspective on the challenges and opportunities offered by innovation. So if we can go to the next slide please. Yes, so the EMA has been mentioned several times I believe you all are aware. So I will go quickly over this so as you all know, same as FDA. Our mission is to foster scientific excellence in the evaluation and supervision of medicines to promote public and animal health. Next slide please. So in order to achieve our goal and to address our public health mission, we are knowledge that innovation is needed. We need medicines of the best quality, which are highly efficacious, which have a good safety profile. We need medicines that address an unmet medical need. And we need to avoid shortages to processes which are improved and processes which are reliable to increase the flexibility and agility, increase years and in the environmental, and decreased environmental impact that was mentioned earlier by one of the speakers. So we are an open forward agency and we encourage innovation. Next slide please. I cannot see them in full. Okay, so reflecting a little bit on the scope of the session, which are the general challenges I see if we if you can press the next button. Yes, again please. I see that both regulators and industry. Generally, we have a traditional mindset, and this can create fears. Next, next one please. And next one. So industry has fear that their innovation would not be accepted by regulators but regulators as well on our end we need to have early visibility of which are the companies developments to ensure that we are prepared. Next one please. So we all need training to make sure we understand these innovative technologies. So that we develop appropriate processes and then we regulate them accordingly. Next slide. Next one please. So yes, we are knowledge industry has to do on a front capital investment that is one of the risk. But we also need to constantly evaluate whether our regulatory framework is appropriate and whether there is the need to update our regulatory frameworks. So we are knowledge that there are challenges at both ends. And then I will go over the opportunities we see next slide please. With regards to the those were general reflections of challenges I see between in among industry and regulators, but with regards to more going more in detail technical and regulatory challenges. We all see that there are more and more complex systems and technologies under development, for example, additive manufacturing platform technologies. We have seen more progressive control strategies, for example, based on performance based approaches, artificial intelligence that has been mentioned earlier in the workshop, advanced automation and advanced process controls. We have also seen portable modular systems that and bedside manufacturing and decentralized manufacturing approaches for example in the case of advanced therapies medicinal products. And with regards to the complex systems and complex medicines I was referring to, for example, here a little bit companion diagnosis and borderline products. Next slide please. Seeing all this, what is EMA doing. So, back in 2020, we conducted a horizontal scanning, horizontal scanning activities to identify which are the innovations that are coming and make sure that our regulatory system is capable of regulating those technologies and novel medicines. So, this is a, I, you cannot sit here but on the lower part of this slide there is the link to this document, where we covered the, the outcome from this horizontal scanning. This was done is that dive deep report done by our police on the regulatory science. Also, meetings we have with industry stakeholders to understand from them, which are the technologies and the challenges they see in the coming in the near future. We could work together and prepare for those. So, given the scope of the meeting here I try to outline a little bit which are the core recommendations relevant for today's discussion. So the one, one of the goals and primary recommendations from this person scanning activity was to facilitate the implementation of novel manufacturing technologies, and another one to promote research and innovation in regulatory science. Next slide please. So, in addition to this, what is the EMA in collaboration with the European Commission doing. So, importantly, and I think is relevant for today's discussion and for everyone of the wellness in November 2020 the European Commission launched the pharmaceutical strategy for Europe. And basically what this means, we are conducting an analysis to try to identify which new technologies among other areas and which new approaches are being developed to ensure that the European regulatory framework is future proof and support industry in promoting research and technologies for the benefit of patients. Next slide please. So, which are the opportunities that we have to engage on CMC dialogue with us. Next one please. So here I try to outline the different opportunities we have. One of the speakers mentioned some of them briefly earlier. The innovation taskforce is a multidisciplinary platform for early dialogue to have some dialogue with us on legal, scientific and regulatory matters. This is, as I mentioned, an early dialogue at touch base so that at an early stage you can start dialogue with us and discuss your concerns, present your technology, and then we can take this forward. In addition, this is from EMA but EMA works in collaboration with all the national competent authorities from all member states in Europe. And in 2015 collaboration was established between our EMA innovation taskforce and the innovation offices from all member states so we can have a dialogue, identify training needs for the European regulatory framework and take decisions that then could be implemented across Europe. Another entry point to get support from us, you may all know, is the scientific advice and protocol assistance platform. And also importantly, was mentioned in one of the earlier presentations, which forum, which forums are available to have dialogue with regulators as an industry and not single meetings. I would like to stress that at the level of the quality working party and the biologist working party, which are formed by a EMA secretariat together with representatives quality assessors on the small molecules and biological area from all member states. Once a year, we have meetings with our industry stakeholders to discuss topics of common interest. So this is one of the platforms we have available. We are also working on the development of a platform to strengthen our dialogue with quality and GMP inspections and you will be hearing from this from us in the near future. And also we want to acknowledge that academia plays an important role in innovation. We have an academia office and we believe that the collaboration with academia and learned societies is an important aspect that we should keep in mind. Next slide please. So these, I wanted to put as well this into global dimension. We believe that developments are done in a global manner. And in this regard, the EMA has collaboration with understanding agreements with several agencies across the globe. We are also a member of different international platforms for dialogue. For example, ICMRA, international platform, regulatory forum, ICH. So I think it's important that industry work together that we don't work in silos, the collaboration with academia and research institutions, and that we all and daily aids with regulators so we all work together to make this happen. We cannot work in isolation. An important aspect that I wanted to bring to the table is that applicants should allow regulators to discuss their applications among themselves. We have found ourselves in situations where we had a new technology. We wanted to discuss approaches with other regulators but we didn't receive the approval from the company. I hear several times, oh, but you know, there is an alignment between regulators but we need the support from industry and the openness from industry to allow us to have discussions around new technologies to make sure that we have tools to try to align our regulatory expectations as much as possible. And of course, another aspect we should consider as well whether there are national regulations at regional level that may prevent to share and discuss commercially confidential information among different authorities. So next slide please. So my day home messages is that innovation is needed for the benefit of public health. I believe that industry and regulators set the responsibility to make this happen for the benefit of the patients. We have challenges but we should work together to overcome them and collaborate. And I believe that early dialogue is essential to pave the way and ensure that there is a mutual understanding. Next slide please. Thank you very much. Thank you very much Dolores. I appreciate your comments and for for keeping us moving along so very dense content but but very well appreciated. Thank you. Our next speaker is Malcolm Barrett Johnson who is managing director and regulatory strategy expert at pharma medic consultancy limited. He is a physician with pharmaceutical experience in medical and regulatory affairs. Welcome Malcolm. Tim thank you very much indeed and it's an absolute pleasure to be invited to speak today. So I'm across a pond I'm based in London. So it's coming up to dinner instead of lunch on this side of the pond. What my background is in general just to give you a very brief understanding of why my views might be of any importance at all in interest. I used to be a regulator. So like Dolores I work with the MEA at one point but I work for the MHIA. And as you know after vex it now we are sort of outside of the fold. So the MHIA is slightly different. I work constantly with the MHIA in a consultancy regulatory capacity. I'm also the director on three biotech companies as well. Manufacturing isn't really my area particularly so I think oh God what's he going to be talking about my more medical affairs so I've actually as a medical director and a number of companies including big ones like AstraZeneca, Pfizer's MSD's in the UK. I'm going to just compliment and say thank you to Janine Jameson. Janine raised an area which I think may act as quite an interesting straw man for discussion just going through just to highlight a few points as a regulator, an ex regulator and someone who works in the industry day by day. This thing is a reflection paper by FPA and FPA the European Federation of Pharmaceutical Industries so they're part of IFPAMA the International Federation of Industries. This issue came out in November 2020 and it was a reflection paper reflecting on the way that manufacturing in one area and sort of small manufacturing units could be used but it does raise a number of issues. Next slide please. Thank you. So the European arena, we are the second biggest area for wanting pharmaceutical medicines and we are a huge sort of by all of them were constrained obviously by as you are in the States by by costings. Everything is very patient centric so I agree completely with what the law was saying. The FDA, the MHI are very patient centric as indeed the FDA are. And the key objectives as you were no all too well are to ensure medicines safe, improve lives available to patients globally and preserve safety efficacy and quality the three cornerstones of the triumvirate stall. And I know the industry has been investing huge amounts in modernization manufacturing and each supply operations generally. This is to very basically make sure that the supply chains are adequate. What this does it also raise is something we've all been through recently yourselves in the States are still going for it and we are also well in the UK and Europe. COVID. What we saw from that was a an absolute need to get supply chains in place. We had a bit of a tiff with the European Union is you may well know, in terms of COVID-19 and the supply of vaccines to that. There was some degree of misunderstanding I think in terms of supply chains, but what it did raise and what was very interesting was the importance of manufacturing and the importance of getting a supply chains right. Standing slightly outside the manufacturing field to my, my view, manufacturing doesn't get the credit credit and impetus that you should do within the companies themselves if you're the medical director level you know about manufacturing you understand the quality she's a course you do, but you don't really see that and I think we've brought manufacturing much more to the fore over the last year year and a half two years, and all good for that too. And the other thing which I think it's also brought before is a need for universal access. We're not we don't live in a bubble, we don't just live in the States we don't just live in the UK. We have to think about the global perspective on that. And as I think he was Kelly Rogers said earlier one of the other sessions she said, things are very complicated things a lot is going on and indeed they are. And who from GSK early also said, we need to look at the international components of this under ICH is incredibly important. So supply chains in disruption are to my mind, one of the most things important things we need to look at. So this portal manufacturing that we're discussing here is I think one interesting area to look at. So you're looking at new technologies. This was brought out in the report to 3D printing, supporting specialization, supporting production or personalized medicines which we talk about a lot on the medical side. I think a lot of us on the medical side I don't fully know what that means. Can we actually dispense closer to the patients. Also, it's been talked about can we have bedside manufacturing. Can we manufacture to the patient but very, very locally that being a lot of advantages. At one point I was involved with the Kurdistan government, where we had a lot of falsified medicines a lot of children dying, because the manufacturing process wasn't there locally. The vaccines weren't there. A lot of the tablets are being given were made out of straw. It won and sand it was not a pleasant sight. It was a pleasant situation. So manufacturing is vital to this and getting it local. Manufacturing has to be agile as well. And this has to be basically addressing things as well from the green agenda. Things like global pandemics have brought that to the fore. And we have to see that the speed of manufacturing is also increased. Next slide please. Part of this and what's what's an interesting area to look at is something that came out of the European Commission. It came out very recently at the end of last year beginning of this is the EU pharmaceutical strategy which the law was I'm sure was working with very closely under the European Medicines Agency. And this is very much ensuring preparedness for manufacturing technologies is bringing out areas such as security manufacturing, making sure that supply line is available making sure that what we have available to us is fit for purpose. And from my perspective and although I'm sitting in the UK, I can claim some degree of Europeanism out in Italian. It's making sure that the this, you know, the European side has a strong voice globally under ICH, and indeed with yourselves at the FDA as well. And also, I think it also brings to the, the, the four things like manufacturing diversification, which is vitally important. Thank you. Very recently we've had something called the European Health Emergency Response Authority set up called HERA. And it could be named after the Greek God, but actually it could be HERO. And this is basically being set up by the European side to make sure that we if we have a situation like we've had with COVID, we don't get caught off guard again. Manufacturing is a very central part of that. And this is why the pharmaceutical strategy emphasizes it. I'll say very quickly at these pods because I think it encompasses a number of interesting areas. These are multiple units that can be housed at a fine set of pharmaceutical operations, but can basically be copied and copied and copied to basically become fully autonomous and can be replicated in an equivalent manner, the process and the quality that you might have in one country to another site in another place. And this should lead to consistency, high production volumes, and a greater patient responsiveness, whether it be local or globally. Next slide please. Well, they also raise a number of interesting issues about acceptance of things. If you go down this module approach on a global basis, is the site itself autonomous and mobile, but also where does that sit with GMP? I do lecture on GMP, and I know just how important it is to make sure it's replicable and make sure that wherever that unit may end up, that can be replicated back to GMP, which kept where it was in the host country. So GMP is a series of registered establishments. We can validate against it. And how do we sort of validate against ability and validation studies in a changed location? It's an interesting area. And something which I thought was very, very interesting when I saw this as a concept. And how do you do things against insurance too? How does insurance cover things like that? So general recommendations out of this report and things which I think are very important are things under ICH. Are we taking those ICH areas adequately forward in things like portable autonomous manufacturing? Are we taking them forward in areas of emergency usage, which we all know too well under COVID? Tom mentioned this, I think, but generally before, with his work on ICH. But are we actually building those discussions between our manufacturing colleagues and our quality offices, whether it be the MEA, the MHO or elsewhere? And I'd just like to finish on another couple of points. One thing which I do think is vitally important and came up in discussion I was showing earlier is manpower. And one thing that came up in this consensus report too, manpower, but not only manpower, but education for that manpower. The technology we're seeing now is so advanced that it wasn't even an existence when I was a doctor several years ago. We're treating people with things like immunotherapies, which didn't exist. Key Truder was an amazing technological advancement, which I didn't even understand when I looked at the original data from SD. We need to educate people and constantly educate them. And we need to do that as well for the agencies. The MHRA, and it's a bit of a problem at the moment, is actually dropping a third of its staff in the UK. I don't know if the FDA know that. And everybody else on the MHRA side is reapplying for their jobs. It's not right, it's down to money. It's partly because we pulled out of Europe. I'm not a Bexiteer, but that's putting a lot of stress on the MHRA. I'm sure the MEA and indeed the FDA got similar problems with money, but also with training. I think that's something we on the industry side can help with and probably should help our colleagues in the agency side to make sure that they're trained properly and understand the problems that we're having on the industry side. So Tim, I'll leave it there. I hope I haven't gone too much over my timing. Thank you. Thank you very much, Malcolm. Appreciate it. We're doing okay here. We'll fold you're on. Not very helpful and thought provoking comments and we'll pick this up in the discussion. Last speaker in this, this short talk session is Mike Oregon, who is owner and managing director of Horizon Controls Group, which is a full service digital process automation company founded to promote the best that the field of engineering has to offer. Mike, welcome and thanks. Thanks, Tim. Can you hear me okay? Yes. Very good. Thank you and good afternoon, everyone. And I'm really honored to present here today on behalf of Horizon Controls Group and the International Academy of Automation Engineering has been a fascinating conversation up to now. And I think a number of the points that I might raise today have already been covered, but I think just Malcolm's finishing points there on manpower and education are something that's going to really resonate with what I'm about to say here as well. So just a little bit of background on myself. I'm originally from Cork in Ireland, and I moved to the US in 2004, and I'm calling in from Bluebell in Pennsylvania today. And as the founder of Horizon Controls Group, we're an automation engineering company who are very much focused on and 100% focused on the life science industry and providing solutions to the manufacturing and the laboratory space within those in that industry. Additionally, we have an area of business that's very focused on training and the upskilling of people on the different platforms and use in the manufacturing space. And in addition to within Horizon Controls Group, we have a growing area of our business that's very focused on the mixed reality and the augmented reality virtual reality applications for manufacturing and laboratory situations. That encompasses machine learning, object recognition and a movement for our business forward with digital twins. It brings me to a point where I might mention a project that we are involved in additionally at this moment in time with MXD. It's funded under the CARES Act, and part of the remit is to install digital twin technology at two life science manufacturing companies and to test the benefit of the deployment of the twins in the event of another national emergency. So really to stress test the benefit of the digital twin. As part of that project, we are working with MIT and we are conducting a survey of companies and of the government, the FDA and bodies and also academia. And if anybody is interested in participating in that survey with us, and we'd be very keen to have you participate and then get a readout afterwards of our findings, which I think is very relevant to the topics we've been talking about today. And hopefully you'll feel the same. On the area of the International Academy of Automation Engineering, it's a not-for-profit automation and digital manufacturing education and capability building entity. I came up with the idea back in 2012, and along with some of my colleagues that are on the call here today and would have put a lot of effort into it over the last number of years since 2016. So just to give a mention to Malcolm Jeffers and also to Gemma Doyle on the call here with me, a lot of great effort. We stood up a life science advisory board in 2016, and some of the advisory board members are on the call today. Specifically, I know Sally made a number of very worthwhile comments earlier, specifically around the change management and the people aspect of that as well and coming back to Malcolm's comment just in the previous conversation around the manpower and education. I think this is a nice intersection point for us. The life science advisory board is made up of leaders from a number of companies, specifically Thermo Fisher, Biogen, GSK who are on the call today, Pfizer, Takeda, Genentech, Vertex and a number of others. And then we'd encourage participation from any of those that are interested. Typically, they're leaders that have a global automation remit or maybe data science remit and analytics, and they bring a lot of taught leadership to the table. And then we leverage what feedback we get for them. We do some research and we share with them, and then we take that into our education programs. So we've a very comprehensive education program built out and it's available online. And we've also worked with Nimble and delivered on some some projects, most recently the spider to project, which was done in association with NC State and Worcester Polytechnic Institute as well. And there was a cohort of maybe nine participating entities on that project. I think it was one of the larger projects that Nimble had led and it was very successful. In addition, we've done projects with MXD and we're also one of the founding partners of BioMaid as well. So that's just a little bit of background on the IWAE. And it kind of leads me nicely into the maybe the next slide, which is an area that I want to speak to. And it brings us to a project that we were recently involved in with MXD. And it's very much similar in the approach and the outputs as to a lot of the conversations that we're having with the committee today. And it's focused as you can see there around the analysis of the advantages of and the barriers to adoption of smart manufacturing for medical products. And this came about shortly after the country went into the world went into lockdown and we started a project in May of 2020. And our remit was to identify and interview a number of medical product manufacturing companies specifically in the US. We identified over the course of time, 10 companies, 10 participants, and nine of those were individual sites within the US and one was a corporate entity. So it gave us a very interesting perspective. And what what we did was we set out a program whereby we focused on the traditional digital transformation and technology adoption approach around people, business processes, technology and regulatory affairs. And we identified leaders within each of the organizations that had responsibility in those areas. And then we set about a engagement which had a comprehensive online survey. The second part involved us utilizing the bio forum digital plant maturity model where we did a deep dive on each of the areas and the questions in the DPMM such that we could get a pulse on where that client sat from a maturity level. In addition, we did a comprehensive interview session with each of the stakeholders, and we basically then generated a lot of content. We de identified the data, and we provided a report back to the FDA, the OSET Office of Counterterrorism and emerging threats and department within the FDA and would funded the project. And at a later slide here and I'm sure as the committee shares the slides and content we will be providing a link to the report that was published and just recently on October 1, and by the FDA. And some of the what you're seeing on the slide now is just one, one, bringing up a couple of slides from the study. And but I'm not going to go too deep into it, because it's much more comprehensive and I'd encourage you to read the actual report that's available online. But what we were using here just a framework and the transformation map that shows a lot of technologies as it's applied to our industry. And basically, we worked each of these technologies into our survey and into the plant maturity model and into our interviews, and we extracted as much information as we could from the participating companies. And we collated all the information and we came up with some interesting findings. And specifically if you just just to move the text will change here just on the next slide movement. So these are just a sample of some of the transformation map items there it's a little bit of an eye test on the left so just figured out make them stand out a little bit. And but specifically you're seeing things like the artificial intelligence and robotics that we spoke about earlier this morning and the future of computing and again I think that's interesting in the context of where where industry is going in the next number of years and I had an opportunity to attend a conference just before COVID and in MIT last year and around the topic of the future of computing. They brought in a number of industry leaders from the IT space and Google and other MIT researchers as well, and they were focused on quantum computing and how it's going to find its way into industry over what they felt was that it's going to be about 10 years from that stage before it starts finding its way in. But I think when you take that into context now of the acceleration through COVID and what we're doing with data these days it's going to push even further and the advent of quantum computing in manufacturing I believe. So some of the other areas there the wrong focusing on leadership and digital transformation of the business processes and then innovation and the whole topic for today. So these were just some of the extracts from the chart on the left. And if you move forward on the slide. Please. What one of the outputs that we have inside our report is this quadrant here which is showing just a kind of a benchmark for the digital mastery for some of the participating companies and the chart that we have was an extract used under permission from a book that was previously published around the topic of digital transformation. And you will see that the two blue dots there was originally from the book. And that was indicating the benchmark of pharmaceuticals and manufacturing and just manufacturing at large in 2012. And what what you're seeing then there is with regards to digital capabilities on the vertical access and the leadership capabilities on the horizontal. You're seeing the placement of our participants on the red dots. And what you know what you can read for that is that there has been an advancement as specifically in the life science industry since the 2012. Now again it's a small sample set and typically the companies that participated in the study came from a background in vaccines manufacturing PPE manufacturing at therapeutics and medical device slash diagnostics manufacturing. So again a small group but I think it was a valuable insight into the status of the industry and a relative to the topics under study. And I think it also teases up a number of new opportunities to continue studies and to develop out on what our findings were here. And if you just move forward just to give a bit of context to the quadrants here and just move forward the text will change on the left. And what you'll just see if you jog forward and you see that the beginners. And again it's fairly self evident the tech wonders. I want to to next on the conservatives and then lastly the digital masters. So what was noteworthy on that and again I listened carefully to a role in earlier and role in was one of the sponsors of the program that we rolled out from the probably the Biogen were an early adopter of that content and they rolled it out at each of their facilities. And I think again when you when you see the level of advancement that the likes of Biogen have made you see that that a number of companies are moving strongly towards you know the digital mastery. And what was an interesting point that one of the participants mentioned that the digital transformation is not so much a transformation but it's an evolution right it's ongoing it's not a there's no definitive end here in this that it's a constant evolution. And I think that's that's evident from some of the conversations here today as well. So again just if we move forward on on this here just to maybe speak to some of the findings additionally. And again I'm taking some of the slides out of context from the survey. And one in particular that's that was stand out in the survey that we were doing, we can jog forward. I think this will resonate with the broader group might be having some some updates delays area so it's just coming up on my side there now so one of the questions that we worked into our questionnaire was asking manufacturers to put on the list of suggested actions from the 2020 National Academy's report, which I think it's very pertinent to bring this up today. And you'll see that there was a number of the actions listed down below and there's the responses are in the vertical columns above. And we've, we've bolden those that kind of stood out the most from the responses. And therefore become familiar with condition based monitoring approaches and provide incentives for their use and I know that was a topic there around the incentives that was discussed at length this morning. So just thought again just some interesting feedback for the committee here on using some of their data in a different context and with a different pool of people. And I think there are five that inspection staff have the expertise to understand the technologies and the best practices in their application. And I think again we spoke at length before lunch around the benefits of upskilling and coming back to Malcolm's point here again on manpower and education. I think we've had more lunch about that the need for it to somebody education, an ongoing and continued education within say the FDA, and but also within industry and I think what we're seeing at the moment is unprecedented movement of personnel within the companies. A lot of mergers and acquisitions that have gone on. And is that a disruption or is it a benefit to the digital transformation and adoption of technologies. Okay. So I think we've addressed some of the kinds as you as you dig into that and, and again, just with considerations and time. I think we've addressed some of those in our study so you'll be able to find that but again I think just the unprecedented movement in the last number of months of personnel is is going to be another challenge on top of education and and the baby boomers retiring and, you know, compete competition from other industry verticals as well so there's a lot of challenges out there. So I think what you know what we found as well is that some of the companies that were advancing their digital transformation were conservative in their feedback and kind of humble in their approach to their advancements. When you compare them to some of the other companies that were maybe not as advanced. Those that were advanced were maybe, as I said, being humble and maybe being tough on themselves because of what progress they were making which is a considerable lift for companies and challenges and some of the feedbacks that we were getting were around the competing priorities which is mentioned earlier, legacy systems and insufficient funding and, you know, just the need for stronger leadership as well right so I think the migration of talent is going to be a challenge to the, to the strong leadership standing place to guide any one entity forward. And so if we if we move forward here I think is maybe done towards the end of the slides here, and then in kind of wrapping up I would maybe just speak to a couple of points here that from a key finding this there on the technology front and a number of the companies were saying that they're slow to adapt new technologies for reasons and outlined previously but what they're looking towards is other companies and other industries are proving the technology first to basically take out some of the risk from from them subsequently deploying it. And one interesting observation I made during our study was a one of the participating companies was part of larger, what I would say, and within their organization, they were the medical manufacturing arm of the bigger company, but elsewhere in the company they had manufacturing entities that were making huge movements in the digital transformation space, and therefore as a byproduct of their progress, the medical division was able to leverage some of the technology deployment that they were making. So I think this kind of stands out to one or two of the points earlier today that of adopting what's been done in other industries, more quickly and partnering with those industries just for sharing of the knowledge, but again that was something that just stood out to me they were able to do it all under one umbrella, but wherever we can, and obviously trying to leverage what's been done in some of the other industries. So the, on the technology front some of the key takeaways again a number of the companies looking towards big data, and the adoption of cloud computing, and also their focus from a technology perspective around cybersecurity, and specifically related to related to AI and machine technology, and lastly then on the technology front around robotics and robotic process automation from a business process improvement on the regulatory side of things wanted takeaways was around headcount to be able to implement more broadly that was seen as a challenge and a barrier. And then we spoke into somebody others that was related to the National Academy side earlier on the people side of things low levels of training and unknown levels of training within organizations. So basically you could present that as visibility of training and maybe insufficient levels of training was seen as a barrier to moving the digital transformation forward as well. And I'll finish on a last point that it's most likely that we presented one one selection of slides and asked them what was most likely to be there areas of training that they would focus on and the leader on the result there was around operational excellence. And so again not necessarily technology focused, but more on the operational excellence side was it was the leading result there but again you'll find a lot more context and a lot more information and on the slide on the reports per the links that are shared here and just leave with a little bit of humor. At the end of this, there was one comment fed back to us and said that, you know, with regards to and relative to the international and the international challenges and the compliance challenges and references earlier to harmonize harmonization. One person commented and said how are we going to achieve harmonization when we can't even agreed on the agree on the spelling of the word. So I just thought that was an interesting piece here given all that that was said previously so again I thank you for your time. Happy to answer any questions in the follow up chat. Thanks. Thanks very much Mike for that. And, you know, perhaps we can harmonize the conversation and then during the community discussion by whatever spelling you all would like. And thanks, Tom Dolores Malcolm, as well as Mike for for your comments and now we're moving into the community discussion, and we really want to hear your voices. And, you know, this is an opportunity for you to speak up on what you view as the hurdles to innovation for the community as a whole. This is particularly important because we have, you know, preparing for tomorrow's discussion on solutions and a path forward. The speakers in session for tomorrow morning and Sally who's preparing to moderate that discussion are dependent on you in the community to speak up and talk about what these hurdles are what the gaps are today that that we see today, so that they can begin to make solutions in response to, you know, these observe gaps, both those that have been spoken about by the speakers, and those that the community as a whole have voiced. So I urge you, please to use the slido issues, I think there is ideas, excuse me, if you just have a comment there. I think it's something that you'd like to raise on something you want to talk about we appreciate that you can use the q amp a to pose questions to our speakers that react to their remarks, that would be appreciated also we'll use the for both of those, but I'm going to get it started a little bit while people are getting going on that with a couple of my own questions that I've been thinking about and we heard about innovative technologies and existing mechanisms and sessions one and two so questions here and I want to get see see what people have to say and we'll we'll we've got the panel up here on the on the screen so I won't call on you but you're certainly welcome to volunteer first others raise your hands as well. I have a question that we haven't, you know, completely and overtly spoken about, but I really like people the voice is, you know, with regard to the technologies themselves. Do people feel like that the pace, perhaps the slow pace of implementation is due to insufficient technical readiness. Fundamentally, you know, is that part of the problem, or is it not part of the problem. Any any thoughts on that. I'll start I guess I do think that that may be part of the problem, Tim and I think that, honestly, part of what we saw in some of the examples today I thought were good examples of investment in technologies ahead of deployment, particularly Norendra's description of technologies that GSK was investing in might be a good example and, you know, in from my perspective, by doing that. Now we're better positioned to implement that technology when appropriate application comes along and I think I've heard from a number of my colleagues in industry that, you know, a lot of times that by the time you know you need a new technology. You don't have the time to develop it and so if we can be proactive enough to invest ahead of the curve in technologies that we think we might need. I think we'll be in a better position to deploy them when when the when the real need materializes. Actually, I think a good example we have seen with the COVID vaccines with the leaping nanoparticles although we had on patrol a proof few years ago, then we because the technology was available as several other companies have been have been using that technology and have been able to develop the vaccines in such a speedy manner. That's right as well, Tim, because you know, the technology we've seen in the COVID vaccine is something we can use for other things that one of the biotechs I'm involved in is using that technology basically something which is different. And I think also I think there's a lot of feeling and I remember this from my regulatory days. You're not scared. But you know, as it came out of the report, a lot of the technologies have in the past been developed for one product or series of small in a small areas of products. So we can get down the line of developing a technology which can be more applicable to a wider range of things are better. Maybe that's something we should think about and say that we're going to give grants innovation awards and stuff to technologies which can have a wider remit there may be a very narrow group of products that may be easy may not be. But when you're looking at artificial intelligence systems. That's obviously an error on the control side where you could do that. So I think that's a very interesting question. Thank you. Any other comments. Thanks. Yes. Actually, we have seen that with other technologies for example continuous manufacturing the first sponsors you will know that use this technology that they have been using the platform they develop with few adaptations for other products and they reach the market. In a more, more quickly faster. So I think there is an advantage there. Of course it takes time and investment to develop the platform but once the platform is there then of course they the development goes quicker. If I was just to add something as some feedback that we often get from from clients when we're engaging on the education level is for more of an industry academia and engagement because what they're finding is that with a number of the graduate graduates when they come out that it takes quite some time to get them up to speed to be autonomous at the plant. And so that's not just from an automation perspective, but I'm just saying in broader terms as well. So I think we need to kind of continue to evolve in the education space to make sure that what we're developing for the industry by way of personnel is appropriate and can help the companies to work faster as well to adopt faster. Thank you, Mike. If I could just add to that. I, my experience is that should be bidirectional. Also, because the students that are coming in often can, especially in areas like digital. They can sometimes affect the thinking of people that have been in the industry for a long time. Rex looks like he's raising his hand. Being in education, I guess I have to say something about that. And particularly since I'm on the side of education that really uses the digital technology and the modeling and the control. And I think the challenge for the pharma industry is actually to attract and retain such students. There's plenty of examples of students who spend a year or two doing applications, one of your companies, and then they join a technology company, a software company that gives them financially much bitter perspectives. And, and I think you have to find a way of motivating and engaging them and keeping them there because that talent pool is on demand across many sectors. Yeah, that's absolutely true. And I think, you know, more and more training is a core competency for all of us, right. And the more we can come up with creative solutions to train our workforce in areas that are important, the better. But we see that as well in the data analytics field. I mean, you can't hire people from top programs that are going to Wall Street or wherever making, you know, way more money than we can offer them. So we have to come up with another mechanism to get that talent into our organizations and train. Yes, this was another topic that I covered in my talk, the partnership with academia, because we all know some, you know, the basic research and so on, generally is done by academia and then it's transferred to industry. So I think the partnership and the collaboration among industry and academia and regulators as well is key to make this translation of these technologies into the market. And one thing actually on that point to him and to bring two things that you mentioned together to some extent as well is is my son's working in but in aerospace. He's he's he's he's qualified from aerospace and rocket science. It is rocket science. But you know what I see from what he's doing is you could take a lot of the technologies on the academic side and bring them over to the other side. We see this also on the business side generally we don't always bring together the farmer components of a company of an academic unit together with the business side. It happens in Kings in London where we've got a very strong development team at Kings London got a business school they don't talk. Sometimes we don't you know could we get I don't know the Swansea or the Manchester Aerospace Group to be talking to the farmer group academically but wider. You know we've also got the Crick Institute in London two and a half thousand PhDs in one building over 12 floors amazing. What they do with it goodness knows they don't develop it very much for this terrible but if you got them involved together with the tech team