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September 10, 2025 54 mins

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Why Operational Excellence is Biopharma’s Next Competitive Advantage

In this special cofounder episode of Lean by Design, Oscar Gonzalez and Lawrence Wong pull back the curtain on the ideas behind Oscar’s upcoming book—and the operational realities that inspired it.

The core message? The biggest risks in biopharma often don’t come from the science. They come from fragile systems, tribal knowledge, and disconnected processes that silently slow teams down or bring them to a grinding halt.

With over 30 years of combined experience spanning R&D, clinical ops, and facilities management, Oscar and Lawrence unpack:

  • Why innovation collapses without operational infrastructure
  • How legacy behaviors and workflow inconsistency compound into massive risk
  • What “owning a process” really means—and why most orgs get it wrong
  • How early-stage companies fall into the trap of ad hoc systems and band-aid solutions
  • Why consistency and connectivity—not heroics—are the foundation for scalable success

Plus, they preview the framework at the heart of Oscar’s forthcoming book: a practical guide for process owners, system stewards, and leaders ready to build resilient operations without boiling the ocean.

If you’ve ever tried to fix a broken workflow while juggling 10 others, or wondered why your cross-functional projects keep stalling—this episode is for you!

Join the book waitlist: https://sigmalabconsulting.fillout.com/t/cjWN43iBNWus

Learn more about us by visiting: https://sigmalabconsulting.com/

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Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
We're back with an episode of Lean by Design
podcast.
I'm your host, oscar Gonzalez,alongside my co-host, lawrence
Wong.
Today we have a special topicthat we wanted to discuss with
folks, and that is that we arecontinuing to evolve our
understanding of what it meansto lead with operational

(00:20):
excellence, lead with curiosity,innovate in our operations and
expose the risk that is withinthe biopharma space and other
complex industries.
This has been something thathas really moved our business
model to where it is today.
It's how we started.
We initially started reallyleaning into no pun intended the

(00:42):
Lean Six Sigma space to reallysolve and reconcile these
challenges that are just ever soplentiful in the biopharma
space, and it led us to a momentin our journey where we needed
to write these things down.
We needed to codify the thingsthat we're seeing, and how are

(01:03):
we using those insights as aconsultant to deliver
transformative solutions to ourclients?
For the last couple of months, Ihave been working on a book.
This book is really theperspective from the last 15
years of my experience as a wetlab, as a bench lab worker,

(01:26):
running a lab manager, goinginto program management, into
the clinical space, becoming anentrepreneur and a consultant.
It's really culminating nowinto this structured book.
And I emphasize structurebecause a lot of times there are
things that we see and we can'tquite put a finger on why these
things are important, how theyaffect us in the workplace.

(01:49):
You know business decisions andeven more technical decisions.
How are they all connected?
Why do some companies flourishand others struggle?
And it's not always about thescience, it's about how well you
can manage the operations as abusiness, Because at the end of
the day, these organizations arebusinesses.

(02:11):
You are developing a product ora service, and so when we
understand those and we considerthose deeply into how we
structure our organization, fromthe data we're producing to how
we're going to govern ourselves, to the language that we use to

(02:33):
describe what we do at theorganization, and how it's all
connected from function tofunction.
We know in today's day and agemost projects are incredibly
complex.
They require a number ofcross-functional representatives
that are very, very technicalin their work, and somehow we

(02:56):
need to connect that technicalwork into a strategy that
connects the strategy fromleadership into action.
That's where people struggle,that's where those things are
left unclear and sort of havethese trickle-down effects.
So that's what this bookrepresents and today we're going
to talk a little bit about thatand that journey.

(03:18):
Lawrence has been a part of itand has been an advocate for me
to put these things down onpaper because it felt so clear
in the moment.
It felt so crystallized but itwas all in my head.
I had no chart to explain it, Ihad no figure.
I had some white papers andresearch and things like that
that were available, althoughwhen you peel back an onion, a

(03:42):
lot of that really nasty stuffyou don't tend to see written
and publicized on the Internet.
So it makes it challenging tofind out what are people really
feeling.
And I think when readers fromthe entry level or new to the
industry, to mid-level managers,to leadership, I think they're
going to read the book andthey're going to look at the

(04:03):
examples and look at the casestudies and say, yeah, I've
experienced a lot of thosethings and hopefully it will
empower folks to go a stepfurther and say I want to change
something.
So I don't want to go too deepinto there because it might just
be a monologue and this isintended to be a conversation

(04:25):
about that journey.

Speaker 2 (04:27):
So here we are.
One of the early things that wehad talked about, when you were
on the way to thinking abouteven deciding to go down this
road of writing a book, was doessomething like this already
exist and we have spent so longjust searching for something
that it's a blend of yourexperience in the industry, but

(04:49):
also all the mistakes thatyou've made.
And then we want to sprinkle insome of these lean concepts,
but we also want to add somerisk management in there.
But then you want to alsodiscuss you know what the world
is today, in 2025, as opposed tosome of these other you know,
very generic, I would saybusiness management books that
don't really give you thatinsight on some of the things

(05:11):
that we've both felt in workingin this industry.
Right, and so the book isreally a piece of art that has
combined a lot of thesedifferent sources of information
and, like you said before,we're still in the process of
transforming our businessbecause we've gone down this

(05:31):
road of your, you know,developing the book and that's
going to be something thateverybody's going to be able to
witness at the beginning of nextyear when we roll out some of
these products.
But, you know, let's go back totalking about the book itself
and before we even talk aboutthe idea of the book, what does
writing a book mean to youpersonally, and how were you

(05:53):
hesitant at first, Like what waskind of going through your mind
when you decided to do this?

Speaker 1 (05:58):
Of course I was hesitant.
Are you kidding me?
A book is revealing.
You are putting your brain, theway you think, how you feel, in
a nonfiction book.
You are putting it all outthere for anyone to essentially
discredit, to agree with, tocriticize.
So there's always this impostersyndrome and that's just a

(06:20):
factor of this or that.
Well, you know there's a partof it that makes you question
yourself because in this sense,things feel very clear to you
and that is a factor of all ofyour experiences where I've seen
this game before.
I've seen how this plays out.
I know that kind of employee, Iknow that kind of leader, and

(06:42):
so when you write those into abook, you start to ask yourself
sometimes am I the only one thatthinks this way?
Am I the only one thatrecognizes these challenges?
Am I the only one that believesthat this is the path forward?
Sometimes we can't see it and Ithink a lot of times you'll see
that folks are reluctant totake on a task like that.

(07:04):
It didn't always start that way.
There's a lot of high energygoing into the type of work that
led into creating a book likethis.
It's such a journey and we'reused to doing social media
content, little blurbs, eitheropinion, or we take some data
that was brought in and we putour thoughts on it and those
things are pockets of knowledgethat we're putting into there,

(07:26):
and what this book is is anentire framework it's for
successful operations inbiopharma and other complex
industries.
What are those real core thingsthat you need to put your
finger on and where are thosestruggles most often happening?
So, when it came into writingthe book, I'm using book
launchers who help youself-publish, founded by Julie

(07:50):
Broad, who's fantastic.
She has tons of videos onYouTube on tips and tricks in
self-publishing and they havebeen really a source to help me
pull even more out what I hadturned into.
Them was so surface level and Ididn't realize it.
I thought, man, I have a bookright here, and as soon as they

(08:10):
told me, yeah, you're going towant to end up with I believe it
was somewhere between like 30and 50, 60,000 words, and I
turned in about 10,000 words andI thought that was all that I
have, and so there was thismoment of do I even have enough

(08:31):
to say about this?
But of course, I had to add incase studies, I have to add in
more details and these thingsare a little bit tough.
So when the book becomespublished and people start to
read these stories, just knowthat I, reading the editing that
we're going through right nowmy body has visceral responses,

(08:51):
I have goosebumps or my heartstarts racing, because these
were crazy moments that Ithought is this really biopharma
?
Is this really what's happening?
But there's so many things thatlead up to the complexity in
biopharma and other industriesthat it's really difficult to
innovate your operations whenyour focus is on the data-driven

(09:15):
science, on thatexperimentation, on that R&D
that is the source of all ofyour capital coming from venture
firms, coming from angelinvestors.
They're not doing it becauseyou know how to run a good
business.
They're doing it because youhave a stellar idea that is
novel, innovative, et cetera.
But when we don't pay attentionto the operations, we can't

(09:40):
tell the story, we can't managethe business, we can't manage
our resources.
And then what happens?
Well, you tell the story.
We can't manage the business,we can't manage our resources
and then what happens?

Speaker 2 (09:48):
Well, you know the story, so let's dive into the
book.
So you talked a lot about R&Dand how it's other complex
industries.
As somebody who's within theindustry and they are working in
this space how should theyframe the ideas within this book
?
Is it more so?
This is how your company shouldbe structured.

(10:09):
This is how you should bemaking decisions.
This is how I should be hiringcertain departments.
What is the intended use of abook like this?
Is it like a textbook, whereit's very prescriptive, or more
of a reference manual where,like here are some examples?
And this is some of the thingsyou might want to think about as
you're going about making somedecision related to X?

(10:29):
Right, you know, I think that'sgoing to help a lot of our
audience and future readers geta sense of who this is really
intended for and how they shouldbe using it.

Speaker 1 (10:38):
That's a great question.
So there's a couple of layersin the book related to the
things that you're talking about.
It's not going to be aprescription.
It's not going to tell youthese are the things that you
need to do.
If you want to do that, justuse any AI system and say, hey,
give me ideas on how I can do X,and it's going to give you very
valid ideas.

(10:59):
I think how well you canexecute those ideas is a direct
reflection on whether or notit's going to work.
Now, the underlying theme behindall of the major components
that I discuss and go deep intois this idea of systems thinking
.
So to position yourself to readthis book and this book is

(11:20):
intended to be a referencemanual, sort of a pocket guide
so you can read it on throughand then I hope that you can
come back later and say let merevisit this chapter, let me
take a look at this frameworkand understand those first
principles so that I can applythose here into the things that

(11:41):
I'm doing, let me understand theshared themes a little bit more
and make sure that I'm doingthat internally.
So there's a couple ofdifferent spaces in here and I'm
sure we'll have some call-outboxes and stuff like that.
That'll be really impactful forthe reader to quickly reference
.
The reason why I bring upsystems thinking is because this
isn't just an idea that asingle person can just push on

(12:05):
through without any involvementof anybody else.
It requires everyone, and whenI say everyone, it could be your
team, your department or yourfunction, everyone eventually in
your organization.
The idea behind thinking thatbiopharma and these other
complex industries are all partof a system In order for the

(12:31):
organization, the business, toprogress, it's not just the
science, it's everything else aswell.
It's how well you can manageyour budget, the resources,
external vendors, many smallerR&D.
They're going to focus on thetalent that can directly impact
in-house.
However, you will find fromearly R&D through mid-stage,

(12:55):
through late stage, you're goingto need other expertise that
does not exist at yourorganization and you may only
need them for a short period oftime.
So, in lieu of hiring afull-time employee that might
cost you $200,000, you're goingto go get a vendor.
Now how well you can manage thevendor to either provide
technical expertise as aconsultant or animal model

(13:18):
husbandry, experimentation thatuses equipment that you do not
have in-house, implementationthat uses equipment that you do
not have in-house, how well youcan plan that, coordinate that,
manage the budget, communicatethe budget back to the team and
the project managers,communicate the right expenses
to finance, to create theseprojected views of your

(13:40):
resources, of who's beinginvolved.
How much headcount is beingrequired in each of these spaces
.
These are all critical to howsuccessful the organization is
going to be.
It's not just about the science.
You still have to connect allthe other pieces and I want to
emphasize from this book withsystems thinking is that your

(14:04):
data, your work product,whatever you do in your job,
whether it's processingpaperwork, doing experimentation
, creating presentations,whatever it is you do, your work
product is critical forleadership to make decisions.
It may not be the thing rightbefore they make the decision,

(14:28):
but it is somewhere in thatchain of events.
Perhaps you get raw data andyou have to analyze it.
Well, you have to make surethat analysis has a good handoff
to the person who's going to bepresenting it, because you're
not a part of that team meetingor you're not a part of that
governance meeting.
The central theme in this entirebook is connectivity, is that

(14:52):
these things need to movetogether, and it's rare to find
especially early companies thatare growing at the same pace
along their departments.
You know you'll hire somebodyand say, okay, now you're VP, I
want you to create this groupand go off and do it, but you
never talk about the data.
How are you going to connect it?
Who are going to be thestakeholders in your workflows?

(15:14):
Find out what the company isdoing already.
What are the tools you're using?
Who are the subject matterexperts?
How are you describing theprojects as they move through?
How are you connecting the rawdata of an experiment that has a
cost, that has a personassociated with performing it,
that has an analysis timeframe?

(15:38):
Back to the timeline, back tothe project manager, back to
leadership, so that they canmake the most informed decisions
informed, data-driven decisions, not just using data, but
creating context to that data.
That is what the central themeof this book is about.

Speaker 2 (15:59):
Yeah, and as you were talking, it reminded me and I'm
going to use an analogy toreally simplify some of the
things that you just mentionedis it almost sounds like you
were talking.
It reminded me and I'm going touse an analogy to really
simplify some of the things thatyou just mentioned is it almost
sounds like you were like anycompany.
You know, when you start outsmaller, even when you're really
big, it's essentially a smallvillage or a large city and you
have all these differentbuildings and different people
interacting with each other, butyou really have to establish

(16:22):
certain roadways right for thisflow of information to get
anywhere, and so it's mucheasier to construct and, you
know, tear down a building thanit is to rebuild a road, because
once you build the road there,it's kind of there, and so it
sounds like the book is reallyit's not going to give you
specific answers on this is howyou should build the road.

(16:44):
It sounds like it's more.
These are the questions youshould be asking before you go
about setting those things up toconnect certain systems and
people and processes together,if I get that right.

Speaker 1 (16:56):
That's exactly right.
You know, this book is notdesigned to be the one solution
that you can buy and it's goingto prescribe to you how you're
supposed to be going through it.
Because, guess what, everyorganization is different.
If you're in agri-tech and youare developing for specific

(17:19):
crops that grow in your region,in your state, your regulations
are going to be different.
The people state like yourregulations are going to be
different.
The people that are on yourteam are going to be different.
The functions that you have aregoing to be different, but
there are core components ofthat organization as a complex
industry that requirescross-functional technical

(17:42):
expertise, that requires deepstrategic initiatives, that
requires very complex equipmentand all has to be manufactured
or produced according toregulations.
These are things that make themcomplex, make biopharma complex
, but there are core functionsand spaces that you need to run,

(18:05):
that you need in order to run asuccessful business.
So what this talks about is howyou should be connecting those
spaces and what they look likeand what happens when you don't.
What happens when youdisconnect them, the amount of
time people spend, the errorsthat you find, the lag, that you

(18:26):
have weeks to make a simpledecision that should have been
done right from the onset.
So, again, I hope that thisbook helps people pause and
reflect and start to askquestions.
That's where all of this started.
I couldn't stop askingquestions why are we doing it

(18:47):
this way?
Do we have to do it like that?
Is there another way that wecan do it, where it's faster?
But maybe we can only do somany per week?
Or anything related to changinghow things were done when those
things led to friction points.
You know, what we're trying todo is establish a map, and the

(19:08):
map for Moderna looks differentthan Novartis, looks different
than Amgen, looks different thanVertex, looks different than
J&J.
Everybody has a different map,but I guarantee you they all
have R&D, they have businessfunctions, they have legal teams
, they have finance teams, theyhave projects with project

(19:29):
managers and they have technicalstaff.
All these things are universalacross the board.
We're trying to show them howto build their map to make their
organization successful andreduce the exposed risk that
their operations are posing.

Speaker 2 (19:47):
I love the idea that you know this is really meant to
raise questions about howpeople are thinking, about how
their departments are structuredor how their processes are set
up or how their workflows aredesigned, and it really speaks
to you know.
There's not a right answer forany of this right, and the idea
is you should be questioning howthings are set up so that you

(20:10):
can improve it, because I thinkearly on, especially when you're
new to the industry, you comein and you think that, oh yeah,
somebody put a lot of thoughtinto building this thing and
this makes complete sense.
And then you quickly realizethat that's bullshit and that is

(20:31):
not how things are set up.
And people are in and out ofcompanies pretty frequently
within our industry and it'salways like we have a running
joke that it's a very incestualbecause people go from one
company to the other and peopletend to know each other, so they
build a lot of the same thingsand when that happens, you have
a lot of similar problems acrossthe board.
But I think what makes it uniqueis that we obviously have a
very diverse set of businessconstraints, depending on the

(20:54):
company and their portfolio andwhat your budget is going
through and the people that areinvolved.
So it gets very messy in thatsense, no-transcript flow of my

(21:37):
data, or how my departmentshould be connected, or some of
the risks involved with makingcertain decisions.
Right?
How do you, you know, play withthat idea of we're looking at,
obviously, a lot of verydistinct departments and,
depending on the company, right,they're at different stages of
development, right?
So you'll have companies thatare maybe more early stage and

(22:00):
they have a, let's say, a lessmature portfolio, but then you
have other companies that have amassive portfolio, they have
huge groups of departments.
Is the questions going tochange depending on the context
of these companies and wherethey are?
And, if so, like how do wethink about standardizing the,

(22:24):
the questions or the, thethought process behind how those
things are built?
Right, this is a very loadedquestion because it introduces
this, this and this concept thatwe've been toying around with
randomness.
Right, like we don't wantcertain strategies to only work
because it's a very specificenvironment, some of these
things are that are coming outof the book.

(22:44):
They're applicable to bothsides, whether you're a large
company, a small company, ifyou're early or late stage
development, but you have tolook at it from a different lens
that people are typically usedto.
So I think, to no surprise,people in our industry are very
siloed and chances are if youwork in R&D, you're probably

(23:06):
going to stay in R&D and chancesare if you work in
manufacturing, you're going tostay in manufacturing, right?
So it may be very foreign topeople to understand.
You guys deal with the sameissues, but you really have to
understand how things are laidout to be able to ask those
questions that you're bringingup.

Speaker 1 (23:22):
Yeah, there's a lot into what you're asking there.
If we take a step back and wesay what are the questions?
That sort of ignore thefacility itself, whether it's a
business facility where a lot offolks are working on their
computers with a little bit ofscience, a laboratory here or
there, or a large manufacturingfacility that is 40,000 square

(23:45):
foot with tanks and valves andall these different things to
measure output, in one case youhave something that's very
discreet.
You have something that willsay oh, here's an issue, the
valve is detecting a pressurethat's too high or it's too hot
or it's too cold.
Those are going to be verydiscreet, very easy to say hey,
here's a problem.
Earlier in the process and I'musing process that's actually

(24:09):
going to roll into my responsehere there are more fluid
processes that are developed atorganizations.
Whoever comes into the role orto the position gets to decide
how those things are going to bedone.
Often what happens is thatthose do not carry guardrails.
So that's where you start tocreate these really big forks.

(24:31):
And how things are done at theorganization.
Oh, we have nine differentsoftwares that all manage a
timeline and those people justuse Microsoft Word, those people
use Excel, those people useSmartsheet, those people use
Trello, that one uses Notion Imean, you can just name it, it's
all over.
It's important and critical forus to have those guardrails.

(24:53):
I think that you see more oftenin manufacturing and facilities
.
You have to have the rightpermitting certifications and
all of that requires very finite, discrete measures across the
build, the transfer, the handoffand the functioning of those
spaces.
When you're earlier non-clinicalin your preclinical work, you

(25:15):
can set things up however youwant.
However you think that abusiness should be ran Now, in
many cases we're bringing folksthat are industry veterans
Doesn't necessarily mean they'vebuilt a business before, right.
So what do they do?
They hire another industryveteran to come in and say, okay
, you've done this over here, wewant you to do it here.
But building from the ground upand keeping something status

(25:38):
quo are two very differentthings.
In a lot of cases, when you gointo these smaller organizations
, there is nothing set up.
You have to do it.
So how do you balance buildingup the guardrails of the
business while trying to pushand pursue the science?
That is the reason why you got$200 million in your Series A.

(26:00):
You know some ungodly amount ofmoney to do science, not to
build the business.
So there's a little play therethat you have to consider at the
organization.
But I think when we gospecifically into what questions
we want to ask in thatframework, we initially came up

(26:21):
with sort of this trio.
There's nothing reallydifferent than what other folks
do.
Mckinsey has a 7S, lean, sixSigma, have a number of
principles and theories thatthey add into there to help
guide you into that, into Lean,reducing Waste, and Six Sigma,
which is mostly on yourconsistency, like how consistent
can you be within given margins?

(26:41):
In this case we saw threedistinct areas detect and
diagnose, contain and simplify,fortify and adopt.

Speaker 2 (26:50):
Yeah, I remember now We've played around with so many
different frameworks and tryingto find something that fits and
then we realized none of thesefit and there's a reason why
nobody widely adopts them,because they don't make sense
for what we're using it for.

Speaker 1 (27:05):
I think what became evident is you want to figure
out what the problem is, so youwant to be able to diagnose the
issue.
What we end up findingoftentimes is that people are
looking to reconcile symptoms asopposed to the problem.
Oh, this happened, so let's fixthat.
Well, the problem justmanifested here, but it started

(27:26):
two months ago at this part ofthe process, very hard to see
when you don't have a processmapped out, when you don't have
a centralized space that tellsyou this is what we're supposed
to do.
You may say we have so manyprocesses, how do we get moving?
How do we get started?
Focus on the things that areactually going to move your

(27:46):
needle.
Don't focus on the process thatreally does not impact.
You know that blast radius isso small.
Don't focus on things like that.
Focus on things that are.
You know you're budgeting.
How much of a pain is budgetingat the organization when you're
trying to get cross-functionalnumbers that everybody has their

(28:07):
own way of managing vendors.
Everybody has their own way ofmaintaining a log.
Some people don't even maintaina log, so they have to go back
to their emails and look at letme see when payments were made
in order to give them anaccurate number.
That's just a lot of work, andguess what it's going to happen
next year and the year after andthe year after.
When you see something likethat, it really is presenting

(28:30):
you the opportunity to createsomething concrete that
eliminates that burden of everyyear.
We have two months where we'retrying to create a budget, to
modify the budget, to understandthe budget.
There's a cadence that I talkabout.
But let's go back to those threestages the detect and diagnose,
contain, simplify and fortifyand adopt that first area of

(28:54):
detect and diagnose.
You have to first detect thatthere's a problem.
If everyone is walking aroundacting like everything is good,
no one is honest, everyone'slike yeah, you know, this is
fine, it's not perfect, butit'll do, but it is a core part
of their operations.
Now, what happens?
That person leaves and so doesthat Frankenstein process they

(29:17):
created in order to supplementthe bad process.
Oh, it's fine, because I justtake it here and I export it,
and then what I do is I transferit into here and then I use
this free version that's onlineand I take that data and then I
go back here and then I scrub it.
Okay, try to explain that tosomebody who is going to replace
that person when they leave.

(29:39):
It's unsustainable.
So you have to detect where theproblem is and understand what
is the impact of that problem.
How bad can it get?
How bad has it gotten?
You can detect an issue, but ifit's an annoyance at the moment
and you haven't really seenanything that severely impacts
the organization, maybe it's notsomething we're going to focus

(30:01):
on today.
You can't do everything at once.
You can't boil the ocean If youdon't know where to look.
Look at things that directlyaffect your company goals.
Ask somebody, try to find astrategy map.
Try to find some layer of thebusiness that your work directly
impacts, and then find allthose pieces in there.
What are the biggest issues inthis workflow?

(30:23):
And then you have an open bookto diagnose.
Okay, our problem is thisworkflow.
Why is this important?
Because it points to here, hereand here.
How often does it happen?
Once a quarter?
How long does it take One month?
How long should it take?
Seven days?
What's the issue behind it?

(30:45):
It's not about consolidatingdata more quickly.
It's about setting up yoursystems to answer those
questions.
You know, a lot of the times weget questions from leadership
and we have the data, but whathappens?
We'll get back to you.
We got to go back.
We have to pull out data, wehave to scrub it, we have to

(31:05):
translate it into like what itactually means outside of the
raw data.
There's all these things.
But these questions that we getfrom leadership a lot of times,
they're pretty common how long,how fast?
What does it mean?
Thumbs up, thumbs down.
They have 25, 30, 40 otherprojects.
Thumbs down they have 25, 30,40 other projects.

(31:29):
They don't need the down in thedirt details of everything that
you're doing.
Once you move from there, youneed to contain Something is
bleeding.
Stop the hemorrhaging, stop thechallenges that are happening
right now.
Contain that so that you're notfeeding this issue across the
organization.
Once you have that contained,you want to simplify your
approach.
What are we doing?

(31:50):
Why is it complicated?
Why is it not working?
Why is it unsuccessful?
And it might be the type offile that you're passing on.
It might be the handoffs.
We have cross-functional work.
It goes to one person, then itgoes to business operations, for
example.
You have to identify that,simplify that.
How do you improve something?

(32:10):
Make it easier, make it easierfor anybody to come into the
organization and to proceed withthat.
How do you make sure that thiscontinues, that this doesn't
revert back to what it was?
Fortifying and adoption arecritical, and I will tell you

(32:30):
this most of the failure happensat the end.
We get excited about creating asolution.
We get excited about we'redoing something new, we're doing
changes, and it takes time.
And then you get toward the endand you have to ensure adoption
.
What does that mean?
You got to get people intorooms.
You got to make sure that thereare trainings available, that

(32:54):
you are putting them on people'scalendars, that you are
becoming a vocal advocate forthe changes that have happened
in your workflow across theorganization.
These are opportunities.
These are opportunities forthose early entry, entry-level
workers.
They're going to see somethingfor the first time and that's a

(33:17):
beautiful perspective, becausethen you're going to scratch
your head and say, hmm, Ithought this would be cleaner
than this.
What are the constraints?
Why do we have to do it thisway?
Oh, okay, I see we have tochange file format at this stage
.
So we set it up a certain wayso it's easier.
Or maybe you don't.

(33:37):
Maybe that's the change.
Maybe you make earlierprocesses more adaptable to what
has to happen at the end, sothat you don't get to the end
and say, okay, now we have aweek to make this transfer of
stuff.
These are the things that we'retalking about, and it all ends
with the adoption.
Because no matter what we do,no matter what changes we make,

(33:59):
no matter what we can affect inthe moment, if you cannot get
the rest of the stakeholders,the organization leadership, in
it with you, it's going to belike trekking through mud.
You're going to struggle tohave people adopt it and you're
going to have folks that revertback to legacy stuff.
Habit is hard to break.

(34:19):
You are creating a new mindset,a new habit, a new
infrastructure, and it demandscontinuous attention so that the
people that come in thinkthat's the only way things are
being done.
Don't see this other terribleFrankenstein effort and the new

(34:40):
folks continue to get visibilityon how to do things most
efficiently to have the biggestimpact in their workflow.

Speaker 2 (34:52):
I think the adoption is definitely the most difficult
, because you have a lot ofhuman behavior changes that need
to go a certain way and youwant people to use the new thing
that you've built, becauseyou've invested so much time,
money and resources into thisnew way of working and obviously
, a ton of different strategiesabout how you do the adoption,
but the idea is that you want toleave it so that whoever is

(35:13):
coming in after can understandwhat has happened and also pick
up.
If the business decides tochange, which it always does, is
to allow the next person tocome in here and go okay, yeah,
we understand how this thing isdesigned and now we're going to
iterate on it.

Speaker 1 (35:29):
Right, you have a baseline.

Speaker 2 (35:31):
You have a baseline right.
We have too many things thathappen in our industry where the
baseline relies completely onan individual working at the
company and then, once thatindividual leaves, the whole
thing just falls over like ahouse of cards.
We repeatedly make this mistakeover and over and over again,
and you got to wonder why andwhy do people do this and why do

(35:52):
companies are set up this way,and I don't think it's
necessarily something that theyintend to do.
But, like you said, it's wherewe're all being asked to do so
many different things throughoutthe day, throughout our jobs,
and it's really this idea ofnobody has the time to step back
and reflect and take a look atis this sustainable?

(36:14):
Is this the right way to dothis?
And I think the questions thatyou're going to bring out in the
book are really going to helppeople do that self-reflection
and bring those questions out sothey can build something that
is more sustainable and moreuser-friendly to everybody
that's working with them.
Right?
I think the other part that youmentioned way in the beginning
was identifying the problems andbeing able to detect them, and

(36:38):
that is that is not simply hey,what does my manager think about
this?
Right, it's, it's there.
There should be a weightapplied to certain things
depending on the context of theproblem itself.
The problem itself and you knowthat's something that we're
actively trying to incorporatein this new product that we're

(36:59):
trying to build as well is tounderstand the context, just
like you've outlined in the book, and using that as a multiplier
, in a sense, to put weight oncertain risks for some of these
situations that our clients findthemselves in.
Obviously, there are a ton ofdifferent frameworks that can
assign numbers to certain thingsand give you a score like a

(37:21):
failure modes effects analysis.
Fmea will do that for you.
But I think what we're doing isa little bit different in that
it's not only scoring things.
It's actually there's a lot ofopen-ended questions that you're
asking in the book.
Right, that it gives that humanelement of it incorporated with
the scores itself, so that youcan really pinpoint how to not

(37:42):
only fix things.
But is this right, for the teamIs like are they going to adopt
this?
Like there's so many differentquestions that you have to ask
it's not simply a math problemwhere you go one plus one equals
two, but is so-and-so going tobe using this?
Like, whose life is this goingto make harder?
Does management have visibilityto decisions that need to be
made?
I think there are a lot ofdifferent questions that stem
from that approach, that toolsthat we've seen in the past just

(38:06):
don't do that.

Speaker 1 (38:08):
We have to also think about, like, who's going to be
owning it?
Like, when you own a process,these should be the things that
you own.
I think that there's a lot ofpeople out there that sort of
just like.
I want to, you know, come hereand do what I'm being paid to do
, and that's where we direct ourattention to.
You direct your attention tothe clinical trials that are
happening.

(38:28):
You direct your attention tothe R&D work that's happening,
and I think that's what we endup seeing is that the solutions
that we carry out are in themoment and that's it.
Oh, we're going to have a singlevideo call that goes over it.
There's no documentation thatgoes anywhere.
If there is a slide deck, theslide deck doesn't provide any

(38:52):
context at all.
It just says here's the datesthat we're going to be doing
certain things.
That's not a training.
That's not something thatsomebody can pick up and say, oh
, okay, so what's the templateto manage our purchase orders?
Oh, we don't have a template,you just do it on your own.
Okay, so what are the importantthings that I need to collect
on all my purchase orders or allmy vendors?

(39:14):
When you fail to outline thosethings, you have to expect very
different results across theboard.
In order for you to besuccessful with your
organization, there has to besome consistency for these very
critical data sets.
That are not the science, thatare your operations.
Everything we do, everythingyou touch, from the dates to the

(39:38):
person, to the experiment, tothe milestones, to the goals
that lead up to those milestonesall of those things are your
concrete operational data.
It's not just that you processso many samples, that you ran so
many experiments, that you ranso many iterations, it's also
the process.

(39:58):
It's also the hard-coded datathat is probably already in the
systems.
And that's the things.
Our systems of use LIMS, eln,project management I mean you
name it.
There's going to be a tag for adate, there's going to be names
in there, there's going to beprobably ID numbers that are

(40:19):
generated.
All of these things are usefulto connect to the broader system
, which is the organization.
I think what you were describingearlier is, in effect, being
given or being told hey, youhave a goal, now to fix
something, and that fix becomesa one-time point, a point in
time that I created a newtemplate and I'm going to share

(40:44):
it with folks and that's it.
Okay, how much impact did thathave?
Well, we do that once a year.
Okay, what is the plan for nextyear?
Are you going to share it amonth earlier?
Are you going to remind peopleabout it?
Or how does this work in themiddle?
You know, when we look at theseworkflows that are business
operations, uh, sort of centered, we focus so much on the very

(41:12):
beginning that we don't doreally any kind of training or
maintenance on.
Hey, let's make sure thateverybody is collecting the
information the right way,because it's not just having
these early processes, it's isyour data syncing.
How is the integrity of thedata?
Do the people that areresponsible for providing that

(41:32):
have the same way of producingand logging that information?
Probably not.
So what is that going to do?
It's just going to add moretime at the another part of the
workflow and they're going tosay we need to get faster at
doing that.
It's not getting faster, it'sgetting more consistent.
Your consistency will breedyour innovation.

(41:54):
When you get consistent acrossthe board, you turn the whole
company into a machine ofeveryone that actually knows
what they need to be doing andhow they're supposed to do it.

Speaker 2 (42:05):
It's interesting and this is something that we
haven't talked offline, but itjust reminded me that the
concept and the intention of thebook.
It almost seems like it's a howto guide for process owners in
our industry, given the contextof a business environment.
Right, because it's not justowning the process in your

(42:26):
little group, it's how does thisimpact the business overall?
And at least I have never seenthis, especially in this
industry is this is what itmeans to be a process owner?
I don't think I've ever seenthat.
I don't know if you've seenthat.
No, no.

Speaker 1 (42:42):
Usually a process owner becomes just the SME.
It's like one single personcannot execute this for a
company of 10,000 people yeah,this for a company of 10,000
people yeah.

Speaker 2 (42:54):
Yeah, process owner is, I think, something that is
more relevant, obviously in alldifferent aspects of biopharma,
but I think in R&D it meanssomething different than it
would mean in my world of whereyou have facilities, management
and labs and manufacturing.

(43:15):
I think the term that we use issystem owner right.
So I think that is also aconcept that has been just
loosely thrown around and Ithink it means something
different in each company.
But until we've standardizedwhat it actually means to own
the process to own a system, Ithink you're just going to get

(43:37):
very inconsistent behaviors andoutputs from people that have
that type of responsibility.

Speaker 1 (43:46):
We talk about that.
We talk about that in the bookand how, since the dawn of
technology, we have seen thatwe've had that uptick of IT
service and anything related toa system goes through IT.
Okay, who knows how to do thisbest IT?
Okay, who can train me on thisIT?
I'm sorry, it has their role,but you are the function that is

(44:10):
using this system as a core toyour work product.
You should be the SME, youshould be the system owner, you
should be the process owner andyou should be involved in how
other people train.
Because here's the issue,lawrence, that I see all the

(44:32):
time I go into a group and youhave one or two, you know two or
three rock stars working on asystem.
Everybody else is kind of okay.
And then you have another groupof people that are just
terrible at it, and this istheir role.
And then what do they say?
Oh, if anybody has anyquestions, just reach out.
No one is going to have thetime or the foresight to reach

(44:56):
out.
So this is part of the adoption.
I'm like when you hammeradoption, just schedule it,
schedule and say here's a timethat doesn't work.
Fine, if you have a problem,you need to come to me.
I am putting up very so manyopportunities for us to have
conversations.
The only time people want tolearn is when they have a

(45:16):
problem, and that's not right.
You should be learning toeliminate the issue of
troubleshooting any of yoursystems.

Speaker 2 (45:25):
Well, I haven't read the fully edited version of the
book yet, but I think we shouldadd in there what it means to be
a process owner.
It does not mean that you're anapplication owner, because
that's a different thing for ourIT partners that are
responsible for how the softwaregets distributed and licensed
permissions.
That's completely differentthan how people are engaging

(45:48):
with it day to day for their ownwork, right.
So we've kind of bounced arounda bit on this episode and
hopefully, if you're stilllistening, you're following us
as we close for the episode Um,what can people expect in the
coming months for thedevelopment of the book?
Like um, do you have a timelinethat you have in mind?

(46:09):
And if people are interested inthe book, how do they reach out
to you?
Is it just the email or is?
Is there something going to bedeveloped by the book company
itself to really take all ofthose interests?

Speaker 1 (46:23):
So there's a lot of exciting things that are
happening right now.
We are looking and sort ofaiming for a launch around
February, early 2026.
Right now, we are pretty deepinto the content editing.
We've already gotten the firstdraft out there.
It looks great.
Obviously, we're going to gothrough and make sure that the
language and everything is areally smooth read, and this is

(46:46):
intended to be more of aconversational read.
I want the reader to pick thisup and feel like they're having
a conversation, feel likethey're discussing these things
and in a way that lets themthink about challenges that
they're facing currently.
So we are planning to createsome bonus material that will be

(47:07):
coming out at various timesleading up to the launch.
We have a form for anyone whois interested now.
Sign up now so that you can getall of this bonus material,
from what the framework lookslike to tips and tricks, to
releasing a chapter early, too,so that people can get an idea

(47:27):
and get a feel for what'shappening.
So we'll put that in the shownotes.
If you reach out to my LinkedIn, oscar Gonzalez, there's a link
right there at the top of myprofile to get onto the book
waitlist.
That will also give you accessto the bonus and the marketing
material that's going to comeout from that.
But in the next couple of monthswe are continuing with editing,

(47:49):
planning how we're going totalk about the book and what
avenues we're going to be using.
We'll talk about it through thepodcast, talk about it in other
podcasts and then hopefullywe'll be designing the cover and
stuff.
So there's some exciting thingsthat are coming that even I
don't even know what it's goingto look like.
You know, from the spine of thebook to the front, to the back,

(48:09):
things that esteemed folks aregoing to be contributing to that
.
But we are in a space now thatthe majority of the content is
in there.
So we'll be doing more design,not just the framework, but
we're going to be deconstructingthe framework and posing that
as images in different spaces sothat it can kind of slow people

(48:32):
down and say, okay, here arethe different areas and how they
connect to all the otherpillars that we talk about.
The book discusses five pillars.
I'm not going to bring those upyet, but rest assured that I
think a majority of the contentwill start to bring in those
pillars and really connect inwhat it means.
So sign up, tell your friends,like you were saying before, we

(48:53):
have tried to do a lot ofresearch to look at things that
take on biopharma in this manner, and there is nothing out there
like it.
There is nothing out there thatcreates this framework of what
really pushes these companiesforward.
We talk about it all the time.
How much money do you have?
How much time do you have?
How many resources do you have?
Where are you putting thatmoney?

(49:15):
All of these things areessential for a business to be
successful.
You have the data.
You just need to connect it theright way, and so this book is
hopefully going to be a guidefor that entry level new to the
industry, to the middle managerthat's trying to create action
out of strategy, and also to theleader to say hey, leadership,

(49:37):
this is also your responsibility.
It's not just execution of thescience, it's also promoting
healthier systems, healthierworkflows and stronger
collaboration.
Work on those handoffs, reallytalk to the other side and say
what makes sense for you, whatmakes sense for me.
Let's find that middle groundso that this part becomes smooth

(49:59):
.
Those are the importantconversations we need to have,
and hopefully this book does agreat job to outline that for
all the future readers.

Speaker 2 (50:09):
Excellent.
It sounds like some perhapsmerch, or even a poster that you
can put in your office withsome of these concepts, maybe.

Speaker 1 (50:17):
I know.
I know there's a lot there.
There's a lot.
You know.
I've thought about the coffeemug already.
You once challenged me to thinkabout what I was doing.
You even looked at me and saidexplain it if it was a plant,
and that sort of carried througha little bit in the book.
So we'll talk about the rootsystem of your organization, how

(50:39):
you can produce the fruits, theflowers and the fruits which.
What is the fruit?
Your data, your real that iswhat is pushing it out forward.
But you got to have a strongstem.
You got to have a strong base.
You have to be in the right pot.
If anybody's ever tried to growplants in the beginning, I'm

(51:00):
sure you killed a lot, as did I.
You know you get the succulentsthat people say you don't have
to water.
Well, you got to water a littlebit because they just shrivel
up and die Well.
Thanks, lawrence.
I'm glad we got to talk aboutit.
I'm excited for the launch andwe are combining those efforts
into bringing a product linethat I think is going to benefit

(51:21):
a majority of people,especially now in 2025, where
things look a little differentBudgets look a little different,
composition within ourorganizations is different.
There's been a lot of layoffsover the last two or three years
, and so we want to make surethat we're still delivering the
value to organizations that weknow is critical to not just

(51:44):
excelling in operationalexcellence, but surviving and
exposing the risk and being ableto contain it.
Until next time, talk to yousoon.
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