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September 29, 2025 57 mins

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On this week's episode of the Business of Biotech, Rob Abbott, CEO of ISPOR, explains how startup and early-stage clinical drug development companies benefit from conducting health economics and outcomes research (HEOR), and not just with patients and commercial payers. HEOR, viewed as a strategic lever as opposed to a compliance exercise, can help answer investor questions about market differentiation, pricing pathways, and real world product validation. Abbott talks about the value of cost-of-illness studies, burden-of-disease analyses, and payer landscape assessments, and how AI, real world evidence, and patient-centered research can improve drug and trial design and accelerate market access.       

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Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Ben Comer (00:07):
Welcome back to the Business of Biotech.
I'm your host, Ben Comer, chiefEditor at Life Science Leader,
and today I'm delighted to speakwith Rob Abbott, CEO at ISPOR,
that's the International Societyof Pharmacoeconomics and
Outcomes Research, which is aglobal professional society for
health, economics and outcomesresearch, or HEOR.

(00:29):
ISPOR was established in 1995and has been growing ever since.
There are now 20,000 membersactive in more than 100
countries.
I wanted to have Rob on theshow today to talk about HEOR
and its value proposition inlife sciences, particularly for
listeners at startups andearlier stage companies who may

(00:51):
not be as familiar as largepharma is with HEOR and ISPOR,
but and I suspect Rob will makethis case during our
conversation they absolutelyshould be.
We'll learn how to set up anHEOR program, how it can help
companies attract investors,current trends in HEOR and how

(01:13):
it's changing in light ofemerging technology like AI and
what's on ISPOR's agenda in thenear future.
Thank you so much for beinghere, Rob.

Rob Abbott (01:23):
Ben, you've just done an extraordinary job of
introducing myself and the topic.
It's a great pleasure to behere on behalf of ISPOR and I
really look forward to sharingsome of the insights that we
have from a health economics andoutcomes research perspective
with your listeners,particularly, as you suggest,
those listeners that areactively engaged with a small to

(01:44):
midsize or indeed early stagebiotech.
I think there's a lot thatISPOR and HEOR have to offer
those kinds of companies, asthey clarify their value
proposition and really seek toexplain themselves to audiences,
including investor audiences,that may not otherwise be as

(02:05):
familiar with health economics,no-comes research and the value
that can help to provide.

Ben Comer (02:11):
That's excellent and I want to jump right to that.
But first, before we do, I wantto get to know you a little bit
better.
Rob, you have a diverse set ofbackground experiences and I'll
just I'll ask you maybe you knowwhat are some of the through
lines that connect those variousexperiences.
You've worked in nonprofits,you've worked at a private

(02:34):
company, you've worked ingovernment.
Tell us a little bit about youknow, your approach to your
career and what circumstancesled you to the CEO role at ISPOR
.

Rob Abbott (02:47):
No, I really appreciate this opportunity
because when I look back on mycareer and to a certain extent I
view my current role withIceborne as something of a
capstone of sorts I look back onmy career and I realize that
from the outside, looking in, itmight seem as though I've made
some rather bizarre choices,because at various stages I

(03:11):
could very comfortably havesettled in and climbed the
proverbial ladder in governmentor in the management consulting
community or the not-for-profitcommunity, you know.
Instead, you know, I veryintentionally chose to move
around because I wanted to lookat particular issues and
opportunities from multipleperspectives.

(03:32):
But the through line, whatunites all of this, is that I
have had a very longstandinginterest in human welfare and
how we actually improve humanwelfare globally, and that has
expressed itself through workthat I've done related to

(03:54):
corporate social responsibility.
It's expressed itself throughwork that I've done as the CEO
of the Canadian Genetic DiseasesNetwork and the Canadian Gene
Cure Foundation.
It's expressed itself throughthe work that I've done as a
management consulting, you know,working for and on behalf of
health policy change.
But I think the commondenominator is that, for me, the

(04:21):
relationship between socialresponsibility on the one hand
and business viability on theother, or how we craft policy
that's smart, policy thatactually improves human welfare.
These are the things that areexciting to me.
These are the things that makeme want to get out of bed in the
morning and show up for work.

Ben Comer (04:43):
Well, it's an important role, maybe
particularly right now in the US.
Let's get into health economicsand outcomes research For
listeners who may not be asfamiliar with what it is.
Can you give us a kind of topline explanation of HEOR?
And listeners, bear with us.

(05:04):
There are some acronyms we'regoing to be using throughout
this conversation.
Refer back, you know, to thebeginning of the episode if you
need to.
But HEOR, health economics andoutcomes research what is it?
What value can it bring to lifesciences companies?

Rob Abbott (05:19):
So I'm going to try and keep the acronyms to a
minimum and simply say thathealth economics and outcomes
research is a multidisciplinaryfield.
Firstly and that will become, Ithink, more interesting to the
listeners as we get deeper intothis conversation Because when
you start thinking about, well,I need to bootstrap an HEOR

(05:43):
department at my small biotech,where do I get started?
It's not as though you have tohire someone that you know did a
degree in health economicsnecessarily.
The reality is that, as amultidisciplinary field, yes,
there are economists workinghere, but so are there
epidemiologists andstatisticians and others.

(06:05):
So, first things first, heor isa multidisciplinary field that
uses data to informdecision-making in healthcare.
So that's the headlineMultidisciplinary, relies on
data to inform decision-makingin healthcare.

(06:26):
Now, if we drop down just alittle bit, the idea is to you
know, think about you know,cost-effectiveness, real-world
effectiveness andpatient-centered value.
These are kind of the three bigthings.

(06:47):
Is it cost-effective?
Does it actually do what youknow, we thought it would do?
And what is the patientexperience in all of this?
Not only in terms of theefficacy of the drug or the
service, but the ease of use,the drug or the service but the

(07:10):
ease of use, et cetera.

Ben Comer (07:10):
So you know this is very much what is at the heart
of health economics when itcomes to research, and you know
you've talked about thismultidisciplinary practice.
You also said you know youdon't necessarily need a health
economics or health economist,you know, hired on to start up,
uh, an heor program.
Uh, at you know a startup at anearly stage company, um, how do

(07:34):
you start one up?
You know, how do you a companythat's hearing you right now and
thinking, wow, you know, I'dreally like to be able to, you
know better elucidate the valueof my products, make the case
you know to governments, topayers, make sure that you know
our medicine is, understand interms of what it means to
individual patients.

(07:55):
How do you get started withthat else, rob, you might say
just about the kind of businesscase you know for someone at a
small company who's saying Ireally think we should get
started on HEOR here and here'swhy.

Rob Abbott (08:12):
So I mean, the first thing I would say to you know
the listeners, ben, is you knowI think that HEOR is crucial and
you know it has to be viewedespecially from the perspective
of a startup or a small tomidsize biotech.
It has to be viewed, you know,strategically and it has to be

(08:37):
scaled appropriately.
Experience that resources aretight, data is limited and the
priorities generally are focusedon proving the science and
securing funding Like this iswhat drives the.
You know this is what drives theday-to-day business.
Now I do want to justforeshadow something that I hope

(09:01):
we get a chance to talk aboutin a few minutes, which is all
about, you know, the investorperspective and how HEOR can
support.
You know, de-risking andvaluing the asset that is the
biotech.
But before we get there, Iwould just say that, you know,
as a small biotech, you need tounderstand that payers,

(09:25):
investors, prospective businesspartners, they want evidence of
value, not just efficacy.
So the mantra that I routinelysay is you've got to think
beyond approval.
Approval is a necessary butinsufficient condition for

(09:46):
success.
So health economics now comes.
Research can, you know, helpshape smarter development, it
can help reduce risk, it canattract investment.
But again, you have to kind ofapproach this, you know,
thoughtfully and strategically.
It can strengthen the valueproposition.
So in particular I would sayhealth economics and outcomes.

(10:09):
Research can help quantify, youknow, unmet need and the
economic burden of disease,which you know directly
translates into prospectivefuture business value, directly
translates into prospectivefuture business value.
And early modeling,particularly cost of illness
studies, burden of diseaseanalysis, can justify the

(10:35):
relevance of a drug or a medicaldevice to prospective investors
and partners.
So that's kind of just the.
You know the beginning of whereHEOR may start to become more
relevant for an early stagebiotech.

Ben Comer (10:53):
Yeah, and I think your comment about launch or,
excuse me, approval essentiallybeing table stakes is an
important one, especially givenyou know the data we've seen on
just how unpredictable successcan be with newly launched
products.
Something like 50% of newlylaunched products are not

(11:13):
meeting their forecast, I think,which just shows how important
proving the value of a productto a whole lot of different
stakeholders you know might be.
Yeah, go ahead.

Rob Abbott (11:28):
Absolutely.
And I think the thing too forlisteners is that you know this
can sometimes seem like you knowthis mountain that you have to
climb and I would say, look, youcan break it down If you're an
early stage biotech that's, youknow, raising capital, you know,

(11:49):
especially beyond Series A,let's say you know the first
order of business is, you know,have some basic health economics
and outcomes research materialsat hand, and I'm thinking of
things like cost of illness orburden of disease studies.
You know the payer landscape orpricing strategy and probably a

(12:15):
reasonably clear sense of whatthe economic endpoints you know
look like.
Like that's kind of thefoundational piece.
You can then build on that andbasically say, ok, whench, right
now, you know, can I show thatI understand how value not

(12:49):
efficacy, but how value isassessed, because that's
different from efficacy.
And if I'm in the pre-revenuestage, health economics,
outcomes research can be a proxyof sorts for prospective
commercial traction, you know.

(13:10):
Then ultimately you need tohave a sense of how I can show,
you know, a pathway toreal-world validation.
So what are my plans forpatient reported outcomes, real
world evidence generation andpost launch data collection.
So you can kind of break itdown into those three stages,

(13:35):
let's say.
But the first order of businessis probably one of saying wait a
minute, like what is you know?
Ultimately, you know what isthe health outcome for dollar
spend, you know, and how is ourproduct or service going to
shape that positively?

(13:56):
I mean, there are a number ofthings that HEOR brings to a
biotech, in my opinion, you know.
I think it can serve as abridge between clinical
innovation on the one hand andmarket success on the other.
I think it can help to justifypricing and gain access.

(14:19):
But at the end of the day, it'slike what is the health outcome
per dollar spent?
And can this product or service, you know, positively shape
that?
And you get to begin answeringthat question when you have the
cost of illness or burden ofdisease studies in hand, when

(14:39):
you kind of understand what thepayer landscape looks like, you
know, when you have a bettersense for what those economic
endpoints might be.

Ben Comer (14:52):
Right.
And so when, you know, whenshould a company get started on
this?
So I'm thinking of maybe it's a, you know, a preclinical
company, you know, transitioningfrom animal studies into their
first in human trial, you know.
Or maybe it's a company that's,you know, moving into a phase
two or even a phase three, youknow.

(15:13):
I guess my question is do youwant to start this process of
developing your HEOR dossier forlack of a better word, but you
know your, your group of HE dataand documents?
Do you want to start doing thatonce you know, or are fairly

(15:34):
certain that you know, you'velanded on a product that you're
going to take all the way intolate stages and, hopefully,
approval, or is this somethingthat should start, you know,
even earlier, even at, you know,the very earliest preclinical
stages?

Rob Abbott (15:54):
you know, the very earliest preclinical stages.
So my bias here is that youwant to be starting as early as
possible.
You know there is an adage thatyou know you begin with the end
in mind, and so I think youwant to be thinking about okay,
what are those foundationalpieces of work?
I mean, I've spoken of cost ofillness or burden of disease,
studies and so forth.
You know you want to bethinking about that early on,

(16:17):
like what is it?
What is the science that we'repursuing?
What is this company beingbuilt around?
What is the disease that we'retargeting and what is the
outcome that we hope to achievefrom a from a, you know, health
improvement perspective?
Certainly, but what is theoutcome we hope to achieve from
a business perspective?

(16:38):
You've got to be thinking aboutthose things early on, Because
if you wait too long, you're notgoing to have the time to
generate the real evidence.
Because this is the other thingthat I find fascinating is that
in any biotech's journey, youknow there is a stage where you

(17:01):
are in an iterative dialoguewith partners or investors, and
the investors have a wholeseries of questions and they
don't all come at the same time,but those questions have a lot
to do with.
You know, is there a clearpricing and reimbursement
pathway?
Is there strong marketdifferentiation?

(17:23):
Is there proof of value tostakeholders?
Is there an understanding ofreal world use?
Is there a sustainable andscalable you know commercial
model?
Now those are differentquestions, but they're all
legitimate questions thatinvestors have.
And I will say the good news isthat health economics now comes

(17:45):
.
Research can help you answerthose questions.
Because if someone's concernedabout pricing and reimbursement,
for instance, we might say, ok,here's, here's our budget
impact analysis, or earlyinsights we have from payers.
You know we've done thathomework and it's not one and
done, it is iterative.
You know we're back and forthwith payers or we're back and

(18:08):
forth in terms of the budgetimpact analysis, but we've at
least got something.
Or we might say here's ourcomparative, you know, cost
effectiveness work.
Or here's what we have in termsof patient reported outcomes
and the burden of illness data.
So for most investor questionsthere is an HUR signal or an HUR

(18:33):
response that fits.
But you can't wait until you're, you know, at stage two
clinical trials to startanswering these questions.
You've got to start early.

Ben Comer (18:45):
So is this something that you know each individual
company needs to?
And I guess what I'm thinkingabout here is are there, are
there shortcuts to this?
Are there shared resources thatthat I spore can provide, or is
does each individual company,you know, given their very
different products, differenttherapeutic areas, different

(19:07):
drug mechanisms?

Rob Abbott (19:37):
different therapeutic areas, different
drug mechanisms.
Is it something that they haveto think about and build
themselves, or are there tools,resources?
You know that, that I conveythe impression that you know one
size of evidence, if you willthat particularly small and
early stage biotech would findenormous value in.

(19:58):
So you know, I appreciate thatthere are, you know, a large
number of studies that ISPOR hasbeen involved in and we have
those on our website or we havethose readily available for
folks.
And, by the way, I'mincreasingly interested in
hearing from the biotechcommunity because I would

(20:22):
actually like to grow the numberof biotech companies that are
part of ISPOR.
But certainly, you know, wehave some resources that you
know can help to sort of smoothout that learning curve a little
bit.
And it's true that becausecompanies are driven by, you

(20:43):
know, different boards ofdirectors or different, you know
motivations, they're going tohave a nuance to their strategy
that needs to be respected.
So there's a little bit ofbespoke work that individual
companies will at some stageinevitably need to do.
But there's also a lot of workthat ISPOR has that we can make

(21:04):
available.

Ben Comer (21:06):
I want to just circle back to something you said
earlier and this is sort ofcontinuing on what we're talking
about here and this you know,appealing to love to have a
robust HEOR program.
But you know, I'm trying tokeep the lights on right now.
What you know, how do you youknow what's your argument to a

(21:39):
company that says, essentially,you know you're gonna, if you
make this investment, and maybegive me a sense of, like, what
that early investment might be,but if I'm willing to make this
investment in collecting thisHEOR, you know how does it come
back to me?
What's?
You know what's the ROI oncreating an HEOR program as an

(22:01):
early stage company?

Rob Abbott (22:02):
Well.
So again, just to be reallytransparent, it won't be lost on
some of your listeners that youknow, over the last two years,
let's say, there has been, youknow, very significant
consolidation quote unquotewithin global biopharma with

(22:23):
respect to HEOR, and I know thatyou know any global biopharma
C-suite representatives thatmight be listening would say,
okay, hang on, we haven't gottenrid of the HUR function, we've
simply redistributed it orrearticulated it in various ways
, and there's absolutely sometruth to that.
But the underlying argument, Ithink and I've written about

(22:49):
this and spoken about this, Ithink that the H-E-U-R community
has actually not done itselfany favors historically because
we've been so focused on themethods and the curation of
evidence that we haven'tnecessarily connected all of the
dots and demonstrated how thatevidence does generate an ROI.

(23:14):
We've basically said look, thisis, you know, we've done our
work.
It's now over to our marketaccess colleagues, or our
whatever you know colleagues inmedical affairs to, you know,
carry the ball forward.
And I think that we can andneed to do a little better than
that.
So, although I don't have adefinitive answer today, I do

(23:36):
want all of your listeners toknow that ISPOR is currently
sponsoring, you know, a piece ofempirical, quantitative
research that is focused verysquarely on the ROI of HEOR
Typically HEOR practitioners,whether they're in the private

(23:58):
sector or elsewhere.
We've operated to a certainextent like academics and so we
point to oh well, we publishedthis many papers or we've done
this many studies, and that sortof thing.
Honestly, investors and C-suiteexecutives don't care as much
about that sort of thing.
That might be a necessary butinsufficient set of conditions.

(24:21):
You know they actually careabout the fact that, ok, if I'm
spending $50 million a year as aglobal biopharma company on
HEOR, you know what am I gettingon the other end, because I can
say with some certainty that ifI spend that same amount on,
you know, advertising ormarketing and communications, I
can measure, you know what thatreturn is.

(24:42):
We're not there yet with HEORgenerally, whether it's small,
mid or large scale, but I knowthat the work we're currently
sponsoring is going tocontribute pretty significantly
to, I think, a refreshed debateabout the business value of
H-E-O-R.
Now, you know, in the meantime,for the early stage or startup

(25:05):
biotechs that are listening, Iwould say look, you know, if you
want to understand some ofthose foundational things that I
mentioned earlier the cost ofillness or the burden of disease
, for instance.
You know you should reach outto ISPOR and we can.
I don't want to suggest thatwe're in a position yet, as a

(25:28):
not-for-profit, to become yourfractional HEOR department, but
I think in many respects youknow some of the resources that
we have can help to bridge thatgap.
So you know it's a complex andlayered question.

(25:49):
When we start talking about thevalue, I think the most
important thing, as it usuallyis, is just to begin to get
started.
And for the early stage orstartups, then I would suggest,
hey, don't fight this drama asif you're all alone.
Don't fight this drama as ifyou're all alone.
You know, reach out to us.

(26:10):
We are the Professional Societyfor Health, economics and
Outcomes Research.
If you reach out to us, we havean interest in helping you.
And chances are some of thequestions the early stage
biotechs have.
We've probably already answeredmany of those questions.

Ben Comer (26:29):
Right Right.
Ispor's science strategyidentifies on an ongoing basis
emerging themes that impact HEORand how it's used.
Ispor also publishes a top 10trends report.
You know there have been a lotof technological changes, just

(26:49):
for one example since, since1995, when the organization
began.
You know what are, what aresome of those, those topics or
technologies that that ISPOR hasidentified as being important
to you know collecting and usingHEOR effectively now collecting

(27:13):
and using HEOR effectively now.

Rob Abbott (27:14):
So I'm going to maybe mention three things, and,
you know, can expand on any ofthem as we see fit.
No surprise artificialintelligence and the use of
artificial intelligence inhealth economics.
No-it-comes research.
Obviously, the use of AI inhealthcare decision-making more
generally Massively importanttrend, quote-unquote.

(27:38):
At the same time, real-worldevidence and the use of
real-world evidence to informdecision-making.
What's most interesting to me,though, ben, is, you know, the
third big trend that I think hasbeen gathering a lot of
momentum is patient-centeredresearch and patient centricity.

(27:58):
Now, patient centricity is oneof those things that's a little
bit like corporate socialresponsibility.
Everybody likes to talk aboutit, but you know, when you get
right down to it, I think thatyou know Patient centricity is
fundamentally important and it'snot well understood.

(28:19):
I think there is a lot of whatI would characterize as tokenism
that takes place under theumbrella of patient centricity,
and I think it's reallyimportant for all companies, but
especially for early stagecompanies, to think about
patient centered work as astrategic business decision and

(28:40):
to understand that patients andthe views that patients have are
every bit as important, if notmore so, than what that health
economist down the hallway mighthave to say or what that
statistician might have to say.
So in my mind, we're going tocontinue to hear a lot about

(29:04):
artificial intelligence and, tobe sure, helping with systematic
literature reviews,synthesizing data, helping to
tailor treatment protocols andso forth.
I think there's a lot ofpromise there, to be sure, and
we still need human intelligenceto complement that With

(29:26):
real-world evidence.
We're kind of getting more intothe realm of patient centricity,
because we're basically sayingwhat has the actual experience
with that drug or medical devicebeen?
What are patients actuallytelling us?
What are we seeing fromelectronic health records and so
forth?
And then we get into patientcentricity writ large.

(29:48):
And this is where I seetremendous opportunity because
and I know some of the earlystage biotechs that are
listening might be going, yeah,but that's like down the road.
I'm an early stage biotech Likehow important is this for me?
And I would say look, byengaging patients early and

(30:11):
often, because it's an iterativeprocess, you're going to
heighten your possibilities ofdesigning better drugs, running
smarter trials, building trustand differentiation and
ultimately accelerating marketaccess and adoption.
So you know, the patientcentricity piece as a trend for

(30:35):
me is hugely important because Ithink, done well, that can be a
game changer, and I think thatthere's, even in this rather
interesting climate in which wefind ourselves in the US and
elsewhere.
Quite honestly, I think there'san appetite for listening to

(30:56):
patients in ways that we haven'thistorically, and I think that
for those companies that do itwell, it holds tremendous
promise.

Ben Comer (31:06):
Do you think that technology is playing a role in
helping to improve this?
You know patient, real,patient-centered research
approach.
Obviously there's you, there'sthe ePro that's been out now for
a few years electronicpatient-reported outcomes.
I wonder if you have a sense,rob, of if more companies are

(31:27):
starting to incorporate thatinto their trials, if you're
seeing any sort of trend.
I hope that's moving up, uptoward more.
I don't know, though.
I mean, what are you seeing interms of how patient-centered
research is being conducted inthe context of a clinical trial,
and whether you know there isemerging technology that can

(31:51):
help with that?

Rob Abbott (31:53):
So I think I would say maybe five things.
I think that, yes, overall, thearrow is pointing upward in
terms of increased awareness,understanding and use dare I say

(32:14):
, if that's the right word forpatient-centered research and
patient-centered work.
And the five things I wanted tohighlight would be validating
unmet need.
This is especially prevalent inrare diseases, because patients
define success often, anywayyou know, quite differently than

(32:38):
regulators or physicians, andso validating unmet need is one
important area that we'reactually seeing, you know,
change around Informing, targetproduct profiles and development
strategies.
So what features matter most toa patient, you know, is it the

(32:59):
mode of administration?
So it makes you know.
Ultimately, you need to knowwhether this injectable drug
that you're working on isactually going to matter to the
patient.
If the patient actually prefersa pill, that's a problem, and
you want to hear about thatearly.
That's a problem and you wantto hear about that early.
And the same would be true for,you know, frequency of dosage,

(33:27):
tolerability, that sort of thing.
So you know, informing TPPs anddevelopment strategy is a sort
of second area in whichpatient-centered engagement is
starting to change.
Of course, enhancing clinicaltrial design.
Are there barriers toparticipation?
Are we articulating meaningfulendpoints?
You know, are we seeing, youknow, patient-reported outcomes

(33:48):
that are truly, you know,meaningful and material.
You know building trust and Iwould say building trust and
possibly even building, you know, advocacy and advocates,
because patients, alongsidetheir experience and their
expertise, you know, if you canget patients advocating on

(34:11):
behalf of your product,advocating on behalf of your
company, I mean that's gold andthat's gold to the company.
I mean that's gold and that'sgold to the company, it's gold
to prospective investors andpartners.
You know.
And then, ultimately, you know,I think patient engagement, you
know, is very actively linkedto, you know, what I would

(34:35):
broadly characterize as payerand HTA engagement.
So you know, how do we actuallydo this and what are we seeing?
Well, I think what I'mobserving is that you know
patient advisory boards,qualitative work, and that can
include one-on-one interviewswith individual patients or

(34:55):
patient groups, surveys andsocial listening sessions,
protocol design.
These are all things that arehappening now and the sort of
how to do it piece is, again,you have to start early and, by

(35:17):
the way, I spoke to an investorlast year and you know, his
company, you know, does notinvest in companies that are not
actively engaging patients.
You know, at that early stage,because it's really a signal, I

(35:37):
think, of the attitude andapproach that the company itself
has.
Like.
If you, you know, if you placethe patient truly at the center
of what you're doing, thenyou're going to engage them
early to help shape thetrajectory of the drug or the
product that you're developing,and being respectful in terms of

(35:59):
hey, you know, are youcompensating, you know, patients
for their participation?
Are you creating multiplepathways for them to participate
?
And also, you have to as acompany.
You have to realize that youknow patient engagement is an
iterative process.
This is not a check the boxOkay, I spoke to these patients

(36:24):
at you know this stage and we'redone.
No, you circle back and youwant to be targeted as well,
like, you really want to bethinking, and this comes back to
thinking about this in astrategic business context.
You want to come back to, okay,what is the burden of disease,
what are the endpoints, what isthe usability of the drug or the

(36:46):
device and so forth.
How do patients perceive this?
So you know, again, there'sjust an element of how aware am
I as an early stage biotech orlate stage biotech for that
matter how aware am I of you?

(37:08):
Know who my customer quoteunquote ultimately is.
You know, that's the populationI need to be in communication
with.

Ben Comer (37:16):
Right, that's the population.
I need to be in communicationwith Right.
I want to ask a question beforewe move on on real world
evidence, which is not a newidea.
It's been around for a numberof years now and I remember a
time period it's probably beenfive or six years ago where
there was a lot of excitementabout anonymizing patient data.

(37:36):
You know from big healthinsurers Optum, for example,
created a group where they had,you know, millions and millions
of patient records based onclaims data and the idea was,
you know, this is going to openup a brand new area of research
where we can really understand,you know, not just the safety
and efficacy of a drug but, youknow, a patient with a

(37:57):
comorbidity and how this drug isgoing to impact them.
All these different thingsoutside of a traditional
clinical trial could potentiallybe gleaned by doing deep
analysis on things like claimsdata.
I'm just I'm curious to getyour thoughts, rob, on kind of
the state of real world evidenceright now.

(38:19):
You know it's easy to imaginethat AI could absolutely
revolutionize the use of realworld evidence by making the
analysis.
You know, maybe, some of theways that it's being used now,
how it's changed, I guess, inthe last few years.

Rob Abbott (39:12):
OK, so that that's a , that's a PhD.
I can respond from a, let's say, of the world's leading experts
on real-world evidence,particularly in the context of
healthcare decision-making.
So rest assured that if there'sa nuanced question about
real-world evidence, you know wehave within our membership, you
know the people that can answerthat question.

(39:33):
This also, by the way, allowsme to put a plug in for the fact
that you know, ispor isactually convening a real world
evidence summit later this monthin Tokyo, actually because of
the importance of real worldevidence within the Asia Pacific
region.
So I think that real worldevidence has been very, very

(39:58):
consistently in the top threetrends that we have been
tracking for many, many yearsnow as part of our top 10 trends
work.
I think it's important forlisteners to note that we
actually, at ISPOR, release atop 10 trends report every two
years, release a top 10 trendsreport every two years, and, for

(40:22):
several iterations now, realworld evidence has been in the
top three, and I think that's areflection of the fact that,
okay, the clinical trial givesus critical insights in terms of
the efficacy of a drug, andthat's fundamental in terms of
ultimate approval and, you know,access to the market.

(40:43):
Real world evidence, though, isthe backbone of the outcomes
research piece of HEOR.
We actually, with very clearintention, get the patient
experience, whether that'sthrough electronic health
records, whether that's throughpatient-reported outcomes,

(41:04):
whether that's throughindividual interviews and so
forth, and so I would sayreal-world evidence needs to be,
and be seen to be, as importantas the outcomes of the clinical

(41:29):
trial itself.
At a minimum, it needs islikely going to be alongside AI
and patient-centered research.
This is something that's goingto be with us and viewed with
increasing importance over thenext five to 10 years.

Ben Comer (41:53):
Great, I want to move on.
I have a question about healthtechnology assessment, rob, you
know you've worked at thenonprofit health technology
assessment international.
Does not, you know, considerHTA, or doesn't have a

(42:21):
formalized HTA program, as acomponent of drug approval or of
decision making generally?
But we have seen in recentyears private insurers, you know
, increasingly using HTA likeinformation to make coverage
decisions, you know,collaborating in some cases with
groups like ICER, the Institutefor Clinical and Economic
Review.
My question is do you think,rob, that that FDA or CMS, in

(42:46):
the context of Medicare andMedicaid, should consider
formally adopting an HTAframework, underscored, of
course, by the quality, thequality adjusted life year, what
, what are your thoughts there?

Rob Abbott (42:59):
So that's, that's a.
On the one hand, that's a greatquestion, ben.
It's also, you know, a loadedquestion, because I know that,
you know, many of my colleagueshave very strong opinions on
this, you know.
I think I would say thefollowing and it is important, I
suppose, to acknowledge whatthe FDA's current remit is, and

(43:26):
the reality is that you knowthat current remit really
doesn't extend into theevaluation of quality.

Ben Comer (43:39):
I mean, it's very much centered around efficacy or
cost.
It doesn't talk you know theFDA does not talk about cost or
economics right.

Rob Abbott (43:47):
What I would suggest , and you know it's become a
very live and importantconversation, especially, as you
know, the US administration hastalked about international
reference pricing and a host ofother approaches to drug pricing
and I think, in the wake of theexecutive order, in particular

(44:09):
that came out in May aroundreference pricing, you know some
of my colleagues have said look, there are probably better
approaches that could be taken,and that's where HTA has started
to emerge as a you know,perspective, you know option.
I think what I would say isthat, you know, historically the

(44:31):
United States has notnecessarily been friendly, you
know, towards the concept of HTAfor a number of reasons.
We don't necessarily need todebate those reasons right now.
I think that there's a renewedinterest in what this could look
like and I'm glad you mentionedour friends at ICER because I
think they would say well, we'rekind of doing this.

(44:54):
And I think that that's a goodplatform and a good place to
begin, because what I wouldsuggest is that the FDA and CMS,
you know, would benefit fromcloser collaboration with HTA

(45:15):
and payer bodies, with HTA andpayer bodies, better alignment
on data needs and promotion ofvalue-based evidence generation.
And that can happen, you know,without any change to the, you
know, remit of the FDA and CMS,like that can happen right now.
So I think what I would, youknow, what I would, you know,

(45:36):
suggest is that, rather thanjumping straight to you know,
the FDA should formally adopt.
Or, you know, I would just say,actually, you know, there's
room and space right now tocollaborate, you know, more
closely with HTA bodies andpayers and align around some

(46:01):
common gaps, and that then couldestablish a foundation for
further work that could be donedown the road, that could
conceivably lead to somethingmore formal.
I think that I would not wantto advocate, you know, an
immediate shift towards formaladoption.

Ben Comer (46:25):
Yeah, and I agree with you that we don't have
anywhere close to the time toget into the pros and cons of a
quality adjusted life year.
But I will just mention becauseICER ran into this I believe
has worked on their methodologyto try to improve it.
But just one example worked ontheir methodology to try to

(46:45):
improve it.
But just one example.
You know rare disease patientshave criticized, you know, the
quality adjusted life yearcalculation.
You know used by regulatorslike ICWIG in Germany or NICE,
the National Institute forHealth and Care Excellence in
England, which of courseprovides guidance, you know, on
drug coverage to the NationalHealth Service.
But rare disease patients, youknow, have said the QALY metric

(47:07):
doesn't adequately consider drugattributes that are meaningful
for patients.
Getting back to this, you knowpatient directed research.
So you know we won't debate theQALY.
But I will ask you, ask you rob, if you could describe ispore's
value flower and if this is akind of spin off of quality, if

(47:31):
it's similar to what icer'sdoing, or maybe just give kind
of an overview of what that is,if you would so I want to say
maybe a couple things here.

Rob Abbott (47:42):
Firstly, for your listeners, at the end of 2023
and into early 2024, ispordeveloped and released a new
strategy for the society as awhole.
It's our 2030 strategy, and I'mmentioning that because,

(48:05):
firstly, I'd like as many ofyour listeners as possible to go
to the ISPOR website and have alook at it.
But I'm also mentioning itbecause it really is anchored by
two goals.
One of those goals has a lot todo with ISPOR becoming, you
know, the trusted HEOR authoritythat is helping to shape health
policy globally.
You know, the trusted HEORauthority that is helping to

(48:41):
shape health policy globally.
The other goal has a lot to dowith value, and this is where
the value flower, I think, isimportant a particular way.
If you're an investor, youthink about value maybe in a
slightly different way, and ifyou're a patient, you think
about it in a very different wayas well.
The flower, you know itattempts to, you know, tease out

(49:07):
what are these dimensions ofvalue and from that perspective,
it's been, I think, anincredibly important
intellectual and pedagogiccontribution to the field In
practice.
You know, the reality is that,as health economists, we have
tended to think about valuequite narrowly and we know that

(49:30):
if we talk to patients or wetalk to, you know, people that
you know aren't currently apatient, you know we hear things
like well, what matters most tomy health is access to
affordable housing, access tonutritious food, social networks

(49:51):
and connection employment.
You know some prettyfoundational, fundamental things
.
And, again, you know, ourconception of health and our
conception of value in healthhas been much more narrowly
focused.
So it's been focused aroundquality, adjusted life years,
for instance, and what we'rewanting to do increasingly is

(50:13):
say well, wait a second, how dowe factor in some of these
things that patients and peopleand people are telling us matter
to them?
So the value flower, you know,is important and we are very
deliberately wanting to, youknow, undertake the work and
we're doing that right now atISPOR.

(50:34):
We're undertaking the work toexpand and broaden our
definition of value toexplicitly reference what is now
, I think, increasingly andpopularly referred to as whole
health.
So you know health beyond thepurely physical, and health you

(50:57):
know beyond simply the treatmentof a particular disease.

Ben Comer (51:03):
You mentioned the Real World Evidence Conference
coming up in Tokyo at the end ofthis month, but what else is on
your agenda?
Rob at ISPOR, you know what areyour top priorities for the
rest of this year and maybe thestart of next year.

Rob Abbott (51:18):
So I'm really, really excited about the fact
that we have our Europeanconference coming up very, very
shortly as well.
So we're in Tokyo at the end ofSeptember for a real world
evidence summit, and inmid-November we'll be in Glasgow
, scotland, for our annualEuropean conference.
And this is the important thingabout these conferences.

(51:42):
So we have an annual NorthAmerican conference and an
annual European conference.
At present, these are thelargest conferences in the
community together and welcome,you know, those that are new to

(52:08):
health economics.
Now comes research and new toISPOR.
But I think what excites memost, though, is that we're on a
journey right now where I thinkit's fair to say we've
acknowledged that for most ofits 30-year history, ispor was
focused on the definition of thefield and the articulation of

(52:31):
methods and so forth, and thatwas necessary.
Now, increasingly, we want todrive increased awareness, use
and impact of health economics.
Now comes research, and thatmeans we need to be stepping
into the policy arena in waysthat we haven't or haven't done

(52:51):
as much historically.
And that's what really excitesme, because, honestly, on the
back of every ISPOR businesscard, it says improving
healthcare decisions.
Well, the only way we're goingto improve health care decisions
is if we're actually engagingwith decision makers and
bringing our evidence to bearand helping they, in their

(53:16):
capacities, make better, moreinformed decisions grounded in
data and evidence, and, at thesame time, what really excites
me is the possibility to haveconversations like this and,
through you know, your listeners, you know, reach new audiences
and help them, you know, becomeaware of ISPOR firstly, and

(53:39):
hopefully to help themunderstand that, hey, I'm an
early stage biotech or I'm alate stage biotech and I have
questions about, you know, thevalue of my product and how I
communicate that value.
Well, this is where this is, orindeed seek to be acquired

(54:20):
having that impact on healthpolicy, but also having that
impact on stakeholders withinthe healthcare ecosystem.

Ben Comer (54:31):
Rob, we have covered a lot of topics during this hour
.
You've been a really good sportand I very much appreciate that
.
I know that this conversationis going to be valuable the
operative word for thisconversation to our listeners.
You've already given some, Ithink, excellent advice, but I
just want to maybe end with arethere any final messages that

(54:56):
you would like to leave with ourlisteners?
Thinking of startups, earlystage companies who are looking
for ways to grow their businessand get medicines excuse me to
the patients that need them.

Rob Abbott (55:09):
So thank you, ben.
It's been a real pleasure forme to be part of this
conversation and I would say tothe early stage companies
especially, you heard me say itearly in the conversation so
I'll bookend it now.
You know, think beyond theapproval.
You know there's a real, youknow, adoption reimbursement and

(55:49):
that flow of return.
So that's one thing.
The other thing is that Ireally want you know listeners
to understand that healtheconomics now comes.
Research can, which can sound orappear to be a rather dry and
arcane topic, but this isultimately about how we deliver

(56:11):
a greater patient experience.
You know, all of us have beenpatients or will be patients at
some point in our lives.
All of us know people that arepatients or will be patients,
and so it's in our self-interestto improve the healthcare
system to the best of ourabilities and make it accessible
so it's there when we need it.

(56:32):
Make it effective so weactually get what we need.
Make it efficient.
Hey, I'm an economist, you knowI look for efficiency, you know
, but I also care passionatelyabout affordability, and so you
know what ISPOR is continuallyanimated by is this quest for

(56:53):
accessibility, effectiveness,efficiency and affordability.
And we're a big tent and I wantto make that tent bigger.
So anyone who's listening youknow I want them to know that
the door is always open at ISPORand I welcome anyone that wants
to reach out to me or any of mystaff to learn more about ISPOR

(57:16):
and health economics when itcomes to research.

Ben Comer (57:19):
Thank you so much for being here.

Rob Abbott (57:20):
It's been a real pleasure, ben, thank you for
having me.

Ben Comer (57:24):
We've been speaking with Rob Abbott, ceo at Ispor.
I'm Ben Comer and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts and be
sure to check out new weeklyvideocasts of these
conversations every Monday underthe Business of Biotech tab at
Life Science Leader.
We'll see you next week andthanks, as always, for listening

(57:45):
.
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