So could you just start by saying your name and your current title?
Yes. So my name is Martin Montoya.
I'm the senior operations manager at the Clinical Biomanufacturing facility,
which is currently part of the Pandemic Sciences Institute in the University of Oxford.
Brilliant. Thanks very much. And fairly briefly, but I'm interested in how you ended up where you are now.
So would you like to just give me a kind of run through your career from from your initial education to how you got to be where you are now?
Yes. So I have a degree in engineering.
That's probably why I understand the processes and how to optimise it.
Engineering way of thinking. And I have another degree, which is an executive MBA from the US from Northwestern University,
and that's why I, I believe I have this notion of how to add value without wasting resources.
So how I ended up here? That's a very good question.
My, my career was always dynamic. The only constant was the change.
And it so I 20 years back, I started in retail.
Then I moved to construction from construction to bigger construction projects.
And then I was in I grew up in the Middle East, in Jordan,
and at that time I was there working on projects in the Middle East area Jordan, Saudi Arabia, Qatar, Dubai.
Uh, then the I've noticed the change and the overall business environment and what's going on and the with, with the Syria, with the war in Syria.
So I, I got involved with the humanitarian response for the Syrian war, and that's were that was a turning point for me.
My focus became on humanitarian aid, how to get things to places.
No, no one can get to, how to move supplies, move it, move resources,
including people and labour and, you know, trainers and human beings to go and work in places.
And at that time, by the way, remote working was a thing for me.
And when I say at that time, it's it's like ten years back because I used to work with people from different background,
different professions where they have to shift from being and let's say a schoolteacher is becoming now an accountant,
working in a place where we have no idea how does this this looks looks like just to help the people there.
So then I became involved with one of the major responses there were.
Similarly. So those are two of the main milestones in my career, which this one which I'm going to mention now and the COVID project,
that at that time all borders were closed in Syria and and and a lot of people were displaced here.
We have to provide supplies to them to help them, the basic supplies.
But nobody was able to get there and we were unable to send money,
therefore be able to buy things and distribute it, considering all the sanctions or with what's going on.
So I came up with the idea of, uh, legal smuggling, let's say.
Yeah, which sounded a bit weird at the time.
Uh, and. Yes. What is that?
Okay, we can have it legal from the other side sides of the borders by getting the approvals, like from Jordan, for example.
But on the other side, it was like no man's land. How would we do that?
We have to. You know, similar operations are built on trust.
Uh, low profile operations, extreme lack of security and access.
And, yeah, here I come employing my my skills to get this done.
Building and maintaining our good relationships and managing the relationship with various authorities,
managing expectations, high living and high quality of communication with authority used with community leaders.
You know, it was crucial to the success of similar operation in a war zone.
And were you what were you doing all this remotely or what on the ground?
I wasn't. Jordan. So yeah, it wasn't Jordan.
No, the Operation Self was remotely was inside Syria.
Mainly started focusing on southern Syria. But I wasn't Jordan.
But literally I was standing at the border sometimes observing the implementation of what we have created.
But we cannot go to the other side, of course. And there was bombing at the time.
You can see it sometimes you have to just do emergency evacuation, just leave the area immediately, you know?
Yeah. Until. Yeah. This remarkable access, delivering humanitarian assistance to vulnerable people created this kind of motivation for me.
Yes, we can create impact. We can create impacts, we can change things and we can help people.
And at the same time, it can be a way of living.
I continued working there. Then my career expanded.
I started to focus more and more and on material supplies in other areas like South Sudan, Somaliland, Yemen.
Bangladesh. Had to travel a lot.
I remember 2019. Maybe I. I took more than it was about 40 aeroplanes in a year in 2019, which is.
Yeah. Now after the COVID era, this sounds too much just to travel to all these areas, to talk to people, different backgrounds, different cultures.
And I believe this is one of the skills which helps me to keep going with what I'm going with.
With what I'm doing. Mm hmm. Uh, yeah.
So then I. I moved to the U.K. with the.
With an interest to expand my work further.
And what and what year was that? End of 2019.
Okay. Yes. November 2019.
Okay. Very, very, uh, coincidental timing.
Yeah. Yeah. Yeah. And, uh, yeah, it was fun, because sometimes I used to ask myself a question.
Is it a correlation between where I am and.
And the humanitarian crisis, whether it is a manmade crisis, a natural natural, like a manmade disaster or a natural disaster, or it is acquisition.
So I so I thought it will be more some more of settled emergency because my focus was I started establishing
contact with with research institutes and and research bodies within Oxford and other places to work on projects.
The their trials, you know, the trials are happening everywhere overseas in the UK.
My experience will be valuable if they want to implement trials and let's see in Africa,
in the Middle East, Southeast Asia, and honestly speaking, it's like wishful thinking.
Uh, yeah. I met Kath Green and Dec.
Mm hmm. And, uh. Yes.
Okay. Come on, Omar, You can come.
We had this kind of interview, and they joined the team, started working with him because I had to travel again in January.
So I delayed my my start to work with them to handle the operation of the clinical biomanufacturing to 20th of January.
Yeah. So this was my career and how it started and how it progressed.
So if you if I look at it, if I go back 20 years and it was impossible to connect the dots,
but now looking backwards, it's very easy for me to connect the dots going, Oh, I'm here.
But it's very I mean, maybe I'm wrong.
Maybe I should go back and ask Kath. I interviewed Kath a long time ago.
I agree years ago, but we didn't talk about your appointment and I'm just very interested that somewhere that was.
I mean, I know that the CPF has many outside links,
but it's still part of a university and for a medical research institute to hire somebody with your background in operations and logistics.
I mean clearly now it makes a great deal of sense. But at the time it was quite an unusual step.
I mean, are there many other people like you working in biomedical research?
So, yeah, that's a very good point.
And I still receive this question. Much often like recently.
After all, what we have done,
like how we were able to to communicate what you are capable of doing and how Kath was able to communicate to you what she wants.
Yes, yes. Because we like speak different language.
Not different language in terms of language, I mean in terms of terminologies and concepts.
So it was very interesting when we heard when we did this interview and the appointment, it was flawless.
You know, Cath knew exactly what she wanted. And I was able to express myself very well to her.
And trust me, the day with I when I left the clinical manufacturing facility, going back home, I was.
They're very confident. About this.
This discussion was very positive. And yeah, you know, in a week or so I received this confirmation and started all the negotiation.
I did not know that gas was one of the important, you know, very highly respected scientists in the field.
And I negotiated the the the package, you know, in a ways.
So. Later on, I understood that it was a struggle for her.
It was a struggle for her actually to convince the university to to hire me because it was like,
yeah, so this guy is very far from the written textbook about what you want.
You know, when you say a textbook answer, I was the opposite of a textbook answer.
Yes. Yes. And one of my colleagues, Richard Terence, uh, who's a Cup qualifier person,
he told me once that when Cas decided to to have you join the team, she told them, Yeah, I'm bringing someone you can consider as a wildcard.
Yeah. So honestly speaking, I did not know.
What does that mean? So I had you to google it if. If that was a good or bad thing.
It can be both. It can be both. Yeah, exactly.
So, yeah, this is how it started. Yeah.
Tony Jones Well, you joined the team 22nd of January.
I received an email from Cath telling me, Let's meet in front of the of the green building.
1:55 p.m. Okay, we're going to meet Sara Gilbert.
Okay. So I did not know who was Sara Gilbert and who.
Yeah, I'm still trying to know who's Kath GREENE.
Yeah, yeah, yeah. So. And me and her, we went together and we met Sara Gilbert were on the 22nd at 2 p.m.
You know, significant change was a turning point for the facility operation.
Were both of them what they were discussing?
Obviously, which came to be known now COVID.
Yeah. Yeah. So when I'm just asking everybody this question,
was that the first time you became aware that COVID was potentially a pandemic threat, or had you heard about it before that?
No, I, uh. So I can't recall exactly how I first heard about the COVID 19.
Hmm. But I remember that I was following the news, which was covering a new virus spreading in the city of Wuhan, China.
And I assumed, like many others, that we are probably dealing with an epidemic spreading immensely in certain geographic area.
Like most of the viruses we heard of in the past 20 years or so, like size or mass.
Even when some countries starting started imposing travel restrictions.
So I did not bother and you know, it did not bother me at the beginning.
I was still under the impression that it would only last for a couple of months.
But after I started seeing the unforgettable images and videos of people falling in the streets and not being attended by medical staff,
yeah, it became I became definitely concerned about it.
And that was, I believe, around that period of time, third week of January.
About its potential impact on the world, especially since it was a new virus with no known cure or vaccine at the time.
So tell me more about your meeting, your initial meeting with Kath and Sara Gilbert.
What what was the goal of that meeting? What was the decision that was taken there?
Yeah, so that was my third working day, obviously very busy week.
So. I was not aware of the purpose of the meeting.
I thought it would be an introductory meeting to Professor Gilbert.
However, it turned out that in this particular meeting the so the main purpose was a major shift in the facility's operation was about to happen and,
and of the senior operations manager. So. Yeah, I'm supposed to be there?
Yeah. Yeah. Catanzaro decided to reprioritize the efforts towards the new virus.
So they decided to reprioritize the, you know, the, uh, the goals and.
Most wanted. There was a fine. They have to fine tune a balance.
Like to find the balance here. Whether they prioritise the new virus or.
Which will three which will impose postponing the ongoing very important projects at
the time on developing the vaccine like for Ebola and NIPA until further notice.
So how do we do that and how do we decide to make that decision?
Uh, so I try to, you know, to understand to what?
What's going on at the time. And by the way.
I, I was still getting the hang of, of the first week and other was trying to figure out my way around the facility.
I didn't even knew if I have a designated work workspace or not.
So yeah. Uh, so but I realised your position was a new position as well, wasn't it?
So there must have been an established management hierarchy that you have to feel your way into.
So my position. Was newly created.
Created by Kathy Griffin. And never existed before in this clinical manufacturing facility.
So and I have to fit myself there.
I have to meet other. Senior people within the team.
I have to meet other operators within the team. I have to introduce myself.
It was very difficult to you know, it was a bit challenging.
How would I work with everybody?
Because I work, you know, across all the teams.
So. So how would I be able to to extract the information I want?
How would I be able to analyse it and how would I make decisions or at least propose options and solutions to cast to other teams?
To Sara Gilbert. Uh, so yes.
Uh. So yeah, as I said, it was a very busy week and then sent out a very busy year.
So I mean the first task must have been to.
So the first yes, the first shut down the existing, the existing research programs and I've talked to MRO little bit about that.
What was that what was the challenge there? Yeah.
So the first task for me was a bit yeah, a step ahead of this.
So Kath asked me to have a discussion with our two qualified persons.
And are you familiar with the term queue? No, I'm not actually.
So. So, yes. Yes. Occupy is a.
Is the person who certifies a badge to go for to be up to go for a clinical trial.
So they are responsible, legally responsible for the safety of the vaccine.
Let's say once you inject it in a human right for human use.
So that's a very. High responsibility.
So the two senior cubs at the time, uh, Dr. Adrian Notary and Dr. Richard Tarrant.
Uh, so Kath asked me to have a discussion with them and to figure out what is the plan and what are the timelines.
Uh, and when I say the plan is like the actual plans in terms of available resources,
what other resources we would need, what, what are the timelines?
When we talk about these resources, we talk about human resources, we talk about materials,
we talk about equipment, we talk about subcontractors, all these things.
So that was my first task. Um, so I had this discussion with both of them.
Obviously, it's, yeah, it was a bit awkward sitting with two very senior scientists, I would say.
And maybe you already, you already Georgina,
you already realised that I'm probably the only member of the team who does not have any relevant scientific background.
Yes, yes, yes, I do realise that. Yeah. And, and it's very important to realise that it was.
A challenge in terms of communication because scientists, they communicate with very strong terminologies.
And they use terms I never heard of.
And not only me like they even like. And this is the way how they communicate.
It is nothing wrong with that. But of course, it's a it's a challenge.
So. But I focussed on objectifying things.
I did not bother with the details. So it's like the engineering way of thinking.
Mm hmm. So and we were discussing.
So the cubes had two methods under consideration, two manufacturing methods under consideration,
and there was no consensus on which one should be tested first or edit or which is the the most senior QB and.
The most senior at the time and in the CBS and some of the duration.
Also, she once suggested that we follow the method which has been used before in vaccine manufacturing.
The CBS, but was relatively consumed much time in comparison with the Northern Missile, which is the new one.
Okay. But we have an opportunity to use the new muscle, which could save us also at times.
So it's a huge gain. A. Uh, it's a huge gain if if it is successful.
If. And then, yeah, my operational sense came into practice.
I told and I said, okay, let's draw a timeline for both.
And how long did it or how long would it take you?
To see. If this process will fade, how long would it take you to be confident to say it failed?
If it is, if it is really failing? She said, Why are you asking that?
I said, Look, it's good if we're going to fail. It's fail faster so we can succeed sooner.
And yeah, she did not like it at the time.
She said, I know what I'm doing here. We cannot we cannot just think about it.
And why would we waste our time in something we know that it will fail?
Okay. Yeah, because we don't know that it will fail. So let's fail faster so we can succeed sooner if we're going to fail.
And yeah, so the plan I submitted my recommendation to Cath had a discussion with her and yes,
they went with that partially as my understanding that they went with, with this recommendation started in parallel.
Uh, working documentation wise on the, on the, uh, traditional manufacturing method, which we are already experienced and, and the other one,
uh, so it don't know told me it would take two weeks, but it took a week or so to, to identify that this process will not work out.
Right. Which was, which was a great gain by the way. So it was like hitting two birds with one stone.
We, we knew that one process needs improvement and at the same time, we saved a lot of time rather than having never ending discussions,
you know, between the team, this one, that one, this one with that one. Oh yeah.
So that was my first desk. Oh, very interesting.
Yes, yes, yes. And and so once the the the manufacturing got underway.
Yes. What what did your life look like?
I mean, where were you actually going? In to the the centre or were you working remotely.
The facility. Okay, So. So this year we're still in January, don't we all?
Are we still. Yeah, yeah, yeah, yeah. So we haven't, we haven't got to lockdown yet.
I think we were still in the first in the last week of January or first week of February.
Yeah. We were still in January. Yeah. Oh yeah.
And, you know, time was the rarest currency at that stage.
But you had you so you did have the the the month of February and and the beginning of March.
Yes. So the before everything had to conform to the guidelines on social distancing.
Yes. And so, yes, in order to get to really get to know the people in the facility.
Yes. Yes. And I think that COVID at that time was a gift to me, you know, to to to show like to, you know,
to to try things in practice of my previous experience so that at that point,
I started working on business continuity plans, emergency preparation plans.
And so I. Disaster recovery policies.
So if. For example, I immediately started communicating with everybody to produce risk register, identifying business critical areas.
What are the critical activities and skills? Obviously, it was also new terminology to my colleagues, What are you talking about?
So I thought, okay, don't worry, I will simplify everything to you.
So I try to make everything look simple and very concise, easy, very short communication to everybody collecting information.
But I was what I was achieving with that.
If key individuals in the business critical activities can be replicated, can assign deputies.
All of that I started working on in January because this is what I do ensure if our plan contingencies does not affect our GMP compliance,
because this GMP thing is very, very regulated and you know, like we have to be.
So there is no room for manoeuvring in terms of compliance.
And at the same time in emergency response, you know, maybe you heard about this, like when they say perfection is the enemy of good.
So yeah, okay. So you can. Chayes The fiction in the normal situation where everybody can be successful, you know.
When you go with the flow, but now everybody's against the flow of with everything happening.
So and also what I prepared analysed our decision tree for taking on your activity is projects that
are emergency staged or in the beginning of the conversation I mentioned to you there was a balance.
Whether we shut down everything which Emma talked about with you and or whether we start working the starting material while still working,
but a bit slower on the current projects. So there was a decision tree for decision making to make this draw scenarios.
I had to draw scenarios six communication plans and emergency hierarchy at all levels so nobody else feels left behind.
And also it was yeah, it was tough to say. That's one of the scenarios of if whole team went went down.
And so yeah, it's now, you know, it was taking me back three years,
literally three years back thinking about what about what was happening in January then it is a different plan.
Shall we have a framework agreements with other departments in the university
who have DABS who can outsource their There's time to us and their people,
to us, their equipment? Would that be compliant facilities vendors to take over critical activities, if not safe areas are identified?
Can we plan for contingency areas? This literally was part of what I, I produced and worked on, which has nothing to do,
by the way, with the clinical manufacturing, with the science, with this, with everything.
And that's why maybe Cath keeps mentioning that we have a diverse team because it was at that time.
Yeah, it was a lot of pressure on my colleagues also for me to extract all this, all this information.
No, I was wondering whether how they reacted to that.
They think it was unnecessary bureaucracy. No, it was I because the way I tried to make it short and simple.
So if if it's nice, if I look back at my records when I ask you something,
I just make it bullet points very short thing sometimes just yes or no answer, and then I compile it, analyse it and present it.
So also, are we able to allocate more reserves of consumables and material?
Yes, maybe. Yes. Do we have space to store that?
Oh no. So what should we do? Think about short, short shelf life items?
You will never think they will run out of dry ice, for example.
Oh, okay. But so what shall we do?
There was in terms if lockdown happens, but that was the story of my life and previous years,
and especially when we were distributing the safe food and in the war zone.
So yeah so worked on this conducts a preventive maintenance for the equipment what is due let's say in the next 6 to 12 months.
We started doing preventive maintenance for that. So we don't have any field machines or equipment, have a standby technology and I.T. equipment.
We also set emergency budget to access to cash accounts and budget holders in case we so the university finance team went down.
So, yeah, so this was the business continuity plan side of things in terms of emergency preparation plan worked on what is our unified statement,
which is sound weird because we are a subunit of a subunit within university.
Well, not an independent body, but at that time you have to act like you are an independent body because you don't know who will stay,
who who will remain standing, who's the last man standing, And yes, central data board on which we can have access,
visible access to only critical deliverables and be concise, don't distract people.
Uh, availability and the ability of resources, especially if we're looking at partners as well.
Uh, yeah. And identify potential risk problems, assign responsibilities than mitigation actions we have reviewed also.
Our distribution processes. Yeah. So. Try to optimise the operation as much as possible,
but also to streamline it and to simplify it so everybody will will understand what the what is required from them.
Communication and transparency and visibility was key.
Uh, yeah. So that that was my January and early September.
Mm hmm. So, I mean, one thing that comes to mind is whether the fact that you were treating the likely evolution of the pandemic as an emergency,
as severe as what you'd seen in Syria. Do you think that it kind of increased the level of alarm among your colleagues or
the sense of urgency among your colleagues about what they were about to embark on?
Yes. So. I believe I have.
I had this. I saw this as an opportunity.
To. To implement.
What time? What? What I. I know.
And I can do. And I had yes, I had the sense that this is a serious emergency response.
And part of it is like we are.
Yes, it is an emergency planning phase.
If we think about it this way, it's a planning phase. But in no time it's became like there's no time to plan.
Now it's execution. Yes. So I was used to that.
I was used to that. So planning is good, but you have to plan for.
Scenarios. And, you know, you have to think about everything, what could happen.
And when you think about the.
So resources are limited, so you have to be realistic in your plans and what you can access.
This created the sense of. Collaboration actually, within the team.
Hmm. Uh, some people were like, Yeah, that's too much information.
But they also, you know. They were also motivated to try to figure out what what they were trying to do.
And yeah, I. As I mentioned, I was able to communicate.
I was able to build this skill of communicating with people where I never met community leaders, different cultures, implementers on the ground.
Taxi drivers became logistics experts because you couldn't find anyone to do that.
You have to train them. You have to simplify everything to them.
And you have also to maintain due diligence to to to ensure segregation of duties, you know, all these things.
So it came into practice.
And so when you got to the implementation stage, what were some of the key stories that you remember from that time about challenges that you met?
Well, implement program. Yeah, well, establish a compensation system for the four extra hours worked.
But now, you know, everything looked nice, but now we would have to do additional hours.
So we it's a bit. Yeah.
It. What. It's not and. Easy thing to do within such a scale institute to to change the compensation system.
So usually it is it is not a paid thing.
It's it's more of a compensation. I was like, toil. Yeah.
And the university has their policy. It's published on the website.
But it cannot is you cannot have everybody.
Aligned and committed to what you're trying to achieve without thinking of them as.
Yeah, but they all you have to. So this was one of the challenges.
And nobody can take time off and do when you're all working so hard.
There isn't time for anybody to take time off. Yeah.
So cast, Cath, while Cath is very smart and a great leader.
So I remember the day when she said, okay, it seems like we're not in a job anymore.
This is a mission. So it's not a normal job.
It's a mission. So and when you think about it, yeah, it's the mission.
It's a global scale. So we are becoming heroes. Maybe.
Maybe accidental heroes. We don't know. Okay, so we had this.
I saw that in the faces is the eyes and the way my colleagues used to talk and communicate and work.
Everybody saw this as as a mission. Not as a daily job as before.
So. And you know, as a leader, you create direction, you identify the direction and you define alignment with all what's going on.
But also, you have to gain commitment and commitment that is gained with multiple ways.
It's not black or white. So, yeah, so commitment was one of the challenges for me to, to, to implement.
So as I mentioned, this compensation system, the limitation of resources.
So and here comes how we can, you know, how we can balance simplicity in scale.
And at the same time how we can maintain.
Eyes on the prize. Uh, so, yeah, so it was.
It was, uh. But but it wasn't.
I would say it wasn't that. Challenging the implementation itself because we knew what we wanted to do.
And how to do it, of course, how to fix. Because.
Because we already knew who can backfill for who, who can't.
Yes. So one of the things I always. Try to achieve is adding more capacity from the existing resources.
So. And this is. Operations management.
So, you know, like in the normal context, managers all the time,
they try to add more headcounts, get more resources, get more people to work in their team.
But. Scott It's very it costs this this resource at the time.
And also one of my other challenges was is to to recruit new people to come and work with us.
So. So I had to.
To work on that. Were you are you able to to to try to figure out so this individual's doing this in this lap,
would they be able to we are another to put on another hat to do something else.
How would they figure it out without knowing what they're doing? Because I as I said, I objectify things, but I don't know what are those things?
So easy questions, simple questions with everybody, you know, discussion here, quick chat there.
Try to understand what's going on here with this person. So and this led to to a fully optimised team.
And everybody was working around the clock like a beehive. So this was the thing about the implementation in terms of resources other.
So we started the project and. Life was good working on it.
And here we go. Early March. And then, you know, or we became with the difficulties of the flights.
There was the. No commercial flights where there were a lot of difficulties, uh, continuous cancellations.
Uh, you cannot guarantee that your shipment will arrive.
So there was a time, I believe the first week of March, Cathy came to me and she said we were supposed to be shipping some.
I think still growth medium to a company in Italy.
So we were supposed to ship the thing,
but due to the difficulties with with flights to Italy and the fact we might actually need it for ourselves in our manufacturing campaign,
we have decided not to proceed. Do you think that you can somehow.
Figure out a way funny, considering that you have the guy who is who has supply chain experience.
Okay. For us to place an order for. I think what was it was a small order like two litres of this medium from a company in Ireland.
Fujifilm is. And you ship it to Italy.
So ships. Something from Ireland to Italy rather than us, because we already identified this material as cause material.
We might need it and will not be able to source it.
Okay. Yeah. So that was one of the challenges.
Of course, I was able to do that, luckily, and with the support of my team to figure out what is this material,
would it be considered as a dangerous goods and the to classification?
Uh, you know, all these things come, all the details matter. And how did you resolve that?
Because I have heard the story about the chartering of a private jet.
Oh, yeah. So this is the stuff that's. Yeah, this is not the same story.
Okay. There are a lot of stories like this. So, yeah.
So this one, how I resolved that. Simple.
I talk to the people in Fujifilm, I talk to the people in Italy.
It's always about communication, you know, communication, transparency, Try to be as clear as possible and concise.
Talk to both sides so we have material.
Does it exist? Yes, we have it in stock. This people read this material?
Yeah. Nice. How would we send this to the. We have all these options.
Okay. How do we make sure it arrives there? Safe temperature, temperature monitored, you know, all these things.
So I've mapped everything possible. And if you remember, I think that happened 10th or 11th of March, just at the beginning of the lockdown.
So panic attack everywhere. And.
Yeah. So where's the money? The money? Kath told me.
Yeah, you can use this grant quote. Okay. Um.
I just shifted from Ireland to Italy with the with the best suitable way.
It wasn't that complicated. Italy. Yeah, but, you know, very close and dynamic and continuous communication.
So it's not like, yeah, please send this thing and then disappear.
Of course it has a lot of details, but if I look back at the correspondence, you would find all the details was simplified in one page.
So no needs in this situation, no need for those very long essays and, you know, unnecessary communications.
So yeah. While shift to Advent, Advent were happy to have it, they were working.
Advent is the the partners the other manufacturing company in Italy.
Yes. Who were going to manufacture. Yes. Is of the vaccine for the trials.
The clinical trials. Yeah. Yeah. So that was March. We were very happy.
I still have the picture of the of the first file ever of this vaccine when it was labelled.
I help the team to do the labelling.
It's many were labelling.
So I remember I was working with my colleagues, labelling the table, sticking the labels that you know which, which is something.
Yeah. We used to stick labels of boxes, we used to ship them to South Sudan or so it's, it's, it's same context, different material of course.
Yeah. Uh. Then.
Yeah, then we had that. That story about the charter plane.
I. Yeah, it was famous. It was famous. Well, tell me the story again for the benefit of people who haven't heard it before.
Okay. So there was a you know, so Advent had made their patch.
So to continue in the clinical trial and by the way, most of our time telling you now.
So when I say to continue the clinical trial.
At that time, I knew that this is very important material, but I did not know what is the purpose of that material was shipping from home from Advent.
But the key is. Simplify things.
I keep always telling this to me, my colleagues and I was very called, by the way, during the whole thing, and they made the comments.
Some of them they used always to make a comment on You are so calm, so relaxed all the time, what's going on?
So it was good. I don't know. So it's it's all good. Advent that time was very difficult.
And in Italy, if you remember, I believe I don't remember that was maybe in May.
Maybe in May. So.
Advent made this batch, though it was very small batch, like less than half a litre.
I think that's the volume of the material.
But that's okay. That's enough. I think that was enough for about 500 doses.
That right? Yeah, yeah, yeah, yeah, yeah. So.
And. We were trying to ship the material.
We had this giant big pharma astrazeneca some.
So communication already started. We are talking to them.
They're talking to us. We are communicating with them.
I am communicating with them with regards to the operation, to the distribution, to clinical sites, which was very I will come to that later and.
And then we had this. This 500 dosage which we need to ship from Italy.
Continuous cancellation of flights. No flights coming from Italy at that time.
Okay. So what shall we do? No.
No. Courier company was able to guarantee or confirm that they were able to ship the material.
Very specialised companies, of course, we work with because it's a cold chain, supply chain.
It's not a normal supply chain or ambient temperature.
And so, again, I establish this communication, this very good relationship with the people in Italy.
So I asked them how they will help people leave Italy if they want to leave in the lockdown.
So they said, yeah, it depends. But some people, they managed to leave Italy with using mottos like it's okay.
So I was like, okay, So I opened Google Earth and Google Maps and tried to figure out how a motorcycle guy could be able to do that.
Are we able to maintain the -80 temperature using dry eyes?
How we replenish the dry ice? Are there points in this route?
So it was like I believe it was like 32 hours.
And and also, how would they again, are we are we legally smuggling them or is it illegal to do what I'm doing here?
And then then I called the friend who is a Jesuit, who is an Air Force pilot in Jordan.
I called him and I said, Listen, are we able now to charter planes?
And he said, If you have clearance like the the necessary approvals from the destination, yes, you can do that.
I took two cars and I told her, Listen. So our friends in Italy, they think it's somewhat just, I could think,
ignore this idea because it will be a complete disaster if we cannot replenish that dry ice.
And then we have to throw away the 500, the very precious 500 doses, dosages and.
Do you know that we can charter plane? I just was like, Really?
Yeah. We can shelter clean. Okay.
She took to Andy Pollard. She talked to Sara Gilbert.
Sara I remember. I remember when Sara Ehman e-mailed back and said.
So can we do that? Is this something positive?
I don't remember how she wrote that, but can we look into that option?
I was like, Yeah, of course. So again, you know, this very nice feeling of doing something different.
The only constant is the change, as you can see. Okay.
I talked to our friends again in Italy. Uh, contacted multiple companies who can provide charter plane.
Uh, yeah, and I remember, So we got the calls for that.
So I told Cath, listen, for sure, it's less than six figures.
But I don't know. How much would that be? So.
Can you figure out if we can pay for that? So silence, a moment of silence for about three, 4 hours.
Then she came back to me and she said. Can you get us the exact cause for that?
I said, Yeah, of course I can do that. So the.
We got the course. It was five figures, obviously.
Um. And I waited for the approvals.
Then we had this kind of placing all these purchase orders, the documentation, things, you know, the institutional processes.
Mm hmm. We had no time to do that. It's like multiple chains of approvals or everything, like.
So I was like, Listen, guys, if if we can have a higher level commitment by email, then we can deal with that.
That? Yes. You're happy to pay for that.
AstraZeneca guys came back and said like and said, Yes, we're happy to do that if you guys can make it happen.
I was very happy and very proud that this response came from this giant monster.
Yeah, I can't do that. Why not? So. Instructed everybody to go to to mobilise stoked again to my friends in Italy told them, yeah, this is happening.
There was like they were like, Oh great. So prepared everything.
I was walking in the corridor and, and the offices and Oxford's and, and, and the board of it.
The WHO led the Professor Antipolo to lead the clinical trials.
He was like, Oh, you are almost right. I said, yeah, I'm I'm, you know, I wasn't you when like, there was no time for introductions at the time.
He knows there are in the emails I think but never and we all familiar faces.
But there was no time and they were not face to face meetings at the time.
And then within the units themselves, with the social distancing, everything.
And of course we were key workers. I had to cycle 40 minutes to work every day back and forth.
You know all that thing well, I was like, yeah, I'm I'm not.
Yeah, you are. The chance to clean good. So would we.
So what do we have the the the vaccine by tomorrow I said yeah, yeah.
I understood you wanted it by 3 p.m. He said, yeah.
I said yeah I hope my, my, my plans shows that you would have it by 1 p.m. in Oxford and literally this is exactly what's happened.
And yeah, so Kath wrote about it in her book.
I was very happy to see that, that she mentioned it since like Rockstar, I did not realise actually that was too important until I saw it in the book.
Yeah. As you can see, like things were. Just get things done, you know?
It's a mission, you know, nobody cared about, you know?
The. The publicity or credit.
It's like we eyes on the prize.
We want you to be successful in that, hoping that it will be a successful vaccine and we'll be able to end this pandemic.
So you mentioned that you might have more to say about the interactions with AstraZeneca, because they.
Well, I mean, both we should say we covered this in other interviews,
but so the the clinical Biomanufacturing facility made enough vaccine for the phase one of the clinical trials.
Right. And then I'd made enough for the phase two.
Yeah. Around about that point, AstraZeneca came in to scale up for the rollout.
Yes. Right. So. There was the other aspect of this operation, which was the distribution to clinical trial sites.
Usually this is not within the scope of the clinical research facility.
This is the scope of the clinical trials team.
But at the time, as I said, we have to wear different hats and we were like working as what, one body, you know, one team like.
So our senior QB, Eleanor Perry, who makes sure that everything goes right and the material ones arrives to the right place at the right time.
F when I mean, the right place is the clinical trial sites.
Hmm. Uh, um, the rest of the team who were working on distribution the so I got heavily involved with them on reviewing our distribution processes.
And we've worked very closely with AstraZeneca and with, uh, with the courier companies, and we have decided to work on contingency plans, so.
You know, when you think about contingency plans, well, it's not one courier company.
So at least two courier companies established this relationship to get the agreements in place,
get the cost in place, negotiate with all these details.
A. And do their due diligence on the AP to do the work for you or not.
And when you say that, it's like it's not something you can call someone or ask for a reference, it's it's a different thing.
So this is very new to everybody. So and so I've worked on reviewing all these processes with the team.
It was very interesting when you think about the process with all this margin of error and things,
yeah, it's all under control and actually it is not unsafe to do that under the normal circumstances.
However, in our situation, any correction is very expensive, as I said, but time was one of the rarest currencies at that stage.
And also now the vaccine is another real currency at the time.
So you cannot just say, Ah, yeah, so let's destroy some some vials because there were not delivered in the right way,
which shouldn't be the case anyways. So I've worked with with Eleanor and Helena, one of our team, and with the AstraZeneca guys,
to run a simulator, to create a simulator as a mock-up and run it with the courier companies.
And by the way, they did not know it is a simulator just to identify any issues and take action and take corrective actions.
And we identified a few issues. We will never think about it and was like whether we drive to Scotland or we use aeroplane and when we use aeroplane.
I like to fly that the vaccine there.
Are we able to track to have life life like real time tracking of the temperature of the vaccine when it is waiting in the
airport or we only extract the data once they have the temperature drops delivered on site And then if there's an issue,
we figured out that, yes, there is an excursion or there's a problem.
So so as you can see, like that was one of the interesting concepts we had worked on and didn't really life.
Like, why would you run a simulator? You can say, Yeah, we try them for a few for one or two shipments, but in this case, no, that's not an option.
You have to get it right first time. Yeah. Yeah, that's. Yeah. You have no other options.
Yeah. So, yeah, this is the other story. Ooh, ooh.
You know, there's so much, so much involved that. That it's a story that doesn't usually get told.
It's. It's almost like a magic wand was waved and all these things happened.
Yeah, but yeah, it's very interesting to see the, the back story and I mean, presumably AstraZeneca do have operations people.
People who speak your language. Yeah. Yeah.
And. So when we speak the same language.
We amplify the effect. And that was a very good relief for me.
However. Sometimes. So the good thing that Oxford and AstraZeneca, this relationship.
Which of course we are not involved with, with all that this arrangement.
It's it's a that's a it's a different level within the university but it was like.
There was common goal, common interest. And yes, so it's the conditions with a light and.
We. It was nice that whatever we were suggesting and whatever we were proposing and sometimes imposing.
They were very responsive. And yeah, I'm very grateful for their professionalism.
They worked with us. But, uh, yeah, they, they showed throughout the process.
And they were very collaborative.
And yet even at the individual level, it was yeah, it was very nice, like the this sense of ownership of of this operation.
So yeah, they would. Part of everything I would say like from May until the end of of of this project.
And I mean, at what point were you able to relax a little bit?
When when were you able to say, well, the CBS job is is done now and it's now out there in the in the world and others are taking care of it.
So. I wouldn't say I wouldn't say I wasn't relaxed because it was very rewarding what we were doing.
So, you know, I was relaxed. Yes, I was.
We were very busy. But I was relaxed because I was able to see that.
There's something great happening here. You know, it's like a legacy.
Like, are you able to contribute in something like that? That's amazing.
Ooh, yeah, that would be interesting and interesting story to tell your grandchildren, you know?
Yes. You know. What was the atmosphere like at that key moments, like when the, you know,
the first trial participant received an injection or even the the the initial rollout of the vaccine to the general population?
Was there a sense of euphoria in the.
Yeah. Yeah. Yeah. And a little bit.
Consciousness and a bit stress stressful, you know, because the next day there was some awkward news about this.
The first participant. Oh, yes, Yes. Which was fake news?
Yep, yep, yep. And we were like, Oh. What's going on here?
You know, someone on social media said that at least one of the participants had died when she had.
Yeah. Yeah, There was like. Yeah. Myself. Was that feeling?
No eye contact. Almost. Don't make eye contact with any people.
So they don't ask who know that you are working on this so they wouldn't ask you a question, you know.
But yeah, there was. Priorities.
You know, it's like the human brain is built on a survival mechanism.
There was no time for distraction.
So it was, as I said, maybe this feeling like you once you achieve a good, then it's becomes the the foundation of the next goal.
It's not like something you just celebrate and relax, you know?
So, yeah, you get to this goal. Yeah. Then you just forget about it.
Let's go to the next call this go to the other one. So that's going back to your question.
Well, when I was able to be due to to be relaxed at that time, we had.
This planned action of. Working on.
The documentation. Like in a way, we. We saw thought it out.
And, you know, I'm trying to use the right words, you know.
So. So everything would be correct and in place and yeah, on time.
In terms of documentation. That was one of the important aspects.
And maybe you already know that that's one of the very critical aspects of the GMP.
Manufacturing is the documentation side of. So and all these documents were nearly finished, but not finished yet and not closed.
We give them a name, we call them frogs.
And we had we had to eat those those frogs, you know, like it's just eat this frog and then enjoy the rest of the meal.
Yeah. So we had this operations committee meeting.
And I used to cheer. Yes, I share those meetings.
And Kath, of course, she's. She's the head of the facility, yet she was responsible for getting these things loose.
Forks entered the cups were just pushing that.
Yeah. We have to finish this and that and. So.
We discussed this, this challenge, and we came out with a plan that why we don't have a focussed approach towards that.
And when I have a focussed approach, I always my brain works this way.
Is it a process or a project? So if it has a deadline, then it's a project.
Okay, easy answer. Anything. Everything is simple. So yes, that's going to be a project.
Okay, good idea. So I named that project back on track.
I gave it to name. That was.
In May. I remember the first draft was published for this project around 14th of May.
So as you can see, there's no time to relax. So we kicked off this project, reassigned everything, looked at timelines, simple things.
How long would it take you? Who can help you with that? How long would it take you?
But what is the duration for you to finish that? So people were confused.
What do you mean? Like when you ask me how long would it take you? And then you ask about the duration.
What do you mean? And this is one of the very important concepts, by the way.
Like, Yeah, you work on that like 4 hours, but it might take you two weeks to finish it.
Wipe the equipment if you need that equipment to work on.
Because of other stakeholders who need to review the documents.
So I had to gather all that information. Use some.
Professional software which people are not used to use these kinds of things in this similar context for project management.
And so all the information had to meet with all the teams, team by team,
ask every single individual all those very simple questions against their their activities.
Just three or four questions they have to fill like how long and blah, blah, blah.
All these things we can help. Drafted the first draft of the plan.
And here here comes the the surprise. Looked at the timelines we needed like huge hours, like more than 2000 or 2400 hours to get this done.
Okay. So we need to you know, we need to to recreate our team maybe three or four times to achieve the timelines.
How would you do that? No way. So I, I discussed the details that we had.
We started to dig into the details. Is this will this timeline, why we have this and we have that?
And then here we identified some overlaps. We identified things which can be done by someone.
But actually, if it is reassigned to somebody else who did it before can finish it in much faster time.
And yeah, the second draft was issued after less than a week with a time reduction, I believe like 40%.
And then people like, okay, so as you can see during this time I was lucky with all these things to, to build this trust and to, to have my team.
Trust me, I had to say, yeah, this guy, he knows what he's doing here.
Yes, he speaks a different language. But yeah, we can see that.
We can, you know, numbers don't lie. So the.
We this project was very intense, eating the frogs, critical frogs.
Then we have important frogs, we have medium importance and we have low importance.
Fox No important importance. Frogs Why they are frogs.
So the the, the, the quality, the cups, the quality assurance team that were like, oh, really?
Why? Why therefore is they're not frogs because they're not in the low importance.
So they're just, you know, create distraction.
And this is against the concept of, of adding value. So anything with not added value at this moment has to be eliminated.
I made that clear. So people started to relax that the owners of those documents, like they had like 20 documents,
now they have 15 documents to work on that was very rewarding.
And yeah, so now this document, yeah, somebody else can help me with that.
So as you can see, this was the second phase, the back on track, which was which ended in September.
And we and that was a point we celebrated the end of this of, of this phase of the COVID vaccine.
So the work and the documentation and yeah, and Kath made this executive decision.
Okay. So we would have it as a project and Omar will take the lead in this project and I was like, okay, let's see how it goes.
Yeah. Oh, very interesting.
And what point did the facility decide it was time to stop working on COVID and move back to the work on the Ebola?
End of 2020. Yeah, that was the end of 2020.
It wasn't to. Our involvement with, as I said, with the distribution, with the clinical trials, took a lot of time, however.
Uh, the manufacture itself was done.
Was done? Yes, yes, yes. Yeah. So, again, back.
Back on track. We can we can have we can make more useful products, too, for universal health foods.
And is that is that what you're working on now?
Are you continuing to oversee that, that process?
Yeah. So so now I'm I oversee the process.
I make sure that our operation is optimised.
I manage the finances. Of course, we have no, uh, main other main challenges.
Like, for example, we are expanding our manufacturing capacity 300%, 300% additional, 200%.
And this is. It's not as simple as as that.
You know, like to to make this capital project, to make the building, it's to follow all the guidelines and to recruit.
We have to recruit people. We have to decide when and where and who we need to recruit with to decide what is changing in our process.
So. And yeah, unsurprisingly, I am the change control owner.
So quality people who might listen to this quality assurance people will understand that for this expansion project.
Uh, uh, I think, I think I need to take a step, step back.
So the, the clinical biomanufacturing facility used to come under the agenda,
but now it comes under the Pandemic Sciences Institute, as he said at the beginning.
Yes. And so that is does that entail you moving to a new building?
No. No. So but you are. But you are building more capacity.
Yes. Yes. So we're building we are building a new building next to the existing building.
Right. So both will be working together.
Yeah. And will that enable you to work on more than one?
I think that campaigns more than one campaign at a time.
Yeah. Yeah. So at the moment, the moment, we can only work on one campaign because we have only one something called clean room suite.
Yes. Well, so sometimes, you know, there is the contamination thing between projects.
So we have to avoid, uh, contamination and we so we cannot do two campaigns at the same time.
So but with the expansion, hopefully would be able to add two additional suites, so we'd be able to do three runs in part on it.
Yeah. So we've got this. We can respond to three pandemics at the same time.
Yes. Yes. So, you know, all the way through 2020, you were very much working in emergency mode.
How how different is it now that you're not facing?
Well, actually, maybe. Well, I mean, there have obviously there has been an Ebola epidemic recently,
but you're not you're not in an emergency mode in quite the same way you were previously.
So does does that make a difference or do you try to keep that emergency mindset just to make sure that everything is done as well as it can be?
So it's not an emergency mindset. This is like an emergency balance.
It is something where I can deploy when, when, whenever needed.
The team was up to the challenge. Everybody was great leadership, the rest of the team.
So we are confident that we can deploy that whenever needed and we are confident that we would be successful.
But at the moment, one of the key challenges for me, which I'm working on how to do,
how do we balance the long term for our long term value proposition?
So as you can see, like we are now, we were in the news and under the spotlight.
So this is a very strong differentiator.
Far more attention from funders, from researchers, from academic institutes,
even from private companies who are working on their candidates products and drugs.
So we. So this is this is one of the things I keep in mind that at the moment that long term, very positive proposition.
How can I balance our simplicity and scale?
You already know that we are we only make small scale for early, early stage clinical trials, products, vaccines with our growth strategy.
And how would they balance that? You know, and I approve now of them in areas I focus on the finances.
How we become more and more affordable through, you know, economies of scale.
To be able to support the other researchers applications when they request funding.
So big chunk of their funding goes to the GMP manufacturing.
Who are us? Mm hmm. And it's very important we become.
We make our offering. I wouldn't say cheaper like more cost effective for them.
Mhm. So they will be able to get more funding and eventually we would be able to deliver
more products to clinical trials hoping that those products would be successful.
As you can see, it's the whole healthcare ecosystem here.
Place it comes into place I think.
Michael But I implement my course or I observe the, the restructuring, the team.
We, we had a restructuring currently we are working on on expansion.
I wouldn't call it another structuring, but you know, it's not a linear expansion of course, so it doesn't mean like you add.
Addition 200% capacity. This means your team has to grow this way.
Then where is the economy of skill? And he comes to the strategy, the strategic way, the strategic concepts, implementing strategy and operations.
And that and finance is, of course, I just noticed in passing how have the number and can you put a figure on how the numbers
of personnel have changed since you joined in January 19 to 2020 and today you projected.
So at the moment, at that moment when I joined, I believe we were at the beginning of 20 something people.
So yeah, another part of my I mentioned that already is to recruit new people and create new jobs.
So we we were like 20 something, I believe we are like 23 now.
We are 30 at the moment.
Uh, 29. 30, yeah. And we are projected to grow further.
So yeah, if anybody listening to this podcast, it will be come and join us if you're interested to call and talk to us.
We are. We make great things. Yeah, one minute at a time.
I think I'm just going to ask you my final question,
which is whether your experience of working on this project has changed your attitude or your approach to your work,
and is there anything you'd like to see change in the future? No, I.
It just expanded my view to things.
So I. I used to see the impact on local areas.
Initially. Then I saw like local geographical areas or local populations.
Then I started to see it regional, see expand it. But this specific this the COVID pandemic gave me the opportunity to see it at a global level.
So now I believe I can see.
Yeah, it was very helpful for me to think globally and whenever.
Now I think about something I work on, something I always try to see the bigger picture.
Yeah, maybe we have realised how vulnerable it is.
Is the world we live in. And. And how small it is also.
So. What?
One of the things I've learned very well is we always have to learn how to maximise
the advantages of collectivity without losing the benefit of individuality.
So this is something like, you know, when you think about these things, you think of maybe,
I don't know, like machine manufacturing plants and like machinery lines and, you know,
armies mobilising and moving, but which is collectivity, that advantage of collectivity,
but also the benefits of individuality when you need to be able to contribute and to decide.
Or at least have a saying on the activities which will be directly affecting them or they will be directly working on.
At the very early stage so they can say what they think about it.
They can't work on it at all levels. This creates very significant value.
And I always I've learned this very well during the course of it when I noticed,
like people when they are in mission mode, they become super, super humans, super heroes.
And this affected my. My perspective of the future in my career, personal perspective as well.