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INTERPHEX Live 2021 Session: “Pros and Cons of Global Fill-Finish”

once again i want to thank everybody for joining us for INTERPHEX Live this again is one of our

virtual or slash recorded sessions normally we meet at the

at INTERPHEX at the Javits Center in the Crystal Palace

this will not happen this year however INTERPHEX will take place October 19th through the 21st look forward to meeting

everybody there this is in a continuation of a previous discussion we have surrounding global

vaccine and joining us again today is Ed Kelley is the Chief Global Health

Officer ApiJect he was prior to that he was who where he was Director of the Integrated

Health Services and in that case he helped out lead the organization’s COVID 19 response

creating the first who public private collaboration in addition we have with us Jason

Collins a buddy of mine from our affiliate firm IPS he has like 20 years of experience in

the design of pharmaceutical facilities his expertise is focused really on barrier technology and

advanced aseptic facility design he will be giving us some of that information as it relates to the context

of what we’re talking about today Omair Ahmed and he comes to us and thank

you very much for joining us from Nexus he is the Chief Strategy Officer is

responsible for growth strategy and strategic partnerships in the nexus pharmaceutical organization today we’re

going to be talking about the pros and cons of a global fill-finish

so obviously what we’re going to be doing is let’s think about where we’re at and

we’re going to be talking about this in response to the COVID 19 pandemic where health agencies around the world

would have joined together however they are developing quality vaccine

programs including fill finish to support global immunization but as that will tell us that we’ll touch on that

this was even before COVID came countries were facing increased demand

and primarily because of the population growth and we’re also going to be talking about the challenges and opportunities as

governments and former manufacturers seek to establish fill-finish facilities in

worldwide to enable improved and greater access to procurement

manufacturing and code with vaccines while improving preparedness in the event that we are faced with another

pandemic so ed when we talk about global fill finish let’s put some let’s put a

little frame around it what is it and why is there such attention to it presently

yeah well the whole issue around phil finish

obviously it’s something that has been part of the chain for a long time but i think

there’s a lot more people probably listening today who know the term still finished than  did before COVID it’s

like many things we’ve all learned how to be public health experts i suppose but the biggest reason

that fill-finish has come on board now has to do with the pandemic itself so we

can just set the stage were this past week at about a 110 million sort of

cases globally we’ve got 2.5 million deaths we have distributed 6.5 billion

doses around the world but the problem is that about three percent or so of

those have gone to lower income middle income countries so huge consumption in parts of the world

so very inequitable and secondly at least half of the deaths that have

happened have happened since we’ve had vaccines so two issues there one

people are concerned about the global fill finish portion of the equation now because it’s seen as a

I mean if you’re cynical a magic wand or it’s seen as a solution

if you’re not cynical to the fact that we haven’t been good about getting

vaccines and vaccinations in particular all over the world and secondly

fill-finish itself as a global solution has come online because we’ve been so much focused on this upstream vaccine

question I think you’ve heard a bunch of G7 leaders talking recently about we need to move from vaccines to

vaccinations President Biden talked about it at this global smit that just occurred

recently we had a piece in the la times that talked about the need to look to the last mile questions of those issues

he was raising so i think all of those things have come together probably months and months too late of course is

everything with this COVID pandemic but it’s all come together for people that care of the global fill finish right now

I think in a lot of cases people focus on the upstream rather than the downstream and you know let’s face it

you know you can’t distribute vaccine when it’s in a 100-liter cryovac container don’t work that way as we’ve

said on a couple of different occasions so from a global health perspective ed what are you who are the

organizations active in the global fill finish effort now who’s put who’s pushing this along

well first of all we should say that unfortunately the

global health infrastructure is yeah it’s like us i suppose where just like the rest of the

world didn’t think enough about the downstream aspects of the supply chain the fill finish aspects a lot of the

global health work rushed into the work on bulk vaccine

production which yeah of course we needed to create those new vaccines we did it in record time

I probably would note that the malaria vaccine also came out people saw that

announcement it came out  it was about 10 years in the making  malaria

only exists in sort of certain parts of Africa and Southeast Asia you know so maybe there’s a little bit of a

different in terms of how we fast we created different vaccines that’s an interesting lesson but

the malaria vaccine and the MMA vaccine will face the same issues about fill-finish  down the road  but the

organizations that are concerned with it now that have to do with stepping

which is an organization that that looks at pandemics and innovations as based

in Europe we also have the world trade organization and the

International Federation of Pharmaceutical Manufacturers Associations they have worked together

to create what’s termed the global manufacturing a sort of task team that is

offshoot of the what people have heard the global response to

COVID the Kovacs Financing facility that’s out there

working which is UNICEF who world bank and other organizations and that team was put together to look at the

manufacturing and gaps but only recently the sort of fill finish aspects they had a smit

four months ago and the fill finished piece was sort of one part of one panel that was there and again I think

there hasn’t been enough thinking about those downstream elements by the global health team partially because

many of them are not involved in fill finish that’s understandable so you know I

think that I think again that’s a that becomes a major roadblock and I don’t think

people have come to realize it so from a manufacturing standpoint let’s talk about yeah I mean this is all part of

the supply chain so Omair from a manufacturing standpoint i mean how’s that how is the supply

chain evolved i mean you know let’s pick it let’s say okay you know let’s go a little further back than


kovit so give us like what does it look like in the last 10 years or so so it’s really evolving and


globalization has never stopped in the industry it really took  over the last 10 years


really really expanded we’re looking at asia china india it’s not a surprise there are huge players and especially


upstream components intermediates raw materials and then you’re going downstream phil


finnish india is a huge player in that as well and then europe and the united states  and prior to even COVID


hitting we were already experiencing constraints on the supply chain there was definitely not enough especially

aseptic line time available to even fulfill what we were currently doing the population

continues to grow and we were just barely keeping a pace and then you throw in a pandemic where a very significant

portion of the sterile fill finish capacity was taken up you started hitting all kinds of bottlenecks

so we were already trying to work on ways and many companies have established facilities globally to help address the

need but like a lot of people are moving to now with the need for isolator technology you’re really removing a lot

of the labor aspect of it so i think that also caused firms to kind of understand do we really need low cost of

labor across the globe or can we start to consolidate and right-size our manufacturing and you did see a lot of

that as well especially with some of the companies of spinning off manufacturing assets and

different facilities those created into different CMOs and whatnot so it’s definitely a dynamic environment and

COVID really shed a light on we weren’t maybe as far or as ready as we may have

thought we were whether it was vial and stopper components all the way to line time for fill-finish

I think as a global manufacturer ourselves we’ve experienced

some sort of delay on every possible component you can think of to make a sterile drug product so it really

it’s just mind-boggling to think that this and i think we can all be frank here this is probably our first real

global pandemic but not our last so how are we thinking about it going to the future and trying to make sure

there’s some more rigorous safeguards to prevent the kind of crunch that we’re feeling today

is there a specific trend no more i mean you know about you know as a result of COVID

win in other words okay we’re going to look towards you know you know you know vial manufacture

we’re going to look towards stop you know is there a specific trend that got came out of this

i think there was definitely being a big push towards lean manufacturing

have there be no waste just in time inventory making sure that from an economic basis we’re able to produce the

most amount of product most efficiently as possible I think that is definitely being looked at now that we do need to

build in more redundancy we don’t want to be so let’s say hand to mouth when it comes to a lot of our components things that we

definitely took for granted before including labor to be quite frank we have to really look at every aspect and

see where we kind of be shortfall before it was just assed you would issue a po six months later your po is filled and

full and now maybe they’re saying here’s a third of your po and we don’t know when the rest of it will be filled so making sure there is that kind of supply

safety net and i think a lot of companies are looking at that not being so reliant on whether it’s just one

component manufacturer or even just a specific line really trying to build in more redundancies it’s probably an

industry-wide trend that we’re seeing today Omair if i could ask a question

are you seeing manufacturers building in some additional capacity even from supply chain right through to production

to be able to have the ability to respond to pandemic events

I think it’s definitely the case there’s a lot of manufacturers coming in whether it being new filling suites whether or

not it’s trying to get more vertical in your own components whether it be API or even some other components in there

we’re definitely seeing that happen nowadays and even before when we started to build our facility a few years back

we saw there’s an added investment in especially domestic manufacturing no we’re talking about global fill finish

but the US had seen quite an exodus of manufacturing overseas and now we’re definitely seeing that trend reverse and

seeing significant investments from large and small pharma to onshore some domestic manufacturing

because not only are we talking about supply chain and shipping things coming from overseas but also

during emergency times there’s never any kind of rhyme or reason we don’t really understand

what can happen in the future if you have some drug product coming from overseas what’s to stop a particular

government from holding a drug product for themselves for example we saw a lot of things happen during covid that

definitely raised some eyebrows so i think the onshoring and expansion of manufacturing is a trend that we’ll

continue to see grow and just to mention really quickly on that sorry to interrupt but i think you

even saw tomorrow’s point you even saw this morning some or this weekend we had some news from India about

holding back for instance syringes that being you know they have a second biggest producer

of syringes up after China really and so it creates these concerns of the

public-private partnerships can go both ways actually

some incentive from government funding to onshore some of that capacity as well


yeah I’ll tell you know there’s a couple of things that weren’t you had mentioned  i won’t get into too deeply but the

the personnel shift staffing we’ve talked

people from the selling gene therapy biosimilars i mean everybody who’s on

have past couple of panels have indicated that so that seems to be a common problem

but so ed let me let me ask you this question based on the conversation here so

distributed manufacturing for vaccines we’ve not heard much about

that we’ve heard about that but we haven’t heard too much about the fill finish you know manufacturing and distribution

what is it that should change I mean okay we’re look I

think we’ve found out what’s wrong you know Jason’s picked up a couple pointed out a few things so where should we hit

well I think that it’s a one of those things that’s made me scratch my head so anyway

that you’re asking it but it is a hard one to wonder and honestly i don’t know if Omair

is the same or Jason has the same feeling but when i have explained to people just as an example that for instance US

donations on during the covid prices up to kovacs or even bilaterally or China

donations or other big nation donations that those doses don’t automatically go

with syringes for instance or they’re not already filled finished people they

your average person doesn’t understand that they i mean the UNICEF who unfpa have a policy that no vaccine should be

had out in the field without should be one-to-one it should be kit put in a kit and bundled along with

safety boxes etc. but that’s not what’s being done by nations during this

this outbreak and it’s a big head scratcher so the fact that we forgot about them when

we’re even doing vaccinations i guess it’s no wonder that we’ve left them off the table when we’re talking upstream on

manufacturing too so i i can only think that that’s really the issue and it gets

to the nature of public policy makers and the supply chain which we’ve talked

about before that I’ve had numerous policy makers during this outbreak say

to me i never knew i needed to know so much about supply chains i mean it’s just one of those things that ran until

now and honestly the stretch on the supply chains like was mentioning with that has to do with personnel materials

and all sorts of stuff and we’ve talked about that before is something that’s pushed us on this on the global

filter i think really what needs to happen is that there you know we take there are some

examples which we can come to but there needs to be a stronger public

private push on these types of operations in countries around the

world there are some growing hubs and investment for vaccine manufacturing around the world there could be a much

easier way and lower cost way of investing in a few hubs for

at scale product fill finish capacity in Africa in Southeast Asia that could build on some examples that are already

there i think we’ve touched on a common problem so let me I’m gonna the next

question is gonna be directed towards Jason and Omair so having against the backdrop of what

we spoke about you know what are the current trends in aseptic facility design are we are we paying more

attention to the full finish aspect and not the upstream or vice versa I mean so

where is it going why don’t you lead off Jason sure

i think you know without a doubt

that the major shift in the industry over the last let’s say 10 to 15 years has certainly been

towards barrier technology right and the majority of the aseptic facility design

is supporting the technology for manufacturing and so with barrier technology we’re certainly

seeing mostly isolator technology being used because of the benefits of more

efficient facility design but also that the added benefits of protecting operators and ultimately protecting

patients in a better way by you know really minimizing the possibilities for contamination of

product but when we get into

you know different types of facility design i think overwhelmingly what we’re being asked to do is produce flexible

facilities and what we’re learning is flexibility means different things to different people

so sometimes flexibility could mean we want the building to be able to accommodate x production today but be

able to be retrofitted in in 5 10 15 years for a production or a process that

we don’t yet know about and we’d like that to happen without any other impact to ongoing operations

so that’s one level of flexibility other levels of flexibility could be

again based on minimizing impact at a particular site a site that may not have

a lot of capacity to support construction so flexibility may mean off-site

construction as much as possible a modular approach or looking to skid as

much as possible doing a lot of fabrication off-site and then just bringing things in to

essentially install them and get them up and running so you know that’s really what we’re seeing is just the request

for flexibility and once we understand what flexibility means how to build

that into the design is pretty straightforward

I’ll echo what Jason said a lot of it is down to flexibility in terms of when we look at a facility how can it be

expanded in the future and what are we don’t want any line to necessarily do only one product because we don’t know

in the future how we need to adapt and that’s definitely been our thesis as we design our own facilities that we look

to partners is can we do cartridges and syringes can we do liquid and myopicalize products on this line that

definitely needs to be the approach going forward for us when we built our facility, we had no idea

that the pandemic was going to occur, but do we have the ability to fill vaccines yes we built a

a model that could be adjusted on the fly and reliant a lot less


on kind of how things may be used to be manufactured a lot of things are modular cleaners things that can be

changed and adjusted with minimal effort and minimal disruption and then i

just mentioned isolator seems to be the biggest trend going forward in all new facilities as we all know the largest

source of contamination in the facility is the operator so the more and more distance we can keep between the

operator and the finished product the more regulatory agencies as well as the companies themselves feel comfortable

with their processes and it creates a more efficient and safer working environment so those are the two biggest

trends we’ve seen especially on the isolator side just kind of getting away from our

what we used to do with just larger clean rooms passive rads and things like that and moving to a much more integrated and

automated system that the isolator can provide us yeah we’re also seeing the vendors are

responding as well to the needs for flexibility and we’re seeing a lot more equipment

allow multi-format filling where you could be doing syringes one day vials the next ampules on another day

and you know with that comes a lot more specialized solution

and so you know we’re starting to see less of those large capacity filling lines that

that can just do you know one or a handful of vial sizes and vials only and

we’re seeing you know the more  smaller filling lines that can be you

know set up for different configurations based on the container types and so

what we’re seeing is what’s called more of a scaling out than a scaling up where you might have you know two smaller

filling lines versus one large capacity line so that you do have that flexibility to adjust and maybe you’re

reducing capacity of one of your products while you’re addressing the pandemic but you

can still do it and at least keep you know your other products running at the same time

bring up a good point Jason I mean you know even in the small molecule area we do a lot of our own work

yeah based on the lessons I’ve learned from you guys in biotech and you know concepts is my recommendation is always

to scale out don’t scale up because you kind of paint yourself in the corner so

and I think the multifunctional fill finish that’s great I mean you know this gives you that flexibility so

let’s get back so on this whole thing about the globalization and the fill finish so

I mean obviously there’s a lot of moving parts there’s regulatory there’s financial there’s government there’s

yeah do all that stuff so you know ed so the global fill finisher brought

together obviously the public and the private sectors you so what players and what examples do you have

for us well I think you know the recent examples and we have to say they’re not

always perfectly positive some of these partnerships like you know there was good work under for

instance the us’ effort under the in its first part of the response

partnerships with companies in the US for fill-finish

some of them had some bps in the road in the recent past there’s also been work

in East Africa in in Kenya also West Africa on types of efforts and it’s a

to pick up on this point about flexibility I think two things that were missing one was this idea of flexibility

that you could produce capacity that could

adjust to different needs across even you know not even just working on health and vaccines and come out with another

you know be finishing a different vaccine but you might even work in an entirely different sector so that’s

something that’s gonna be the future of these types of partnerships but you didn’t have

sort of the financial   buying power in a lot of these

places that were most in need of fill-finish in West and North Africa as you do now with the financial powerhouses in

South Africa Kenya Ghana other places but then you have Indonesia even Bangladesh have moved a lot on fill-finish

so you part of that has been a recognition that your market needs to be

broader and that’s been facilitated by a number of new free trade zones that have been created

there’s a new massive new work on Africa free trade zone but East Africa and West Africa have these economic

communities that means that previous efforts that fill-finish that didn’t pan out so great for Kenya because it

was just looking at the Kenya market was not really big enough for the scale they wanted to produce

meant that that now they’re able to serve a much a much wider

market I think so some of those examples i think also you have new work that’s being

actually I know we don’t talk about our day jobs but our team at ApiJect working

with a number of other partners in the German government for a project in

Ghana and in Kenya on until finish it’s a consortium and it’s not it’s not just sort of looking at our work it’s looking

at how can fill-finish that’s produced at scale like Omair and Jason were saying and that’s flexible and that could

have things like blow fill seal but also glass and give options to that whole market

and again not just for Ghana but for the countries all the way around have been part of the

pieces that people been looking at and actually just to finish i think part of the challenge has been to get people looking beyond COVID because

everything’s been so much about COVID right now but by the time most of these things are up and running they’re gonna be looking to the next pandemic and

also feel finishing for routine vaccinations and other needs you know one of the things i mean other

than you know people kind of forget about phil finish let’s talk about where

facility I mean you know i mean if you’re going to build something Jason in an emerging economy I

mean there’s got to be some unique challenges there I mean I’ve been down the road you know we’ve all been down

that road where not only isn’t there any people or folks that we can staff with

the bottom line is the infrastructure can’t support so you know why don’t we talk a little bit about you know the emerging economy putting you know

facilities sure i think the industry has done quite a bit of work over the years thinking of

ways of bringing fill finish facilities to emergency emerging economies you know

we’ve looked at different strategies of utilizing maybe local building practices

to build a shell and then modularizing the fill finish components and shipping them and

bringing them in after the fact you know those have been some aspects  but if you think about you know the

overall build of the fill-finish facility they’re highly complex facilities and

even if you can solve all of the issues with getting the materials there

there’s always the technical challenge of skilled labor for installation

for tying the systems together the work that needs to be done on site and even if all of those things can be

overcome and likely can be overcome with the initial build initial construction it’s what happens

after that i think becomes a primary challenge and possibly where a lot of these exercises tend to stall

it’s you know having a skilled workforce having technicians that are knowledgeable in aseptic technology that

are willing to relocate and live in the in these in these localities

to see it all through it’s the maintenance i mean the maintenance

requirements and schedules for these kinds of facilities and additional parts and the know-how to do

the required maintenance and installation of those items becomes you know all of the things that

need to be followed up on after the fact so you know i think there’s a lot of good solutions out there for how do you

get a building built but I’m sure you know my colleagues on the call here today

have probably thought about you know what happens after and how do you keep a facility like that running and how do

you maintain quality in creating those products and and getting them to the patients you know that whole throughput

that you know from the supply chain coming into this you know the cold chain going out those become the strategies

which become the real head scratchers i think just while we’re on that aspect

you mentioned quality i mean to me you know one of the things that you know we talk about people forget about the fill

finish but the other thing is sometimes we forget that we are in a highly regulated industry so how do you

assure regulatory compliance when you’re building these facilities in various areas or regions that perhaps doesn’t

comply to whatever you know maybe different compliance aspects i mean how do you do that what’s the plan what’s

the strategy so it I think it’s complicated

but it’s not as complicated as it might sound i mean after when you work on finished projects around the world

there’s a common language of aseptic technology of filling

and creating parental products and i think there’s a lot of alignment there

so from that standpoint the actual manufacturing process is pretty well thought out and although we have

some novel delivery types coming out there is a common language around the world and how you make profitable

products which is great from a compliance standpoint you know really there are two

governing or regulatory agencies that that

really dominate globally there’s the US FDA requirements and then there’s the

requirements from the from the EU and what we find is I would say

maybe 80 of the countries around the world really take guidance from the EU documentation and guidance and

others based their guidelines on the us FDA requirements

and so if we find that if we focus on those two guidelines look for ways to harmonize them and essentially

design for the more restrictive of those two then we get you know pretty close to the

total requirements and then it’s straightforward to then overlay local government requirements whether

it’s containment control and things like that or if we need to comply with who requirements

which tend to be a little more prescriptive than the others which are more guideline based

you know that’s really the pathway that we that we follow and you know

we we’ve been doing it for some time now because most clients most people that are building new facilities are

pretending to follow a global mindset they want to comply they want to be able to provide products anywhere because

they don’t know where their markets are going to take them so it’s starting to become more and more a norm

versus previously where you may you may see a US-only based facility or you know similar for other countries we just

want to supply products locally I think the economy the industry is moving to

global production thanks Jason you bring up a good point that i want to get back to with Omair and

that is you know obviously when we’re talking about diverse you know sourcing so where is the future

with outsourced pharma i mean you know does everybody have their own bricks and mortar maybe they got

outsourced where’s it going yeah it’s definitely going to be i think a combination of the two I think we’ve

become heavily reliant on the global infrastructure that for example so much API production had moved out of the us

out of Europe into China and India where maybe the environmental controls were not as restrictive and things like that

I think there will definitely be and what maybe other companies or countries excuse me have done a

political will behind the national security aspect of drug supply and understanding that we know

where our food is coming from we know where our fuel comes from but do we know where our pharma is coming from do we

have an idea of if xyz is unavailable for whatever reason what are we doing you know millions hundreds of millions

of Americans take some sort of prescription drug daily so we need to really understand that

this can be a national security risk I’m not saying that every country will be solely reliant in producing their own

pharma exclusively but at least have redundancies in place and have strategic stockpiles of whether it be syringes

whether it be alcohol swabs whether it be you know pharmaceutical starting material and whatnot there really needs

to be a conservative effort from the governments of this country to make sure that you know we have security surrounding

key pharmaceuticals and key medication delivery in general

components to make sure that when there’s a global pandemic when for some reason cargo gets cut by 50 and things

get very disruptive how are we going to respond you know that’s what we need some sort of emergency map which i think

is going to happen it’s just a question of how much this public private partnership continues when maybe COVID

isn’t so top of mind will we see these things through because as i alluded to earlier these you know these are five

ten year plans these facilities they know these cities don’t go up overnight it takes years of design years of

construction so will that political and public will still be there when things have quieted down a bit that is probably

the most interesting thing we’ll see you bring up another point Omair I

actually as maybe come up with another question that I was going to ask but now to get back to you know get

back to Jason and that is you know let’s talk about that you know gee whiz I want to build a facility so yeah construction

what’s the what has the greatest impact on project delivery I mean where does the where’s the road bp

yeah that’s an interesting question so when it comes to speed you know a lot of

work has been done you know of course you know I’m within the engineering and construction environment and you

know we’re constantly thinking of ways to speed up design speed up construction

but when it comes to fill-finish facilities actually the greatest or the longest lead

item is the delivery of the equipment, and you know we’re seeing anywhere from 18 to 24 months for the delivery of

a filling line once the order is placed and so that really takes the construction of the facility off

the table of the critical path and you know we can follow a more traditional although fast track approach

and make sure the facility is designed as appropriate but the thing that really slows projects

down and what we see time and time again is an unrealistic view of the total cost

expectations of the project and you know there’s many times where projects begin where you know a budget

is not really known yet or there’s numbers that have been flowed floated that are 50

you know or 75 of where they need to be and unfortunately with fill finish

facilities they are very expensive, and the expense comes with things that are absolutely needed

in the project so if a set capacity is required then there’s things

that you absolutely have to have and there’s not many opportunities for cutting

corners you know and months can be spent trying to get budgets to where they need to be or

trying to get the facility designs to where the budgets need to be but overwhelmingly the solution is

usually to get more money and an you know that just takes time because

you know looking at the low hanging fruit we’re always asked we’ll cut the warehouse cut the offices cut all of

those things that they don’t put a dent into you know reducing budgets significantly to where

they may need to be the fact of the matter is there’s a lot of benchmark information there’s a lot of data

and you know within a you know short period of time we know more or less what a facility is going to cost or

at least where the budget might be but there’s a lot of that’s not an easy conversation to have I think

you know it may start right with the on the owner’s side you know if you want to get a project up and going you may not

want to scare people with the true cost of what it’s going to be but hope that you can socialize the costs later on

and can get where you need to go so right from the beginning there may be unrealistic expectations set and

even with service providers you know when by the time your service providers get on the project you know they

may caution and say okay well you know your budget is challenging but we’ll work together, and we’ll see

if we can get there because nobody wants to cancel the project nobody wants to say

you know this is unrealistic you know you want to you want to try and develop that relationship and get to a point

where hopefully you can achieve that so I’m you know I’m not sure what the

answer to that might be but if I think those costs were more realistic from the beginning you

could speed right through design and construction rather than having delays at every phase of design where you spend

months trying to get the cost down when it’s not feasible to do so

it’s an interesting take i mean it sounds like we you know you hear a lot about we’ll do whatever it takes but

also we have to do whatever it takes as soon as the budget is in the place that i want it to be in okay yeah i get it

all right but so Omair so the risks today within a globalized fill finish we’ve

heard you know getting the facility up getting the facility ready to go costs involved

hidden costs involved but the bottom line is globalize fill-finish the supply chain what are the

risks I think there’s a lot of hidden problems there not problems, but they’re hidden

hidden roadblocks there that people don’t understand what’s your take on it yeah i

think we need to kind of reevaluate everything we’re doing and level set i think before everyone had an idea of

what the overall risks were but now everything should be treated as a potential risk and we need to have

mitigation strategies accordingly I think components that were being taken for granted whether it be

components for filling bags and compounding whether it be stoppers whether it be just the raw glass for example there’s

so much been so much consolidation in the name of the efficiency and help drive down costs globally that we’ve

lost a lot of the ability to respond to switches and changes that are occurring with things like the pandemic when all

of a sudden we have to create 10 billion doses of a vaccine out of thin air right we can’t build a

facility in 18 months and Jason said at least you can’t get it qualified I didn’t get everything in time there so

we’re talking about extraordinary measures that had to be taken so we really need to evaluate okay if we can’t

get x component what are we doing and i think really the risk comes down to a lot of the regulatory agencies as well

are they going to be as flexible as the private sector in terms of trying to figure out ways to achieve the goal

and deliver medication to patients as quickly as possible and whether that means you know change controls changing

the way we’re doing things changing methodology changing components we need regulatory agencies globally to be

willing to embrace those changes and understand that it’s the science comes first where’s our real risk here have we

evaluated it we live in an industry that thrives on guidance very few rules a lot of

guidance so it’s up to the private sector to really defend how we approach

different strategies especially when it comes to risk mitigation at this point so will the

agencies globally whether FDA EMA who be willing to accept you know science-based

changes that help us achieve our goal during these kinds of crisis situations and how will they respond accordingly or

will they just continue to do business as usual which I don’t think is in anyone’s best interest

so that brings us back to you know what we see next globally i mean

in the distribution of phil for so let’s asse coven is behind us that pandemic

so ed where we’re heading i mean you know I mean i think FDA stepped up to the challenge let’s face it that was

historic in that decision they made public I think the put the public

into a state of shock but nevertheless here we are I mean the bottom line is

what do you think’s going to happen did we learn where we’re going what’s the next what’s the next pandemic going to

look like yeah well that our capacity to forget learning

is quite limitless so the if you look at some of the

statements that and even by my colleagues my former colleagues at the world health organization coming out of

the SARS pandemic   the individual is currently leading the emergency

programs there of a wonderful Irishman by the name of Mike Ryan is on in

about just about 10 years ago predicting exactly what is happening right now and

the need to prepare for it so i do think there’s a big risk that this fades from

public view I think probably one of the biggest

inhibitors in our covid response in general have been national elections wherever they’ve

happened to take place because there tend to be short-term promises made and i think this is why it’s so key and it’s

why anybody it’s why one of the reasons why i moved from who to work

with the private sector team working on this is this point that come that was made earlier by Jason and Omair about

sustainability like these projects have to be sustainable there are no funding streams that come out of the us

agency for international development that are 10 years 15 years 20 years to

to build and maintain a sort of this type of capacity globally

in countries that might need extra development dollars for it so that’s why it’s going to be so important that regional banks

national governments are invested in this but that it’s private sector driven around a sustainable model

and so that’s one thing i think we’re going to have to see i think you’re

there’s going to be a big push though African union is committed to produce 60 of its vaccines by 2040 that was a big

statement they made so i think there is no getting around the fact that there will be more attempts at distributed

manufacturing and fill-finish but I think we’ll also we would do ourselves a favor if we look forward

mentioned earlier I think Omair mentioned it around to the next pandemic and the next challenge which doesn’t

just include the next outbreak but could also be biosecurity bioterrorism and in those cases the ability to go to scale

very quickly when you have for instance the bioterrorist event on a fill finish

aspect is going to be really needed so this is why you need a mix of methods you’re definitely going

to need BFS you’re definitely going to need glass you’re going to need other methods for this and have that flexibility going forward so I think

that’s going to be some of the future areas that people are going to worry about fill-finish

I said Omair I want to thank you Jason appreciate the input obviously we’ve

surfaced a lot of stuff I think it was a great conversation and with that i

hope to see everybody at the Javits Center October 19th-21st

and  that’s it take care

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