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BTOES Insights Official
By
June 05, 2021

BTOES HEALTHCARE LIVE - SPEAKER SPOTLIGHT: Empowering Excellence in R&D

Courtesy of Sanofi's Vatsala Sadasivan, below is a transcript of his speaking session on 'Empowering Excellence in R&D' to Build a Thriving Enterprise that took place at BTOES Healthcare Live - A Virtual Conference.

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Session Information:

Empowering Excellence in R&D

The biopharmaceutical R&D value stream process is complex, lengthy (10 years average to develop a biologics drug from discovery to commercial launch) and highly matrixed. It consists of technical processes which interfaces with various business processes needed to enable the drug development process.

In addition, the R&D environment naturally focusses on “scientific excellence” and faces cultural challenges to embrace “operational excellence”. Thus, the long lead time to develop a drug combined with the highly matrix interfaces and cultural barriers makes it challenging to develop an operational excellence roadmap for R&D. The road to operational excellence in R&D is very young and more complex compared to the manufacturing and service businesses

  • requires adaptation of traditional approaches to fit the R&D processes
  • requires transversal collaboration to be successful
  • requires cultural change within the organization

This presentation will demonstrate the impact of Operational Excellence for R&D, in terms of transforming R&D into a highly efficient organization and enabling scientific excellence in R&D. It will show you how to build your own roadmap for empowering excellence in the R&D environment, which will include the following

  • overview of the biopharmaceutical R&D process
  • challenges in applying operational excellence in R&D
  • how to develop a strategic Operational Excellence roadmap in R&D
  • examples of case studies

Session Transcript:

Very excited about our next guest. She's coming directly from Kuala Lumpur, Malaysia today to talk to us about empowering excellence in research and development. We have ... with us. Hello there, Vassallo, great to have you with us.

The Salah is a strategy and Operational Excellence leader with business that can go and organizational skills focusing in the biopharmaceutical industry. She has working for different biopharmaceutical companies, from R&D, to clinical, and commercial manufacturer operations, with experiencing process analytical science, technology development, manufacturing, quality control, operations, and quality systems.

She's an operational excellence experts whose skills, both in strategy and operations management, a strategic thinker, who is able to translate vision and strategy into operational solutions. But Sally's currently, the operational excellence leader for sanofi's are indeed North America business where she is responsible for driving strategic operational excellence roadmaps to increase efficiencies in processes and operations within R&D in North America and global Sanofi. What a pleasure to have you with us directly from Kuala Lumpur Malaysia today to our global audience. Thank you for sharing your expertise.

Thank you.

Thank you, Jose, for the introduction and, as Jose mentioned, and that's us into seven from Sanofi, the operational excellence lead for the R&E North American business of Sanofi.

So, today, what I'm going to be talking about is how do you drive excellence within R&D?

So, I spent most of my career in operational excellence in the commercial manufacturing space but over the last three years, I moved into the R&D side.

And what I really have learned a lot is that it's significantly different compared to the traditional classical operational excellence, methodologies and approaches that you can apply in the commercial manufacturing space.

So today's talk is going to be mmm hmm.

About first, giving an overview of the drug development process to the R&D drug development process, and the challenges of applying operational excellence in the R&D space, and how it's different than that commercial manufacturing space?

And also, how do you then develop an operational excellence roadmap for R&D, because it's so different compared to the other traditional spaces, some case studies? At least one case study, if time permits, I can run another one true, with assembler.

Firstly, just to give an overview since Sanofi, So one of the major job tree, pharmaceutical biopharmaceutical companies in the world.

So within the R&D value product stream is this is what you see the traditional R&D value streams to develop a drug.

So the first challenge is that it takes about 10 years on average to make a biologics product. So the lead time is very long. So that itself shows, it's very different compared to, let's say the manufacturing space where you can, you're making several batches or hundreds of batches are here.

Here you have just one going to go one project in 10 years. And that gives you limited data, so that's right. The one challenge.

Also, the other challenge is that there is nobody that owns this process end to end, from the beginning, till the end from early discourage, commercial product launch.

Each manage by various different project teams throughout the life cycle of the product development. So that makes it also very challenging. So it's very highly matrix. You don't have one owner.

And then, on top of that, what makes it even more challenging is that, then, on top of the value stream process, you have your business processes that stuck interfacing, like in the Y axis, what you see here. Various different business processes, which are very traditional business processes, such as procurement processes.

Screenshot 9-1So, these processes that are scientists have to deal day-to-day, in addition to developing the drug, they have to interface with these processes, Shipping and logistics, for example. Managing contracts, trend to have to have external collaboration, regulatory processes, tech transfer, and so on and so forth. So, the, when you put these 2%?

Boom. Boom.

They again, are not owned by the global corporate processes, and it's very difficult to influence and change that because it companywide processes, and oftentimes these are the most cumbersome processes that actually interferes with the scientists day-to-day life.

So if you put all of these together and that's rare, you know, the challenge of applying operational excellence come into the orange space with this highly matrix organization.

Yes.

The culture, and as probably most of you can imagine even if you have not been an R&D, is very different than the commercial manufacturer. The culture is driven by science.

As scientific excellence is what is focused, primarily, and oftentimes, operational excellence is forgotten or not emphasize as much.

But the irony is that, day-to-day scientists are struggling in the labs. We are dealing with bureaucratic business processes that take away the time from doing science.

So so actually, operational excellence is actually highly needed in the R&D space. And it's the challenge is, how do you change the mindset of scientists to embrace operational excellence, that actually, you know, they can do better signed by operating more efficiently. And I think that's the key what I've learned. And it's totally doable. It's possible, I'll show you some case studies, but it is challenging.

So with that, There's no traditional cookie cutter, standardized approach, or methodologies.

You can input.

When do you like the commercial manufacturing of from the classical methodologies that you typically apply in a manufacturing space? That's what I've learned. In typically in R&D, you have your strategic roadmap that everybody's familiar with. You know, where we are today, and where we want to go to it.

But now, the operational excellence roadmap should be actually PD.

The enabler to execute your strategy.

So it's really the roadmap in terms of how do you operationalize your strategy. Yeah. How do you operationalize the solutions, just strategy?

And so this is an example of a, call it, a home-made recipe that I use the model.

And it's based on three pillars, and it seems to work in any, any process of any challenges or improvement, that you're trying to make an R&D, at least from the last few years.

So the first pillar uses capacity.

So you need to make sure you have capacity that people can keep people capacity. That's FTE equipment to make sure you have enough equipment and space center executing a strategy. Then, they added capability, which is very important, as well. So one is people capability. Very important is, having the right organizational structure, ropes, and competency and skills. And the other capability, which is extremely important, R&D, innovation, and technology, is staying up to date of innovation and bringing in new technology and innovation.

execute your strategy to drive efficiencies. And then finally, the processes pillar is, what are the processes you need to execute, the strategy and these processes? Link them back to the first slide I showed you showed you, that is the X and the Y axis.

They could be our X axis, which is your drug development processes, all your business processes, either one or that could be a bottleneck, that you need to increase efficiency.

And then finally, some of the key measures in R&D that are very important is increasing productivity.

So, what that means is increasing the number of products in your pipeline. So that's one.

So how do you bring more products, increase your products in the pipeline, and bring them quicker to market? So, that's reducing speed, increase in reducing time, increasing speed, especially with curve it. I think we've all seen that increasing speed is highly critical. You can't make a vaccine that takes about 10 years Now, You gotta make it much quicker.

And that's now, I think it's going to accelerate our industry, in terms of bringing products to market. And our industry is reducing costs. It's becoming more and more of an emphasis, as we have more generics and agility is highly important because, in R&D space, you're not in a commercial manufacturing space.

Btog CTASo you need to have some room to be agile, to be able to still move with incentive spaces. So agility becomes, again, very, very important as well.

So with this model, and when I showed you the case studies on this.

So the first case study here is a very technical thought process within your drug development process.

And so this is essentially, the values that are shared for doing it is called a similar process.

It's a very First, is the first step. In the development of a biologic product is the entrance point.

When a biologic product a drug moves, from research, into developing, I'd say, to a critical step, essentially, I call it the life of the drug.

So for every product, you is one project, what we call, and for each product, you only make one cell line, by the way. And that's a line carries through the entire life cycle of the drug during the drug development phase, as well as your commercial space forever, essentially as long as you're manufacturing it. So it's such an important process.

And this process essentially was a bottleneck for us couple of years back.

So, what did you do some backgrounds as a selling development process, supports the global pipeline person and free. So, it's one center of excellence that produces cell lines for all our drugs, R&D pipeline. So, for each cell and I mentioned basically four, sorry, one, commercial product unit, one cell line.

So, but we had a const challenge where we had to cross the biologic product pipeline more than 50%, from 20 17 to 20 18.

And on top of that, we're much more complex, um, molecules and diverse modalities. So what happened here is the agenda cell development process became a, was identifies a bottleneck due to this increase in pipeline. So if we don't solve this, we know that they can't meet the product pipeline. So we needed to increase the cell line development process capacity by two falls, within two years. That was the challenge. We're not increasing head down significantly.

Let's go to the line.

So just a quick overview here.

Development process, so you start with raw materials. You start the secret to DNA sequence, and your end product is yourselves, the cells that can express the drug.

And within this process, you have two key steps. one is your technical process steps, and then you have a governance and decision steps.

The government and decision steps are extremely crucial. That's what I think a lot of people neglected.

Because these are showstoppers, You can move to the next step if you do not have these decisions, clear decisions made by a certain time.

So, you saw the challenge, what we found in this process.

So, first of all, how did we solve this complexity here?

How do we solve the VIP?

In terms of, how do we get to have solutions? So, it doesn't need to be used in operational excellence, methadone, basic. Fairly straightforward, simple, honestly. You're not being just basic Android mapping that the process end to end, they identified which steps, who are the suppliers, inputs, outputs, for each input and output. You know, we determined.

Um, resources, raw material, equipment as documentation, your customers, your gaps from, their need from the ..., prioritize, identify solutions, use the matrix, and came up with a high level project plan which consisted of 16 goals when it goes 16 solution.

It became 60 projects soon.

The key challenge, what we found when we did this mapping exercise, was that it revealed, again, what I mentioned in the beginning, The complexity of the R&D organization, that highly matrix interface, they refund only technical processes that were bottlenecks, that were causing issues.

But more importantly, the business processes with them once they were actually taking a way the efficiency from the scientists taking a wait time, in fact, their capacity from developing cells, such as finance processes. So this is a process where we had to outsource certain steps. So it is a finance process involved in that process was not working efficiently ...

process because everything was fully manual.

Um, so we had to deal with IHS process and procurement processes, so when you exit, you are setting up testing. For example, the external testing. So there's a procurement process, shipping and logistics cells have to be shipped between US and Europe all the time, and that process is highly complicated. CRO.

So this is basic contracting out, Teresa tokenization. These example processes that would challenges, I would say, what are the bottlenecks to the cell line development process?

So, in addition to using the structured Methodology to transfer, So, collaboration, I cannot mix highly emphasized again. Because of that nature.

How matrix is it, it is in R&D, you cannot do anything without collaboration across the company, not just sort of R&D, across global functions, such as finance, procurement, IT, as other groups, even commercial manufacturing, as well.

So that was, again, a very important, I would say, success factors.

So, in terms of the roadmap, roadmap, essentially. So, just to summarize.

When we started, when we identify the gaps, you know, we could only produce X number of satellites for you. And some of the key gaps that we had, capacity constraint, we didn't know.

We knew that they couldn't, we can make more satellites, um, to increase the capacity of the products in the pipeline, more than 50%.

If we don't solve, but we didn't know it was in the bottom line of people, over the equipment space, we didn't know process, or fully manual, The data management was fully manual.

The analytics, The testing.

So you had lot of testing that needs to be done, that they couldn't even test day, didn't even have enough capacity to do testing to support. The current productivity, as we imagine if you gotta go to for renewed, definitely. Do conduit. We didn't have any backup, see I was really at one CRO there was doing just external testing and then we found four key inefficient processes deathless.

32The taking away capacity from the scientists, governance, processes, as I explained, shipping and logistics, external testing.

So these are the contracting out process, the procurement process, report writing the processors, another inefficient business process. Very long course, and very many.

So in order to get to our future, which is to increase productivity by truffaut's, two satellites per year, true of the operational excellence methodology, we came up with what we call the work that goes.

On the generic approach petition, before what I call the triple as, essentially capacity, capability, and processes, So the goal is to optimize capacity utilization, essentially, to meet business needs.

So, there were several, goes under, the goal of the capability below is to bring a new innovation.

New technology of people capability was not an issue here.

And processes, the goal was to simplify key business processes that was causing a noise. I call it no interference interfering with the cell line development process.

So, what I would do is, because we don't have much time, I'm going to walk you through some examples, just to give you a flavor of the different goals. So, we have in total hit 13. Google sounds like getting solutions we had to implement to reach a final. And some examples, because it's a different issue.

Different flavors, in terms of types of challenges that we face. So, one example under the capacity pillar is we didn't understand what was even our current capacity, so let alone a how are we going to know what is the capacity we need to meet the future demand for this? goes into developing a capacity model. Very basic. Here, we applied. a traditional.

Took the traditional approach from a manufacturing plant, you know, scheduling system pretty much. So, you can think of it as a cell line.

Production, you can, it's like a manufacturing production, essentially.

So if you come up with a scheduling, so, first of all, we came up with a strategic tool, just which was the capacity model. And then from there, we could determine the optimal pacing, which is the scheduling system for the satellite. Because before that, we did not know what that was. The research was just throwing the molecules at any time, any pace and, you know, reached recently couldn't handle it sometime, so we didn't know what was an optimum frequency for that each cell line production, just done.

So, that was an example, another one of those steps, for example.

one says, mendacious mandates year those scientists time, the raw material cost. And you can see that amount of man hours saved here just by doing that. And also, we actually reducing the amount, of course, at the end, Because even though you think of something like the more expensive, it turned out to be much cheaper.

Here, improving the analytics.

So this is the testing team, basically, yummy social spending and the support, they had limitations, capacity.

They would impact the selection of what we call a clone, one of the steps within the cell line development.

So what we did here is we brought in automation, brought a new high throughput method, automated data, optimizers ways of working, and data alone, to increase the productivity of the analytics testing team for just 50 to 60%.

We don't increasing any headcounts, and also man hours was saved as well, you know, quite a bit of man hours on top of that, as well as scientists time, going to be different than a new technology innovation.

So one example, we had to stay this way.

Labor intensive within the film development process, it's cogeneration, step, highly labor intensive, fully manual. We automated the whole thing end to end for that, but that alone increased and decreased.

There's a significant amount of savings for men and cost as well.

She was very manual. It took a long time. The data and analysis was also truly man also.

This is called a high throughput method that we brought in for flow cytometry for screening. Here's shorten the time for that step. Automated data, a lot of man hours saved for the scientists again.

Um, now going to the processes, this is where you start to see.

She is different in the beginning, so many different types of.

Related to technology, innovation and business growth.

one important insights into, it was so much inefficiencies, making decisions essentially and layers, and layers of governance and decisions were not clear when accountable, responsible, where we did it was lucky, established requirements for the research team, for this. So, these are two examples of governance in your research, when writers come from research development. What are the governance?

They could bring in the right knowledge in. Selecting the best clone tool, very key governance steps, which are not.

Just by optimizing that, we were able to save the scientist, because what's happening is these scientists, instead of be developing cell line, they were running around, like chickens, basically, bequests and an acting like co-ordinators, project co-ordinators because of lack of governance. Any of those not their role to do that.

Another example of a process, process, outsourcing testing.

Just XML organizations and the out that is a procurement process at any highly cumbersome process for example, from one cell line by del X number of years and we needed, and me the number of incredible amount. And so, what they did is, you know, we want to fight the process, just reduced the number of pills for each cell lines. Essentially, came down to one P of one per line, where do we need to have 10, will go to non value added.

But, this, again, this profit is not on the R&D procurement, global process, that you had to finance procurement to make these changes which are very challenging. But, you know, when it transfers of collaboration using a structured methodology, we were able to bring awareness. And this was needed to be done, and now, it's being used for the other profit in within the company.

So, just by doing this, are the procurement process, really increased three times, three times faster for this contracting testing process.

And also, a significant amount of man hours were fake, because scientists were spending so much time in the procurement process, and we try to minimize the time, you know, to removing all the non value added steps and significant savings are timeless.

This is a very common process and all companies Huge.

Cell lines we have to ship sails back and forth between US and Europe essentially, and this process was so cumbersome and complex.

It caused a lot of delays to the projects, it cause additional resource and even we have lost risking product loss essentially because if you don't ship sells on time within a certain amount of time, you deploy your code it, you have to throw them away.

Screenshot (4)Um, so, just to give, you know, this is just, shipping is a simple process, not that straightforward, um, because it takes about 30 days.

For example here to initiate the request till it arrives on site in Europe.

30 days, by the way, just to ship one, cell phones.

Compliments the 11 different rules involved.

We realized, when we analyzed it, for one shipment, takes about 30 days, 32 men, always think about this for days, basically, of a person, just according to the shipment, to solve this growth.

That would mean it would be 30 shipments for you to return. So, this, mean, we need more than half of F T, just to manage this shipment of cells and vitamins enough, we don't just ship cells. We should all different biological products worldwide.

Just simply find a shipping process for cell lines. What that meant is we were able to now shift shelves three times faster, not 30 days anymore, but within 10 days and also saved scientists. Time is involved.

And this is an ongoing. Tie, a global shipping process, an R&D for all materials.

And what we're expecting globally, significant amount of savings of time, we'll be able to ship four times faster for trans Atlantic shipment.

Significant savings of man hours, you can see that's a huge number, you just, by simplifying your process, you can save up to 51 FTE's.

Or, if you include all the routing and scientists alone, 83% of the time involved today will be reduced. And really able to also ship 20% more, less man hours, and fast, as well. So this is a very important, strategic project that's ongoing as well.

Kinda, I say, I would say, was said, was, it came out of the cell line development project.

Is shared with you're just selling development. So we weren't able to increase our productivity two times in the last 100% increase in productivity, and because of their real name, we're able to meet the future product pipeline. With almost insignificant, you can see increasing FGM very minimal and we're still able to save more than $2 million a year as well, which was not, our goal was not a goal, here was really productivity, but that was an added bonus as well.

We'll have about 10 minutes, so I will give you another case study.

So, the first case study I shared with you was from the X axis, the value stream. I said that it was a technical process. So I just wanted to show you how you can actually apply operational excellence, even on a technical process.

Here is an example from the business process and a Y axis. Key process in orange, the business process that we utilize every day is called a contract process.

And because R&D, we have to engage with top scientific experts, and he's adapters and academicians from the extended ecosystem. If this is needed essentially to drive innovation. And this process was extremely complex, where you know it's straining relationship with experts.

Long delay, because of delayed payments. Also, compliance risk.

You're having event cancelations and also increase in the cost as well.

So, this process, we call it the expert engagement contract cross At anytime, you need to bring an external expert in, you need to have a contract contract. So, that process is highly complex and lengthy refound.

It takes about 200 days on average, by the way, from the time that he should the country, till the person an expert receive the payment.

And the goal was to simplify this process and to reduce to reduce the time, but at least 80%. We sit while maintaining compliance and improving the relationships with experts. Because, I mean, these are people will sometimes Nobel Laureates, you know the famous doctors, CEOs from different companies, where you know, you didn't, we didn't want to have strained relationships with them, as well, so, that was also achieved.

So, with this, so this is just to show you the high level, what the process looks like end to end. It's very different than the cell line development process. This is really more of a legal process.

So, you had, this is the entrance steps where you have to have a request made.

In us anytime we have a contract that looks to be called the request management process.

Then you have to draft the contract, and then your contract has to be approved by the authorities, and then a payment has to be made out in parallel. that all of different steps that happened is that all compliance steps would recall.

Um, and it looks so straightforward, but again transversal collaboration.

Highly needed here because, as I mentioned, is not R&D involved by themselves.

Again as legal legal procurement, compliance, medical teams, transparency, teams, and be on. Every small. Business is owned by different people. Again, there was one person on this process and to an R&D didn't know any of you wanted, we could have clearly simplified it easier.

So how do we do it again? Re-uses? Again, what I found is, the simpler, the village and R&D, the easier it is.

Not using highly complex approaches are methodologies, because it will throw scientists of G Suite.

Just simple mapping, mapping process, identify the gaps, eliminate them, and then design your future process and how you get there.

So what was to come of this process?

We were able to reduce steps significantly, the contract itself, to simplify the contract. They just do one page contract. We're using templates here.

And then forms of reducing the foam significantly. And then, very importantly, is a number of roles involved.

As I mentioned, do, it was owned by so many different people recreated the role of the business process co-ordinators that now managed.

They were managing the process, but they did what they didn't manage to end to end process.

But now they manage the true end to end process, where they do all of it, like, all the different steps, as well, including drafting the contracts, using the templates, instead of the legal teams. Also, they took over the procurement steps as well. So now, these people have gained additional skills as well, and not just project management. They've gained legal contracting skills of human skills. So that was also a very big win win-win situation. So, the final outcome will be, just as we were able to reduce time period from about 20 days to 20 to 30 days, depending on the type of contract, which was a significant amount of time savings.

Screenshot 9-1We have got many good feedback since then, much less complaints, and also better relationships with all of the other stakeholders that we worked with across the company to draft the content to manage this process.

This time, students. What is the process?

Contracts 6 to 11 times faster, and also we were able to reduce significant amount of mandela involving the people involved at the end to end process which resulted to 40% reduction in costs.

So I'm going to summarize the presentation.

So what I would like to highlight is that the road to operational excellence in R&D is still very young, competitive manufacturing and service base. And that's what I've learned.

It's much more complex competitive manufacturing service, because it's very matrix. And because of that transfer, so collaboration is extremely key.

As you don't own process end to end, it requires traditional adaptation of the traditional methodologies and tools as well. You can't just stick to traditional tools and dumping of solids.

Ladies and gentlemen, it seems like Vasella has had problems with her power in her with her machine on her. And so, I'm going to be monitoring her or if she comes back online, we have a few minutes left here that will be on the Q&A portion of it. The good news is that we have covered all of her presentation. And I hope that clearly, you know, she is in Kuala Lumpur right now. This is there is an audio delay and buffering going on in her audio, but we could still see our presentation and we could certainly see her as lives farewell. And kinda here who are most of the time. Pretty. Well and the level of detail here is is fantastic. But I'm just waiting for you to come back on. When you do let us know that you can hear us and that you can You can continue.

Rosie?

Yes, I can hear you. And I see your slide right now. So we understand that you had a little bit of difficulty there with if you're, if you're running out of power.

I'm really sorry, it was plugged in, but I didn't realize that switch, I'm so sorry about that.

No, not not a problem at all. The good thing I was telling the audience is that you had cover your presentation you had. I think you had got to the end where you're doing the summary.

Is that right?

Years. Yes. Yep. So I will end. It's actually pretty much to the end.

Again, apologies. I guess this is a lesson to learn. Even sometimes plugs don't work.

That's right. You know, I always remember, as as a physics student in college, I had, in our advanced lab, we're doing this incredibly complex. You know, Geiger counter type of experiments.

And, And there was a big banner on the wall to remind us all, that when the experiment doesn't work, plug it in because inevitably, will have this incredibly complex machines. And someone forgot to, you know, to plugging the power to the machine. And as, you know, this is just another one of those cases. So solid. So, we have, like, five minutes or so for Q and A So, what I'd like to ask is that if you're able to, can you turn your Toggle your camera back on, so that the audience can see you as we go through the Q&A?

Let me know if you're able to do that.

Oh!

Is Yes 10, and I'm going to stop sharing.

Yeah, you already did.

Just say No, You're not your presentation is not showing, so you're already good on that, and then there's the toggle on the right-hand side of your webinar control panel that you can click on the camera just below the microphone to bring your camera back on.

There we go.

We can see you.

Terrific. By the way, by the way, of a solid what time is it?

It is right now in Kuala Lumpur, 10 40 PM PM, 10 40 PM.

Thank you so much. I mean, super late. Thank you so much for taking the time to share your expertise with us. Your your video is coming through right now, but the video has frozen, which is OK, don't do anything with it. We can just keep your picture there as it is right now. Your audio is coming through just fine.

So we'll relay the questions based, and you can just answer them as as you can, you know, through the audio.

First question is, is required what you show, First of all, thank you, lots of great feedback from those in the audience who really appreciate the depth of detail that you share with us. Not very often that we get to see biopharmaceutical processes and the challenges at that level of detail. And that was very, very useful. Very, very helpful. And you talk somewhat.

You talked a lot about the such impactful projects you have worked on with certain long lead times as well.

I'm curious about, what kind of governance do you have in place to keep a project that's like two years or longer, going in the right direction? And again, such a collaborative effort across all these matrices, matrix organizations. Curious about, you know, what type of champions did you have and and what type of governance that you have in place to allow you to do the work?

Can you hear me?

Yeah, we can hear.

Hello?

Yes, can you hear me vassallo?

Yep, much better.

I Don't know if you heard my question. Did you hear that?

What type of Governance says yep, do we have in place?

In terms of making Project successful is that what you mean? Yeah. Because, you know, in projects that are, as long as the ones that you mentioned, You know, this is a two year plus project that you're working on. I assume that you have some sort of governance. In there in place. There is a champion, there is a vision, there is a strategy is associated with this. Because otherwise, any project that's more than 3 or 6 months, So just kinda disappear, you know, with the pressures of the day-to-day business. So curious about what structure, even if it's a minimum of structure and governance, You had to keep this thing going for as long as you did.

32Yes, yes.

So, definitely, I definitely think that's very important, and really good point. So, I think sponsorship, firstly. I think that's the most important, having a very strong sponsor.

So, I think we had a very strong spawns up to senior leadership level, You know, who was really communicating the importance of it, having and aligning it, aligning this to the R&D objective. I think that made it very helpful for people, for the scientists involved, to know why it was important, and because, yeah, this is, they had to take extra 20% of the time, By the way, this project, for two years.

In addition to all the work that they had to do, they didn't stop doing, This project was not full-time scientists, know, Dave, only about 20% of their time with, of an external operational excellence expertise.

So the other thing is having a very strong governance within the project, so we're having a core team, you know, according to set up where the core team drives the project plan every week and then there's a steering committee every quarter when you have the sponsor and other senior leaders involved. Where you are reviewing the project progress and you know also having escalations or any decision making that's needed budget was definitely a constraint at some point.

So that's, does that answer your question is Josie?

Yes, it does. That's, that's axis that, that. Thank you for sharing that, and adding some color to, should that background. That is so important. You did have a good governance structure, they are in place to keep this momentum going. That's fantastic. I have a question here that's coming in from ... Van ..., and ... asks, First of all, he says, this is brilliant what you have shared with us? so he's curious about how long did each of these 13 project stake and and then the How big was the team that you have working on these projects?

He saw the core team was about five people.

This is, I call it a core team that meets on a weekly basis. But the total number of people involved in the project was about 80 people.

Company wide, and not just an R&D phase, a large team here, So that 13 projects, each project, had their own sub teams as well. And if you count the number of different work streams like a compound, the total number of people involved in this project, was about 80 people.

Fantastic, Fantastic.

That's, that's great insight, um, William Fuller has another one of our participants says, Very good slides and Presentation. Thank you for that, this is the first time that I have seen the juxtaposition between scientific and operational excellence, so nicely done. That's that's what he poses.

Question.

the question, the question that falls up, is that there is a level of collaborative leadership that needs to take place here for this torque. You're, I mean. And I have tremendous empathy for working in environments like that.

And I'm curious about what type of preparation, if you will, in terms of an introduction to, to, to the participants and not so much the Core team, the five people in the core team, I'm assuming that they are pretty much on board.

But when you start talking to 80 people, what kind of how did you prepare them for this change in terms of, you know, creating a mindset of collaboration and and really shifting from this scientific, neuroscientific mindset to the operational excellence mindset. Tell us a little bit about how you you introduce this subject to them, please.

Yes, yes. And I think that's really not a very good point as well. I think even the coaching, I just want to start with, it wasn't challenge.

It took two months to get them on board, the core team out of this course.

scientists, because date, just to embrace it.

But once it took them about, I would say, about three months to really get them on board to really understand and to drive this than the other people, we basically did a road show.

I remember we will have pretty much was flying between US and Europe for the first six months of the project just doing roadshows, talking to every single stakeholder involved because they were between France, Germany, and US. All the different teams.

Why, you know, change the chart to why this is important, how it ties to R&D, pipeline, if we don't solve this, you know, we can meet it. So I think it's, that's what we did. You know, sharing the chat to, what I call it a roadshow And barking, all the peoples of different departments involved. Before we even have started having workshops. We did that first.

I think we took about 1 or 2 months just doing that.

And then that's when we went into more like the workshop modes.

That's very, very good. Now, if I saw, thank you so much for sharing your expertise today, We're just out of time right now And but I want to thank you for being so late there in Kuala Lumpur right now. I'll stay with us sharing your tremendous expertise in great presentation. We appreciate you taking the time and sharing your wisdom with our global community today.

Yes, no, thank you again for inviting me. It was a pleasure.

Apologies for the small technical issue. But I'm glad at least, we got through the whole presentation and, and hope to see you again in future.

Likewise, and by the way, technical issues aside, no problem at all because this is the reality of global collaborations with the technology and tools that we have.

And it's we're still overcome, overcame the obstacles. So this is a great message for, for the reality of collaboration and technology.

Screenshot (4)OK, thank you, bye. Thank you.

Ladies and gentlemen, that was Vassallo, Hot Sunny, who is the leader for North America Research and Development talking about how you bring operational excellence to this scientific process on the biopharmaceutical company. Tremendous insights! We we know that great enduring organizations are not the ones that are just the most excellent ones operationally, are the ones which are the most innovative.

Great. And three organizations have both, and they have the ability to scale the innovation they create with excellence. And I think that's what you have just seen here with vassallo on her presentation.

So there's a great, a great example of the foundations of greatness, which is intelligent blending of excellence and innovation. And she's just done a remarkable job in sharing that example with us. Now we're going to be taking a break here, and we're coming back at the top of the hour. We're going to move back to North America, We're going to move back to North America with doctor Karen Telstra and and Telstra, an advent health discussing.

How we have to stop the innovation killing and how to become the innovation champion your organization needs.

So they're gonna talk about innovation labs. They're going to talk about innovation processes in healthcare and you do not want to miss this session so I'll see you all back at the top of the hour with doctor Karen Telstra and Andrew .... Thank you.

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About the Author

more (5)-Mar-31-2021-09-58-43-04-AMVatsala Sadasivan,
operational Excellence Lead,R&D North America,
Sanofi.

Vatsala is an operational excellence leader with business, technical and organizational skills focusing in the biopharmaceutical industry, with 14+ years of experience. She has worked in 4 different biopharmaceutical companies, from R&D to clinical and commercial manufacturing operations, with experience in process and analytical science, technology development, manufacturing and quality control operations and quality systems.

She is a continuous improvement expert with skills both instrategy and operations management. A strategic thinker who is able to translate vision and strategyinto operational solutions. She is passionate about global networking, collaborations, benchmarking and has experience working in multicultural environments (North America, South America, Europe and Asia).

Vatsala is currently the Operational Excellence Lead for Sanofi’s R&D North America Hub, where she is responsible for managing Operational Excellence activities in the North America region and global R&D. Prior to the current role, she held various Operational Excellence roles within Sanofi Genzyme in the Commercial Manufacturing Operations business.

Before joining Sanofi Genzyme, Vatsala worked for Shire, Millipore and Pfizer in various functions from R&D to clinical and commercial manufacturing operations. She received her MS in Chemical Engineering from Northeastern University-Boston and B. Sc (honors) in Chemical Engineering from University of Nebraska-Lincoln. She also has completed the Executive Program in Artificial Intelligence - Implications for Business Strategy from the MIT Sloan School of Management.

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