Manufacturing Partnership With Life Biosciences' Jerry McLaughlin and Forge Biologics' John Maslowski

The company's lead candidate is a partial epigenetic reprogramming therapy that it's prepping for a 2025 IND and optic neuropathies , and it's pretty complex work . As is often the case with ATMP development , not just any CDMO will do . That is , if any CDMO will do . I'm Matt Pillar .

This is the Business of Biotech and on this episode , Jerry is back and he brought a friend to help give us a look under the hood of Life Biosciences' relationship with its outsourced manufacturing partner . That friend is the recently anointed president anointed or appointed president and CEO of Forge Biologics .

John Maslowski likely needs no introduction to folks in the CGT sector , has served the C-suite there since 2021 , but just took the captain's chair in October of this year . He's on the board at ARM and Life Science Cares and his biochops span companies big and small , including Wythe , Merck , Teva , Fibrocell , Castle Creek and more .

Jerry , welcome back and John , welcome to the show .

You know , oftentimes the span is considerably more than a year , so by the time I catch up with someone who's been on the show before , there's , you know , two or three years worth of progress to talk about .

In this case it's been just about a year , but I thought maybe you could give us a little update perhaps on what's happening at Life , since I think it was October of last year and you know what's kind of exciting you about the progress going on there .

And we expect to be the first in the partial epigenetic reprogramming space to enter the clinic and , as you mentioned , for two optic neuropathies .

And so what we've been doing since we last talked I think when we last talked we had initial data from a non-human primate study in a Nyon model , which Nyon's basically a stroke in the back of the eye where you have damage to the retinal ganglion cells , and that was fantastic data that really elevated us out of the mouse world right .

A lot of great data in mice , but making that transition to an eye structure that reflects that of the human and being able to get across an interlimiting membrane and demonstrate expression of our therapy , which we call ER100 , but we're delivering three transcription factors , osk , and so that was fantastic .

But in the years time since then we've really made good progress , which we'll hear about today , in manufacturing as well , as we've replicated the non-human primate study which we're building this company on rigor in science and we thought it was a great step forward to move out of the mouse models into non-human primates but then to replicate the data and show

further expansion and support of restoration of visual function and preservation of retinal ganglion cells was really compelling and we think it really puts us in a confident position going forward to IND . Where we are right now is we're right in the middle of IND enabling package and things are going well there .

But on top of that it's been a big year from an organization standpoint and I think it's important to mention . You keep your head down and I think it's important to mention you know you keep your head down , you do good work and you hope maybe someday you'll get recognized and this was our year . I think we're starting to . Folks are starting to take notice .

In March we were recognized as one of the 12 highest , hottest biotechs in the Boston area and just to give you an idea , there's over a thousand biotechs in the greater Boston area .

So it was a pretty good recognition and what you have here it's really the most definitive recognition as an employer of choice and each year you have over 10,000 companies from 60 plus countries applying only about one to 2% qualify , and it's a really good certification .

A lot of employees , prospective employees , look for that certification as a company that would be high on their list .

And then most recently in October , we were one of six companies included , including the Bostino Fire Award winners , and this award recognizes companies in the Boston area not only for innovation in science but also how we support the local community and the innovation ecosystem . So that's just as important to us with how we serve our community .

And so that's been a big year for us as an organization and we're proud of the employees we have here , our life family . We're small now but we will look to grow into the future .

And then , most recently , we presented some additional data from our non-human primate study , our second study , and it expanded upon the data from previous but also reinforced in this replication of the data , and it was presented at the American Academy of Ophthalmology , which is the largest , you know , eye physician group in the world and the largest meeting in the

world . And in the post-mortem of the meeting , ophthalmology Times put out a top 10 takeaways and our program , partial epigenetic reprogramming ER100 specifically , was listed as the number two takeaway from this year's meeting . Really innovative .

They're really looking particularly in glaucoma , looking beyond IOP lowering and looking at therapeutics that have the potential to reverse disease and restore retinal ganglion cells , because we know that even when you lower IOP effectively , glaucoma , the disease itself continues to move forward . So big , big year for us and a bigger year to come in 2025 .

So , congratulations , take a break , take a rest . You know the holidays are coming . Take some time off if you need to . John , I want to turn to you . You know , and I think you know , I think I know the most exciting thing going on in your life right now . You're a couple months into the CEO's chair at Forge .

I mean , if there's more exciting stuff going on , certainly share that with us , but I thought that'd be a nice segue into sort of how that transition unfolded .

We've had this great partnership now for nearly a year with Ajinomoto after our acquisition and you know Tim Miller was our leader through the acquisition , through the birth and growth of Forge , you know decided to for his career to go on and do new things and you know we thank him for all of his entrepreneurship , the leadership through the transition .

But you know very , you know , lucky for me and , as I mentioned , honored to be asked by Higinomoto to take over the helmet and see this transition as we're now really positioning Forge going into more later stage production , more commercial minded discussions with some of our clients and working with really great new technologies like Jerry and Sharon and Michelle and

his teams . You know CMC needs on their program that you just discussed . So you know , great transition for me , really set up well with the team here .

What I've noticed , though maybe to give a quick update on Forge is just seeing tremendous growth in the organization and I think in areas where you want your CDMOs to grow right , we're seeing expansions in all of our technical operations groups MS&T , our quality units are pacing properly with those .

Meanwhile they're still growing our systems as we are graduating now into more of a commercially minded support system . So a lot of that growth over the last year or so with Forge and looking forward now , it's interesting . You know we talk in biotech about I have cash for a year . I got a year and a couple of years of runway .

Here's my plan Now , working under , you know , the umbrella of a much larger organization under Japan . We talk about the 2030 plan now and beyond .

So for us , it gives us an opportunity to focus less on some of the funding and sort of banking side of business and really concentrate on what's really our master site plan , what's our execution plan over the course of the next nearly a decade of gene therapy growth , as we all foresee the future really blossoming into more commercial products and really , how do

we not only treat rare diseases but broader rare diseases and now thinking about supplying non-rare diseases ?

So it's a really great thought process we have here at Forge and now , with the ability to see down the road a bit and think about things like CapEx investments in real ways , it's really a wonderful time for us to be thinking about growth and seeing very good traction , you know , through companies now funded and bringing really , really interesting technologies , and

we're very lucky as we have the chance to work with them and really help them , you know , move their development along .

I'm kind of playing off Jerry's recognition of Life Biosciences as a hot company in Boston , not to discredit Columbus not quite the biotech hub that Boston is but at the time Jerry and I talked about Columbus is just a few hours away from me . I see the city growing incredibly .

Give us an update on the Columbus kind of atmosphere and how that's advantageous to it . Does it remain advantageous to Forge being in the Columbus area ?

Well , nationwide Hospital here is a birthplace of a lot of the original gene therapies that are now commercial , including , you know , invexis and Sareptas products and you know , luckily I have a lot of team members here who come from those backgrounds and organizations .

Not only is the city one of the fastest growing in the US , the life science I'm very impressed with the life science presence here More companies , emerging technologies , universities , quite frankly putting out a lot of scientific majors that we've been very lucky to bring and see to our GMP and a lot of our process analytical development groups .

So , as it's a newer developing area , we do see technical talent . We see really wonderful growth . Reasonable costs for building is really an important part to remember and a hub here that we can ship to . Most we do international shipments and US shipments within a lot of very reasonable timeframe .

So for us it's really became a very advantageous central area for us to concentrate our organization on , even though we have a global presence with our you know commercial sales force and other parts of our business .

But , you know , really excited to see how the next you know the next years really grow the talent pool in the area in a way that you know groups like BioOhio are all contributing to that yeah .

At what point in that momentum , I think my notes say the partnership with Forge came together ? What ? Last spring , so prior to last spring , as you were contemplating the outsourced manufacturing space and your next move there , what was the , I guess , catalyst for that ?

positive results , we had prepped . We went to the board and we made that decision and it's not something we as a small company , particularly in gene therapy . It is the most significant spend to date in the history of the company and a major use of our remaining resources .

So we needed confidence and we staged sort of that as a key milestone and a trigger to set up the agreement . Ultimately it was with Forge , but we had started the process well over a year prior well over a year prior .

So really we look at team , and team by team we mean the technical expertise and the history of those involved , knowing who will be involved , knowing their commitment to our program , and that's sort of a sense you have to get through repeated interactions and doing site visits and having meetings and having calls and reviewing and ultimately it's sort of an informed

gut feel at the end . And then are they eager to succeed ? Are you just another customer , a number , or are you critically important to their business ? And as a small company , our ER100 , our lead program is critical to our life as a company and is it going to be as important to your partner ? And a lot of folks can talk about that .

But do they deliver in the end ? And that's critically important . And two , can they meet timelines ? We look at history of the company and so in the case of Forge , we had to do a proxy for that . It's a history and the proven capabilities of the leadership team there , and we did our diligence on everyone there .

And what we like in this case just to cut to the chase on Forge was we liked the fact that a guy like John not only had manufacturing expertise but was an operator expertise but was an operator and several others in their leadership team , whether it was from a regulatory standpoint or building out the facility .

They had a long history of building and working in facilities and so that gave us a lot of confidence and they had a vision .

These were folks just like us most of our management team we've worked for 20 or 25 years in the industry , but we came to life biosciences because we had a shared vision of how we can change the world through healthspan right , and so we saw the similar thing at Forge .

There's that connection as well a shared vision , a shared mission and the process of what we did . We started out with 10 or 12 . He put a ton of work over months interrogating , assessing technical expertise of 10 or 12 potential CROs . We actually had informal bids sent in from those and work plans .

We then threw an arduous process , including bringing in which I applaud for him he brought in an outside consulting firm , consultants who worked in the gene therapy space for a long , long time to help evaluate each of these and identify where we may be missing things right .

They have a good understanding of the CROs , all their strengths and weaknesses , and so that helped us streamline and sort of put the process on a level playing field .

Over time we took that down to six and then we took it down to three for the more formal assessment , which involves site visits , not only by our CMC team , but I went on those site visits as well and we had a chance to further evaluate the teams and then getting final bids . Over time those bids get more granular and more specific .

You learn a lot in those interactions and ultimately we made the decision that Forge was the most optimal partner for us from their focus , their vision , their capabilities , our needs and what they could provide .

You're probably going to start with a much bigger list because there are far more outsourced manufacturers out there working on those traditional biologics and perhaps your winnowing down of that list is going to be a long and arduous process because you're looking for nuance . Like everybody can manufacture an antibody In the gene therapy space .

The requirements are far more unique and selective and complex , are far more unique and selective and complex . How did that impact that winnowing down process for you ?

Did you quickly go from 12 to six because you just realized like , hey , these first six we looked at , or these six that we looked at simply don't have the technical capability to do what we do ?

There's not a time to have a fulsome process and it's not fair to the CRO . So we quickly were able to narrow it down to six , largely based on technical expertise and just a feel of fit . You'd be amazed how sometimes you're just not a priority on someone's list and that gives you a pretty big answer .

And then from there it got a little more serious spending a lot more time , starting to involve others in the group , expanding just beyond the SVP of CMC but also our CSO , and then bringing even in the executive team to pressure test the capabilities just from a generalist perspective as well and a business relationship , and that took us down to three .

And then ultimately we were able to make the decision . So that happened over . That process was well over a year , yeah .

Um , to your point , I mean that's , you know it's easy to deliver lip service on that kind of thing . How do you , how do you vet that and sort of uh , quantify it , not just qualify it Like yeah , I really like those guys . They're making a lot of promises that sound good to me .

When we got down to the small list , we vet the management team too , particularly in the case of Forge . They were a new entity , they were a little bit of an unknown . We vetted the individuals separately from our interactions . I'll just be honest . That's what we do .

And for us , apple was the future , and we were able to get very comfortable with their integrity , their track record of success and , I think , their ability , because several of them , including John , had worked in nascent biotechs where we have to be flexible .

We need great support , right , we don't have armies of people and so we're going to rely on them as a and everyone says partner , but it's a partner in the foxhole , because this is complicated stuff here . Gene therapy we're getting better at it and more predictable and higher confidence , and we'll get there . But you run into problems along the way always .

There's always challenges along the way , and we needed to know that the team on the other side was going to be there for us , and that's not only their background and where they come from , so they understand , but then building personal relationships , and there are simple things that you would be surprised .

The business development team at Forge was just responsive to every question , every need , in a timely fashion . That makes a difference for a small company because it's a window into the soul of the company . Yeah , before you're working , you're working primarily with BD .

Yeah , and then when I went on a site visit , you're not only meeting with the team in the room , but I like to go into John Price's notes , but I kind of moseyed over to the break room , get a cup of coffee and just see the interactions among folks over lunch and in the break room right , how they , what their attitude is and how they're operating .

And I got to tell you it's a high end . And we did our research on Columbus as well , because we had the same question what's Columbus ? Yeah , and we did our research on Columbus as well , because we had the same question what's Columbus ?

So we got very comfortable with it that they had the technical expertise and the right mindset and right attitude , so it was a really nice fit for us in the end . Yeah , Are you going to take a little bit of a chance going with the new kid on the block , but they're no longer that now .

I think we picked right in terms of their success and their growth .

I've worked I've never worked for an outsourced biopharmaceutical manufacturer , but I've worked in plenty of environments with BD teams who over-promised on capabilities and then left ops holding the bag , so to speak , and I've covered this space .

I haven't covered it for a long , long time , but I've covered it long enough to see that happen in the outsourource manufacturing community . So the question I want to ask you is how and I mean like I'd like you to answer this as objectively as possible how do you guard against that in your role ? You know your management team .

How do you guard against , because a lot of this stuff we're seeing for the first time , folks and it's easy to say , yeah , we'll take that challenge , and then turn around and go , wow , we signed up for something we can't deliver on . So how do you guard against that ?

We all were drug developers coming into this role and I think one thing that attracted me to Forge , coming from developing cell therapies for rare skin diseases , one thing that attracted me to Forge , coming from developing cell therapies for rare skin diseases you know really was can we build a CDMO that avoids the things we didn't like about working with CDMOs , you

know , one of which is exactly what you're talking about is transparency , right , and I think it's very easy when you have a dedicated BD team . That's really pushing hard and I think they do it from the right part of their heart to go out and really try to sell the wares of the organization .

But I think we tried to set it up and also , being in the role of chief commercial officer previously , in a little bit of a different way and it really is to make sure that we're very tightly connected to the technical side of our organization .

What are our true capabilities at this point in time and what do we honestly think we could be doing , because sometimes these programs can be a year plus long as you're moving through development . Where will it be that ? And making sure we're very clearly communicating that with the client .

So overpromising never buys you anything , and I've heard it plenty of times on the other side of the bench , and I think clients appreciate when you can be like Forge is actually not prepared to do these particular things . Here's our plans to get there . Does that fit your needs ? Now here's an actual tangible thing we've done that Chyder manages .

So we've taken a little bit of a different approach when it comes to our sales force . So we do have what we call client development , which is , I think , more along the lines of a BD rep , but they're paired , almost like in drug sales , with a technical sales advisor .

So really , what this is is now a technical sales expert , which is usually a team of AV scientists . We have PhDs . You know . It almost reminds me of sort of like , you know , like a , like a sales , sort of like medical liaison .

Right , you know where they are paired with the sales reps who give the technical sort of readout , collection of information , collect the needs of the client . So we can marry the sales and operate in commercial cyber business a lot better with the technical side .

Now I don't want every scientist in the lab on every sales call right , they need to be doing work in developing programs and PD and AD work . So we actually have a dedicated team that does that to connect the what we're capable of now to where we are in the future . And they can speak the language of the client just as well .

It's really have that technical capability translate that right up the proposals so they're clear of where we are now and what we can do .

And then when we run through the relationship , once we're now a partner and we have them a client relations rep , they continue the process to help translate things challenges in manufacturing or new steps we're about to take stage gate moving into , say , gmp from PD and they can help partner and make sure that communication is clear .

Because I think really one of the biggest challenges if you lose a step or there's a whisper down the lane somewhere away there , you can lose the client's sort of trust if all of a sudden the message is wrong coming through . So we put some safeguards in place to try to prevent that .

Jerry , I want to talk a little bit about the specifics of what Forge is doing for you , and I'm not even sure what the best way to go about posing this question is to you , but from what I understand , forge is going to be supporting LifeBios , aav process development , toxicology , cmgp , manufacturing and analytical services .

So the way I frame it up is like I just put it on your plate , jerry , to tell me what considerations went into each of those four specific areas in your analysis of Forge's capabilities .

I think it's as John was saying , and I'm not just saying it , but it's quite impressive . I think it was their collective learning of what they didn't like about a facility from how you enter a room , how something breaks down . You can fix it from the roof .

Um , if you need to , if you want to keep a sterile room , you can put , you can put material in a in a lock box that separated from one room to the next so you don't lose time .

Um , there's a lot of really interesting things from a facility standpoint that matters to us , and , and so the other thing that I think was a real attractive piece for Forge when we were looking at this versus others was they have their own therapeutic and development , and so they were making I assume they were making lots of learnings we say mistakes , lots of

learnings along the way that we'll benefit from , along the way that we'll benefit from , and so that was intriguing to us and very interesting that they were paving the way and putting their own money behind their own process . Right , and they have their own therapeutic and development . So that made a difference from a toxicology standpoint to us .

And so the other processes . And then , from a scale up , they are now , and boy , when we first started talking to you it was not even where it is today , but at 500 liter they were able to go 500 liter and pretty , I think , john , you're now 5,000 , right , so we could take it .

And we have , as you were saying earlier , we have for our optic neuropathy candidate ER100 , we have a narrow base nion , which is a stroke in the back of the eye . Small numbers , but primary open angle glaucoma is a large population that we think we can help . And so we're going to need scale .

Eventually when we transition to commercial manufacturing and the hope is we can you know we want to be able to stay in the same facility . So that's another thing . And then also , they started with more than one suite .

There are CROs with only one suite , something goes down , you're out of luck , your timelines are shot and for us , an executive in a biotech firm , time is my biggest enemy Time is our cost of capital so high as a small biotech that time kills . And so they had three suites , and I think you're in excess of 15 now , john , at this point .

Yeah , we have 20 operational 20 now , yeah , and so that that really was was another thing we looked at . And then the other , finally and this was part it gets back to once again , I think , having their own therapeutic . Early on , they had their own methods internally .

They outsource very few things , very few items , and it's micro , certain micro that you would want to outsource anyway because you don't want to contaminate the facility . So they had their own methods in place , which is another advantage , right ?

So as we looked and as I get back to once again that they were small , we were small in our own worlds and it was a perfect for us .

It was a perfect fit at our stage and where we were headed and where they were going , and so we've been able to watch them grow and as we advance and we'd like to think we get the early move or attention now , because we're one of the early folks to go in and that's important to us as well , so we had a chance to build strong relationships before they

got to where they are today .

When it came down , you know , Jerry , post-vetting process , we're dialed in . We like what Forge has got going on . We know they're capable . Now let's start hammering out some details in terms of what they're going to do for us and what we need them to do for us that perhaps they haven't seen before .

What goes into that process for you , Jerry , in terms of , I guess , the execution not the execution but the forging , if you will , of the contract . Yeah , I mean we find this .

And we not only had our internal experience but we relied as I mentioned earlier , we brought in some independent consultants who had good pattern recognition on costs and variability and trends and habits of certain CDMOs in terms of how they charge , how they hit cost not hit cost but where the hidden costs were .

So as we whittled it down , we had a good idea of the range from a negotiation , from a cost standpoint .

And then we also it's not just negotiating price but it's negotiating what's involved in services along the way , and so we were able to continue to refine that I think I mentioned that earlier refine the statement of work , but also refine the contract along the way .

So we became confident that we were within a reasonable range and at the end of the day because at the end of the day price is not the final decision because we could get the cheap . If we went with the cheapest and it didn't work we'd be out of business .

So I think from a pricing standpoint we're able to get there and from a work included and detail , we were able to get pretty much what we needed . Of course , there'll always be changes later . I'm sure we've made a number of changes to the work since then , so that was a good thing .

And then , frankly , forge was young and hungry and they were in a good way , they were aggressive and we sort of I can say that now John knows that we sort of leveraged that to get a better deal . We were this poor little biotech company with a really cool innovative technology . Wouldn't it be great if Forge , if you , manufactured our product for us ?

And so I think we were able to trim the edges a little bit there .

What's your , what's your appetite for , uh , for , and I you know , jerry , maybe you can , you can weigh on in this too and speak to any uh , I don't know if you want to call them customization requests or proprietary requirements , like I said , perhaps aren't cookie cutter like you'd see in a traditional biologics manufacturing agreement .

So one , yeah , were there any sort of special requirements going into the engagement that John and his team had to mull over whether they could meet ? John you want to take ?

Where I think , though , where some of the larger ones especially tend to get caught up , is the formality of the deal-making business , and I think where we get lost and where we can lose good technologies is rigidity . This early on .

I think , the way Jerry said it we were very hungry to have great technologies with good management teams come in and really to have high probability of success . Moving into IND , we really looked at these constructs very carefully and trying to give advice early on hey , sequencing looks a little off in these particular sections .

If we're asked to do that , we're happy to do consulting upfront if it means the ability to get to work with these clients . So , in Life's case and others , we have good optionality for flexibility on multiple fronts , and you know , obviously there's a business to run , so we have to maintain certain margins and cover costs .

But you know we took a tack , matt , where we're , you know , not only we try to be very transparent . We include pass-through costs in our numbers . We don't charge specific management fees and things that don't look like real charge items . Those are things we didn't care about when we worked with CDMOs in the past .

Or there's a small fine print to add 40% because of pass-throughs . We want to make sure one that pricing is very transparent , so it's straight through . And , yeah , we absolutely negotiate on the front end , especially with our early partners .

We absolutely negotiate on the front end , especially with our early partners , about terms and things like that , just because we think we wanted good science through the shop . And why don't we get them there ? If you get a number of those heading into late stage and then potential commercial , you show them a good relationship , you're all under one roof .

I want , then , jerry to bring his next program today , right ? So a lot of gene therapy companies work on a platform , right , and so if I have multiple products that are running the same manufacturing process with a different gene of interest , that's less quality work because the batch records are the same and the release criteria is similar .

The you know the PPQ runs at the end of this are very straightforward . You know the CQAs during the process . So it's more repeatable work for us that we can deliver on really precisely , but it's really opening the gate to that later larger opportunity that we really thought about at Forge .

So you know , for us that means if there's some flexibility on front where we can stay on top of , you know the margins , I think that's the best way that we create relationships early and grow the business and it's been successful , you know .

Frankly , we just , you know , moving through our 50th client now that we've just picked up recently and , you know , really able to grow the business base because of that philosophy . So you know this deal and others , you know , try to work with the client , find the best outcomes , perform DOE studies , try different opportunities .

We can do assets developments , things that aren't on a typical platform-only approach . These are example things that we can do to a la carte to help the development process along on top of the original .

That said , I would highly advise bringing in outside consultants to help you run the process internally , because when you're in a small biotech , that's time away from the day-to-day operation and it's worth a little bit of investment to help run a more fulsome process .

I think we owe it to our investors , I think we owe it to the board and the company and the success of the project to run a fulsome process and learn and go through that . It's a little extra work up front , but when you start with that , as we started out 12 to 50 months ahead of time and well down , we had a high degree of confidence .

And when it was time to pull the trigger on the milestone event , as I talked about earlier , we knew it was Forge we wanted to work with and it was just a matter of finalizing the contract , and so we had little wasted time in the end because we had a lot of confidence in our decision .

So I think that's something if I'm speaking to other CEOs or other execs or other heads of CMC . Don't be afraid to bring someone in to help in the process . It's worth every dollar spent when you're talking about an investment . For us , there was a substantial proportion of our remaining cash to go out and invest in the manufacturing .

So that's my biggest advice . And then I would say also really understand . One of the larger CDMOs may be the right place for certain companies , but understand what your culture , your internal talent and how that matches up with your potential partner .

One final thing we didn't talk about , but I think it's important and I think too often and this is something to self-reflect on companies and how to keep yourselves accountable . We always want to push and not blame , but hold the CDMO or the CRO accountable .

But there's also internal processes within your own company that if you're not communicating with the CDMO , how do you expect them to fully help you and solve problems ? So I think we have a great team that takes that very seriously If something happens . I had a discussion with our senior VP of CMC today and asked I said what do you really like ?

What are the one or two best things about working with Forge ? And he said it's a true partnership . And he said , the project manager's top notch , and that's where it falls down . If you don't have the senior exec within your company having a open and honest relationship with the project manager on the other side , everything breaks down right .

Everything breaks down because typically problems aren't with people in the day-to-day operation , it's typically process and relationship and communication at a higher level . So that's the next thing that has to happen and that's accountability on both sides of the equation .

I think that's where sometimes small companies like mine they make mistake and you're so busy day to day and you're limited staff that you forget about those important parts of what a partnership is . Two-way partnership , not a one-way partnership , right .

Obviously you do that at a at a very important stage in your company , when there's some confidence that you've got something that's manufacturable . Clearly , is there an inflection or like a nuance there , like where , when you spend that money , it might be a catalyst to bringing in more money ? Does it have an impact ?

Does this decision have any impact on your investment community , on the capital that you raise ?

But I think it gives confidence to future investors that they're going to walk into a situation where they have material for preclinical and phase one right , that they're not having to make that investment . So that's risk . It's both from a cost and time perspective but also from a development risk perspective that when they come in that is all taken off the table .

So that's how we've positioned it . If I look at risk in biotech companies time , money and execution and that takes something major off the table , particularly in the gene therapy way . This is not simple manufacturing .

So it's an interesting point Jerry makes . Although we always talk about sort of non-clin endpoints and clinical endpoints and trial designs and enrollment rates , I think they recognize , especially in this field , CMC needs to be well-buttoned up with regulatory vetting for us to make a substantial investment . So not an uncommon ask , even at the CDMO front .

What does that look like on the day-to-day for your head of CMC , jerry , and for your team that's working , john , your team that's working on Jerry's project ? How accessible are they to one another ? Are the doors open ? Can Jerry and his head of CMC stop ?

Jerry already told us that he likes to snoop around your break room and observe your employees going about their business . You didn't know that right , which I don't blame you one bit .

At Forge , everyone is assigned what we call a client relations partner , who is the project manager that Jerry is referring to . They're also assigned an internal PMO , so we actually have an internal project manager who sort of manages the project internally .

We have someone who's the liaison with the client and then they work collectively to make sure we have consistent and frequent communications . What I believe in the case of life there's a weekly call where they keep up , especially in times of heightened manufacturing or development .

They may change cadence times depending on different parts of the development , but we try to make sure that we're having regular communications , transparent communications . So if there is an issue , we need them to know right away and then we can work through the problem together .

One of the worst things you can do as an organization is to go off and try to figure it out and then go tell the client Right . That's . That creates just a distrust that nobody wants to manage and it changes the tone of the relation . So we make sure we try to do that quite openly .

We do have a fairly , I think , liberal PIP program , which is a person in plant . We do encourage our clients to be here during major operations and view the process . We have angles you can actually watch visually .

There's camera angles , like we have , you know , and closed circuit cameras to watch , but it gives them the ability then to observe and see us in action how we work , ask questions and you know , sort of be there when we're live during sort of very clinical parts of the process . I get that Like being a CEO of a small biotech before this .

You really want to be close to where your critical risk points are . So we obviously make sure we can give that option to clients to be able to do that . And then we try to meet on routine JSCs . I think that's where decisions can be made .

It's a bit more formal of a meeting Formalize the communication of data , updates , next steps , how we are working , growing or , if there are really good things , take that learning and use it in other clients . So it's a great way for us to learn more about interactions with our trusted partners that come in .

So that's the format , how we try to work with clients and try to maintain that , as I mentioned , it can sort of evolve over the course If they're in the middle of their trial and they're dosing patients and we're really not on the hot plate for the moment .

We may need on a little less regular basis , but we do keep in touch during those times as well , make sure we're just fulfilling the needs of the program and then we also use those opportunities to ask do you have a next program ? And if you're interested in working with Forge again , let's start some pre-planning there , because you know how it is .

You know queues can be long , sometimes there could be some octaves , so we'd like to get ahead of those and try and make sure we're meeting their needs for timing and their boards and their investors' needs as well .

So it's a business update , it's a process update and what's nice , even in those situations , I think the last time we were there we were able to identify a challenge that was on the table and it just organically turns into a brainstorming session .

Our chief scientific officers very , very good at problem solving , right , and before you know it , she and John were having a discussion and I think within a day we saw that ended up not being much at all right , because you're constantly running into .

This is the nature of our business in biotech , whether it's clinical development , whether it's HR , whether it's manufacturing , it's constant . You know it's constant speed bumps and questions and challenges that we have to solve and you know you , just you build a better relationship that way .

So I think that's a you know , I'm not sure that's only forged doing that , but I think it's an important part of the process .

In a client-contractor relationship , you can easily call things problems . Is the approach to addressing challenges inherently baked into the fact that we're in a scientific industry and everyone wants to collaboratively and civilly solve scientific problems ? Or is there more to that story ? Is it just baked into your head of CMC and your chief scientific officer , jerry ?

They just know that they're going to see things over there at Forge that confound them and we're going to have to get together and figure them out . We're not going to get mad about it . We're not going to be displeased with our service . We're not going to be displeased with their subject matter expertise .

We're going to solve the problem because we're scientists and that's what we do .

That's the nature of our job Keep making , we're moving them along in the process . So it's constantly an examination of the business and also looking at potential speed bumps along the way .

We also like to come with solutions to those meetings and engage on a solution . We also like to come with solutions to those meetings . So we usually pretty rapidly meet and say , okay , here are two or three options that we can do . One might be one path that might take a little longer but maybe a little more straightforward from a documentation standpoint .

One might be quicker but have to get some reads from the quality units , see their comfort levels . Generally we always make the right decision for quality , safety and potency as we're thinking about drugs . But it's best to do those collectively with the client and make sure everyone's on the same page .

Luckily , a lot of our clients are very seasoned scientists in the cell and gene therapy space . Now we do have some clients who don't have that , unfortunately . That's why Jerry's advice for hiring CMC internally is a very good piece of advice for early organizations . Sometimes they're small and they're in their seed rounds and they're looking for some early advice .

We try to come up with solutions and advice with those as well , and that's sometimes a little bit more of a challenge , but we always love the luxury of we're actually working with a really great technical team on the other side here .

Let's get together and walk through these now , make sure they hear what we're sort of being challenged with and then use our expertise to try to soft-collect .

The next thing I want to ask you about I hesitate to ask you about , I love to talk about culture and we've hinted at it like we've had , you know there's , there's been , you know they're , they're hard to , it's a hard , it's a hard thing to quantify , right , it's a hard thing to say .

Well , you know , because we have this , this tight culture , and it works out like that's why we're going to save or make money , right , like it's . It's hard .

You can't connect those dots easily , um , but I do want to , I would , I do want to stop there for a minute and talk about this , because I do think it's important for our listeners again , who perhaps are seeing some of this for the first time or about to , to understand what the value of a good cultural fit is beyond .

You know , jerry thinks John's a pretty fun guy to have a beer with , but he's , you know , not necessarily real good at running an outsourced manufacturing company . So , to whatever degree you can , you know , reflecting on the past year working together , can you point to any anecdotes or examples of , you know , the value of a good cultural fit ?

I know it's a hard question to be like yeah , I can ascribe a specific value to that , but you get what I'm going for .

One is internal culture in Forge , because I can't generate a culture with a client unless I have a good internal culture here , and we over the last two years have grown to 370 plus people , so maintaining culture when we were 100 people is a challenge as we grow this side .

Interestingly enough , taking over , I started working on some internal culture philosophies around how we actually interact , not only internally but with clients .

So really establishing some new pillars and forge of what's important to us about how we work together , work with our clients , and ultimately , at the top of these pillars are patients , which is why we're on the call here , talking about why these relationships are important , because we ultimately want to help really sick people get better with my people internally ,

making sure they're in a great environment where they have growth and well-protected , safe environment , but also room for growth in their own careers . And then operational excellence , so clients are actually receiving high-quality product in the time they believe that they need them and moving forward . Quality is another pillar .

We're really focused on making sure quality-mindedness is a big part of our organization . And then clients , because we are in an organization where we have to service our clients and make sure they have the attention and the sort of you know part of Forge they need to make sure their products are being moved forward .

So that's what I'm using going forward to create this more you know operational feeling at Forge as we move in the late stage commercial . So then take that back to like working with Jerry and his team . If we can't even communicate properly on a call , we don't have the same values , it sometimes does make a really difficult working situation .

And if the client is just ready , wants to move forward and we're worried about like this is not a real world example , but I'll give you a . For instance , if a client had a program where I felt it was unsafe , you know that's something that we would have to have that conversation . That might not be the right culture to work with that particular client .

Right Innovation teams like Jerry's . That's where we all meet together and I think that's why we have such a good working relationship . Jerry , I hope you don't mind that I went to one of their quarterly meetings to talk about Forge and introduce it to his staff in Philadelphia , and that's an access for me that I really enjoy .

I want them to know I got a chance to listen to their team and watch how they work together , and that's something that I think creates another level of a relationship , and I think it's really important in our industry , quite frankly , to make sure we're all rowing the boat the same way for helping patients and kids .

And that learning could be an ophthalmologist coming in and talking about glaucoma , could be a gene therapy expert . In this case , we have our legal team , our finance team , the office manager . They know Forge by emails and paperwork , right and bills , but they don't know John and they don't know what's under the hood .

And we thought it'd be a great idea and John was very eager and agreed to come and give us a dimension , help them understand further . That forges the relationship no pun intended even further .

When you have not only our head of CMC and our chief scientific officer and myself who spend more time with John and his team , but the rest of the organization , they become more invested , they understand and once again , it's such a critical component to us . So it's part of the organization being learning .

And then we have a philosophy and I'm very fortunate that our senior exec team and I think it's where , frankly , many folks miss is treat your quote unquote , we like to say sometimes the entry vendors . But treat your vendors truly , not just as partners but as part of the team . But treat your vendors truly not just as partners but as part of the team .

So take the partner out . They are members of the team . You invest time and energy in them and you'll get more back in terms of mind , space and share of their energy and commitment than you could ever imagine .

And so if you treat the CDMO , the CRO , your other consultants , with a lot of respect and include them in a broader aspect of the company , help them understand more what your challenges are and what your opportunities are , it then , I think , helps them give more back to the organization .

So we probably spend a little more sometimes on consultants in some of these situations , more time . But for us as a small company , that's virtual . I can't imagine doing it any other way . It's the only way I think we can operate . You know have operational excellence and that's how it works on our end .

And I talk to John from time to time because they've grown very quickly . John , how are you keeping that culture together ? You know we've talked about it and it's something we keep an eye on and I'm glad you know , I know that John is as well . But and I'm glad you know , I know that John is as well .

So , but that's always the challenge , right , there was a time when they were . They were not nascent , but they were young and growing . But they've grown so fast now and that's the challenge he faces . But so far , so good .

Sometimes I'm a little bit hesitant because my audience goes well , you know , forge and Life wouldn't get on this podcast together if they weren't going to have a great big love fest . We have to protect from that right . To protect from that right . I'm going to say this was a transparent and instructive conversation for our audience . I believe it was .

I think anybody who listened to this conversation is walking away with some takeaways around . Here's some things I should be thinking about as I engage in these discussions and these negotiations and the vetting process . So I really appreciate it . I appreciate you guys coming on and sharing some good anecdotes and concrete examples Good value for the audience .

You just listened to the Business of Biotech we drop every Monday morning everywhere . You listen to podcasts and you can watch the videocast that is under the listen and watch tab at bioprocessonlinecom . Subscribe so you never miss an episode . Leave us a review and some feedback and , as always , thanks for listening .