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August 2025
On this episode, Gunter Baumgartner, SVP Head of Global Engineering at Takeda Pharmaceuticals International AG, and Executive Chair of the 2025 ISPE Annual Meeting & Expo Insights from the Executive Chair, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.
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Welcome to the ISPE Podcast,
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Shaping the Future of Pharma,
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where ISPE supports
you on your journey,
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fueling innovation, sharing
insights, thought leadership,
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and empowering a global community
to reimagine what's possible.
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Hello, and welcome
to the ISPE podcast,
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Shaping the Future of Pharma.
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I'm Bob Chew, your host,
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and today we have another
episode where we'll be sharing
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the latest insights and thought
leadership on manufacturing
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technology, supply chains,
and regulatory trends
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impacting the
pharmaceutical industry.
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You will hear directly from
the innovators, experts,
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and professionals driving
progress and shaping the future.
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But before we start
our conversation,
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I want to mention the different
background you see here
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from my usual home office.
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I'm in a hotel in
Seward, Alaska.
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And yesterday, I took a
really nice nature cruise.
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Saw whales, a lot
of different birds,
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and a lot of other
marine wildlife.
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It was really great.
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And then last night, I'm
sitting at the bar having
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dinner, And the
woman next to me is a
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QC lab analyst from
the Johnson and
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Johnson site in Bierce, Belgium.
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Who knew how small
our industry is?
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So I just wanted to share that
personal note from where I am.
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So thank you again
for joining us.
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And now let's dive
into this episode.
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Our topic today is the
upcoming twenty twenty five
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ISPE Annual Meeting and
Expo, featuring the topics,
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speakers, and key highlights
of what you can expect from the
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educational content and agenda.
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To share more about this topic,
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I would like to welcome
Gunter Baumgartner,
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Executive Chair of the
Conference International
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Program Committee and
Senior Vice President,
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Head of Global Engineering
at Takeda Pharmaceuticals
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International AG.
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Gunther, welcome to the podcast.
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We're glad to have you with us.
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Thanks, Bob.
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I'm honored to be this
year's Executive Chair of the
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conference and have the
opportunity to talk about this
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year's conference with you.
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Thank you.
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For me, the ISPE Annual
Meeting has always been a must
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go to, and I anticipate it eagerly
in the weeks and months prior.
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I have always been inspired
by the case studies, ideas,
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and future trends that you
can hear at this meeting.
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Gunther, what do you see as
the major challenges facing the
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pharmaceutical
manufacturing sector?
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And how will the annual meeting
address these challenges?
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Yeah, Bob, for me, this
conference has always addressed
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the key needs of the industry.
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For instance, stay at the
forefront of Pharma four
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point zero and the
digital transformation,
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be inspired by thought
leaders and peers
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and very important interesting
forward looking industry
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leaders with their keynotes.
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So I see it as well as
a high quality education
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opportunity, extensive
networking opportunities
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in the evening events, but
as well during the breaks,
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showcase and explore the
latest industry innovations.
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Where I see the major
challenges in our industry,
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the digital transformation
at Industry four point zero
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integration.
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For me, why it matters is
the pharma industry is under
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pressure to adapt
smart manufacturing,
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automation, AI, machine
learning and data analytics
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to boost efficiency
and compliance.
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Here other industries are more
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advanced as we in pharma.
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So for us and for me,
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it's an opportunity
that we look to the
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challenge, high
implementation costs, legacy
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systems, talent shortages,
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and validating
digital tools in a
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regulated environment
delay widespread
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adoptations.
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But as well, the
cybersecurity threats.
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As facilities become
smarter and more
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connected, they become
targets for cyber attacks.
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And we have some
examples in the industry.
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So the challenge securing
manufacturing data,
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IOT systems, and intellectual
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property against
ransomware breaches and
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operational disruption.
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As well, workforce
shortages, skills gaps.
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To shift to biotech
cell chain therapy
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and digital operations
requires new
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technical skills.
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So where we have the
issues in recruiting,
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retaining professionals
with hybrid expertise,
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automation, GMP, or
AI and quality in a
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competitive labor
market is increasingly
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difficult.
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But not to forget
sustainability,
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environmental pressure.
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Regulatory and social
pressure is growing
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around carbon
emissions, water usage,
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and waste in farmer
manufacturing.
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So therefore, our challenge
is transitioning to greener
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process and materials
without compromising quality,
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cost, regulatory compliance.
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So you see a lot of topics.
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And here I see our
conferences as the
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annual conference, a unique
opportunity to address
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these topics and to discuss
with industry peers,
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but as well with suppliers,
service companies,
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and to address this
with industry leaders.
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You've listed a really
long list of challenges,
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which I think we
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all kind of acknowledge
in the back of our heads,
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but really addressing them
and really moving the industry
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forward at a faster and
faster rate to keep up with
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technology advancements,
science advancements.
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And of course, ISPE brings together
the science and the technology
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so that we can produce
more of our products and
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reach more patients.
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So anyways, last year, you
presented a keynote about
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Pharma four point zero.
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If you were to write a
keynote for this year,
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what would you say has changed?
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And would there be a different
message and different key
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points you would make?
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Thanks for the question.
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The keynote
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is one of my key
favorite topics.
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And if I would
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have a similar
keynote this year,
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I would have a similar message,
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but worth mentioning
that we had progress
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since last year.
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For instance,
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the Pharma four point zero
conference in Rome was well visited.
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This was after
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the annual conference last year.
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With many use cases
presented and a lot of
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engagement we have seen.
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Similar, two months later
at the FOF conference in San
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Francisco.
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I would say the common
outcome is that we in ISB
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should continue to address
the important topic Pharma
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four point zero and
digital transformation.
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So my message would be similar.
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I was at both of
those conferences,
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and I would wholeheartedly
agree with you.
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Some of the case studies
that I heard were really
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inspiring and give me hope and
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enthusiasm for how this
industry is at least
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experimenting with how to adopt
some of these technologies.
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So let's move to the conference
theme. What is it this year?
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And why was the theme decided?
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Yeah, we had many ideas,
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but addressing the high
needs in the industry,
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we decided for the theme
of this year's conference,
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digital transformation.
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And why this?
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Because I'm as well part of the
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FOIA judging committee.
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And if you recognised,
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last year we had no Pharma
four point zero award
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in twenty twenty four.
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We had applications, but
not at the level of the
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awards which we gave in twenty
twenty three and twenty twenty two.
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Further on, out of the
Pharma four point zero
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conferences, we received
feedback from the
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participants that we
should do more as ISB
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organization as Pharma is
behind other industries
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in digital transformation.
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That's the reason why we
decided for the key topic,
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key theme, first
time in the annual
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conference to address as well
the digital transformation.
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Well, it's really great to
see this continued focus.
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But is there a facility
of the year award for
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Pharma four point
zero this year?
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And do you see more
innovation from industry?
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Short answer is yes,
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we will have this year a
Pharma four point zero winner,
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category award winner.
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We have announced the
winner at the Annual
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European Conference in London.
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This year we are awarding a
project based on the full scale
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application and integration
of the various robotics and
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automation technologies.
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For instance, focus on
real time data monitoring
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and analytics.
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The digital twin is as well
used to develop a highly
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detailed dynamic
process simulation.
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So many elements combined
in one project where
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we saw it's end to
end thought through
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implementation And
that's the reason why
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we awarded this
company for the Pharma
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four point zero award.
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Well, that's really exciting.
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Personally, I'm a big fan of
the idea of digital twins,
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both equipment digital twins,
which the aircraft industry
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has used for years
modeling jet engines,
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how they work and
how they might fail,
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and also process digital twins,
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which is kind of like
PAT of twenty years ago.
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So new name, same mathematics.
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Well, that's really interesting.
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Now, more to Takeda.
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What major initiatives is
Takeda pursuing regarding not
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only Pharma four point zero,
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but also adoption of
other technologies?
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Takeda received in previous
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years the Pharma four point zero
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category award, which was then as
well the overall winner of the year.
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We started relatively
early with our
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digital transformation.
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And in my keynotes,
which I gave in last
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year's conference and this
year's FOF conference,
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I mentioned already
some examples.
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And I would say
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what for us is a base is
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our SAIL single automation
integration layer
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implementation.
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This is for us the base in
standardization and connecting
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all shop floor equipment.
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With this implementation
we have standard
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access to our data,
which we use for digital
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data integration, but as
well for data analytics
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to understand and improve
our manufacturing processes.
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As well, it's easier to
build on the digital twin use
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cases for faster startup of new
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manufacturing sites and
as well to understand
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our data in a better way.
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But as well, other
examples like the
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AVI, the automated
visual inspection
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is for us meanwhile a standard,
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where we are working on
adding AI to improve the
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visual inspection.
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Or predictive maintenance,
where we started
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half a year ago on
the global rollout.
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Or the three sixty degree
vertical integrated
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MES, which is for us in
all the sites standard.
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Other example is
the e validation,
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which we have implemented
in the fast track
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approach all across our
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thirty manufacturing sites
and it's one hundred percent
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implemented.
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And all sites are
using the e validation
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tool where we saved approx
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sixty percent of the process
time in the validation.
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Or control tower
where in supply chain
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for products with
a very short shelf
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lifetime,
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which we have implemented and
where we have received as well
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award
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for supply chain.
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Automatic line clearance
where we have use cases done.
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00:14:37,800 --> 00:14:42,480
There are many, many
implementations or
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00:14:43,560 --> 00:14:47,785
the virtual reality
trainings, skilling training
258
00:14:47,785 --> 00:14:49,785
of our employees.
259
00:14:49,785 --> 00:14:54,905
In future we are talking
of very challenging target
260
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with the one day batch release.
261
00:14:57,145 --> 00:14:59,185
But with all these
262
00:14:59,590 --> 00:15:03,470
implementations, we
are targeting
263
00:15:03,750 --> 00:15:06,830
to this approach
264
00:15:06,870 --> 00:15:10,990
and we are on a good way on
265
00:15:11,750 --> 00:15:17,965
achieving this and
which where we were
266
00:15:19,525 --> 00:15:23,445
confirmed by the FOIA
charging where we have in
267
00:15:23,445 --> 00:15:27,765
the past years received
several awards based on our
268
00:15:27,765 --> 00:15:29,645
implementations here.
269
00:15:29,850 --> 00:15:32,610
This is what Takeda is doing.
270
00:15:32,810 --> 00:15:35,210
That's very impressive.
271
00:15:35,210 --> 00:15:37,570
That's very interesting.
272
00:15:38,170 --> 00:15:42,765
How do you see these
technologies coming together
273
00:15:42,765 --> 00:15:45,645
to help reduce
the cost of goods,
274
00:15:45,645 --> 00:15:48,405
increase run rates and yields,
275
00:15:48,445 --> 00:15:51,605
improve supply
chain reliability,
276
00:15:51,645 --> 00:15:54,285
and maintain
regulatory compliance?
277
00:15:54,285 --> 00:15:57,285
Yeah, all of these tools,
278
00:15:57,565 --> 00:16:01,840
if you summarize,
are supporting the
279
00:16:01,840 --> 00:16:07,080
productivity, increasing
run rates and yields.
280
00:16:07,920 --> 00:16:11,855
For instance, with digital
twin and modeling tools,
281
00:16:11,855 --> 00:16:15,855
we simulate equipment process
performance before the
282
00:16:15,855 --> 00:16:19,855
production or optimize run
settings to improve cycle
283
00:16:19,855 --> 00:16:23,695
time, reduce
changeovers and avoid
284
00:16:23,695 --> 00:16:25,335
unplanned
285
00:16:25,935 --> 00:16:27,060
downtime.
286
00:16:27,060 --> 00:16:30,380
But as well the process analytic
287
00:16:30,660 --> 00:16:35,300
PAT technology, real
time monitoring of
288
00:16:35,300 --> 00:16:38,900
critical quality
attributes helps maintain
289
00:16:38,900 --> 00:16:43,805
optimal conditions, reducing
failed batches and increased
290
00:16:43,805 --> 00:16:45,605
consistency.
291
00:16:45,885 --> 00:16:48,765
Integrated MES, I
mentioned before,
292
00:16:48,765 --> 00:16:53,325
for automate scheduling
inventory control
293
00:16:53,325 --> 00:16:57,500
and real time data capture
reduces the changeover
294
00:16:57,500 --> 00:17:01,820
times and idle assets
increasing our throughput in
295
00:17:01,820 --> 00:17:03,900
the manufacturing sites.
296
00:17:03,900 --> 00:17:07,340
Or another important point
297
00:17:07,340 --> 00:17:11,315
reducing cost of goods
with process automation
298
00:17:11,315 --> 00:17:15,315
replaces the manual tasks
in formulation, filling,
299
00:17:15,315 --> 00:17:20,435
packaging and quality
assurance reduces labor
300
00:17:20,435 --> 00:17:24,680
costs, human error,
which leads to
301
00:17:24,680 --> 00:17:27,360
reduce downtime.
302
00:17:27,400 --> 00:17:31,080
All the AI and machine
learning where we
303
00:17:31,080 --> 00:17:35,080
predict batch failures,
optimized our process
304
00:17:35,080 --> 00:17:41,345
parameters and recommend then
real time adjustments, enable
305
00:17:41,865 --> 00:17:45,465
shifts from reactive
to predictive
306
00:17:45,465 --> 00:17:49,065
operations, as mentioned
before, where we are
307
00:17:49,065 --> 00:17:53,040
implementing the predictive
maintenance through
308
00:17:53,040 --> 00:17:54,480
manufacturing sites.
309
00:17:54,480 --> 00:17:56,840
Continuous manufacturing
310
00:17:57,600 --> 00:18:01,360
moves away from the batch
processing to an end to end
311
00:18:01,360 --> 00:18:03,320
streamlined approach.
312
00:18:03,440 --> 00:18:07,845
But for us or where I see some
313
00:18:07,845 --> 00:18:12,045
limitations, it's
only if you have
314
00:18:12,085 --> 00:18:14,325
production with high volume.
315
00:18:14,325 --> 00:18:17,845
I personally see a
trend in small volume
316
00:18:17,845 --> 00:18:20,845
production targeted medicines
317
00:18:21,470 --> 00:18:22,710
where
318
00:18:23,870 --> 00:18:27,870
the continuous
manufacturing is not that
319
00:18:27,870 --> 00:18:30,630
scalable with
320
00:18:31,390 --> 00:18:34,710
lower batch sizes
and smaller volumes.
321
00:18:35,865 --> 00:18:38,945
Other implementations
where I see
322
00:18:40,345 --> 00:18:44,185
inputs is line performance
management systems
323
00:18:44,185 --> 00:18:49,745
controlled hours, predictive
maintenance, shutdown optimizations,
324
00:18:50,720 --> 00:18:54,400
virtual reality
trainings, digital
325
00:18:54,400 --> 00:18:58,000
twin to improve
the productivity.
326
00:18:58,000 --> 00:19:02,375
Important is for me, there
are many digital ideas,
327
00:19:02,375 --> 00:19:05,735
but not all have a
good value creation.
328
00:19:05,735 --> 00:19:10,215
Important is here to do a clear
329
00:19:10,215 --> 00:19:14,470
prioritization because
you can't implement it.
330
00:19:14,470 --> 00:19:19,270
Implement all at once
and you have to have
331
00:19:19,270 --> 00:19:22,150
a clear focus approach.
332
00:19:22,150 --> 00:19:27,630
What is the highest priority
for us as a company?
333
00:19:28,135 --> 00:19:32,535
What makes sense for
our product portfolio,
334
00:19:32,535 --> 00:19:37,575
and then prioritize and
step by step approach.
335
00:19:37,575 --> 00:19:41,495
So I'm curious, as you
implement some of these
336
00:19:41,495 --> 00:19:45,730
technologies, is
the bigger challenge
337
00:19:46,170 --> 00:19:50,490
the modification or
the adaptation of the
338
00:19:50,490 --> 00:19:54,090
technology into
pharma manufacturing?
339
00:19:54,090 --> 00:19:58,185
Or is it the
organisational change and
340
00:19:58,185 --> 00:20:00,425
uptake that has to occur?
341
00:20:00,425 --> 00:20:02,385
For me it's both.
342
00:20:02,905 --> 00:20:07,145
You have to prepare the
organisation with the new
343
00:20:07,145 --> 00:20:12,200
technologies and be
early enough with
344
00:20:12,880 --> 00:20:16,360
training and reskilling of your
345
00:20:17,440 --> 00:20:18,840
employees.
346
00:20:18,880 --> 00:20:22,920
But as well, then
technology development.
347
00:20:24,145 --> 00:20:26,705
I very often heard not now,
348
00:20:26,705 --> 00:20:31,425
let's wait until
the suppliers or the
349
00:20:31,425 --> 00:20:34,065
service providers
have references.
350
00:20:34,065 --> 00:20:38,140
But if you wait until you
have whatever hundreds of
351
00:20:38,140 --> 00:20:41,660
references, then maybe
the technology is that
352
00:20:41,660 --> 00:20:43,700
fast that
353
00:20:44,700 --> 00:20:46,940
you have already new updates.
354
00:20:46,940 --> 00:20:49,700
So you have to take some risk
355
00:20:50,605 --> 00:20:53,605
and a clear commitment in
356
00:20:54,845 --> 00:20:58,685
your team to implement
a technology,
357
00:20:58,685 --> 00:21:02,650
a new technology, but
then as well prepare the
358
00:21:02,650 --> 00:21:05,690
organization in the right
way in the fast track.
359
00:21:05,690 --> 00:21:08,170
Well, very exciting times.
360
00:21:08,170 --> 00:21:12,170
Is there anything else you'd
like to add regarding the ISPE
361
00:21:12,170 --> 00:21:15,275
Annual Meeting and why
people should attend?
362
00:21:15,275 --> 00:21:19,155
Yes, it's always a benefit
363
00:21:19,755 --> 00:21:20,915
to
364
00:21:22,395 --> 00:21:26,715
have network opportunity,
to listen to great
365
00:21:26,715 --> 00:21:30,470
keynotes, interesting
track sessions,
366
00:21:30,910 --> 00:21:34,030
or visiting the exhibitions.
367
00:21:34,030 --> 00:21:37,230
So the benefit is
always multiple.
368
00:21:37,230 --> 00:21:40,735
I would summarize that
we look forward to
369
00:21:40,735 --> 00:21:44,655
welcoming esteemed
professionals from across the
370
00:21:44,655 --> 00:21:48,815
life science sector, including
regulators, scientists,
371
00:21:48,815 --> 00:21:52,735
researchers, engineers,
suppliers and more to join us
372
00:21:52,735 --> 00:21:56,550
in exploring the groundbreaking
opportunities and
373
00:21:56,550 --> 00:21:59,070
pressing challenges
374
00:21:59,990 --> 00:22:03,270
in impacting our industry.
375
00:22:03,270 --> 00:22:07,350
From the emerging field
of AT and Ps to critical
376
00:22:07,350 --> 00:22:10,405
issues of
digital transformation or
377
00:22:10,405 --> 00:22:14,685
sustainability as mentioned
at the beginning or
378
00:22:14,805 --> 00:22:19,765
supply chain resiliency,
I think the ISB
379
00:22:19,765 --> 00:22:23,765
annual meeting twenty five
and EXPO promises to be
380
00:22:23,765 --> 00:22:28,280
pivotal event for shaping
the future of our industry.
381
00:22:28,280 --> 00:22:32,280
It's really a great opportunity
to meet our industry peers,
382
00:22:32,280 --> 00:22:34,800
supplier service companies.
383
00:22:35,000 --> 00:22:38,280
It's a great event with
more than two thousand
384
00:22:38,280 --> 00:22:39,480
participants.
385
00:22:39,480 --> 00:22:44,685
Therefore, it's a great networking
opportunity to meet your peers.
386
00:22:44,685 --> 00:22:49,245
So I highly recommend
to show up to register.
387
00:22:49,245 --> 00:22:52,525
And I am confident
this year will
388
00:22:52,525 --> 00:22:58,020
be again a great event in Charlotte
later this year in October.
389
00:22:58,020 --> 00:22:59,780
I would wholeheartedly agree.
390
00:22:59,780 --> 00:23:03,140
I've been attending the
annual meeting since the
391
00:23:03,140 --> 00:23:08,315
mid-90s, and I can't
take fifteen meter
392
00:23:08,315 --> 00:23:11,515
steps without running
into somebody I know,
393
00:23:11,515 --> 00:23:14,315
having a conversation,
sometimes short,
394
00:23:14,315 --> 00:23:15,955
sometimes long.
395
00:23:15,995 --> 00:23:19,835
It's just a great event
to be there in person.
396
00:23:19,835 --> 00:23:22,830
So to recap our discussion,
397
00:23:23,110 --> 00:23:27,270
we certainly have seen that
going from Pharma four point
398
00:23:27,270 --> 00:23:32,995
zero keynote last year through
some other conferences,
399
00:23:32,995 --> 00:23:37,035
The digital transformation is
now the theme for this year.
400
00:23:37,555 --> 00:23:41,555
Technology moving at light speed
and the need for our
401
00:23:41,555 --> 00:23:47,115
organizations to adopt and
move our industry forward.
402
00:23:47,460 --> 00:23:50,300
That's really the key points
403
00:23:50,740 --> 00:23:55,300
that we've heard from Gunther
and what Takeda's doing and
404
00:23:55,300 --> 00:23:57,060
what the broader
industry is doing.
405
00:23:57,060 --> 00:24:00,420
So that brings us to the end
of another episode of the ISPE
406
00:24:00,420 --> 00:24:03,500
podcast, Shaping the
Future of Pharma.
407
00:24:03,845 --> 00:24:07,605
A very big thank you
to our guest, Gunther Baumgartner,
408
00:24:07,605 --> 00:24:11,525
for sharing more about what
we can look forward to at the
409
00:24:11,525 --> 00:24:15,765
twenty twenty five ISPE
Annual Meeting and Expo in
410
00:24:15,765 --> 00:24:19,080
October twenty
six to twenty nine
411
00:24:19,080 --> 00:24:21,000
in Charlotte, North Carolina.
412
00:24:21,000 --> 00:24:24,280
Be sure to subscribe to this
podcast so you don't miss
413
00:24:24,280 --> 00:24:28,280
future conversations with
the innovators, experts,
414
00:24:28,280 --> 00:24:31,440
and change makers driving
our industry forward.
415
00:24:31,795 --> 00:24:36,475
On behalf of all of us at
ISPE, thank you for listening.
416
00:24:36,515 --> 00:24:39,875
And we'll see you next time
as we continue to explore the
417
00:24:39,875 --> 00:24:45,558
ideas, trends, and people
shaping the future of pharma.
