hello everyone thank you for attending today’s webinar next supply chain
challenge syringes presented by ApiJect I’m Ross and I’ll be moderating
this webinar our speakers today are Ed Kelly Ph.D
Chief Global Health Officer, ApiJect and Omair Ahmed
Chief Strategy Officer Nexus Pharmaceuticals you can read their full bios on the left
side of your window by selecting the speakers tab just a few technical notes before we
begin the webcast is being streamed through your computer so there is no dial in
n ber for the best audio quality please make sure your vol e is up
this webinar is being recorded and will be available on demand within 24 hours
after the event okay now let’s begin
thank you for joining us today Dr Kelly and the first question my pleasure Russ
yeah great to have you ed and the first question we have is what is the current situation on
COVID vaccinations and where are we seeing the biggest bottlenecks in countries
thanks Russ and thanks for hosting us today and it’s great to be with such a an illustrious
panel well first off i think we should just take a temperature for a minute about
where we are in the entire pandemic we have
over 250 million cases to date in the pandemic over 5 million deaths we passed
that terrible mark recently and unfortunately a lot of countries have
scaled back their testing for COVID for a variety of reasons so actually
those n bers are probably much bigger so
we put a lot of faith into the vaccine programs around the world to get us out
of the pandemic and the state of vaccination
for COVID is I would have to give it at the moment probably at best
53 percent of the world has gotten one dose and as we know
that’s not being fully vaccinated we’ve given out of almost 8 billion about 7.7
billion doses so that’s nearly that’s double what we normally do in terms of vaccinations
every year but only five percent of vaccinations have happened
in low and middle-income countries so there’s big differences even
within regions if I’m located in Europe
and working with a lot of European partners there’s a lot of variation there where I live in France
there’s it’s between 70 and 80 percent vaccinated but other parts of the region some countries Russia and
Eastern Europe are around 30 vaccinated so very low vaccination rates
driving increases in in
cases but then you take a place like Ghana which is actually one of the bright spots as a health care system in
Africa and it’s only eight percent vaccinated so the other issue that you have Russ is that
outside of this wide variation in terms of countries having access to vaccines
is the issue of the fact that in some countries you have
a big populations that have only gotten one dose for instance in India 26
of the population which is a lot of people have only gotten one dose and this leaves
big groups of people vulnerable to perhaps creating a
a new variant a vaccine resistant variant and last point I’ll make just on
the where are we on covet vaccinations or around boosters right now big
booster programs kind of third dose that is being rolled out in high income most high income countries we’ve now given
out more booster doses in high income countries than we have given out even
first doses in low-income countries so that’s about 71 million booster doses given out and only about 43 million
doses given out in some of the low-income countries and you know this all gets back to prom some of the
promises not being kept in terms of the global rollout we had promised about
nearly 2 billion doses to be given out between this year and next and we’ve only donated about 250 million doses so
long way to go 2022 will be big crunch time for us in terms of global covet vaccines
great thanks so much ed so our second question is
surrender shortages are being talked about more and more in the media
how real is the problem and why did we not see this coming earlier
yeah great question i had a reporter recently asked me about this
and say wait you mean when we give out vaccines we don’t give out syringes with them and
actually the world health organization UNICEF and the third organization that’s involved
in vaccinations globally the fpa the family planning
organization has long had a policy that every dose needs
to go with a syringe but that’s not the policy we’re following necessarily in the covid times we talked about it i
and some of my colleagues last s mer together with Margaret Chan who’s the former director general of WHO
saying that we’re not thinking enough about syringes there’s not a big program on it and that’s going to result in
syringe shortages and a whole bunch of problems that go with it
unfortunately nobody really listened at the time and only just recently in
the past two weeks you had WHO and UNICEF coming out with statements that
were probably going to be at least two billion syringes short but that is a n ber if folks have
seen that that is based on auto disabled syringes only so
specialty syringes that UNICEF distributes in the developing world it’s based on the low-income countries which
UNICEF services and it’s not based on a calculation of potential boosters so
we’re easily looking at four to five billion syringes short over the course of the
the course of the vaccination program and yeah why we didn’t think about it you
know Russ there are so many things we are did not think through on this
coveted response this is just one of them there’s a bit of magical thinking
out there I think this is part of it that says look the world needs to spend money on the
upstream stuff the basic science i.e. the new vaccines and then
it’s really up to countries to get it into the arms of people but
many countries struggled are struggling with and struggled with the vaccine rollout that’s happening in Europe and
it’s it’ll happen in the US but will certainly happen in the developing world we had other
complications like the delta variant and other things coming as well export restrictions in some
countries that have constrained syringe supply but the bottom line is that we didn’t think
about the last mile enough when we started thinking about this coveted vaccination campaign
got it thanks ed so related to that question what are the issues we are seeing in
boosting supply of syringes yeah that is it’s a great question that’s the
issue that we have in terms of
syringe supply you know in fact the big crunch is actually
coming because we’ve done such a poor job of vaccinating most of the world and the
places where syringes are in the shortest supply we did have a gap
where it took us a bit to get the vaccine programs going where syringe manufacturers ramped up their work and
they’ve told us we did a recent piece in the Washington Post that looked at the syringe shortage and
manufacturers told us that they had really tried to expand existing lines
repurpose lines where they were able to focus on vaccine size syringes
to the tune of maybe five to six billion additional syringes out there and there were some in the stockpiles but
everywhere you talk to whether it’s the global health organizations like UNICEF or the Pan American Health
Organization that actually distributes syringes or you talk to countries themselves or
syringe manufacturers everyone says the stock are done and all available lines are
running basically 24 7. so we’ve squeezed what we’re going to get out of the existing infrastructure out
there and building new lines you know it takes a year at least and you know Omair
and others can we can talk more about this you can’t build that overnight so
we’ll have trouble getting more syringes out there and remember that every time we borrow or
use existing syringes we’re squeezing routine immunizations many more children
will die from measles the coming year because they didn’t get their measles shot then will die
from COVID so there’s a zero-s game out there that’s really going to be a tough one to
play in 2022. got it thanks Ed so our following
question is what we are seeing in terms of the roles of public and private sector in terms of
supply chain bottlenecks and especially for syringes
yeah this is an interesting point there I’ve been involved with
a n ber of outbreaks I’ve joined ApiJect relatively recently and used to
work for a decade and a half at the world health organization was part of
the Ebola response in 2014 part of the zika response following that
there’s always after each outbreak people
you know the great and the good gather around and say well we must figure out ways that this will never happen again and each
time it’s you know new version has happened again but this time around the magic wand that
people are waving is local production and public private partnerships to encourage
local production of bulk vaccine but also other parts of
the supply chain and you know while the focus on patent waivers and
producing vaccines in Africa is i think a bit misguided in the sense
that it’ll take quite a while for us to get up to speed on that I do think there’s a lot of potential for
public and private sector partnerships particularly on fill-finish
and syringe manufacturing but fill-finish in general in
many parts of the world whether it’s Southeast Asia or Africa that haven’t traditionally produced this and
the issue that has happened in the past whether it’s vaccine
trying to build up a local vaccine production or other fill-finish capacity has been that it’s been driven by public
sector money or foundation money and public sector decision making and by
definition both of those are finite in their funding scheme so
the difference now i was just on the phone for instance with colleagues from Ghana where we have some
some partnerships and there’s a real interest in the
private sector taking the lead role on you know choosing the site getting partners looking for funding and the
public sector role is back to where it’s really best suited sort of setting some of the
regulations helping create the right environments helping assist with
favorable loans or other financing and regulatory pieces and also let’s be
frank investing in some of the pieces that will make these ventures sustainable you need a trained workforce
so you cannot build major fill finish work or even other vaccine production
unless you’re also investing in your medical engineering programs and other bits to so that two three four five
years from now you’ll have a workforce that’s able to maintain some of those sites
great and then our following question is if supply chains are an issue
what other problems do we foresee even if we manage to boost supply
yeah well I think you know
if we do get supply pushed forward there are there are some special issues particularly
with COVID and that’ll come more and more later this year and into next year
that we need to be worried about first off is that there’s been a big push by the US government around and we’re
talking about the global concerns sort of for making the Pfizer
vaccine available globally it’s produced in in the us and the us has been trying to donate as much as possible on that
and be great if even more comes but it uses a specialty syringe a 0.3 mil syringe which wasn’t
in a lot of people’s production lines prior to the outbreak that also takes a
diluent so you need an extra syringe for that the other issue that we have really is
that there’s no coordination effort on syringes like there is on vaccines for vaccines very
early in the outbreak sort of even in January February there’s a big meeting at who was one of the last meetings that
happened in person before sort of the initial lockdown happened to coordinate on the COVID mechanism
sort of a big funding and coordination mechanism for the production of
vaccines and to ensure advanced market commitments for countries that might not be able to afford them
there was no such effort for syringes we need the same kind of push both
coordination wise and finance wise from the global health infrastructure and partners out there on syringes
the third piece i guess i would point to that’s an issue coming up is that
we will soon in 2022 have a glut of vaccines ironically, we’re talking now
and typical keeps talking about you know the vaccine inequity and access to vaccine doses and poor countries
don’t have them all that’s true right now but we even now have
132 vaccines in clinical development
that who that was tracking there’s 194 additional ones in pre-clinical
development so we will there’s no shortage of vaccines that are coming down the road but if you cannot put them
in to get them to countries put them in people’s arms they do no one any good
and so that type of issue around the problem being not vaccines but
actually vaccination programs and getting people vaccinated that’ll be the
big push through 2022 and it’ll without enough investment it’ll definitely drag things out for us
great and Dr, Kelley our last question for you is it seems as though COVID-19 will push
the world to move beyond business as usual in many ways is there an opportunity for rethinking
immunization yeah i really think there is and you
know there’s many places where COVID has pushed for instance the
delivery of healthcare to go much more digital and to you know
to look at other ways of delivering we’ve realized actually that things like
substance abuse and mental health counseling these types of things that were sort of shut down during the initial phases of covet are actually
essential so many realizations we’ve had about aspects of health care much less the rest of how we run societies but
I think there’s really probably three there’s probably more but anyway at least three big items we’ll realize
related to vaccines and vaccinations that’s a chance for rethinking things it’s quite
clear that we will not be able to vaccinate the world unless we
change who can vaccinate the right now most countries the vast vast majority of
countries high middle low income only allow medical personnel so nurses
physicians physician assistants in some cases pharmacists to vaccinate and we
need to change that there’s no way we’re going to reach both
urban sl regions as well as far-flung rural areas if we don’t allow community
health workers to perform vaccinations and to do that you really have to have
different types of easy to use syringes ideally things that are single
dose ideally things that are pre-filled allow community health workers to do that I think also taking
it a step further we will eventually realize that the future of vaccination once you’ve made that j p to community
health workers and kind of social workers in the community being able to to do these while they’re doing other
visits to families is that families being able to self-vaccinate you have
hundreds of millions of diabetic patients around the world that self-administer insulin at some
point we’re going to realize that in a major outbreak like this or in a biosecurity event or other things where
where you have to move very quickly and get it around the world you’re going to have to have people
vaccinating themselves or family members vaccinating each other and again you’re gonna have to have new ways of
presenting the syringe presenting that vaccine to people and ways of digitally
recording it and bringing it back up into the digital data records that are
out there so all of that is kind of a reinventing that is possible now and
I hope we get a chance to start to test some of those pieces the last bit that i think will really be a re-
thinking for us on vaccinations coming out of covid is partially the
superimposition of cop26 and COVID
I think that people are rethinking how all business has done much less the business of vaccination and quite
clearly any approach on manufacturing fill finish and
vaccination programs have to have upfront a focus on the environmental
impact and diminishing that environmental impact and that’s across
the supply chain so not just how you manufacture something not just how you dispose of the syringe but also
transport costs and being able to rethink using traditional materials
things thinking of new ways to transport that are lighter and don’t break
as well as looking at how that could potentially
have a very positive impact coming out of covid not just for health but also for the
environment those would be my three fantastic thank you so much Dr. Kelley for
this wonderful and great insight and now I would like to direct the next
set of questions to our next speaker Omair Ahmed. Omair welcome and thank you so
much for joining us today thank you so much raj it’s a pleasure to be here
yeah a fantastic pleasure to have you so Omair our first question for you is
what is the cons er demand pushing for more syringes
like Dr. Kelley alluded to earlier regardless of clinical setting folks are
looking for easier to administer easier to prepare easier to store medication administration
so the case in most of the developing world we’re really looking to syringes to fill
a void that’s being left at pharmacies regardless of whether it’s personnel shortage space shortage we really are
looking at a landscape where physicians and other healthcare providers are looking for an easier way
to administer medication to patients with less risk of air as well as
less reliance on labor which was increasingly in short supply as covid highlighted health care workers were brought to the
brink and just as Dr. Kelley said in his last question
if we can get more personnel to administer medication without having to reconstitute diluvi we can just go
straight to a syringe to a patient that’s just what we need to kind of increase the
uptake and make sure that we have better adherence across the board as well as just safer medical practices
great thanks Omair so our following question here is how do syringes advance healthcare
to be honest it’s really the next evolution we’ve been working with intravenous medication for over a
century now and as things have progressed slowly in the world there
haven’t been a ton of changes and i think covid is really highlighting that you know what work maybe 50 years ago
with the population of three and a half billion doesn’t work in 2022 when we’re approaching eight billion people on
the globe so really what syringes allow us to do is this next set of
we’ll call it technological breakthrough can really help expand access to medication which has been a greater
issue as of late not so much in the high income countries but definitely in the developing world where we see just the
lack of cold chained prep the lack of proper facilities and the lack of
training has really led to an inadequacy and inequality in terms of access to
healthcare so we view you know syringes without syringes we can’t introduce intravenous medication into our bodies
it’s just not how it works so we really are focusing on where all the vials that
we manufacture all the ampoules all the drugs that are being made for sterile intravenous use they need to have a
delivery system and if you’re not thinking of it as a total solution then you’re only seeing
half the picture so the way we view syringes is that the more products that we can put
directly into syringes as far as our business is concerned we think that allows us to not only make it a better
proposition in terms of value but also a safer overall proposition in terms of medication delivery so you’ll
start to see in the landscape more and more this push to pre-filled syringes auto-injectors
where the delivery system and the medication have now been integrated so as i was alluded to earlier you don’t
have to worry about okay is every vial going on with the syringe well now if that’s just one piece it makes everything a lot smoother and logistics
and delivery become quite a bit more streamlined got it
so our third question Omair is what are the current challenges surrounding the manufacturing and
distribution of pre-filled syringes
a lot of it comes down to component availability the global shortage of
various components whether it be the syringe barrel needles plungers plunger
stoppers covet 19 really put a huge burden on an
already at capacity industry and the inability to source components to
actually use for the filling lines the filling lines themselves
to build a fill finish facility is a three to five year project and when we
you know go down the route of planning and trying to design these facilities the last thing on our mind was okay once
the facility is completed you won’t be able to get any of the components that you thought were going to be readily
available at the time so it really has changed how businesses approach just-in-time
inventory safety stock really trying to make sure we have enough so we can deliver now
that’s led to a global problem of either hoarding by some of the larger
more industrial nations and not leaving a lot for other folks but at the same time all of our syringe suppliers
are trying to increase production it’s just not happening fast enough every increase in production is already almost
spoken for so we really are trying to figure out how do we continue to advance this
mission without having you know a good future forecast on what
the supply will be and i know the government has obviously of all the
European western nations have stepped in in terms of vaccine manufacturing and
purchasing doses but at from our standpoint that’s an
upstream sort of issue how do we go downstream you know the analogy i like to use is we
have electric cars everywhere every day there’s a new electric car coming out similar to the vaccine there’s so many
vaccines coming out but have we really thought about the infrastructure the roads are going to drive on the charging
stations and that’s the same issue here have we thought about how are we actually administering these vaccines how are we going to be filling them do
we have vials do we have syringes and that is kind of falling by the
wayside because it’s not necessarily headline grabbing those are you know and
maybe it was the case before those were just assumed standard categories that were going to
be available and now that those are coming into question it’ll be very interesting to see how
public groups as well as governments respond and if they’re willing to
take on this burden to help increase capacity and help increase supply of
these basic components got it and Omair speaking of
infrastructure how does the global supply chain both help and or hinder
syringe adoption it’s helped in a way where we’ve had so
much more access to the global labor market global technology pool that’s
really i don’t think we’d be where we are without having such a globalized industry sourcing components from Asia
Europe North America all of those coming together to produce you know a single product somewhere and I think without
that we would never have been able to get as far as we have today just to do various restrictions and probably
true of the economy overall now where we run into constraints is
there’s different level of adoption in different countries and we see it globally
you know if it’s Europe and they prefer ampules versus North America prefers vials all of these kind of
idiosyncrasies are kind of slowing us down we haven’t adopted really a worldwide healthcare model the products
and medication that’s used in country a may not necessarily be how it’s used in country b
and the products they’re getting may be different so when you start dealing with these kind of fragmented
economies it’s hard to give a global solution that’ll solve everyone’s issues
you know cold chain is not as much of an issue in Norway for example as it would be in Sudan so you’re really looking at
problems differently and how do you create a blanket solution and so i think that’s hindered some of the
adoption of what we’re trying to do here which is come out with something that can work globally when I first
started we used to make millions of doses now we’re making hundreds of millions hopefully billions of doses in the future but to do that you need some
sort of economies of scale and i think that’s been a big issue as we’ve seen with the vaccine is that
with covid you know different countries there’s a lot of politics involved in terms of which
vaccines are used where how are they administered and so that sort of inequity is definitely going to lead
towards different issues regarding how do we get one blanket solution across
the board got it and along that same supply chain
question what initiatives can governments take to secure the syringe supply chain
I think a lot of it comes down to long-term investment there’s a lot of headlines out there
about grant money going for you know buying these doses building this production facility
and you know those are all great they’re all necessary but these are very long-term projects we need to not be
thinking about necessarily covet 19 today but you know god forbid covet 2030 or you
know all down the line this is not going to be I’m sure Dr. Kelley will speak could speak to this the last pandemic we see
here and we definitely need to focus on how do we build an ecosystem right we
want local production across the world but that requires an ecosystem of trained personnel trained maintenance
folks bringing in that infrastructure reliable power
so that you can actually have local production and these are taken for granted in the industrialized world but
we need to really understand that to increase supply of pre-filled syringes vaccines medications it’s not
just we’re going to put up a building and then all of a sudden it’ll start producing medication that’s not necessarily how it works you really need
the personnel is what really makes it the technology can be great we have the finest technology finest machinery but
if we don’t have trained workforce not a lot’s going to get out of that facility and that requires a long-term
investment from governments not just a short-term shot in the arm of cash we
really need to look at what can we handle much more broadly on a macro level so that the whole world has access
to medication you know during these sorts of acute events
great and our final question for you Omair is what have we learned from the COVID 19
pandemic and how can this help us in the future
I think we’ve learned that we’re not as prepared as we ever think we are
this is not something anybody could have ever predicted and it essentially exacerbated our worst
fears in terms of where do we fall short and i think we’re really learning that our health care system overall is not as
resilient as maybe we had hoped it was in the face of such a crisis now i think our response has been quite admirable we
were able to create vaccines medication ramp up supply in such a short amount of time but at what cost it did come at a
cost there were externalities in terms of what was left behind what other medications immunizations other services
were unavailable because we had to respond with such force here so i think we’ve
learned that nothing comes without a cost we couldn’t just magically create
vaccines and their corresponding downstream supply without it sacrificing
some of the other portions of the health care system so i think what we’re really learning is we need to do more and
have that availability and have that flexibility and understand both from a regulatory public domain
as well as private businesses that things can change so quickly overnight we need to be flexible whether it was
working from home whether it’s totally retooling a production line it really comes down to
the countries and the businesses that will be the most successful are the ones that are the most flexible and i think
that’s probably been the biggest lesson learned post covid
fantastic thank you so much Omair
for this great insight and with that i’d like to thank all of
our panelists for participating in apogee for presenting today’s fierce
pharma webinar I’d also like to thank everyone for attending
and submitting so many great questions we unfortunately did run out of time to take additional questions but we will
try our best to get back to everyone who submitted personally after the webinar please note that this webinar has been
recorded you will be able to access the recording within 24 hours using the same audience
link that was sent to you earlier thank you again for joining and we look forward to seeing you at future events
