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INTERPHEX Live 2021: “Creating a Sustainable Public Health Supply Chain”

thank everybody for joining us again for interphex live so today we’re going to be talking about creating a sustainable

public health supply chain against the backdrop of what just what’s been happening here in the last 18 months I

think we got a lot to talk about and fortunately we’re able to put together a terrific panel we have Ed

Kelley. Ed is the Chief Global Health Officer at ApiJect recently left

his position where he worked for the world health organization as director of integrated health systems where he

helped head organizations covert 19 response and created who public private

collaboration working directly with pharma and med devices and you know to get to the patient safety aspect so

that’s gonna you know key piece there we also have Rob Roy. Rob comes to

us from IPS or our affiliate company Rob that is anyway 35

years subject matter expert engineering qualification application he has a unbelievable amount of

background and aseptic technology he’s my go-to guy when i’m working with folks on sterile process really the best

or the best around Jim Fries is a success-based executive

Jim has 25 years of experience building medical device and diagnostic companies

from a sales and marketing standpoint and external validation. Jim became CEO of RX 360 in February of

2018 as a way of fulfilling his personal lifelong commitment to patient safety.

Very very nice, Jim thank you. Finally, we have Paul Fisher. Paul also has 25 years of experience

in design and management and delivery of complex you know facility design. Paul also comes to us

from IPS top-of-the-line engineering and he will be talking

about development of project master plans and concept design stuff like this

is where he comes from and today what we will be talking about obviously is

public health supply chain in an environment our panelists are going to share their insights on how stakeholders

can maintain a robust resilient supply chain essential for global health and vaccine

security i think a lot of people we’re going to touch on a lot of aspects that people seem not to understand fully in a

vaccine distribution vaccine security when accelerated response time to meet the needs of current and future

pandemics I think you know after SARS we didn’t think this was going to happen again well think again

the building blocks for this supply chain resilience include tech transfer designing right size capacity improving

operational efficiency implementing state-of-the-art technologies establishing regulatory quality systems

establishing things that maintain a solid supply chain in a lot of cases i think the

public suffers from this that maybe we don’t understand the aspect i mean it’s not only making a vaccine it’s getting

the vaccines out and i think that’s where a lot of misunderstanding is so ed

let’s start off by asking a simple question and in a pandemic we are hearing many stories of disrupted

supply chains we’ve heard this the media is all about it and disrupted health services how really disrupted were

supply chains and health services and where were the biggest problems during this last event well   first of all

it’s great to be here, thanks, Russ and fantastic. ApiJect’s really pleased

to be part of   interface and I as you mentioned recently left the world

health organization to be working with ApiJect because   felt one we needed to a quicker faster better way to

get the vaccine out and two that    this is a chance to really

rethink how we do immunization and vaccination   you know before covet hit

we actually still were not reaching our goals and now we’re going to be even farther from them so that has a lot to

do with the supply chain question    i came across this   and getting ready for our session today came across this

one of many cartoons out there on supply chains bizarrely    during the pandemic whereas a guy

standing up like just like this    in a clearly a brand meeting with his   team his marketing team saying you

know look we’re team and he’s on zoom and everyone’s like we are here saying you know team we’re updating our brand

promise from inspiring delicious moments of refreshing togetherness to in stock sometimes so i mean anyway this kind of

stuff has been affecting all sorts of   parts of the economy so if we just take

the disruptions as they occurred   first i think we need to back up a

little bit for people and just say that you know a supply chain is these days not just this

linear chain it’s a network of organizations and you know these

networks are really where businesses are obviously cooperating across to produce this commodity but you have

interruptions that happen even during the pandemic that were sort of interruptions within the interruptions

the whether the Suez Canal interruption that where we had sort of 9.6 billion in trade that got

interrupted    to   issues that were happening    because of different types of disruptions so

you had trade restrictions you had restraint on demand meaning people couldn’t get to health services

so you couldn’t   deliver them and you have and still have transport disruption

so i think it’s important to you know there are a bunch of different problems there that we can start to break down   in this session   and

look at what were some of the causes but the bottom line is that at some point about half of the world’s health systems

were   and health services were disrupted whether it was stuff from emergency care all the way to

rehab services and mental health and substance abuse   counseling so

that was one type of disruption of the health service that was there the

supply chains that serviced those health services were part of the reason but only part of the reason and the you know

the types of things that were disrupted for vaccines were really wide ranging there are raw materials

to filters that are used in manufacturing to large plastic bags for fire reactor aligning so it’s a big wide

range of supply chain disruptions you’re bringing up a good point i mean

one of the things that we’ve seen here too is how different countries   that dealt with it so let’s say let’s

let’s look into you know different countries how did they address this disruption in the supply chain yeah I mean you know major like

the disruptions in in the supply chain people got you know handled them in in

different ways you had some countries that are producer countries

like in India or China that basically put on export restrictions and said okay

look you know we’ve got supply chain restraints and transport issues

so we’re shutting we’re shutting down    keeping stuff domestically

and you’ve got other countries that are receiver countries that didn’t have that luxury and have started to move to other

possibilities so like for instance if you look at in many countries right now just around

syringes that’s one of the areas that i’m worried about you are seeing   even with a push

manufacturing which is definitely come around syringes we will probably unless

something drastic happens be about five billion syringes short over the life of

the pandemic we just are we’re doing somewhere between 14 billion to 19 billion injections more than we’ve ever

done in the history of vaccination campaigns and our ability to scale up is is

difficult so the idea that you’re just going to add capacity there’s some given the system but most of those systems are

set up to operate where they’re operating so some countries have started to procure

locally that’s been another   solution in addition to just restricting

and the third possibility is that you just borrow peter to pay Paul again taking syringes as an example you can

see childhood vaccinations have fallen way down because syringes and other resources are being used for covid

one of the things that i think we have to you brought up like that is it you

know we’ve been down this we’ve been down this path once or twice all right and

so obviously this is not something new so you know I mean did we or did we not learn

what did we learn from the in the past you see what I’m saying I mean we

didn’t get anything or what you know we were asleep yeah well you know I have Russ I’ve been

like probably the same way like there have been so many times in this pandemic where I’ve been

scratching my head thinking i can’t be the only one in the world that is realizing what’s happening here but you

know the our capacity for making seems to know no bounds these days and

people make are in many cases   sort of government political and private sector

leaders are making decisions that are not necessarily based on collective   outcome but if you take let’s take

Ebola no let’s go back to SARS and another influent outbreak there was a

big push around   the issues of access to vaccines at the

time and also the need for local production and there was investment made

in a bunch of different places you take South Africa or a few other countries but it never really got off the ground

for two reasons for instance one was tech trend the technology transfer

didn’t wasn’t appropriately facilitated and secondly people didn’t think enough about the market it was just like ah

let’s supply stuff but they didn’t think through which sounds crazy to the folks we’re going to be talking to at

interface but the public health people didn’t think enough about that there has to be sufficient sustained demand for

this and there’s that’s happening with   personal protective equipment also so anyway one of the lessons is that much

more thought needs to be given to local manufacturing and the idea that you

then within your supply chain need to map it out you need to look at

where are your vulnerabilities are you depending on one supplier are you depending on one you know region

uniquely for certain key parts of your production process so i think

that’s another piece that we didn’t learn enough from both stars and from Ebola but you have to say i mean covet

it’s quite unprecedented in terms of its scope so   we’re

learning all sorts of   new things with this outbreak so yeah let’s stick with that because it’s you know that leads us

right up into where we want to go here and that is so what are the biggest opportunities in the coming year to

build up a resilient supply chain i mean what’s the first couple of steps we got i mean immediately people think bricks

and mortar this and there’s got to be more to it it sounds to me like there’s got to be a lot of political you know make sure we get this all these things

ironed out why don’t you give us that your perspective on that yeah i think you know the big you know

some of the biggest opportunities and you know we can delve more into it but is really on this idea of

public private partnerships   you know i anyway I’ve been in on the public side

for a long time i work for the us government work for HHS and I work for US aid in West North Africa

Latin America and then for who so anyway a lot of work on the public side and

if you look at we spend eight trillion dollars eight trillion dollars every year on health care most of that

actually comes from governments like   probably about you know between five and

six trillion comes from governments so we need to

we need to help government think more innovatively and

in a more resilient way a lot of companies because they have strong

incentives to be in a better position for the next outbreak have already done this thinking a lot of governments

have not done that thing so i think there’s one aspect there that’s not just about the you know the

production you’re gonna have but helping the partnership that you are engaged with both locally and you

know more globally secondly i think we have to realize that things are not going to change just

because disruptions in our supply chain have driven up the cost of producing what we

produce are not necessarily going to pay more for it depending on what it is obviously    we won’t be able

to charge more for it necessarily because competition gets in and ensures that we’re not able to do that so i think we also there’s an opportunity for

us to look at more efficient ways of producing new ways of you know again i come back to this idea

of syringes with ApiJect we’ve looked at you know moving beyond glass files moving into

a new production processes like Blow-Fill-Seal and other ways of being innovative

and producing that I think just yeah I mean just looking at the way your career is evolved I mean

I went from the public sector and now you’re at applejack and so why don’t

you give us a you know obviously where do you see the private sector building up a robust public health system here

yeah I think if I come back to my example that i was given earlier

take off I there there’s an opportunity if we look across

the supply chain for building   more resilient supply chains and more resilient

manufacturing systems   without just looking at the end product

so if we’re going to just stay on vaccines for a moment everyone is focused on both vaccine and bulk vaccine

production as an opportunity for the private sector to step in but you’re

basically taking the most complicated and most   sort of tech and knowledge

driven piece of the process as your opportunity but if you work back

there are other parts of the manufacturing   you know the supply chain that can be done locally give

countries opportunities to control that locally that would be things like fill-finish and others

we have some partnership work with in Kenya and Ghana working with

German government and other private sector partners to look at how you could you know do some of that production fill-finish

capacity in a more local setting and the world is very different now

you have the ability for much more modular production you have capacity

that is far beyond what you used to have in places like East and Southern Africa and then in Southeast Asia and other

places so i think that for the private sector the only other piece that i would mention this is a bit more sort

of like values driven and metaphysical is that we need to be thinking about bringing

value to the relationships that we’re having and not just thinking about the value we’re pulling from it but that

a lot of thought leadership sits in the private sector and a lot of solutions for and during covert times came out of

the private sector so let’s work together to offer that up in a context of creating you know better

production and greater sales and all but specifically coming with a values based or creating more value for

both governments and customers you know you bring up a good point and that was the aspect between bulk and

the fill-finish and you know I know Rob and Paul you know they’ve gone through this a lot

you know we can get in we get involved with firms and they

kind of like forget that part so you know you don’t sell things in a handy dandy hundred lead to cry of that

container you know i mean to me that part could be centralized and the

fill-finish that could be distributed that could be across many countries but anyway let’s talk about that so that so

we hear a lot about building back better is this part of what you’re talking about

yeah I think you know that that piece of it is a big piece of it is looking at

where and what we’re going to build with a more critical eye and

I think there’s very unrealistic or    yeah i guess unrealistic thinking that

happened in previous outbreaks about building local capacity and decentralizing

manufacturing capacity    and really not thinking about the sustainable the

financially sustainable ventures that would come out of this and the overall

market now by the same token    there’s a lot of pushback around

you know sort of production issues work where companies are    you know

reluctant to get into again going back to personal protective equipment and others    because of few the idea that

in the near future that that’ll be production bill that won’t be won’t be used so i think you can’t anyway defeat

yourself before you started but i think we need to think critically about how we have immediate needs how those

immediate needs were sort of gaps that we created for ourselves because we didn’t we weren’t prepared before and

that’s really the build back better people use that term a lot and it basically means sort of

in many contexts here’s how i get my agenda back on the table because it disappeared during covet that’s not what

we’re talking about we’re really talking about how do we avoid the supply shutdowns that we had

in this code outbreak so you know i think this brings us to a point Jim where I think you know from

from the you know from speaking to the private sector to manufacturers how is the coronavirus

pandemic how’s that affected the supply chain security i mean that’s got to be the other piece i mean you know there’s

a lot more to it than just getting this stuff there i mean it’s got to get there intact and all the rest of it why don’t you give us your take on that

i think and a lot of that answer that I’ll provide here from a thought

process perspective ed actually even touched on some of the stuff that he was talking about but

to me you know when it comes to supply chain security especially in the pharmaceutical sector

I think we got over the course of let’s just call it the last 10 years

I think we got very good as an industry of on the in the in the private sector

looking at security issues whether it’s counterfeiting diversion mass mile theft

whatever it might be i think we got very good at monitoring that i think we’ve gotten better at mitigating it

but part of that process in my mind over the last 10 years and 10 years leading up to the pandemic

we got very good at it but i think to maybe use a little bit of a bad term but I’ll say it anyway I

think we got good but complacent and we were focused yet complacent I

think what the pandemic has put us in in the mindset of around supply chain

security is we become hyper focused and what i don’t want to see is that hyper

focus go away because then we fall back into the traps that maybe

routine and kind of put us in you know the other thing that I thought was

really important that ed said which i think really dovetails to the security piece of this too when it comes

to supply chain is interaction between public and private sector

is I see on a daily basis collaboration

amongst private organizations on best practices I think it’s really important to pull

the public entities into those conversations and even for public entities to have cross-functional

conversations with other countries i think you know in one of your questions was how different countries looked at

this well i think that’s part of the challenge is we ask those questions in

hey how did your country do this how did your country do this how did your company do this and we need to

look at it more from an international collaborative   type of situation not

just a private silo or a a public silo it’s got to be more collaborative and

joint get it so let me let me so while we’re on that topic    one of the things that

one of the things that the former sector got hammered on in a couple of spots was quality right yeah I’m making the stuff

I’m going   i got an emergency yeah emergency approvals and oops i got to

reject this stuff i mean so you know former quality you know how is that how are you going

to handle that you know auditing and stuff like that so that that was actually when

when the pandemic even you can classify it there’s so many dates that people can pick around when

when the pandemic started but i think when we started in the in the private sector on the   on the on

the quality side we started to get inklings of the kind of oh moments where we’re kind of

like hey we’ve gotten really good at you know maintaining our quality on pharmaceutical products over the years

again kind of like security but now all of a sudden we go into not

only a hyper focused mode but a what do we do mode because

I can’t hop on an airplane and you know go to go to Taiwan and audit a factory over

there that’s you know producing some raw material that we have for our product how do we do that I

think that the industry very quickly pivoted to a a remote model

that I think really checked the quality of boxes

maybe not as maybe not the same as on-site because

you can always obviously do a lot better on-site but I’ve seen the industry in the last year really kind of embrace the idea of

auditing for quality of materials in a remote manner more than it ever has

I actually don’t see that going away as we come out of the pandemic my challenge

to the industry is again don’t get complacent because remote

auditing if it’s going to be part of our menu the now moving forward on a quality end how do we get better how do we how

do we continue to improve the model    because that is something i worry about you know

when you talk about stressing supply chains like ed just talked about in

there in a minute it dovetails to the quality end i even not like anybody’s doing it on

purpose but just the fact that the supply chains are stressed the manufacturing capabilities are stressed

that leads to the potential of quality issues i mean just take a look at the standpoint and I think get touched

on it but i want to take it a step further is you know the idea of capacity is you might look

at one plant that was you know their main source of production was

putting together you know cancer therapies cancer pharmaceuticals and all of a sudden that same

supplier is now being asked to wait a minute we need two of your lines to

start producing vaccines all of a sudden you see that vaccine

production go up and you see potentially access to these cancer medicines go down

and so it becomes an access issue but it also becomes a bandwidth issue

when you look at those people that are working in those facilities all of a sudden you’re also going from maybe running two eight hour

shifts to running two and a half hour eight hour shifts it it stressed the entire system and i think that’s where

we need to get together more you know again since ed’s the only one to talk before me to get to get together and

think about those collaborative opportunities to share best practices

and to be more forward thinking don’t let’s not wait for those mistakes to happen or wait for those bandwidth

issues to happen we need to be having these conversations now and i know in some in some environments we are so I

don’t want to limit what people are doing but i i think you go from discussions and conversations about

alarms to let’s make what’s let’s put these things in place

collaboratively just not in silence well i think i think one of the things that have come up in several of our

panels is the new norm coming out of this is going to be remote auditing

remote filing remote for FDA visitation they are actually

you know they’re requesting documentation at a level you know it was always there but now they’ve pressed that

button you know we’re actually auditing the company we went through this we had a panel on you know what’s new in the

area of waters and i think that’s one of the things that’s going to be going forward is the remote aspect

I think that is going to be one of the new paradigms you know and that would be towards increasing the quality

whether it’s remote you know it it’s going to be remote it’s going to the quality increase because

we’ve seen this we’ve seen us kind of stumble and fall a couple of times during this pandemic I

mean not great so let me ask you this question how can industry then work more collaboratively

towards the former quality i mean we you know where do you think where do you see us going there I’m going to use it in regards to

to what you just mentioned about remote audit remote auditing and sometimes I

I tend not to use the term new normal it’s normal it’s kind of how we’re

doing business and i don’t think it’s going away and when you look at it from an auditing perspective and to use

you know the example you gave where we talk about    the remote auditing

I call on the industry right now to collaboratively these organizations have

a tremendous amount you know of opportunities to share best

practices and when you look at remote auditing one of my worries is that

the audit checklists or standards that we automate quality to in today’s world

we’re built upon the foundation of an on-site audit somebody going on site

at that facility and doing it on now all of a sudden, we’ve moved to this remote

model that again not going away    it’s not going to be 100 remote but we’re

going to do remote audits moving forward forever I call in the industry right now to

think about the best practices that you’ve installed in your own pharmaceutical organization on how you’ve done those remote audits

what’s worked what hasn’t and start retrofitting those audit checklists

to the remote model because there’s certain things that you’re going to do come up with some different standards

that are equally you know can be transitioned over to the remote model

from the on-site audit model but look at the remote model and say how do we need to beef this up to make sure that we’re

not missing anything on the quality that’s one of my worries is our don’t let’s not fall into the trap when it

comes to pharmaceutical auditing of the remote model skipping steps you know

I think we went through a phase a few years ago with the on-site

audit where quality became questioned I’m not saying that there

were mistakes or anything like that but quality became questioned because the on-site audits maybe were starting to

lose their specificity now i i had one person say to me one day you know very simply

that an on-site audit is becoming coffee and donut time and we

need to make sure that that doesn’t happen we need to kind of again go from

experienced and focused not fall into complacency but really

remain hyper focused and it’s going to take some more resources i i think that’s the other

piece of it is I see this across the spectrum with all organizations when it comes to this

this this remote auditing this auditing this quality issue supply chain security is

bandwidth to stretch and we as private organizations and public

entities need to start looking at up resourcing to make sure that we are

crossing the t’s and dotting the eyes Jim, I think you bring up a couple of

good points and I mean obviously it’s security it’s again you know I think a lot of times

it’s always about it’s about the personnel and you know do I have the right people and i think the key being

is that one of the things that was brought up again and a couple of panels that we’ve already had was that

maintaining a workforce was very tough the other thing and it comes back down

to bricks and mortar okay and you know Rob and I have spoken about this over the years you

know there’s been this gee whiz there’s a cap on the capacity you know this is only so much we could be made well you

know guess what we got around that by coming up with more flexible processing but so you know but let’s talk about it

for a bit rob so you know as opposed to building new facilities you know in response to this you know that’s right

away everybody’s out we’ve got to build more make more is it possible to economically maintain

and ex you know excess and you know capacity and in a sufficient   state of

readiness in other words can we you know can we build up an arsenal can we get this ready can we how would we go

about something like that yeah thanks ross that’s a good question

I think what we’ve seen here in response to the pandemic is everybody wanted to rush out and build a new full finish

facility okay and unfortunately you know with the lead time for equipment and the

to be able to plan and design a new facility so the building and qualification interval is typically you know at a minim   two years you know

that’s really world class or best case it’s more often three to four years before you can build a facility and

qualify the facility to manufacture new drug product okay so you know that model

as a as a potential response to you know ramping up production capacity for pandemic this really doesn’t work okay

you’re gonna need to have capacity installed somewhere and it’s going to have to be a hot capacity we’ll call a

hot or at least a warm capacity that’s ready to go they can be ramped up to begin producing vaccines and say a

three to four month interval you know with this pandemic as well you know we saw you know surprisingly the ability to

develop a new vaccine product in a matter of months right so everybody was out there manufacturing    product ahead

of launch you know they were manufacturing six seven eight months after the pandemic you know the genome

was sequenced for it right so that was remarkably quickly    compared to how fast we’re typically

able to move for this so i think it you know the question becomes then a little bit how do you build a sustainable

business model that allows you to have this excess capacity ready to go okay

and I think one of the solutions there is in some of the newer technologies the isolation-based technology the Blow-Fill-Seal

technology is the ability to campaign on production

okay so our industry is very much a batch oriented industry that model is proven to be


economically sustainable you have a facility you’re going to make four to five batches every week for example

in between matches you turn around you prepare for the next batch okay so that really leaves quite a bit of your

production time fallow in that model and if you have this sort of capacity installed then then being

able to switch from that batch-wise production model to a continuous production model where we fire the lines

up now we run these things you know 24-7 basically making pandemic can you know almost instantly increase your

production capacity by a factor of three or four and we see something similar to that in the flue industry right now with the

syringe fillers we mentioned before that ed talked about    you know the guys making flu have to make a lot of flu

vaccine they have to make it very quickly okay so the norm there is that they’ve qualified and validated these

systems for campaign mode operations where they’re able to go in and begin manufacturing and they can continue

manufacturing for say up to 28 days continuously and make a lot of product doing that

you know i think the other thing that you brought up that’s people think that you know I’ve

developed it and i just take it out of the lab walk it overthrow it in the facility and I’m off to the races

you know and i think one of the things that we suffer from you know what the tech transfer we got to move the products it just even from you know an

existing product from facility to facility    you know how do you know that how

do you know when you implement in regional facilities I mean what’s the challenges

there I mean why don’t we go through some of that yeah we did quite a bit of work recently

with the bill foundation I hope I can mention them here on this and exactly that you

know how do we make a regionally distributed manufacturing model for this and a couple of things became you know

abundantly clear you know one is the technical complexity you know and you mentioned before drug subsidies being technically complex and

even on the drug products side you know aseptic product manufacturing to today’s standards

is a tremendously complex operation okay so one of the things we took a look at

there was you know again these certain technologies again back to blow phil seal where you’ve really eliminated a

lot of that complexity simply by virtue of the fact that you’ve really concentrated the production operation

into a single machine okay so the machine itself is technically complex

but you’ve eliminated you know seven or eight other machines for example    and on the isolator side we’re seeing more

and more manufacturers now that are beginning to produce really truly integrated systems

okay kind of plug-and-play models so you can purchase a small machine it’s relatively easy to install you know and

all the bits and pieces that you need are there so there’s a good deal more you know control system

integration and that sort of operation for it and it speeds you know your implementation time and your

qualification time as well yeah so that yeah i see where you’re going so that gets back you know there’s the drug product

and I think people forget there’s the drug product which is the thing you deliver and there’s the drug substance

that’s the vaccine in both so you know which so let me ask you a simple way so

which is the best to regionalize the drug product delivery or the

you know and or the drug substance manufactured what do you think is the best approach

you know for me i think we tend to be successful here as i mentioned before you know issues will

change into certain areas the regions    the technical complexity really has been the stumbling block for it so i think

there’s technical complexities also logistic complexity okay these things logistically they’re tremendously

complex as well because you have to deliver literally hundreds or possibly thousands of articles to site to be able

to manufacture a drug product or a drug substance so how do we pull that whole supply

chain effort together so we can reliably do that for it so i think really part of it is going to

be as ed mentioned before having this you know private government partnership to provide the assistance necessary here

I know that in a lot of these regions they feel like they feel like they’re taking a back seat you know whereas in the developed countries now

we’ve got a vaccine supply you know our populations are relatively well vaccinated    whereas you know for them

you know there’s really little hope of getting you know sufficient quantities of vaccine for some period of time yes so i think they’d like to be in control

of that so I think it just needs to be something where we come up with a plan that’s going to be patient

we have to understand it’s going to take a number of years to develop the logistic capacity for it as well as the technical capacity to manufacture either

one and then move forward with a test operation that allows them to become successful for it

we did also look at a model where you would have a pilot facility essentially you need to set that up in

the RU or the US or some other relatively developed region for that

and then you would simply be able to instantiate then or just duplicate that facility regionally

that hub facility then could become a training center for people on a regional basis they can send you know select the

teams of people they would like to have operate the facility they can send them all into this training center and then

you know the more    we can stick to keeping it the same then things like you know qualification

documentation is able to transfer sops are able to transfer right the technology transfers so you know again

that simplifies the task as well i agree with you 100 percent there rock one of the things that you know we did

you know what during my time in in pharma before   was that you know we kept things the

same the key being that we had the same process no matter where we dropped it again a globally based company one of

the things was you know you don’t want to look at change so let me ask you this question and I think this is one of the

things we want to get out there so it changes to the drug product the dosage form

or are they required in other words the way we do things now there’s something need to be done to ensure alignment

when we get into this pandemic we’ve got to manufacture the stuff and increase capacity what kind of

corrective steps or could we possibly take where we don’t make that process or fill mistake

you know how do we act you know how do we proactively give ourselves that regional aspect right you know there are

changes in the way we do business are there changes in the way we develop or what

I think if I’m getting your question right here anyway i think we saw mostly with the you know the vaccine distribution the current world model

seems to be you know more or less a 10-dose vial by alpha lies the indoor liquid in the case of the more current

MMA vaccines it is really the model here for and in terms of optimizing full finish capacity

that does it for you too because I’ve got a machine that runs say 400 miles per minute i can make maybe 400 unit

doses for that or the same machine might run at 300 miles per minute if I’m

filling 10 dose okay so now I’m making 3 000 doses a minute so obviously you know the

multi-dose format leverages now our production capacity for it now that said

you know the folks over at applejack with the Blow-Fill-Seal technology we’re able really to come up with equipment

that would have you know a similar very high-end production capacity but able to

deliver in a unit of dose format okay and you know as ed having worked with

the WHO and other organizations really understands I’m sure you know all the issues associated with the multi-dose

you know product format for vaccines especially in developing countries and regions of the world so you know ideally

it would be unit dose i don’t know if we’re going to be able to come to some agreement moving forward

about what we think the next you know dosage is going to look like is it going to be a 10 dose file you know is it

going to be a unidose syringe that kind of thing so that we can better prepare for that i think that I think that’s

something that we have to look at and quite honestly as a tech guy to me you know i would focus on the

the unit those delivery but okay fine you know but okay so you know there’s a lot of stuff

you know there’s a lot of stuff people ask you know Paul one of the things we wanted to get into

was you know we weren’t prepared for this i mean we talked about this like we’ve been down the road about a hundred times

but you know let’s face it everybody feels that we got you know we had sores we had a you

know a couple other outbreaks we got caught flat-footed here what i mean what what went down

personally, I think I think as you said yeah everybody was very much

kind of concerned with their own facilities and what they were making at the moment and you know very busy

you know most clients were extremely busy with their own products and i

think when it came out first i thought people got the impression it was only a flu it

wasn’t that serious you know i think there was a lot of media kind of votes you know one

kind of ex expanded it say it was very serious other people say not so serious it became political became very

political here not so much in other countries so i think that was one of the big aspects of it nobody really took it

seriously I think you know and the fact is well that SARS in a way it was a very

serious disease and people who died very quickly it didn’t spread as quickly as it is because

covet is much different it’ll stay in your body you’ll live but you you’ll spread it a lot more so I think that

kind of caught everybody off guard and i think you know as you say that the drug itself

was produced pretty fast but then with the whole clinical side of things to get it to get it

approved then you had to hold   you know the whole question of how do we actually get it out the door basically

and you know you know you know the certain companies that that did that i was involved with one of them and again

they had to change their whole manufacturing process and basically they had to expand an area and it was all

part of the whole warp speed thing where we got permitting done so quickly we got construction we got everybody on

board day one and everybody knew exactly what the game plan was from the client right down to the guy who was fitting

the clean room together and putting the equipment in but because everyone’s under one page so i think you know the

the lesson learned that i got from all of that basically is we can do this no problem but everybody has to be lined

up and there’s no room for anybody you know for we need flexibility in the future or we need to do it you know for

a product like this you need to be very cold in what you actually want to deliver and   the client that I worked

with we did that they knew exactly what we wanted everybody was on board and we delivered it in record time

I think you bring up a great point one of the other questions i mean one of the things that one of the things

we’ve always been aware of when i was in development was our objective was if need be we could launch

the clinical form yeah we didn’t have to come up with a final market image that was the key so

having said that you know how do you   you know how do you design build and collect you know

how do you build a drug manufacturing facility like that we did it simply you know in other words all pilot phase our

pilot plant was identical to our tech ups plant so how do you design and build in the food

yeah what do you see coming up to help this along flexibility huge

you know even any clinical facility that we design right now you know it’s always in the back of the client’s mind

that we can launch eventually from this site so we designed you know from a

from a   you know from a cleanliness perspective to   you know from

modularity to flexibility it’s all included   you know you get the client on board early what do you want you know

how much flexibility do you want what you know what’s the future for this people are not just designing now for a

little pocket of something that there’s a much more open-minded view of what the facility needs to be

because of these band languages they’re going to come again and you need to be ready and as i said we all got caught

right nobody was nobody was really ready for this so i think lots of clients now look at flexibility how can

we you know how can we transfer this this this facility that we have inside this campus how can we re reinvent this

for the future you know a lot of clients are looking at master planning all their other sites now right and seeing what’s

ready and how can we adapt for the future because you know there’s a big market out there for it for when it comes so we need to be ready so again

it’s master planning it’s    you know seeing what the capability of your site

right now   i i think looking for a new site and building a new facility that’s one way of doing it but it takes

a long time   if you have something you know that’s already there or you have an area of a building that’s

that’s fallow whatever you know or you know you can move warehousing out of there and put production in there and

you know you can offside warehousing you know that’s the thing that people are looking at right now you know they’re looking at

flexibility basically one of the things i learned from rob and working with the guys in biotech was

and we’ve used that with a lot of people in the   small molecule area was you don’t

scale up you scale out you clone your process you know in other words if the process is doing a hundred thousand and

it’s working great don’t make it a million you make another process line that does a hundred thousand

a lot simpler a lot faster so but having said that one of the things that we’ve always seen was guys go to town building

an inventory for us for a launch do you really think overstocking drug supplies is the right approach to this

well again you’re cornered into one market on the drug supply that you have you

know we don’t know what the next virus is going to be we you know or the big you know if

there is another pandemic or whatever so yeah you’re harboring all of this yeah for flu vaccine I can understand

that because it’s every year right how this covert thing plays out we don’t

know yet you know maybe we do they all need a new shot every year eventually who knows you know so yeah you can

stockpile for certain   drugs but are certain problems but you won’t be able to stop well for everything so you have

to have the you have that you can do it for one but you have to have the flexibility and the readiness for another one coming through

I think but a little so a couple of things that you know Jim brought up was the quality

aspect the remote piece i think we’re getting to that point but let me ask you this is every should

every country yeah within reason of course should every country be can be

self-sufficient to respond in other words should we be thinking about putting these facilities

in every country in every country what do you think not necessarily every country but every

country has to have a link to another country that can provide it for them you know the everybody’s going to have to

work in partnerships behind the scenes you know you know like I’ve done a lot of work with Canada they got caught as

well right   and now that they’re getting ready for the next bit you know the US is pretty good shape we’re

probably in the best shape here right you know and then India was pretty good they came up China got their own vaccine

together you know but i think you know even I’m from Ireland originally Ireland had to wait and turn until the Pfizer

vaccine got there you know and they have a whole lot of pharma in that area but it’s just they need to build up

partnerships with the suppliers right because some countries can’t afford it you know and

they don’t have the injury in in in that country so you’re going to have to come up with a partnership with a country

nearby and be ready like Europe got caught a lot worse than we did you know i think

there’s still you know it’s improving but i think yeah i think

there’s a there’s a lot of work to be done between behind the scenes with all these different countries to sort out

for any future one and it’s not just third countries even first world countries need to need to sort it out

because you know it’s the future and we have to be ready for it i think some of these partnerships and

alliances that we talk about you know i think we have to be careful i mean you

can go too fast i mean you know and invite a catastrophe yeah what do you think there

yeah exactly i think you know i i think there are partnerships but you need to know

your partner you know there was a lot of rushing that there was a lot of you know suppliers you know you know getting

somebody else to fill the product for them   you know all over the planet and i think

that needs to be dr you know there was no dry run it was straight into it right we had to get the product to market so

you know there you go this is it fill it   package it get it out the door and I think yeah it’s the right

thing to do but I don’t think for a lot of these partnerships I don’t think there was a dry run i don’t think people

checked quality protocols you know as we spoke about earlier on and all that needs to be nailed down I mean Jim

brought that up earlier and that you know for the future i think you know you need to have a partner and you need to know you know one or two because you

can’t just rely on one and you have to do due diligence with all of these people and they have to do it with you so everybody everybody’s ready for

when we do it again so we’re good having listened to this

dark panel folks here i mean let’s go back let’s come around full circle i mean stepping back from your

app project I mean put your   you know put your    your   you know your former life back in

perspective here what do you think i mean you know obviously we’ve had the bad partnerships the alliances

the quality piece let’s face it i mean we’re not going to get into specifics but we’ve seen a lot of you know some

major companies go down to sewer a little bit here with the   you know screw-ups and qualities and so what do

you think what have we learned based on all this conversation

yeah i mean i think that the with great points by

Jim Paul and Rob that like that it’s

you know quite clear that   the

that again this point that we came to the public private investment that that a big push and you

know Paul was just saying this one of the reasons EU was in such a good shape was a big push by

the US government and public money to get stuff off the ground and guarantee

a market guaranteed delivery so that the risk management could be there for these companies to move on things

and the issue I think we didn’t do a good

job on was anticipating how much

how far money can yeah how much money can buy i mean it can it can buy you a lot but

when if India decides like hey sorry we’re closing the borders because we’re going to we need to leave this stuff

domestically until we figure out where how bad this is going to get for us

all of a sudden decision makers didn’t know i had so many policy makers i could tell you very prominent Swiss

policymaker to folks in Germany France and the US Canada other places say i never knew I

had to care so much about supply chains it’s it was just like the I don’t know it’s like the plumbing that’s running

like you know but then all of a sudden the entire world decided needed to flush the toilet at the same time and all of a sudden things exploded but it’s really

it’s really one of these issues that i hope we take away that partnerships

addressing these kind of nuts and bolts the real skeleton of how we run our health

systems is going to be what we need and then secondly saying well what we

went with what we had for the first phase so we came earlier that was honestly that’s why we’re in multi-dose

files that’s not the best way it kills who talks about this it kills a

million plus people a year because of syringe reuse and infections that they

get so we could have two to three million dead a piece we did earlier this year based

on if we just had peacetime numbers not even concerned with the other strains so i think we need to now take

the brief pause that we have and we’re definitely not done with covet even though many of us you know are magically

wishing that it’s gone away to say what are the innovations we need

I mean not just for five years’ time but literally for the rest of this pandemic so from 2022 2023 for sure that’s

around in the vaccine world that’s around single dose pre-filled syringes that’ll be an event eventually the

future of immunization I’m sure but that’s also around these partnerships that we have in terms of

the other parts of the supply chain thanks Ed I think we’ve covered it

sounds to me like the public sector who’s got their work cut out for him I think we have

a lot of knowledge we have a lot of experience I think we have to put it to work this

time so that we don’t get caught flat-footed we’ve learned and yeah I think we got to ramp up I

want to thank everybody for joining us today so just for everybody to recount

we will have there will be the INTERPHEX show October 19th-21st at

the Javits Center this video will be available on Reconnex 365 that along with all the

videos we’ve done over the last few years so that you can see how things have evolved and developed i want to

thank our speakers i want to thank Jim and Paul and rob thank you very much guys take care


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