global messaging alerts

Expert Content LibraryWebinars

Fierce Pharma: “Next Supply Chain Challenge: Syringes”

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

Social media & sharing icons powered by UltimatelySocial