CDMO + Emerging Bio Partnership with Forge's John Maslowski and Ray's Jenny Holt

I'm planning a good 30 minute grilling of BlueSphere Bio CEO and Biotech legal expert , keir Loyakano , on legal and IP protection considerations for new and emerging biotechs .

Keir is an Esquire and a veteran biotech attorney turned CEO with a ton of experience , and when I'm done with him , I'll turn him over to a select group of viewers you business biotechers who will have the benefit of 30 minutes of face to face Q&A and interaction with Keir and other members of the call .

This hour will be incredibly consultative and offer great value at no cost but your time , and it's an opportunity for some face to face virtual networking with fellow business of biotech listeners who just so happen to be the coolest cats in the business .

Go to the link in the show notes of today's episode to register and I'll see you there Back in October 2021 . On episode 65 , we enjoyed a conversation with Forge Biologist co-founder president and CEO , tim Miller .

That conversation focused on the growing biotech's effort to balance demand for its CDMO services with development of its own internal pipeline of candidates for infantile Crab A and rare monogenic diseases . Since then , the company's CDMO services business has exploded to the point that it's now a global leader in outsourced gene therapy manufacturing .

One of its clients , a biotech called Ray Therapeutics that's developing optogenetic therapies for a range of degenerative retinal diseases , was also featured on this podcast when Ray co-founder and CEO , paul Bresge , joined me last October on episode 119 .

This episode is special because we're bringing Ray Therapeutics and Forge Biologics back this time together for an introspective dive into the genesis and continuity of the sponsor-outsourcer relationship . I think it'll prove educational for any biotech seeking to create outsourcing success from the outset . I'm Matt Piller . This is the business of biotech .

Joining me from San Francisco is Jenny Holt , chief development officer at Ray Therapeutics . From right down the road , so to speak . Maybe the other corner of the state Filly is John Maslowski , chief commercial officer at Forge Biologics . Jenny and John , welcome to the show .

You're sort of a member of the supplier vendor community to us . We focus on biotech , exec , so one feel privileged , feel honored that I'm having you on this show .

So we thought best to have all these drugs on the market so they can all access them and treat their care as much as they need to . That mutual admiration turned into an opportunity to work together and you know I've been in the cell and gene space for about 18 years now .

I go quite a ways back and most on the board of the Alliance for Genive Medicine as well . We track and really advocate for the space globally . Manufacturing , of course , will continue to be one of the sort of ongoing needs that will continue to grow and evolve with such complex processes .

You know , having experts centralized in a way that can help growing biotechs actually advance their programs really is a benefit . So it's me , you know , being asked to come in and run , but essentially the commercial wall of running not only sales and marketing more in the classical sense but also the client relationships .

Our client resource group will actually work directly with groups like RaytherapyDix and help them , you know , not only keep them up to date in advances of their program , but also answer questions . You know interact , work very collaboratively together . You know that also falls within our commercial group as well .

So I have the lucky benefit of not only being part of Forge but also getting to touch on all these wonderful advanced therapeutics that are coming through our shop and seeing them come to fruition . So yeah , very nice .

That episode is one of my all-time favorites for a couple of reasons . One , because Paul is just an amazing man , like an amazing man with a super inspiring story , and I just really really appreciated his transparency . But also , selfishly , because that episode lit up the scoreboard man , like that episode has done so so well for us .

It really resonated and that's one of the reasons I'm excited about this episode because it's going to follow a similar format . We , you know , in that episode we had Paul and Dima on talking about their relationship .

You know , sort of that ecosystem of biopharma and investor and here we're , you know , kind of having the same format in the discussion around biopharma and outsourcer . So Ray's a great company . Paul made that very clear . Super exciting place to be . How did you end up there and what do you do in there ?

In my background I have over 25 years in gene therapy and you worked everything from biotech to big pharma . I worked as a scientist for a good chunk of my career and then I went into the management side program management , alliance management , and I'd worked at a few startups . So I became aware that Paul needed a project manager .

You know we do have a grant with CERM and that is a requirement and we were great relationship with CERM and we suddenly he needed somebody and it was a good time for me . I was at 40 molecular therapeutics and other AAB gene therapy based company phenomenal company . I loved my time there .

But I do love that startup environment and Paul is so inspiring that I thought you know what . I think I can really help here and really help get this company off the ground and working with Paul and I became soon after the chief development officer it's more recent After going through a series A-ray , series A .

After going through a series A-rays and we're fortunate enough to raise $100 million , I became chief development officer and so now I work closely with Paul and our chief scientific chief medical officer , peter Francis , and , of course , the entire team just to help monitor everything that goes on at the company yeah , yeah , activities , anything and everything .

So I'm really enjoying it and Paul is inspiring and his story and the patient perspective is on our minds every day , definitely .

Luckily , we have the opportunity to market widely and use a lot of our mechanisms including Marina , who met earlier , and the rest of my marketing group to really get to meet these qualified leads , and Ray was one that's come through with a lot of wonderful feedback about their technology , about their target audience for patients , and so for us it was a wonderful ,

intriguing project to hope to take on .

We know what we're doing and I've been my past being on the development side , so I've luckily got to be on both sides of the fence . Know that when you go to a CDMO and you end up teaching that CDMO more than you're actually getting service from , it's a very frustrating place to be in a group who really needs , you know , time on their side .

You know they have cash burn , they've got a board and they also have patients who are very , you know , have been waiting a long time for relief , and so with that in hand , you want to make sure you're working with the right people and that you also have a platform to get you there quickly .

So we endeavor to show that not only just meet the commercial team but meet Dr David Dismuik , our chief , our chief scientific officer , our chief technical officer , and the rest of our team will actually be the technical leads working in our true AV experts in their field .

I think that you know that to us is how we would try to go to Ray and say you know , hey , you know , look what we have . Come see our facility , make sure you're comfortable and and that you trust us as a partner .

They hired a consultant and did a very rigorous landscape analysis , looked at the number CDMOs are , determined who is the right fit for us and , as John said , who had the right stuff and and that became forage . And so that was , you know , learning . That , you know , put me at ease . And , as also John mentioned , the technical expertise was a was a big one .

David just MOOCs , not only a experience , but he actually has some background in optogenetics and we're an optogenetics company . Yeah , I was gonna .

We wanted more of that collaborative partnership style , not just a provider . And that was also what we established with Forge and that was important to us as well .

The consultation engagement that that led you to forge as a candidate and sort of the I don't know , I guess , sort of the criteria that knocked , knocked some of the other folks out ? Maybe some color on that .

So who we work with , we still work with . This is a well established company that with you know , with solid technical expertise and the people stayed and the company had good funding .

There's also a lot of new CDMOs popping up that don't make it and then that's a risk for your project and forge had good funding and was established and so just they just kept checking off all the boxes as we were comparing them .

it's mind boggling and the money going into them . So this is the space I cover emerging biopharma . And you know I interview hundreds and hundreds and hundreds of execs of emerging biopharmaceutical companies who outsource their development and manufacturing . I mean , how can you not make it in this space , forge ?

When I talked to Forge a couple of years ago they were already big and growing . I mean , the success has been rabid there . It's like how do you not make it Like well , I don't know , I don't know if I'm asking you that question rhetorically .

Let's look at the volume of clinical trials and cell and gene therapy . Arm reports on them . Every year they're growing . The year over year was 11% , you know , that was reported previously and I've seen numbers ranging , you know , you know quite a bit , gaining that growth and then the turnover for commercialization .

So you know , luckily we are continuing to see the agency approving more cell and gene therapy products and that reimbursement is occurring , you know , and getting through payers . So as this sort of you know , acceptance grows , so does the manufacturing department .

So , to your point , it sounds like every leader , every cell stack , every , you know , cell factor , everything should count . But then it comes back to I think what Jenny and I were sort of talking about is , you know , is the right team in place ? Do they have the expertise actually carried them along ?

I'll give you , for instance , like we have our own regulatory support as well , some clients , you know , when they're very small , you know , struggle to navigate the CMC field with the agency . It's sort of , you know it's ever changing .

So our head of regulatory , chris Schilling , was with Nationwide for , you know , for many years and saw dozens of INDs , including those who recently approved drugs . So that expertise , I think , is what will centralize a lot of the companies to come towards and maybe consolidate some of that manufacturing .

But it's difficult to get that team together and be properly funded because it is a lot of capital right to build a facility and build the infrastructure and do it correctly and qualify . And I think a lot of people forget about qualification validation . That's a big lift and I think that's where some of the differentiation occurs when you're selected .

You know I hear from my vantage point , spending a lot of time talking with the leaders of emerging biopharma companies . You know well , I should say , when everyone was flush with cash , you know , pre-covid coming into COVID , like when COVID there was just money everywhere .

Cost , I mean , yeah , it was expensive and people talked about the expense , but it was sort of not as big a factor as timelines . And then I would say scallop might have been a close second right , the ability to scale .

Give me a , I guess , just give me some color on what you're seeing now , Jenny , from like what you're seeing in terms of timelines and what a company like Ray's expectations are . You know I liken it to this is a very bad . My wife tells me I'm terrible at analogies all the time , so I'm going to put that on full display right now .

It's kind of like an outsource . A CDMO is like a mom or a dad who has , you know , 47 children and they're all clamoring for that same amount of , you know , for a finite amount of time , a finite amount of like resource of attention , and that if dad doesn't have a partner or whatever , like it's , you know it's tough , right , like it's tough .

Yeah , yeah , I proved it . It's a bad analogy .

But you , you know , I have a big background in program management and there's always that I think they call it the golden triangle where you balance quality , time and cost and you have to decide what are you giving on , what's flexed If one , if one side of that triangle changes , so do the others .

So it's a constant balance and we have to decide what's as important to us . Now , obviously , gmp manufacturing , going to the clinic , quality is not something you can cut corners . This is going , you know , going to treat patients . So then you're balancing okay , you know a timeline budget .

So we have worked really closely with Forge , like you know , telling them , you know our goals to get to clinic , you know , and work with them and how to reach those goals , and always balancing budget , you know . But if we have changed the budget here and there as we go in order to hit all the other goals , you know .

But working together as a team to have those discussions and make sure we keep that quality in mind , as well as an appropriate timeline for rate therapeutics of the company . It's a constant balance and a constant conversation actually .

I went out there and recorded some podcasts with a few execs at their HQs and in a couple of those conversations we were talking about how , like , the BPI show was going on . You know , it's like a . It's like a . I'm not sure if Forge was there or not . I'm not sure if I saw Forge there or not .

But we were talking I talked with a couple of these execs about the difference in the difference , like the change from like sales engagement with an outsourcing BD , business development wrap through contracting , to execution , like where during that process , like things can often go .

Like you know , here's where we were during the sales process , here's where we are now and it doesn't align Like it's not . You know , what was promised isn't necessarily there .

Now , jenny , I know you weren't there , probably during the contracting phase , but so , john , I'll let you kind of comment on that , like in your experience , having worked on the other side as well , right , Having . Worked as a biopharma exec .

What are some common areas of failure between the pitch , the contract and the beginning of the execution of the relationship ?

And we did it a little differently in fortune our past of our experiences where a couple things when people tend to be involved the entire process I've had experiences where you talk to a client development rep and then you're moved to legal and then you're moved to contracting and now you're on your sixth or seventh contact and it's whispered down the lane .

All your terms are starting to get a little muddy right . So what we purposely do at Forge is we've established a couple subteams that all work with that client through the entire process . It's generally a client development representative , which is sort of the folks who are out there making the relationships and spreading the sort of Forge story .

But we also carry a technical sales group . And why we do that ? These are , you know , a-v scientists who work exclusively on the sales side to act as almost like an NSL if you're talking about in the classical pharmaceutical drug sales term to help partner with that client development rep and explain the technical parts of the process .

So we're not pulling all of our processes developing people off the floor every day . They're actually scientists who are trained in that area and can move ahead . And then it moves into the client relations who are also involved early .

So that whole process is seamless in that you know it's the same team we're keeping in contact , so there's a clear understanding of transparency with the client . We also provide technical questionnaires and meetings so we make sure we're actually creating the right program . You know what is your stereotype . What sort of comp is it ?

Is it single , stranded or self comp ? You know what's your . You know what's your target tighter goals . You know what's your route of administration , even just because we want to make sure we're fashioning the right product profile for that particular program .

I think if that's done piecemeal along the way , you lose that traction and at the end you end up sort of different street from where you started your journey . So you know one of the goals we have is let's eliminate a lot of that noise and try to keep it seamless with the same group .

Are you , john ? Are you the primary caregiver to the Ray relationship ?

I think this is an important point and maybe good advice to other CDMOs and I know a bunch who do this as well but I see it missing sometimes where there's not sort of that .

You know , that concierge approach of this is the person to come to who will coordinate and be your internal advocate and forge , and that's what this client relations group's job is to do is to make sure if Jenny needs something , they get on the phone right away . They make sure that we pull the right team together and we're answering questions .

We're working through a scientific , you know , sort of sort of puzzle together and you know we make sure that advances properly . So that is , I think that approach is very important , you know , to keep a sort of transparent and honest relationship through the process .

And although their routine you know sort of discussions occur at , you know , on a daily level , there's also access to Tim and I and to David .

We're on a lot of these calls as well and that's also important too , because we need to , you know , we want to make sure that , you know , jenny and Paul and everybody on the team and Peter really are heard and that they're making sure they're having the right sort of you know questions answered , but not only that , that we're meeting their sort of time needs ,

because we've all been on that other side of you know , you know we , there's a study starting , we have to make sure you have delivery , and so I think it's important for groups to not get overly regimented about . Here's your manager . Good luck , you know it's really you really do need a broader personalized relationship . We tried to do that .

So Jenny and I met when she joined and we've seen each other at conferences , playing just at HGCT recently , and I don't know , jenny , if you'll be at the Met meeting or the Mesa meeting next week . We'll both be there and catch up there as well .

But tell me about those weekly meetings what are you doing , like ? What are you doing in those meetings , jenny ? What do you need to come away from those meetings with ?

We want to go over this technical step , we want to , and it's usually an update on status . It's a very mutual building of the agenda and a lot of back and forth from both of us . So that's weekly and it keeps us up to speed .

And then , as needed , there's ad hoc follow-up if we don't forget out of time or have more questions , or obviously email follow-up . So I feel like the team is accessible to me anytime it's needed .

And sometimes I'm like I can't remember what did we talk about with this and I'll just email , said I'm so sorry I can't find my note , can you remind me of what ? And they get right back to me within a business day , which is pretty rare for a CDLO to be that communicative .

And , as John mentioned , I've also had a lot of interaction with John and with the CTO , david Dismook . They're also there for us anytime , which is also rare , and it's not going above the team's head . It's just sometimes you want to get a different perspective or just have a discussion in a very professional group .

The pod is brought to you in collaboration with Citeva , a global provider of technologies and services that advance and accelerate the development , manufacture and delivery of therapeutics . Check out their resources at Citevacom backslash emerging biotech . That's CYTIVAcom backslash emerging biotech . John , I'm not going to ask you .

The first question that popped in my head listening to Jenny's response for you was how does Forge enable that level of attentiveness ? I'm not going to ask you that question because it's going to give you too easy . It's a softball .

How do I test that ? How do I test that out with a number of potential CDMOs to feel like I'm insured that I'm going to have that access going in ?

But I think the way and this may be a little bit of my past activity when I was doing my own searches , but we see a lot of clients do this is visit them physically , visit them and , if one , if you can get a visit and get a tour , that's a good start . There are actually RCDMOs that won't do that .

They say we don't give tours or we can show you a video or our facility and upon that visit , who actually attends your meetings , who comes in and says hello and actually walks you through these sections ? And I can tell you that David myself are very common features in those intro meetings and we do that . There's a reason for it too .

We want to show that we're committed and also to show that Forage is sustainable and come and see who's leading Forage and come see it's a sustainable business and give you some comfort .

New potential client you deserve that coming in here , even if you're a seed round group with great tech and still waiting on your Series A , but you want to start with some early research work . They should receive the same service , in our opinion .

So the other way we sort of manage it too is we're very careful not to overload our teams , and by that I mean you have to carry so many representatives . There should be a threshold that representative actually sort of manages . So you don't want a client relations manager who has 30 clients all in GMP runs . That'll be .

How do you white go out of service like that ? You just can't . So we're very careful with our hiring . We obviously don't over hire . We want to also make sure that we keep our touch points very personal . So we actually monitor these actual numbers and make sure we're maintaining them through the sort of life cycle of our clients work .

So how do you give it , give us some flavor on how you guys work together to tackle challenges that you might face , like some , maybe some of the unforeseen , and then you know we're collaboratively to fix those challenges .

It's not an easy job and with there is any challenges on the manufacturing side , we always grab on to forges technical experts first , and I have the technical experts I speak to on a weekly basis , but they will then , and the client relations manager will go grab additional technical experts as needed if there's something we really need to discuss and what's the

next best step , what is that next best step ? And sometimes then David Dismut gets his input , and so that's usually the approach . We have to take a holistic look at you know , what's the challenge , what's the technical aspects , what are the options ?

And then take it internally and go okay , what's the best choice for a therapeutics , what's that best choice next step and what are the risks . And so that's usually our approach and working with Forge on that .

I'd welcome you to give me a little bit of color on that , though , Like I mean , you know , the manufacturing challenges can come from all sorts of places . At Johnny's point , this is not an easy space . So what's sort of the default position at Forge around , like okay when something goes unexpectedly or when we have a problem that we're having trouble solving ?

Here's our de facto approach .

So we , we offer this as a service to our , our clients . We actually sometimes do this work also to make sure , you know , is there anything here that we can see that might cause problems down the road ? Right ?

So I like it because it's a more of a proactive approach to a program that can cut time up front , even though you may spend a little time going through some upfront evaluations . So we think that helps with success rate .

But to your good point , to you know , with all the variability of sizes of genes of interest and serotypes , obviously there's variability where you know if we have issues arise . You know Jenny sort of alluded to it .

But we , when we find things , you know , if we were to find something , there's a triage task force that comes and looks at this with our experts . And what I think is important is to come to the client with actual ideas . You know , walking to a meeting go ? Oh , we got a problem , good luck , or you know . What do you think you know ?

I think , that comes across a little bit naive if you're a you know , a self-tatted CDMO manufacturing expert and you go into the client with no ants , not even an option . So you know , what we like to do is at least create a few options , knowing that the every client has a different level of sort of flexibility .

You know some would rather go back and do more characterization work , some just wants to move ahead as quickly as possible . So we try to come up with solutions that you know sort of need , both ideas or , you know , whatever is custom fits to the client .

But we do think it's important to make sure we're at that needed , with actual data and sort of the path to the idea that's been sort of stamped by our leadership , including David and folks .

I need you , jenny , to hand me a report that is proving the value of the money we're spending on forged biologics . I need success metrics in my hands because I have to turn around and go to the board and justify all this money that we're spending in this engagement .

Now I'm not going to ask you to give me that report right now , but maybe the cliffs know it's like . If you , if Paul , did demand such a report , how would you go about sort of measuring or quantifying the success of your project ?

So for me it's well , here is our original budget and timeline , here's where we landed , when are we on time or on budget and what was the deliverable . And so for me it would just be summarizing that and showing what value we got out of the money spent in that way , and then what's next , and , of course , a lot of budgets .

You do some prepays and okay , here's what we're working on now and that is how we'll measure success of that next deliverable . So it's actually pretty easy . It would be more of a , I think , in tables and bullet points . I'd probably put a table together and show you know we contracted for this . This is when it was delivered .

This is what was the deliverable compared to what the original request was .

What's sort of the thought process there ?

We want to plan for commercial early and we've already have with Forge , establishing what we are doing with Forge now can pivot to commercial and as well as we're starting a US based clinical trials . But also we've been discussing with Forge their capabilities to release for EU .

So those are important conversations and we confirm things with Forge and make sure , like you know , are we are we going to be able to move all through trials and into other countries with Forge ? And the answer is yes .

You know , harken back to those days and now having the experience at Forge , because I know you're going to tell me like , yeah , the capabilities are all there , which is , which is great , but what questions to validate the things that Jenny just just talked about ? What questions should should should new biotechs be asking ?

Matt , the , the , the , really the sort of we're Jenny's alluding to , sort of the sort of the end to end capabilities , and I know I'm sounds like that now I'm selling again for Forge , but no , no , like I said , you pose it in the , in the you know , in the context of like these are the things you should be looking for . Yeah , yeah , and it precisely .

And I think one thing you know and having done this in my past as well , you know keep referring to some of the things I've seen . You know there's a lot of regulatory risk and actually moving products around through its life cycle . Right , you know comparability is very difficult . You're lucky if you can do analytical .

Once you're starting clinical trials and now talking about the potential to have the need for clinical comparability , especially if you're in pivotal trials , that becomes a challenge on a program that really you know is on a delivery timeline and can add a lot of time . And not only that .

You're dealing with licensing of cell lines and materials and things that you may have had at university . Now you're bringing to an industrial CDMO . So you know one thing's that you know we always wonder the first how much can we do under one roof ?

So not only can we have that continuity from discovery through the clinical process for comparability , but also , you know how do we manage this ? We're a small team . You know how many project managers do we need to look at who's doing analytical testing , who's doing the actual manufacturing , who's doing cold chain .

And then I also have a CRO to take care of it . I also have , you know , I have medical monitors and things like that . So it becomes a little bit of a corporate issue . You know , how do we continue to manage ? So that's why we've designed a little bit more of an under one roof approach .

We also think it's a bit cost effective as well , from you know , from a processing and an audit standpoint . So I think you know , for folks who are out there shopping at a CDMO , you know , think about the sort of sort of labor hours you're going to have to put in if you choose to take a more piecemeal approach .

And then you have to hope they're all talking together . Hey , you know , contract lab , my samples are on the way . Well , you know we missed them on the dock . They're going to get tested next week . You know stability pool was missed because you know we had four others that week that were from another client .

You know these are sort of things you might want to think about when you're doing your actual selections and again making sure they have the capabilities to go to commercial , like when Jennings also mentioning producing for Europe .

You need a QP designation to do that and you know , not only for the lots themselves but the actual facility producing them and , you know , have you probably scaled up to a late stage commercial design for your air flows and your clean room designs and everything . So so I think that's all you know .

Take a look at all those aspects prior to making any decisions , because what you don't want to do somewhere is have to start contemplating an expensive move that can cause a big delay .

Yeah , jenny , you mentioned when I asked , when I put you on the spot and asked you how you could respond to a Paul Bresge grilling about your investment in Forge you mentioned some completed contracts .

Can you kind of , I guess , briefly , take us through or give us some color on what your outsourced partner has helped you sort of achieve to this point , sort of project outcomes like how you know maybe how far you've been able to move the ball downfield preparing for phase one that you otherwise , you know , may not have without the right partner ?

We have completed our master cell banks , plasma manufacturing , including GMP manufacturing of plasmids , which is great doing it under one roof because then you know the plasma team and that deliverables in touch with the GMP production team and you know you don't have to try to ship things around the country , it's all right there . And so we have .

We have completed those tasks and in support of GMP production , we have completed a number of research production lots to support a number of nonclinical activities that we need moving towards our I and D filing and clinic .

And we have , we're initiated initiating our GMP manufacturing run , so that you know that's the big one and it's exciting that we've reached that point and a lot of activity right now with the team on that and so hope that answers your question we're just really full bore ahead towards the clinic with Forge .

But even just the anecdotal sense that I get spending time talking with biopharma companies that outsource development manufacturing , is that like , once you're committed , you know they're low to make a change . You commit a lot of time , energy , expense , intellect . It's not an insignificant endeavor to say you know what things aren't working out with Forge .

Let's look at X right , like it's not an insignificant . Nobody wants to do that for understandable reasons . Yeah , there's got to be times where it's justifiable . I mean people . You know people are forced to do it . What is like if I'm in a bad relationship and things aren't working out ? What's justifiable ? What's considered cause for a switch ?

Jenny , I want your perspective on this first , like what would be considered cause for a change in your CDMO selection ?

And of course there's I've seen switches happen because you know not enough communication , the activities and deliverables aren't happening and you're getting delayed and delayed and more money spent but you're not getting what you want and you've as a company you've got to work to hit your timeline . So those are hard decisions .

I mean it really has to go south to do that , but I've seen that happen with others . And but for me a more logical one is , if they can't support your full clinical development program to commercial , you have to think early on when and how do we do the switch and it is a it's a big task .

I think everything Jenny is talking about is is usually a lot of the reasons , but one I'll add is you know , sometimes CDMOs run their business on who is their biggest clients and sometimes big clients start taking a lot of attention and I've seen multiple , and you know , talking through networks , folks who had to walk from a CDMO strictly for lack of attention .

You know , which is why we were very careful about I mentioned earlier about ratios of clients versus our client relations representatives . They look , you know , they see a revenue source and their cases and they're saying , well , we're going to divert our attention there and you know , we think that's got a high rate of success .

Some of them track those types of clients very closely . They actually look at their percent chance of success , even on revenue , based on their clinical progress , and I think that's an unfortunate approach because then you lose a lot of the innovation that's coming behind it .

So you know , to add on to things like , you know , lack of lack of platform , expansion , lack of ability to sort of , you know , move to commercial .

I also think if they make sure they have the right mindset to see the sort of , you know , see the sort of sort of the long term plan and really stick with you through that plan and work towards a commercial goal together .

So I just yeah , I was nodding because I totally agree , that's a huge one . That I've seen again and again and again and sometimes you just have to leave . You have to leave that relationship . It's a bad relationship . You got to go somewhere else and that's it's hard but it definitely happens .

You know we trust them and their technical expertise so much and that's how we we've added on in our team of EPSC MC to help with , with , with , with therapeutics time . You know , in that partner , that partnership , we have to spend our time as well , and so I'm happy about that .

But I wouldn't change anything on the work we have done and have planned with Ford and I look forward to what those next steps are as we go into clinical development and planning those , those future needs with them .

And the progression of the relationship , whether that's a res , another resource at at Ray , on the CMC , your quality side or whether that's , I don't know , to be cloned because you need more time , what would you like ? What would you like to see next ?

You know we have a lot of plans and if we're successful in our first phase one , we have a lot of patients that we want to reach with these , these rare , random , blinding diseases . So there's so much to do and it's it's very much on my mind to have that time to spend those discussions and those discussions with forge .

So that answers your question , but they're just that's the focus kind of get past where we are now for the next month or two , but we and we have to start planning that future out in detail .

Or I'll let you off the hook and say , like , what do you , what would you like to see next ?

We're sort of talking to the , we're speaking to the choir with them . They know how to advance drugs , they know their targets or what they need to do . So so it's , it's a lot easier to be collaborative . But I'll speak more generally that I would like to actually see more integration .

I know I've touched about this a little earlier , but you know we we do see groups who I think you know have , have , have some raising and some interesting tech , but maybe aren't from our space and I think are a lot larger gap of learning to to .

You know , let me give you for examples for , like you know , the gap to what is really needed to create a preclinical study for a G 30 candidate .

You know , what are the components they can do , what's by distribution really about and then really what are realistic sort of timing for for clinical phases , like if you come with me with the GOI and say you're going to be commercial in two years . We probably need a broader discussion .

So what I think is if there's a bit of a way to meet with these teams early , you know , speak more about the industry for the ones who are a little less sort of knowledgeable and help them actually like , look , we're not , we're not trying to be a , you know , an investment bank to help them do their raising and we can give some advice about what that

looks like . So when you go to pitch for series A , it doesn't sound . It doesn't sound . You know , impossible , quite frankly . And also , you know I touched on molecular development . You know , luckily that's in place now .

You know I there are clients that would love to have that earlier so they can actually benefit from some of the sequencing analysis or some of their early ideas to maybe cut down some of the early research work . And luckily that's in place now .

And I actually see the impact on that in some clients who either had a very old sequence that they haven't , you know , they've had in the sort of drawer for a while and they want to go back and look at it like , oh , by the way , there are some , there's some , there's some sequences here that may cause some issues for you or maybe maybe want to look at

your ITRs or where you're actually positioning . So so I think that what I'm trying to get to a little bit here is is there ways to help clients be successful sooner , you know , in their programs and see the light ? Don't lose a year ? I've seen it , you know . Lose a year and funding .

We all know there are great programs out there who just don't get to the finish line because of some of these things and it's unfortunate for patients . So there's a way to sort of cut through some of that noise and I'd love to add that to their programs .

You're both fantastic . I thought this was . I thought this was very valuable , engaging and fun .

I'm just giving you a hard time .

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