174 - Global Collaboration & Open Innovation (S12E9)

Welcome to the deep dive. We're here to, you
know, cut through the noise and get to what matters.
Exactly. And today we're jumping into something
pretty transformative in the world of medicine
development. We are. It's all about global collaboration
and this concept of open innovation. how they're
really shaking up drug development. And for you,
our listener, the learner, we want to make this
clear. We're pulling insights straight from our
sources, that's transcripts, and also some detailed
research papers, specifically from OPR &D Organic
Process Research and Development. Yeah, we're
aiming to give you the core info, the stuff you
really need to know. without getting bogged down.
Right. We're going deep, not just scratching
the surface. Now, it's interesting. Our sources
don't just give us a simple dictionary definition
for global collaboration or open innovation.
No. They don't. But you'll definitely see what
they mean through the examples. You get the practical
sense of it and why it's important. OK. So where's
a good place to start seeing this collaboration
in action? Globally, I mean. Well, you absolutely
have to talk about the ICH. That's the International
Council for Harmonization. It's really central
to this whole thing. ICH, right. Tell us about
that. So think back before 1990. If a company
developed a drug, getting it approved in, say,
the US, Europe, and Japan, it was messy. Different
hoops to jump through in each place. Totally
different. You might have had to run similar
tests multiple times, different paperwork, different
standards. It was incredibly inefficient. Wow,
yeah. Sounds like a huge waste of time and resources.
Exactly. So ICH was formed. It brought together
the regulators, the FDAs of the world, and the
pharmaceutical industry from those three big
regions, the US, EU, and Japan. And the goal
was? The main goal was harmonization, to create
one set of standards, basically, so you wouldn't
have to repeat all that work, to streamline things.
Make it more efficient. Less redundant testing
precisely the mission boiled down is ensuring
safe effective high quality medicines get developed
and registered efficiently Worldwide that makes
a lot of sense cut down the duplication speed
things up potentially Yeah, and potentially cut
costs freeing up resources for you know actual
innovation not just redoing tests And it didn't
just stay with the US, EU, and Japan, right?
It grew. Oh, absolutely. It's much bigger now.
Many other regulatory authorities are involved,
either as full members or observers. Think Canada,
Switzerland, even China, Brazil. It's really
expanded its reach. So it's become a truly global
forum? It has. And what's unique is that it's
regulators and industry scientists working together.
Ah, OK. So it's not just regulators laying down
the law. It's a collaboration. It really is.
They jointly develop these harmonized technical
guidelines. Technical guidelines, like how you
should run a specific test. Exactly. Like before
ICH, maybe the rules for stability testing, proving
a drug lasts on the shelf, were slightly different
in the US versus Europe. ICH creates one guideline
that satisfies both, or hopefully multiple, agencies.
So a company designs one study program. And it
works for everyone. or at least more than one
major regulator. That's the idea. A single development
program that meets multiple requirements. That
sounds like a massive improvement. A real game
changer for efficiency. It really has been. While
our sources don't list every single guideline
in its specific impact metric, the overall effect
is clear. A smoother path to getting drugs approved
globally. Fewer roadblocks, less repetition.
OK, so ICH is a huge driver for global collaboration.
Let's shift a bit to open innovation. Where are
we seeing that play out? Well, one really interesting
area connects to something we've touched on before,
the explosion of data, particularly from digital
health tools being used in clinical trials. Ah,
right. Wearable sensors, apps, that kind of thing.
Exactly. Things that track heart rate, activity,
sleep, maybe blood oxygen, glucose. Continuously.
Instead of just relying on what a patient reports
during a clinic visit every few weeks. Precisely.
You get this constant stream of real -world data.
It gives you a much, much richer picture of how
a drug is actually working or not working in
someone's day -to -day life. More objective data,
too, potentially. Yes. It's a huge contrast to
those infrequent snapshots you get in a traditional
clinic setting. And this data flow, you could
argue, is a form of open data flow. feeding back
into the development process. Interesting. Does
it allow for, like, adapting trials on the fly?
Well, the potential is certainly there. The sources
don't explicitly state that's happening routinely
yet, but having that continuous data could definitely
inform trial design adjustments down the line.
It opens possibilities. Now, these digital tools,
they often fall under medical device regulations,
don't they? That's right. And the FDA, for example,
has a risk -based approach here. Risk -based,
meaning? Meaning... The level of scrutiny depends
on the potential risk. A totally new, high -risk
device might need what's called a PMA, pre -market
approval. Very rigorous. OK. But if a device
is pretty similar, substantially equivalent,
is the term, to something already out there,
it might go through the 510k pathway, generally
less intensive. So it depends on what the device
does and how novel it is. Exactly. But regardless
of the path, a huge focus for regulators is validation.
Making sure the tool actually works, measures
what it says it measures. Yes, and that the data
it generates is reliable, trustworthy. That's
absolutely core. You can't just use any tech.
It has to be proven. We got it. OK, so that's
the data side of open innovation. What about
collaboration in the actual research process
itself? Can we see that in the OPR &D literature?
Oh, definitely. The OPR &D papers are quite revealing
if you look closely, particularly in the acknowledgment
sections. The acknowledgments, really? What do
they tell us? Well, you often see these long
lists thanking specific people for specific contributions.
And importantly, these people aren't always from
the same lab or even the same company as the
main author. Ah, so it shows the network involved.
Precisely. You might see Thanksgiving to someone
at a university for doing complex analytical
work, or another expert for NMR analysis, or
someone else for mass spec. Or maybe safety testing,
or even help with manufacturing scale -up. Exactly.
Safety assessments, help with outsourcing strategy,
building prototype equipment, computational modeling,
flow chemistry expertise. The list goes on. Sometimes
even just for insightful discussions. Wow, so
it really takes a village, sometimes across different
organizations. It often does. It shows that drug
R &D is frequently this very multi -disciplinary
effort, pulling in expertise from various places.
It implicitly demonstrates that collaborative
environment. Okay, that clearly shows collaboration.
How do these papers show the openness aspect?
Two main ways, I'd say. First, look at the citations.
The references to other papers. Yeah. They're
constantly building on previous work. The OPR
&D papers reference studies by researchers from
all sorts of institutions all over the world.
They stand on the shoulders of prior discoveries.
Which is fundamental to science, right? Sharing
knowledge and building on it. Absolutely. It
highlights that open nature of scientific progress.
People aren't working in isolation. They're part
of a global scientific conversation, referencing
and extending each other's findings. OK. That
makes sense. What's the second way? The level
of detail in the papers themselves. OPR &D is
known for publishing very detailed experimental
procedures. Like the actual recipe for how they
did something. Pretty much, yeah. How they made
molecule X or prepared salt Y. The exact conditions
for a reaction Z. They lay it all out. So they're
not keeping it secret. They're sharing the how
-to. Exactly. It's public. Other researchers
can read it, potentially repeat it, learn from
it, adapt it, build on it. That's open dissemination
of the research findings. The transparency is
key. It lets the whole field move forward faster.
Right. And sometimes even the topics themselves
show a shared focus. For instance, there might
be a paper digging into trace metal residues
from a certain reaction type. Why is that significant?
Because things like trace impurities and safety
are huge concerns for everyone. Regulators, companies,
patients. Investigating those issues openly benefits
the entire community. It's about shared safety
priorities. Got it. So through OPRND, We see
collaboration via shared expertise and openness
via citations and detailed methods. OK, so we
have global harmonization in this increasingly
open data rich environment. What are the big
hurdles companies face navigating all this, especially
on the regulatory side? Well, with the digital
health tools. Just keeping up is a challenge.
The tech evolves so fast. And the regulations
have to try and keep pace. Exactly. Guidelines
are constantly being updated, refined. Companies
need to be really agile to stay compliant. And
then there's the data itself. All that personal
health information, privacy and security must
be massive concerns. Huge. Absolutely paramount.
Protecting patient data isn't just good practice.
It's a strict regulatory requirement. Companies
have to have robust systems, follow rules like
HIPAA in the U .S., GDP. in Europe. So compliance
with all these data privacy rules plus the medical
device regulations like from the FDA we mentioned,
it's a complex landscape. It definitely is. It's
a significant undertaking to manage it all correctly.
Okay let's try and pull this together then. We've
seen global collaboration with ICH playing a
key role in standardizing rules across borders,
making things more efficient. Right. harmonizing
the regulatory pathways. And we've seen open
innovation showing up strongly in data sharing,
especially with new digital health tech, which
opens doors for maybe more personalized approaches
down the line. And also in the way research itself
happens, as seen in OPR &D building on past work
openly, sharing detailed methods, and collaborating
across disciplines and institutions. So even
though we didn't get a neat definition handed
to us, the examples really paint the picture.
You see how these concepts are practically reshaping
drug development. Definitely. So thinking forward,
here's something for you, the listener, to chew
on. How will this push towards more real world
data from digital tools combined with more global
regulatory alignment? How will that continue
to change drug development? Will it accelerate
things even more, make them fundamentally different?
And maybe more importantly, What new challenges,
maybe ones we haven't even thought of yet, might
pop up because of these trends? Interesting questions
to ponder. And if you want to dig deeper into
any of this, the OPR &D literature is out there.
And keeping an eye on regulatory updates is always
worthwhile. Absolutely. Well, thanks for joining
us for this deep dive. See you next time.