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Darshan

Hey everyone, welcome again to the DarshanTalks podcast. I'm your host Darshan Kulkarni. It's my mission to help patients stress the products they depend on. And our guest today is going to be helping us with that. As you know, I'm an attorney, I'm a pharmacist, and I advise companies with FDA regulated products. So if you think about drugs, wonder about medical devices, consider cannabis or obsess Oh, pharmacy is the podcast for you. I do these video podcasts because they're a lot of fun. And because I find myself learning something new each time today is going to be no exception. But it's always nice to know when someone's listening. So if you like what you hear, please leave a comment, please subscribe. If you want to find me. Please reach out to me on datia on twitter at DarshanTalks, or just go to our website at DarshanTalks, calm Our guest today. Um, we've had him before actually relatively recently. But but he's just such a fascinating, fascinating guest. So we were excited to bring him back. And you guys wanted to talk to him as well. So we're excited to have him again. Our guest today is the SVP of regulatory affairs quality and operational excellence at cerros. Ashley, press them. Hey, Ashley, how

Ashley

are you? Hello there, Sean. It's pleasure to be back. Thank you.

Darshan

Pleasure to have you. So so let's, let's talk a little bit about what you've been up to since the last time we spoke, you spoke What have you been doing at Ciro's the last few weeks or so.

Ashley

So last few weeks, I've been really looking at planning out the operational excellence activities for Cirrus. It's a relatively new function that we've opened up only as of the end of February this year. And so I took that on in addition to the other responsibilities that I have, because there's some synergy with how we operate. And I also have a kind of an interest myself in in operational excellence and process and making sure that companies can scale in a meaningful way as they move through, you know, from an early biotech stage, you know, and grow through to being a fully fledged commercial biopharma.

Darshan

So let's start with the beginning, which is the term operational excellence. How is that different from say, what what a CEO would be doing? Which would be operational as well? Or is it the same thing,

Ashley

it can be the same thing? Yeah. So depending on where you sit within the organization, so right now my responsibility for operational excellence, really centers on the clinical development space for Cirrus. The principles are equally applicable across the organization. Really, the the impetus for doing this was the need to be able to grow the organization and scale as you move. So Sarah says, you know, as his was formed in 2013, and now we are over 100 100 staff, and so I find that they that critical mass for biotech companies, when you reach the 100, Mark 100 to 200 people in the organization, you start to see teams of teams operating, you know, so, you know, no longer do you have the same people going to every meeting involved in every every decision. So you have you have coaches and players rather than the player coach model, which is great. And it exemplifies that the organization is growing as successful. But it's also important then that the teams are empowered and enabled, and they have a clear understanding of their role and responsibility. And, you know, whilst Why do you think if you think about all the activities that a company conducts, you know, some of those are governed by GSP. And so there's very clear laws and regulations that cover them, and you have a quality management system to administer. But all the other things that you do within within an organization are still critical, even if they're not under their GSP banner. So for instance, how you how you decide your clinical development plan, you know, FDA is not concerned with how you internally decide what to develop, and when they're concerned with when you do develop it, you do it according to the laws and regulations. But that investment is huge for a company into it, what are we going to develop? And how are we going to develop it. And so having a robust governance framework and a process for creation and review of those clinical development plans is critical for the success of the organization, even if it's not, you know, a gx p governed activity. And so when, you know, when the, when the organization is small, that's easy enough, and the ideas kind of float around and you can, you can sort of manage it ad hoc, but as you double or triple the size of your organization, you know, becomes people scratching their heads who Oh, I'm new to new to this company, how do we do this? How do we decide on this how, who has to be involved, who has to approve and so on. So it it you know, makes sense to have some level of structure, you know, it doesn't have to be formal, so please, but some level of structure that gives some consistency and robustness to to how you operate. It gives you It gives people the confidence of what they're responsible for, and what they need to do when they come in. To the organization, and it's really the only way to grow sustainably, otherwise, it can become a bit of a mess.

Darshan

I've been I've been part of organizations where that did not occur. So not 100% can be a mess. So which really raises that question, right. So the one thing that sort of stood out to me, as you were describing this, you said, this is a new this a new role for you the last six months or so. And when the first two parts of your title is quality, and regulatory, both of which really scream based on my own experience of doing it, screen control, you're what you really want is, you have processes in place and making sure that they work cohesively to build well more cohesively with existing structure so that you have a clean sort of process built out. On the other hand, one of the key things you mentioned about operational excellence, is growth and scale. So to me, and obviously, there's still control in them. That's part of the whole play. But it sounds like if you're building a rocket ship, the first two are about solidifying the structure, while the last one's about putting more jet fuel in there. How is that, first of all, an appropriate characterization of what operational excellence is? Or am I still not fully understanding where you go with it?

Ashley

So I mean, I see your point, I could, I think there's a lot of synergy between the functions in the sense that you can even you can have operational excellence in in your quality management system. In fact, you should well you should be at its core, I think, you know, it was really originated by Dr. Shingo, a Japanese industrial engineer who worked with the Toyota company and you know Toyota's manufacturing processes is you know, famous worldwide for its its capabilities, its precision, and you know, that they the Kaizen concept of continuous improvement. So, really what it is, and so, when, when Dr. Shingo published his his, you know, thoughts on operational excellence, this became the Shingo model, and the centers around that the principle of that culture should be at the center of what you do. So, employees should be empowered and enabled to, to review what they're doing and to and to provide suggestions for continuous improvement. But then from the top down, leadership needs to encourage that that environment, and then a set of guiding principles that he established around how to implement that. So that can be applied across an organization in total, across all the all the different functions. So I see your point, it's, it's really about having an open mind to improvement not not change for the sake of change, but change, for the sake of improvement and change for the better. And it's really about making the process that you apply to any given task appropriate for the importance and the level of rigor for that task. So as we say, you know, Jake's processes have, you know, far more rigid structure to them, new GMP manufacturing is, is very clearly and rightly so it's heavily controlled. But again, there are other things that you do in an organization that needs some level of understanding and some level of governance, but not that, not that same rigor. So it's, it's a balance as well. And that's, I think, that's where operational excellence helps you to, to balance out the needs as you grow the organization. And that can change, you know, you add more functions, you need more structure, and so on. But you don't want to overburden the organization, because that that will bog it down in bureaucracy.

Darshan

What I'm also hearing you say is, and again, feel free to correct everything I'm saying, by the way, but what I'm also hearing you say is, obviously, there's a role for a CEO, which is really managing the day to day affairs. But what operational excellence is almost doing is creating a framework or a, preparing the ground for something, IT department, by department, by department, so that once it gets to a point where the CEO is managing things, he or she is not walking into chaos, but organized structure that they can help manage from there on. Is that fair? Or did I misunderstand what you said?

Ashley

No, absolutely, absolutely. It's really operational excellence as a philosophy and, and a culture you can you can build that into culture the same way as we look for a quality compliance culture, as well. So those two things come together, I really, I really, really believe that. So you thinking about a culture in the workplace where problem solving, and teamwork and leadership come together to be constantly improving and putting the right structures in place? So the CEO needs to do that for the whole organization? Absolutely. And and, you know, in a large organization, you would have that applied in different divisions or different functions as well.

Darshan

So you said that you're starting to do this in the clinical development space. Could you talk a little bit about the considerations you had, or you have as you're developing this app What are you thinking about? Your one of the key pieces you mentioned is what will you develop? And when? How do you put structure around that? Like it's one of those questions that every pharma and biotech companies going for 515 products? Who do I give weight to? And which ones are my dogs that I can get rid of? So how do you figure that out? What?

Ashley

Yeah, so, excuse me, operational excellence really is, is the framework by which you make those type of decisions and consideration. So not necessarily specifically, you know, on the topic itself on the program itself, that would be I mean, that's a decision for the team, but the team needs to have a framework in which they can operate. So you know, we have a process Okay, well, how do we create the clinical development plan? Who reviews it, who's responsible, accountable, and you know, the typical raci matrix? And then what's the governance at which level is the the team, which level of team is making the decision, and then how does that go to management or the C suite or the board depending on the size of the investment or otherwise. So all of those parameters are about is what operational excellence puts into place. So that we can we can do it in a in a robust and repeatable way, and an efficient way. Another element that is important, and a really big topic of sort of academic research, as well as implementation practically is decision quality. So you know, companies are now thinking heavily about really, truly injecting decision quality into their decision making. And that came out of work from Stanford from a gentleman named Carl Spitler, who also originated an organization called strategic decision associates, I believe, is the name of the company. And he was sort of the key a key academic and is a key academic still in in that in that space, and it really behooves companies to think critically about their decision making, because these are big bets. These are, you know, drug a drug development costs a lot of money. And so you really want to make sure that you are eliminating as much as possible any potential biases in your decision making and quality decision quality affords you the the tools to actually make sure that you are making really the right decision. If people when you think about a decision, people sitting around a team, sitting around a table as a team, have their own collective experience. And you think, Okay, well, we've got, you know, 30 years experience in this in this room, we should be able to make the right decision. But those those people can make the right decision. But they also you also have to recognize they carry with them the bias of their previous decision making the bias of the previous experience. And so decision quality really helps you to, to tease apart those biases, and really put in place a framework that that's, you know, directs you towards the correct decision for your particular scenario and your situation.

Darshan

So to partially jumped out at me from that conversation, the first thing that jumped out at me, before we get into decision quality, is is the idea of operational excellence. On one hand, I 100% stand behind and agree with everything you described, which is you need to put a structure in place so that governance is simpler. On the other hand, isn't this the beginning of bureaucracy? And Isn't this what people would sort of go, I jumped into a startup, and I'm now reporting to people and I, the person that could just pick up the phone and talk to you two weeks ago, is not someone to reach through like four lines of four that is not four people away from me. So how do you battle that? That that pushback because I imagine employees aren't that culture change will start affecting them and an employee satisfaction becomes affected. So what's your take on that?

Ashley

Yeah, that's a very good point. And that's where it's, it's a balancing act, because you need to have a certain level of structure as you grow an organization. But you don't want it to be so overbearing, that it is, is counterproductive for people and, you know, both functionally and psychologically. And that's, that's absolutely important. And, you know, as someone who's worked in quality and Regulatory Affairs for a number of years, you know, nobody loves SFAs only because they've been in a in an environment where everything's done, because the ESOP said so and that's not not the philosophy, you should, you should take anyway, the SFP should record what you do, not not the opposite. But in any organization, if you have four people sitting around a table, and you've got your molecule and you are the for function, who's responsible for all of the work around that molecule, you know, what's happening directly, and you know, what's happening day to day on the on the product, and you can guide that product through development. But once you scale the organization to where your team is now representing your function, or functions on multiple programs, you know that that is just not there's just not enough hours in the day to have that level of high touch. So you need to have a structure in place whereby those people on the team understand fully their role and role possibility within the organization, and that that can come in a small environment just through sort of discussions, ad hoc discussions and an understanding between people. But when you, as I said, when you double, triple the organization or more, it just can't happen. And so it needs to be at least written somewhere, it can be very simple, can be a set of slides that says, This is how we do this, it goes from A to B to C to D. But that's lots it gives consistency for anybody, any new person coming into the organization is trained in that way. And they also then on the flip side, and this is operational excellence, as well, they have the opportunity in a structured way to input and say, Well, I think we could do this differently. You know, what if what if we went from A to C and then back to B, because of X y&z reasons. So there's that opportunity, which doesn't quite happen as readily. When it's not written down anyway, it's sort of a little bit ad hoc. But yeah, you're right, you have to scale it with the commensurate with the size of the organization. Otherwise, yeah, you're overburdened with, with bureaucracy, and people, you know, turn away from them.

Darshan

So how do you how do you give that voice to employees to have to know that they get their be asked for the input, as opposed to be told what to do?

Ashley

So this is this is where it's central to the idea of operational excellence culture sits at the middle of the of the diamond, if you like, to culture results, process tools, and, and systems. And so culture in the middle is to be driven from from the top down, as well, from management all the way down, that a culture of openness, a culture of transparency, a culture of engagement, and that you need to tell people, you know, this is what we're trying to achieve, you have to clearly articulate that vision for operational excellence, we are trying to achieve better for our organization, as we grow, and we need your help, because nothing happens without other people in the organization at the end of the day.

Darshan

So So what you're talking about is clear lines of communication, which was a lot easier to do in what people are now referring to as the before times. How is that happening now for you? Like, are you doing like all hands with zoom meetings, and saying, This is what operational excellence looks like for us? Now we want we welcome your input. Are you doing this more? Let me send you the slides, and just call me if you have questions? Or how do you bring people on the same page, when you're doing such a fundamental structural reframing? If you will,

Ashley

yeah, so it's definitely going to be, excuse me a combination approach. So there is there is the the slide deck approach, you know, and, and the sort of, you know, the rollout of, of ideas, but you also have to engage with the individual stakeholders themselves, or the function heads and make sure that there's buy and make sure they understand the value of what you're trying to achieve. Because as soon as, as soon as they can see some value in what you're trying to do. They're bought in and it's the, you know, the wheels are turning, and then it's a much smoother ride, than if there's initial resistance. And of course, everybody in any change, everybody sits on a different place on the change curve. And it's really number one is the communication of that understanding, communication and empathy for for people and their position on the change curve, that that allows them to shift through that curve, and come along for the journey. So what we're doing right now is, right, in the next in the last few months, we've been really in the preparation stage, the mapping stage, if you like, mapping out your What does what does the current state look like? How do we make decisions right now in the organization? And then using that we can then stress tests, and you know, pick apart some of the ideas and say, Well, does it really have to be made there? Can it be made somewhere else? Can it be? Can the team make this decision and make a recommendation? does everything need to go to the management team? And I can tell you the answer is no, because they have the same number of hours in the day as everybody else. And that's but that's the whole point. I think it's a was General McChrystal. Famously, as has written a whole book about the teams of teams and empowering teams to do their best work and that that philosophy really rings true in any any industry. But, you know, in the biopharma industry where almost everything we do now is across venture of cross functional matrix system. So those teams of teams need to be empowered to do the work do their best work.

Darshan

So it's this this is amazing, because I'm thinking through a lot of the clients I've had in the conversations we've had one of the comments you said earlier. I wonder if it's the difference between legal and regulatory when you when you said that? And I figured out why you're saying I totally understand what you're saying. And it just kind of an interesting comment where you said, the point of an SLP is to record what you already do. And that seems so intuitive and obvious. from a legal perspective. I'm kind of The point of an SLP is to tell you what to do so that you stay within those roles so that if anyone comes back and challenges you, you go, this is what I followed. So they're both saying the same thing from two different perspectives. Such an interesting perspective difference if I I'm curious, have you had that conversation before?

Ashley

I'm definitely happy? Oh, absolutely, absolutely. So if you think about a GSB process that is governed by laws and regulations, and so there are certain things you have to do, if you're if you're doing you know, any particular process in in GMP for products, for example, there are certain elements that are dictated by law or regulation or guideline and your process must, must meet those needs. But the way you operate, and the way you meet those needs, can be variable in that sense. So what you what you want to do is make sure that, that you understand and you map your process, what physically is and write down to the manufacturing side? What is the operator doing, physically to conduct this business activity, this this, this, and then your recipe should reflect that. That then has to be what they're doing has to be compliant with the laws and regulations. But it's, it's if you do it in the opposite way, and you write down what the law says, You must do this, this and this, and then you hand it to the operator and say, well, you have to do this, because ESOP says so that inherently is is a, it opens you up to compliance issues, because that might not be exactly the way they're doing, even though the end result is a compliant product and process. So really, that's that's the way that's the way I think about it, you have to be, of course compliant with with the laws and regulations. But if you start from mapping the activity itself, and then write that into the ESOP, you find that you get a higher level of compliance,

Darshan

I'm gonna ask a really basic question, because it's complex in a few different conversations I've had with a few different clients. What is the role of slps? And that's something such a fundamental basic question. But the reason I'm asking the question is I've had clients who look at slps, as essentially what I need to show the FDA, that's one perspective, that's pretty much the entire thinking around it. A lot of that that thought process I've seen primarily in like the pharmacy world, but it's literally go by, so please keep it within like the plastic wrapping. And when the FDA comes, they will rip it open and just show it does not reflect reality at all. So that's one perspective. Another perspective is, this is a university work within it's adapted for our use, but it's a 10,000 foot view of what we actually do. And we're going to have work instructions that, that take that next level, if you will, and tells you operationally what you should be doing. And then there's the third perspective, which is slps are the only document we look at, and it's going to be comprehensive, it's going to be operational. And it's also going to give you that 10,000 foot view, we're going to have in three different formats. So you're gonna have the written word that the 10,000 foot view of what you're trying to achieve the operational perspective, and maybe like a diagram with attachments, in your opinion, what's the right way and why.

Ashley

So I'm in my own opinion is to, is to really utilize that quality triangle with the policy policies at the top. So please work instructions and associated forms and documents. And to maximize that with the purpose of each so your policy sets out your high level principles, like on a given topic, your recipes led to me should be lean. Because the details should be held in the work instructions, that's that's the way I've always operated and the way the way we operate, you know, at Cyril speaking, your recipe then is it should be clear and simple enough that someone else coming in fresh to the organization to the team is able to follow it and achieve the same result. So the way it's written is, is critically important. And the simplicity of it, and the the scope of it should be appropriate for what you're trying to achieve. But it doesn't, it really gives you that that framework of what is required. And and you know, so this step is required, this step is required to be approved, and so on and so forth. The details of that can be captured elsewhere. And there's a few reasons for that. One, it simplifies your SRP and makes it easy for anybody to understand and people you know, because we work in a cross functional matrix, multiple functions might be involved in the same are involved in the same process and same SRP and so they might be involved in step one, somebody else is involved in step two and somebody else in Step three, so They need to know the detail of their particular step. So that can be compliant. But that can be captioned later on in work instructions that apply to that particular operation. So they don't need to have all of that bogged down in the details in the SRP. The other element is consistency and updating. So it's a huge effort within within organizations to update and maintain the quality management system. And if you if your esops are to detail, you know, a small change in what's happening at the work instruction level, what should be the work instruction level, can have a massive impact in the updating for No, no real good reason other than your major recipe to detail. So you can you can update your work instruction without affecting the actual process the ESOP itself and remain compliant. And so, you know, I've seen many companies get bogged down in the ESOP update cycle, just because of their very reason they were, they were too bulky.

Darshan

They were actually, you know, we usually aim for about 1520 minutes, we're already at the 25 minute mark. So I appreciate your patience with me. A couple of questions if we if you don't mind. First question. What is the question I'd like to ask the audience based on what we just talked about?

Ashley

So I guess I'm interested to know people's perspective on operational excellence? Have they been involved in it? Have they applied it? And what do they like? And what did they not like about it?

Darshan

Love it. So what is your perspective, operational excellence? I, I will admit that, in my experience, I've mostly seen horror stories around operational excellence. I have. I've seen companies try it. And if they struggle, I think I think one of the advantages you bring to the table is you've seen it across so many different places, and I've seen the mistakes being made. It sounds like you guys have a better chance of success than most. But, but I've seen it, I've seen more horror stories than not, has that been your experience? Has that been different from what you've seen?

Ashley

I think if you I guess a horror story would probably be a lack of operational excellence.

Darshan

I guess I managed to initiate the first part of a larger evolution. Yeah. So. So if you compared to the final version, you're kind of going we were really starting from very little, but that was what I meant. But yeah,

Ashley

yeah, no, absolutely, I think you you have to start somewhere. And, and you have to just bite off pieces that you can, you can chew, you know, you really take it stepwise and you'll make incremental improvements, which is the whole Kaizen concept in itself. So I think you definitely have to make a start, but you have to also be clear about what you want to achieve and have everybody bought into that because the lack of buy in and you know, the inability to communicate effectively and bring people along the change curve is going to be the number one stumbling block for implementing operational excellence.

Darshan

Agree 100% the two questions I usually ask what was the most memorable part of this month for you?

Ashley

most memorable part of this month getting some sunshine and finally some you know, get outside we can you know, get some vitamin D

Darshan

it's great. We haven't had that Or have we it's just been cold so I'm enjoying that as well. I'm 100% with you. Um And last question What did you learn this week? This last week but yeah,

Ashley

yeah, absolutely. This week I learned myself a lot about operational excellence to be honest you know, it's been a you know, every day's a school day, I think it's always something you can learn so the more you dig into these things, the more you see examples of what's good, bad and ugly and and try and try and learn from those. So

Darshan

yeah, what was one technique that stood out for you

Ashley

i think it's it's really the the importance of the culture and and instilling operational excellence into culture. So I know that that when these first thing when these things first came out, the idea of operational excellence came out it was very heavy on systems and cool and we were focused on we need a system for this we need a tool for that without having the the culture itself to underpin you know, the the principles of applying operational excellence into into the organization.

Darshan

That's awesome. I'm not gonna do a quick summary. We landed up starting talking about operational excellence, excellence, you briefly discussed the value of synergy and the value of teams and, and the sort of role of operational excellence as it ties into scale and building the building blocks, if you will, for a for scale, and the larger community building so that the company grows together. We've all seen experience unexperienced companies that didn't have that piece together and it's coming back to bite them after the fact. You then talk a little bit about how this is impacting Have you already seen some some positive impacts in the clinical development space, and you spoke about how it this, this becomes more and more important, as you start getting into the 100 200 people range, that stroke, he spoke about the GSP processes, and how this becomes extremely important in GSB. But it was a fundamentally answering is, what will we develop? And when and how will those decisions be made? We spoke about the difference between scale and control between your different titles, and and how that all comes together. And your and the fact that you have to learn that balancing all of it. We spoke about Dr. shango, we talked about costs betzler, and decision quality, decision quality, which I really want to get into the next time we have you on. And then we had a discussion around slps and their role slps versus work instructions and how legal versus regulatory see it. And it's not that they're contradictory at all. They're really complimentary, if anything, so I thought that was fascinating as well. And the key piece being in operational excellence, the value of managing teams of teams, and what that means and going across the cross functional matrix. Did I miss anything?

Ashley

No, that's it's spot on.

Darshan

Perfect. This was wonderful. How can actually how can people reach you if they have questions?

Ashley

You can reach me I'm on LinkedIn or you can reach me at a Preston at Cirrus comm

Darshan

perfect. And if you have any questions, you can reach out to me at darsan talks on Twitter or on our website at DarshanTalks Comm. Actually, this was wonderful having you on Thank you so much.

Ashley

It's a pleasure as always,

Ashley

thank you. This is the DarshanTalks podcast, regulatory guy, irregular podcast with hosts Dr. Shaun Kulkarni. You can find the show on twitter at DarshanTalks or the show's website at DarshanTalks.com

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