Insights from the 2026 ISPE Europe Annual Conference Committee Chair

April 2026

On this episode, David Estapé, Technology Manager Biotechnology at CRB Group GmbH, and International Program Committee Chair of the 2026 ISPE Europe Annual Conference, 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.

• Guest

  

  David Estape

  Technology Manager Biotechnology

  CRB Group GmbH

• Transcript

  Download Transcript

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  Welcome to the ISPE podcast, shaping the future of pharma, where ISPE supports you on your journey, fueling innovation, sharing insights, thought

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  leadership, and empowering a global community to reimagine what's possible.

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  Hello, and welcome to the ISPE podcast, 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 the latest insights and thought leadership on manufacturing, technology, supply chains, and

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  regulatory trends impacting the pharmaceutical industry.

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  You will hear directly from the innovators, experts, and professionals driving progress and shaping the future.

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  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 six ISPE Europe annual conference featuring the topics, speakers, and key highlights

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  of what you can expect from the educational content and agenda.

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  To share more about this topic, I would like to welcome David Estappe, chair of the conference international program committee and technology manager

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  biotechnology, CRB group, GMBH.

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  David, welcome to the podcast.

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  We're glad to have you with us.

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  Thank you, Bok.

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  Thank you very much, that you invite us to and to you that you bring, the conference to your audience.

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  It's very important for us to to be able to share it.

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  We are very excited about the conference.

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  We believe we have a great program.

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  And I believe also where the expectation is that we are raising the bar one more time in Europe with the conference, basing the number of

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  attendees that we are seeing.

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  And this, I believe, is because of the it's a lot of years working in that direction, but also the quality of

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  the all the expertise that the committee, organization committee brought in.

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  And at the end of the day, the conference will not be possible without the people who decide to attend the to contributing to the conference, yes?

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  We had open positions to make a presentation, we had about 64.

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  We got more than 200 proposals.

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  This means three times more.

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  That means we could make a conference and it will be three times the size.

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  It's impossible.

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  But this has allowed us and with respect with all the proposals through CherryPIC and to believe that we got excellent content and an

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  excellent quality in the conference.

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  I mean, We are very, very, very excited.

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  Well, that's amazing.

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  So looking ahead to this conference, what major forces do you see shaping the future of pharmaceutical development and manufacturing?

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  And how is this year's program designed to support that evolution?

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  How long we have for the respond?

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  Because a lot of things is happening in the pharmaceutical.

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  I had the feeling don't ask me when.

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  This is the time before the COVID.

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  This is clear.

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  A few years before the COVID.

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  But we had, like, we were in, like, in a plateau.

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  Nothing was moving so much.

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  I had the feeling like, this is my personal view.

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  Things were, like, everybody was in this comfort zone with business plans, with regulators, not moving so many new

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  annexes, covered whatever you like.

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  And then from the day to the night, I don't know where we are all here accelerating and accelerating in directions.

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  One, in the amount of things that we see that we need to adapt to.

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  It could be new regulations, new product modalities, AT and Ps, radiopharmaceuticals, ADCs, mRNA and new

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  tools, yeah?

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  We need to digitalize.

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  We need to modernize manufacturing.

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  We have the new AI.

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  In addition, we come with sustainability, very strong here in Europe.

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  At the end, it's like, it's like, oh my god, from being in this plateau, in a comfort zone somehow, we are exposed to I don't know.

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  I'm sure I'm sure I'm for I'm this is the ones we are covering in the on in our program, but there is much more.

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  And this, in addition, we are asked to in to give respond faster.

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  It's not now above in ten years, we should know.

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  It's to be five.

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  And if we can do it, in three.

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  And this, we are not using the farm industry at this speech.

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  That means we have a very challenging times ahead of us.

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  Very difficult to bring this in one program, as I mentioned, but we did our best.

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  We had done we refined five different tracks.

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  Very important, this is a must have, and huge interest in the industry about digital compliance, Pharma four point zero in action.

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  This is how we COVID-two, the first two tracks to cover all what is going into this field of the digitalization and the transformation of the from the the

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  pharma industry.

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  But at the same time, we have the the typical, but also very important, working engineering with this and good manufacturing practice

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  subject delivery and moving into how we bring facilities to reality, yeah, and very also quicker, quicker and more quicker.

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  We have sustainability, a substance and a a substance of concern.

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  And finally, we decide to bring back, because Varcie was not there, regulatory and quality.

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  I think an ISP conferences without regulatory and quality should never exist, and we did bring it back.

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  And there is a lot of things also happening there with new regulations coming soon and with a lot of updates of the annexes or guidance

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  being done, yes?

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  Anyway, if you ask me, there is a huge, perfect content or there is a huge content.

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  I am afraid.

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  And we had one of the things that I was suffering from from chairman, it was that we create key words.

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  It's like, ah, this is the regulatory quality, and this is the engineering.

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  And this is I think that the entire team had been able to bring in each of the tracks different views from

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  different perspective about the different topics.

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  And I think this is very important.

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  It's always a challenge.

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  That means at the end of maybe we did 50% of the world, the other 50% should be that indeed who comes in and move between tracks.

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  Don't stay in I will always recommend don't stay in one track.

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  But that is the overview, very quick overview of the content of what we are facing in the industry and how this is reflected into the program.

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  Well, I think, you know, you go you go back to pre COVID, and now here we are, with a totally different, environment.

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  I know of many companies with pipelines that are pretty promising.

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  And then in the small discovery companies, the science and the use of AI to discover molecules.

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  So the products are all out there, it's now up to us to get them manufactured.

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  So, let's move on into the details of this conference.

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  Can you tell us who is speaking in the keynote sessions and what we should expect?

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  Are there any standout talks that you would recommend?

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  As a a chairman, I should not I should not point to a specific Well, the keynote.

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  I will make an an exception.

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  But the point's gonna come with the keynote.

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  So what's what's what should they not miss in the keynotes?

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  That's correct.

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  We have in total eight keynotes.

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  We have eight keynotes.

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  We did an effort, all with the ships in the in the pharma industry.

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  And very important, we did an effort to bring people representative from the industry, the manufacturers, as well as many from the regulatory.

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  That means we try to balance and to give voice to both sides at the keynotes.

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  If you ask me, let me choose from the eight, maybe four, that maybe cherry picking now.

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  One for me that is a pleasure and a privilege to have him opening the conference in addition.

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  This was Jorgensen, the Chair of Healthcare Denmark, but he was everybody knows him because he was the CEO of Novo Nordisk.

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  And from him, I expect that he will bring the say

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  his we're forming that of you.

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  A mass recent speech or presentation from keynotes, yes?

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  Maybe if I make a remark in everybody knows what they in a conference, in ISPE conference, we started recording what he said.

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  The U.

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  S.

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  Innovates, the Chinese replicates and the European regulates.

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  Nobody forgot that he was the man, and we will have him live in Copenhagen.

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  I think this is don't miss it, don't miss it.

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  Okay?

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  Maybe from the regulatory side, a key name also is Brendan Cuddy from the EMA.

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  Mhmm.

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  And he's going to bring the perspective of all the being done from the upgrade of

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  guidance.

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  He will have a overview of all the work being done and all the initiatives being done from the inspector side.

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  It can be new guidances or update of guidances, trainings, very important, working in the international cooperation also

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  from that point of view.

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  And also the improving oversight of the supply chain.

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  Very important when we are talking about rack shortage being one of the challenge in the industry at this point in time.

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  Well, that's exciting.

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  Looking forward to being there anyways.

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  If if you like, I'd like to add one more because I was surprised.

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  I had the the the the opportunity to invite Vas Peterson for Fuji from Fujifilm.

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  Mhmm.

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  He's Fuji he's more in the CDMO side.

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  And working in his we gave him opportunity to define his topic.

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  And he bring the topic saying, people, the way we are manufacturing today our the bioproducts,

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  we are not going to have the capacity to reach to all the patients.

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  We need to and then he brings the word industrialized manufacturing as all the industries have already done.

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  I just got to say, if we just produce cars, exclusive cars, we will not reach everyone.

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  We need to go to the industrialization of car manufacturing.

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  He is saying, let's go to take this idea, and we need to apply this idea to pharma.

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  And we need to industrialize manufacturing.

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  We need to work in a different way that we can provide the therapies or the medicines to all the patients.

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  Interesting speech, very interesting speech.

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  That's a topic that you and I could discuss for a long time.

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  But let's move on here.

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  Following your quiz notes, the program has five parallel interactive forums.

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  Now this interactive forum, is that a new conference format?

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  And you could can could you clarify what an interactive forum involves, what participants should expect, and the overall objectives of that,

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  kind of a an approach?

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  Last year, we had already something that was called workshops, okay?

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  And we took this idea, and we shape it a little bit more.

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  This is the ISP conference, and the ISP conference is not just where the people present present, the the educational part.

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  We have ISP to cooperate.

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  That means we need that the people speaks up.

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  First, relax.

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  Come into the conference, relax, Feel at home and start to cooperate, start to talk.

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  Take a question.

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  Don't nobody will look at you back because you make a question.

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  That means that not everybody is at the same pace, yeah?

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  But that means to bring that that means to bring dialogue.

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  And the way to do that, we decide that before we go to the educational sessions where presentation, presentation, presentation, we say, let's go to try to break the ice.

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  And the best way to break the ice is to bring dialogue, basically, make these interactive sessions.

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  And the interactive session is nothing else that we will have one hour and a half, and we'll have two three to five I don't like to cope let's

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  go to experts.

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  They will have five to ten minutes, but elevated speech to introduce their view in the topic or their experience in the topic, and this to

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  bring some basic to start a Q and A session, a discussion.

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  And here, this is not a panel discussion.

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  There's and it's not a panel a panel.

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  It's to create dialogue that the people make questions and even the people if the people in the audience feels that they have something to say, give an answer,

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  they also are invited.

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  That means this is back and forth dialogue with everybody who is in the room.

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  And this is what the intention is.

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  I have a high expectation from that, from as the Chairman, and I hope it's working and brings dialogue into conference.

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  Well, that sounds, innovative, ambitious, and I'm I'm excited to to give it a try.

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  Let's take a deep dive into the five tracks.

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  First, Pharma four point o in action.

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  Pharma four point o has moved from concept to practice.

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  Finally, can you share examples that you've seen of these plug and produce systems, robotics, or connected manufacturing that truly demonstrate

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  the next stage of smart, interoperable pharmaceutical production?

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  I think there is, without being an expert, there is things that we can see with our eyes.

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  Let's go to say, we go to an out to a filling line, and we see the robot taking the prepackaged syringes in

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  and nesting, taking the whole process without the intervention of the operator.

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  I think this is the first thing that everybody knows and everybody recognizes.

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  It means things that they were already there.

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  We will finalizing to make the step to do it.

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  But with the new regulations, everybody feels like now is the time to to apply this type of solutions.

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  And then to these people who is designing isolators, especially for the, for instance, the ATMP field, where there is the the

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  the part where brings the clean air fixed, and I can go from the backside and exchange the unit operation that is going to be there.

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  And the system immediately recognized the change.

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  It's a real plug and play and know that there is a different unit operation being installed and ready to go, yes?

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  And there is other things that we don't see.

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  Anyway, maybe a comment in that, I think.

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  And these are things that data, yeah, data how the data is interconnected within the equipments.

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  There, I I will need the call to for the expert to give us a real because this is the when I think

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  in a world we are going to have a challenge.

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  We are maybe I right to say, we are people who are more analog and there is people who are more digital.

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  And analog, we understand the robot very easy, very quickly.

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  But when it's coming to digital and to understand what how the data move between machines, databases, which

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  type of databases we need, and how this is also compliance.

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  It's a challenge because it's much more abstract to see.

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  But a lot of things, this have been done in that field, direction.

  200
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  Well, let's move on to the next track, digital.

  201
  00:18:17,855 --> 00:18:24,335
  Now that you mentioned analog versus digital, digital transformation is certainly accelerating rapidly.

  202
  00:18:25,375 --> 00:18:35,989
  What do you see as the most significant pain points that companies face when trying to apply AI, cloud platforms, and automation

  203
  00:18:36,630 --> 00:18:40,069
  in ways that remain fully compliant with GXP requirements?

  204
  00:18:41,894 --> 00:18:44,615
  Here, I am also a student, if you ask me.

  205
  00:18:44,615 --> 00:18:52,934
  And means I will give my personal understanding, and is that we are learning AI.

  206
  00:18:53,015 --> 00:18:56,934
  We are learning what AI what it is and what can do.

  207
  00:18:58,049 --> 00:19:01,169
  And there is especially in the field they are driving.

  208
  00:19:01,169 --> 00:19:02,369
  This is very important.

  209
  00:19:02,609 --> 00:19:11,250
  But in some way, all of us will need to make go to school and learn what AI is what it means in some way.

  210
  00:19:11,654 --> 00:19:21,974
  And there is one thing at the end that is behind, and I think this is one of the challenge that we have in front of us when we come to some type of applications of the AI is

  211
  00:19:21,974 --> 00:19:22,694
  trust.

  212
  00:19:23,095 --> 00:19:24,295
  Can we trust AI?

  213
  00:19:24,539 --> 00:19:26,220
  What are the databases?

  214
  00:19:26,619 --> 00:19:27,819
  We train the AI?

  215
  00:19:28,140 --> 00:19:30,539
  Is the buyer's AI or not?

  216
  00:19:30,539 --> 00:19:31,340
  Things like that.

  217
  00:19:31,340 --> 00:19:33,179
  That means we need to trust.

  218
  00:19:33,180 --> 00:19:37,900
  I like to remember one it's a very old sworn I remember from the FDA.

  219
  00:19:37,900 --> 00:19:39,259
  It was in god we trust.

  220
  00:19:40,255 --> 00:19:42,335
  All the others needs to bring paper.

  221
  00:19:42,654 --> 00:19:46,494
  In some way, we are not going to bring paper with AI.

  222
  00:19:46,494 --> 00:19:50,894
  We will bring digital data, but we need to we need to make an effort there.

  223
  00:19:50,894 --> 00:20:01,049
  And I think this is what is being done from the regulatory side and also from the the industry side, yeah, understand and look

  224
  00:20:01,049 --> 00:20:11,065
  what applications are there and what is the simple application and what are GMP relevant application of the AI and measure at the end of the

  225
  00:20:11,065 --> 00:20:20,744
  day if we still need the final human saying, yes, this makes sense, we can use it or the bytes release or things like that.

  226
  00:20:21,259 --> 00:20:31,259
  But, there is a the trust under how we apply for me as a learning student, it's a key.

  227
  00:20:32,619 --> 00:20:33,259
  All right.

  228
  00:20:33,259 --> 00:20:43,285
  Well, let's see if we can, talk more in in a subject area that you and I are familiar with engineering, as is with most of

  229
  00:20:43,285 --> 00:20:44,244
  our audience.

  230
  00:20:44,884 --> 00:20:55,149
  On the engineering side, digital tools like digital twins, model based design, and advanced simulations are becoming

  231
  00:20:55,149 --> 00:20:57,149
  standard in CapEx projects.

  232
  00:20:57,950 --> 00:21:07,764
  What do you see as the biggest opportunities and biggest risks when integrating these tools into GMP compliant facilities?

  233
  00:21:09,684 --> 00:21:16,484
  As you mentioned, if I listen, yeah, you have mentioned these are tools.

  234
  00:21:17,500 --> 00:21:20,859
  And you have the best tools, but it doesn't make the best cooker, yeah?

  235
  00:21:20,859 --> 00:21:23,980
  You can have the best path is right now.

  236
  00:21:24,140 --> 00:21:24,380
  Mhmm.

  237
  00:21:24,380 --> 00:21:29,259
  That you you have a best the best photographic camera, it doesn't means that you'll be a good photographer.

  238
  00:21:29,625 --> 00:21:36,585
  That means we have tools there, very modern, very powerful tools, and I think there is no way back.

  239
  00:21:36,585 --> 00:21:37,865
  We must use it.

  240
  00:21:37,865 --> 00:21:47,640
  It cannot be that in the 2026, a quarter already into the of the century already gone, and we are still using Exos.

  241
  00:21:47,640 --> 00:21:49,080
  No, we cannot do that.

  242
  00:21:49,080 --> 00:21:55,559
  I think it's obviously that we need to use the tools and implement the tools, and it's what is being happening.

  243
  00:21:56,144 --> 00:21:57,184
  And it's more.

  244
  00:21:57,184 --> 00:22:03,505
  I think one thing is the tools, as you mentioned, digital twins, but now it's coming AI.

  245
  00:22:04,065 --> 00:22:08,625
  And I think AI will even transform more the way the engineers works, yes?

  246
  00:22:08,625 --> 00:22:18,720
  There is people playing and saying, make me a P and ID of a paf, the P and ID appears instead of to wait maybe one

  247
  00:22:18,720 --> 00:22:21,119
  day or try to whatever.

  248
  00:22:21,919 --> 00:22:22,960
  The P and ID is there.

  249
  00:22:24,005 --> 00:22:26,485
  The question will be and there is no way back.

  250
  00:22:26,485 --> 00:22:36,404
  I think if you I just can reproduce what is I will send in my company or we do the or we do the change or the market will take us.

  251
  00:22:36,404 --> 00:22:37,924
  That means there is no option.

  252
  00:22:38,005 --> 00:22:38,725
  We have to.

  253
  00:22:38,725 --> 00:22:42,480
  We need to earn, and we need to make the step, yes?

  254
  00:22:42,720 --> 00:22:45,440
  But tools doesn't mean compliance.

  255
  00:22:45,440 --> 00:22:47,440
  That is the biggest challenge.

  256
  00:22:47,440 --> 00:22:49,440
  How we bring the compliance?

  257
  00:22:50,480 --> 00:23:01,105
  And this is I think sometimes maybe you are an engineer, the industry doesn't the rest of the others doesn't

  258
  00:23:01,585 --> 00:23:10,929
  understand what means the engineering because we are asked to before, we had four years to make a facility, then it came three, And then it come 2.5.

  259
  00:23:10,929 --> 00:23:14,529
  And now they are saying, hey, in two years, this should be up and running, yes?

  260
  00:23:14,609 --> 00:23:18,690
  And it's like, yes, but I have a new regulation, a new Annex I.

  261
  00:23:18,929 --> 00:23:21,169
  What is the interpretation of the Annex I?

  262
  00:23:21,169 --> 00:23:23,489
  Interpretation of Annex I takes five years.

  263
  00:23:23,890 --> 00:23:34,025
  And then we it's a challenge to be designing a facility when the people is discussing or there is once again, we have different speeds, yeah?

  264
  00:23:34,184 --> 00:23:39,705
  When other people are discussing how we make the interpretation or if it will be a new annex or not and when.

  265
  00:23:40,109 --> 00:23:41,230
  And this is challenged.

  266
  00:23:41,230 --> 00:23:51,230
  At the end of the day, we take the risk that to pay more money that we should have been investing into the

  267
  00:23:51,230 --> 00:23:51,950
  projects, yes?

  268
  00:23:52,294 --> 00:23:58,454
  It can be because we need to we take the right way.

  269
  00:23:58,454 --> 00:23:59,255
  We need to repeat.

  270
  00:23:59,255 --> 00:24:01,014
  We need to fix a few things.

  271
  00:24:01,335 --> 00:24:03,174
  Or maybe we do it the other way around.

  272
  00:24:03,174 --> 00:24:04,294
  We over engineer.

  273
  00:24:04,294 --> 00:24:06,134
  We then we do this, this, this.

  274
  00:24:06,329 --> 00:24:11,369
  This is usually the pathway that we take, and this is very challenging.

  275
  00:24:11,369 --> 00:24:17,289
  That means, at the end of the day, knowledge, the engineer quality.

  276
  00:24:18,009 --> 00:24:24,894
  And I don't like to be negative, but we are also going through baby boomers going out.

  277
  00:24:26,095 --> 00:24:34,494
  New people, that means this knowledge transfer and knowledge sharing and to be able to breach it is going to be very critic.

  278
  00:24:35,200 --> 00:24:39,440
  Important tools, but people is still, for me, a key.

  279
  00:24:40,240 --> 00:24:50,874
  When when you get right down to it, annex one is basically a long list of things you should do or consider doing

  280
  00:24:51,275 --> 00:24:57,595
  to control the risk of contamination and poor product quality.

  281
  00:24:57,914 --> 00:24:58,315
  Right?

  282
  00:25:00,794 --> 00:25:09,889
  And there are people whoever wrote it, which was the industry, it was everybody's collective wisdom.

  283
  00:25:10,529 --> 00:25:10,929
  Right?

  284
  00:25:10,929 --> 00:25:19,409
  And AI is also a probabilistic risk kind of tool.

  285
  00:25:20,184 --> 00:25:20,664
  Mhmm.

  286
  00:25:20,664 --> 00:25:21,384
  Sorry.

  287
  00:25:21,705 --> 00:25:32,265
  So it's probably not trained yet to the point, you know, with enough data from operational, ins and outs and failures

  288
  00:25:32,265 --> 00:25:34,390
  and and whatever.

  289
  00:25:34,789 --> 00:25:44,789
  But at some point in the future, it ought to be able to analyze a design and say, you have an uncontrolled risk

  290
  00:25:44,789 --> 00:25:51,605
  here or you have a risk that's a little too high, you need to put in a little more controls.

  291
  00:25:52,085 --> 00:25:56,005
  Or over here, it might say, that's not a problem.

  292
  00:25:56,404 --> 00:25:57,285
  Don't worry about it.

  293
  00:25:57,649 --> 00:25:59,329
  Anyways, that's for the future.

  294
  00:25:59,409 --> 00:26:02,209
  One day we need to make a podcast about that.

  295
  00:26:03,889 --> 00:26:12,130
  I I maybe I am very there is the the topic of I'll give you an example.

  296
  00:26:12,454 --> 00:26:15,654
  Risk quality risk management.

  297
  00:26:15,654 --> 00:26:21,174
  That means in the engineering now we do risk assessment and risk assessment, risk assessment.

  298
  00:26:21,335 --> 00:26:23,815
  And and in any part of the pharma.

  299
  00:26:23,815 --> 00:26:24,134
  Yeah?

  300
  00:26:24,134 --> 00:26:24,615
  Mhmm.

  301
  00:26:24,615 --> 00:26:29,460
  But and this is what we have to fit into our AI system.

  302
  00:26:29,940 --> 00:26:30,500
  Okay?

  303
  00:26:30,740 --> 00:26:40,934
  Now it's coming, the regulator and say, hey, guys, you have been doing this very not really science based logic

  304
  00:26:40,934 --> 00:26:41,335
  thinking.

  305
  00:26:41,335 --> 00:26:43,095
  There is a lot of subjectivity.

  306
  00:26:43,815 --> 00:26:44,374
  Exactly.

  307
  00:26:44,615 --> 00:26:44,934
  Yeah.

  308
  00:26:44,934 --> 00:26:45,414
  Yeah.

  309
  00:26:45,654 --> 00:26:46,374
  Sure.

  310
  00:26:46,615 --> 00:26:47,974
  I cannot I can agree.

  311
  00:26:47,974 --> 00:26:48,934
  I can disagree.

  312
  00:26:49,015 --> 00:26:50,614
  Everybody brings his part.

  313
  00:26:51,015 --> 00:26:57,950
  Now we are training our AI with subjectivity in or we wait that we have a better data?

  314
  00:26:58,190 --> 00:27:02,109
  Or the AI will be maybe a generative AI push.

  315
  00:27:09,630 --> 00:27:10,349
  A bit.

  316
  00:27:11,164 --> 00:27:12,284
  Did wrong.

  317
  00:27:12,765 --> 00:27:19,325
  There's some Alright.

  318
  00:27:19,325 --> 00:27:22,204
  Well, let's, let's get back to these tracks.

  319
  00:27:23,539 --> 00:27:25,779
  New topic here is sustainability.

  320
  00:27:25,859 --> 00:27:29,940
  It's not new to the industry, but shifting away from digital for a moment.

  321
  00:27:30,579 --> 00:27:35,140
  Sustainability is certainly a rising priority across the industry.

  322
  00:27:35,785 --> 00:27:45,865
  And how are engineering and digital digitalization teams incorporating sustainability from modular design to reduced

  323
  00:27:45,865 --> 00:27:49,384
  utilities into future ready facility strategies?

  324
  00:27:52,539 --> 00:28:09,595
  Let let me without going into the details, I I was

  325
  00:28:09,595 --> 00:28:09,994
  reading.

  326
  00:28:09,994 --> 00:28:14,474
  This was in the report of the from pharmaceutical companies who say, hey, we are more sustainable.

  327
  00:28:14,859 --> 00:28:24,859
  We change the gardening of the facility in Vocationix from green grass to cactanes or something like that, that

  328
  00:28:24,859 --> 00:28:26,460
  we consume less water.

  329
  00:28:26,460 --> 00:28:27,019
  You are right?

  330
  00:28:27,019 --> 00:28:29,259
  That's the first it was the first step.

  331
  00:28:29,585 --> 00:28:39,585
  I think we went then to the water systems, for instance, to start to question, keep systems like a water system before nobody was touching

  332
  00:28:39,585 --> 00:28:40,464
  the water system.

  333
  00:28:40,464 --> 00:28:42,970
  Like, this is the distil, Don't question it.

  334
  00:28:42,970 --> 00:28:44,409
  This has been always like that.

  335
  00:28:44,490 --> 00:28:46,489
  Now the people will start to question.

  336
  00:28:46,730 --> 00:28:51,129
  Do how I can save energy in these systems?

  337
  00:28:51,289 --> 00:28:53,529
  Do I need to heat it, cooling down?

  338
  00:28:54,025 --> 00:28:56,585
  This means a very a lot of inefficiencies.

  339
  00:28:56,585 --> 00:29:02,265
  That means they are working very precise, and they are bringing fantastic new systems to the market, yes?

  340
  00:29:02,265 --> 00:29:11,440
  There is a but you can see that we had need a push to go out from that and be able to question the systems we have today.

  341
  00:29:12,319 --> 00:29:22,494
  What is, to my point of view, is going to be inter sustainability, and this is really open to me a new box, is that if the from the European side,

  342
  00:29:22,734 --> 00:29:28,734
  we bring sustainability as part of the drug approval process to say, okay, how sustainable you are.

  343
  00:29:29,375 --> 00:29:31,774
  Because then we are opening.

  344
  00:29:31,775 --> 00:29:36,960
  That is not the garden, is not the utility systems that they are indirectly.

  345
  00:29:37,039 --> 00:29:39,039
  We're gonna start to walk into the process.

  346
  00:29:39,920 --> 00:29:44,640
  And to walk into the process, to say, do do I really need this step?

  347
  00:29:44,640 --> 00:29:50,825
  I've seen presentations into people who's questioning, like, do I need this chromatography system?

  348
  00:29:51,704 --> 00:29:57,464
  And the answer is, like, yeah, we have it for the endotoxin reduction just in case.

  349
  00:29:57,464 --> 00:30:01,625
  And it's like, but just in case means so much water, so much this, so much that.

  350
  00:30:02,119 --> 00:30:08,759
  That means then we are start to have a discussion between product safety, product quality and sustainability.

  351
  00:30:08,920 --> 00:30:14,279
  Of course, sure, the product quality will prevail.

  352
  00:30:14,279 --> 00:30:14,840
  That is clear.

  353
  00:30:15,184 --> 00:30:21,264
  But maybe we will then we will question how we make the process itself, yes?

  354
  00:30:21,345 --> 00:30:31,640
  And this is then connected to drug substance of concern, PFAS, that maybe is not only in our raw

  355
  00:30:31,640 --> 00:30:33,399
  materials or consumables.

  356
  00:30:33,720 --> 00:30:43,720
  There is direct use of this type of substance or very strong in related to chemical synthesis of the new type of drugs

  357
  00:30:43,720 --> 00:30:45,079
  that very popular now, yes?

  358
  00:30:45,384 --> 00:30:54,585
  That means this is a big challenge how we are going to produce some of the chemical entities that are our products, our therapies.

  359
  00:30:55,304 --> 00:31:05,179
  That means sustainability is that like a wound that it's Well, it's Probably it's not blowing.

  360
  00:31:06,299 --> 00:31:16,765
  There's the concept of quality by design, which really gets back to how you design the modality, the

  361
  00:31:16,765 --> 00:31:21,884
  the molecule, how you make it, what the unit operations are.

  362
  00:31:22,845 --> 00:31:33,079
  It sounds like we're talking about sustainability by design and bringing together the intersection of quality by design and

  363
  00:31:33,079 --> 00:31:34,839
  sustainability by design.

  364
  00:31:36,119 --> 00:31:40,704
  Hopefully, they they align and don't conflict.

  365
  00:31:40,704 --> 00:31:41,984
  That's correct.

  366
  00:31:41,984 --> 00:31:42,864
  That's correct.

  367
  00:31:43,105 --> 00:31:43,345
  Yeah.

  368
  00:31:43,345 --> 00:31:44,224
  That is interesting.

  369
  00:31:44,224 --> 00:31:46,224
  It's very, very, very interesting.

  370
  00:31:47,505 --> 00:31:49,984
  The last track is regulatory.

  371
  00:31:49,984 --> 00:31:51,424
  Can't forget that one.

  372
  00:31:52,304 --> 00:32:03,269
  How are regulatory and quality functions evolving to support innovation, collaboration, and global harmonization

  373
  00:32:03,750 --> 00:32:10,390
  while maintaining robust quality management systems, effective risk management, and inspection readiness.

  374
  00:32:13,144 --> 00:32:23,705
  If I think the I think regulatory and the regulatory agencies, they also realize not

  375
  00:32:23,705 --> 00:32:33,750
  far that they need to change, that they need to that we need a easier, quicker dialogue within

  376
  00:32:33,750 --> 00:32:44,044
  the industry that they need to understand what are the our challenge and to bring as quick as they can

  377
  00:32:44,125 --> 00:32:47,484
  respond to help to move on.

  378
  00:32:48,045 --> 00:32:58,049
  There is a lot of we can find in the FDA, we can find in the about especially innovation, yes, of new technologies as well as for

  379
  00:32:58,049 --> 00:33:04,929
  new modalities, chemical entities or products, yes?

  380
  00:33:05,090 --> 00:33:05,970
  That is obvious.

  381
  00:33:06,835 --> 00:33:17,394
  And I think the industry is also participating on that, opening because usually, it's like don't share much more than you need to share.

  382
  00:33:17,394 --> 00:33:19,394
  I think there is a change in the attitude.

  383
  00:33:20,539 --> 00:33:24,139
  And this is making that this dialogue is happening.

  384
  00:33:24,460 --> 00:33:25,660
  But this is a need.

  385
  00:33:25,660 --> 00:33:30,539
  I think it's we cannot go on as we have done until now.

  386
  00:33:30,700 --> 00:33:39,924
  There is a superior need, And this will change the way we the type of relationships we have between regulatory and industry.

  387
  00:33:40,804 --> 00:33:48,089
  And what is today like an experiment, which is going to make an innovation group, this should come become to a routine.

  388
  00:33:48,730 --> 00:33:54,009
  Nonetheless, and this is my opinion, yes, there is so many things happening.

  389
  00:33:54,809 --> 00:33:57,289
  And I'm talking now as European, yes?

  390
  00:33:57,529 --> 00:34:02,265
  We are waiting that I will not do anything until I have a regulation.

  391
  00:34:02,585 --> 00:34:08,824
  And in some way, we have the somebody who said, you are doing right.

  392
  00:34:08,824 --> 00:34:10,025
  That is the way you need.

  393
  00:34:10,025 --> 00:34:12,425
  And we cannot wait to that.

  394
  00:34:12,559 --> 00:34:22,559
  I think we need, and this may be a challenge, once again, a knowledge, to go to the basics and understand why we regulate and how much

  395
  00:34:22,559 --> 00:34:24,239
  regulation is necessary.

  396
  00:34:24,559 --> 00:34:34,994
  Because if we expect a regulation for every new modality, for everything we do new, for every new technology, yes, you can go on.

  397
  00:34:35,235 --> 00:34:36,994
  This is not efficient.

  398
  00:34:37,554 --> 00:34:40,034
  We cannot do that, my opinion, yes?

  399
  00:34:40,510 --> 00:34:47,070
  That means regulatory is, I think, is changing, but it will be even changing much more.

  400
  00:34:47,070 --> 00:34:54,190
  It will not be the agencies will have a different way of approaching compared to what have been until now.

  401
  00:34:55,414 --> 00:35:05,574
  Well, from my perspective, if you've got new modalities, new technologies, new devices, delivery system,

  402
  00:35:05,574 --> 00:35:16,190
  whatever, that as long as you've really thought through the process control system and the contamination control system, and

  403
  00:35:16,190 --> 00:35:26,394
  you've got everything buttoned up, tightened down, we've got this in control, whatever the risks to quality, the risks to

  404
  00:35:26,394 --> 00:35:28,795
  the process contamination.

  405
  00:35:28,875 --> 00:35:33,675
  If you've got those figured out, you don't need a regulation.

  406
  00:35:34,635 --> 00:35:35,994
  You're complying.

  407
  00:35:36,234 --> 00:35:42,420
  That that would be my, take on it or advice to a client, for example.

  408
  00:35:44,420 --> 00:35:54,820
  Well, as conference chair, what conversations or emerging topics are you personally most excited to bring to the forefront in

  409
  00:35:54,820 --> 00:36:05,215
  this conference, whether new regulatory landscape, AI governance, digital validation breakthroughs, supply resilience, future facility design.

  410
  00:36:05,454 --> 00:36:10,335
  What's what's, got you excited, to talk about at the conference?

  411
  00:36:11,819 --> 00:36:17,420
  If you ask, I've been a lot of conference over the years.

  412
  00:36:17,739 --> 00:36:20,940
  And before, I will have, as you mentioned, we are engineers.

  413
  00:36:20,940 --> 00:36:27,025
  I will have gone to the engineers and spent the whole day in the engineering until you get saturated, yeah?

  414
  00:36:27,824 --> 00:36:31,425
  With the time, and to me, it's a big recommendation.

  415
  00:36:31,425 --> 00:36:39,824
  Maybe if you are in a special topic for engineering, I will go and spend the time in the engineering, maybe 50% of the time.

  416
  00:36:40,670 --> 00:36:50,829
  But I will always recommend and this is the beauty of to be in this type of conference where we are is multiple topics at the same

  417
  00:36:50,829 --> 00:36:58,695
  time to go and sit down with the regulators, even the quality and regulatory track.

  418
  00:36:58,695 --> 00:37:08,769
  And you will see how discussed, I will go to a little bit of all the tracks and try

  419
  00:37:08,769 --> 00:37:10,929
  to learn.

  420
  00:37:10,929 --> 00:37:12,609
  Maybe I even don't understand.

  421
  00:37:12,690 --> 00:37:22,784
  Maybe I go to a presentation and I say, I I really but then I will also realize that I'm in strings that is happening next to me in the next door that

  422
  00:37:22,784 --> 00:37:27,425
  I don't have an idea, and I should be aware of it.

  423
  00:37:27,425 --> 00:37:29,425
  I cannot live in isolation today.

  424
  00:37:29,425 --> 00:37:31,105
  I cannot be just an engineer.

  425
  00:37:31,585 --> 00:37:37,450
  I will always recommend it and to work to the other disciplines.

  426
  00:37:37,450 --> 00:37:46,329
  This is why I don't take I think and everybody's important.

  427
  00:37:46,329 --> 00:37:49,930
  People should understand how so how we make projects.

  428
  00:37:51,505 --> 00:38:01,985
  I don't like to make a priority first what is your feel, but also listen if you have the chance to listen and look what

  429
  00:38:01,985 --> 00:38:04,784
  else is happening around you because it's important.

  430
  00:38:05,139 --> 00:38:13,380
  And don't forget, and sometimes engineers also say, wow, the keynote speakers, they are some way far away from us.

  431
  00:38:13,699 --> 00:38:15,619
  Yes, but they have a view.

  432
  00:38:15,619 --> 00:38:22,555
  And sometimes it's very important to really listen what this how the people thinks because they are guiding us.

  433
  00:38:22,875 --> 00:38:30,875
  That means what they are telling to you today maybe is in five years the the truth, and then you will understand the changes.

  434
  00:38:30,875 --> 00:38:34,394
  That means even keynotes, it's a must rule.

  435
  00:38:34,394 --> 00:38:38,900
  That means don't I will not make a special pick.

  436
  00:38:38,900 --> 00:38:41,859
  Try to absorb as much as you can.

  437
  00:38:41,859 --> 00:38:52,204
  And the most important, charge batteries because conferences to me is to charge the batteries with energy, with all the what you listen, what you learn

  438
  00:38:52,364 --> 00:38:55,005
  and the discussions you can have with your peers.

  439
  00:38:56,765 --> 00:38:57,885
  That's so true.

  440
  00:38:57,885 --> 00:38:58,925
  That's so true.

  441
  00:38:59,244 --> 00:39:03,724
  This has been a great conversation.

  442
  00:39:05,480 --> 00:39:13,159
  Maybe to recap a little bit, we've got some great keynotes from both regulatory, and industry leaders.

  443
  00:39:14,199 --> 00:39:24,675
  You've got a new format, this, interactive kind of format to these sessions, which if if it gets

  444
  00:39:24,675 --> 00:39:29,394
  done right, that'll be really exciting and really engaging for the participants.

  445
  00:39:31,109 --> 00:39:41,429
  And then just overall, we've talked about how, technology and science and the patient needs that are out there, how

  446
  00:39:41,670 --> 00:39:50,244
  we can meet those so much more effectively and hopefully faster, when we bring all those things together.

  447
  00:39:51,925 --> 00:39:58,644
  That brings us to the end of another episode of the ISPE podcast, shaping the future of pharma.

  448
  00:39:59,719 --> 00:40:10,679
  A big thank you to our guest, David Estappe, for sharing more about what we can look forward to at the twenty twenty six ISPE

  449
  00:40:10,839 --> 00:40:17,465
  Europe Annual Conference, April in Copenhagen, Denmark.

  450
  00:40:18,744 --> 00:40:27,710
  Please be sure to subscribe so you don't miss future conversations with the innovators, experts, and change makers driving our industry forward.

  451
  00:40:28,349 --> 00:40:38,510
  On behalf of all of us at ISPE, thank you for listening, and we'll see you next time as we continue to explore the ideas, trends, and people

  452
  00:40:39,002 --> 00:40:40,602
  shaping the future of pharma.