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
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kovit so give us like what does it look like in the last 10 years or so so it’s really evolving and
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globalization has never stopped in the industry it really took over the last 10 years
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really really expanded we’re looking at asia china india it’s not a surprise there are huge players and especially
8:47
upstream components intermediates raw materials and then you’re going downstream phil
8:52
finnish india is a huge player in that as well and then europe and the united states and prior to even COVID
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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
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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
