Category Archives: YP

ISPE D/A/CH YP&S Member Spotlight – Robin Schiemer

– Biochemical engineer by training (B.Sc. + M.Sc at KIT)
– PhD candidate at Karlsruhe Institute of Technology with focus on
   artificial intelligence and machine learning for bioprocess engineering
– newly elected chair of the ISPE DACH YP & Students, YP member since 2017

Why did you join the ISPE community?

When I joined the ISPE, I was right at the end of my first internship in the pharmaceutical industry and joined the very first ISPE Hackathon in Barcelona. I very much liked the vision of bringing together young people, introducing them into the industry network, sharing knowledge and ideas and bridging the gap to the senior experts. It felt like the group is on the move and wants to achieve something.

How was your process to decide to do a PhD?

During my time as a student, I was always intrigued by research and the new solutions it may generate to various kinds of problems. Having worked for several companies, I learned that these solutions must be efficient and feasible to be implemented in the industry. For my decision to perform a PhD, it was important that my work is tightly connected to an industrial application and that a multidisciplinary research group surrounds me.

What would your “dream job” look like?

In my “dream job”, I steer a multidisciplinary group of people from various backgrounds to implement state-of-the-art solutions to improve people’s health and have a positive societal impact.

What are your takeaways as Co-Chair of the ISPE D/A/CH YP&S?

It was great to see the ISPE D/A/CH YP&S subgroup growing throughout the last years. I really appreciate the increasing support from all sides and the engagement of all our members. The collective motivation and the momentum one generates by hosting events, sharing knowledge or brainstorming new ideas is the key aspect of my experience with the group.

Where do you see yourself in ten years?

This question can be answered from different perspectives. Personally, I see myself as a (hopefully) happy, open-minded and curious 36 year-old. Professionally, I envision myself as the leader of a small team within a life-science company, progressing my managing capabilities and collaboratively working on valuable products for the broad society.

How do you spend your free time?

I spend my free time mostly outside doing sports like running or climbing or enjoying the nature while hiking or mountain biking. During my physical breaks, I like to read books, watch series or play computer games.

Future Leaders’​ Day 2019 – Connecting Expertise with Fresh Ideas

When was the last time you looked beyond the boundaries of your everyday business?

Last week, 50 Emerging Leaders and students from the D/A/CH region took the chance to expand their horizons through participation in the ISPE Future Leaders’ Day 2019 in Berlin.

In the headquarters of Bayer AG Pharmaceuticals, the two-day event brought together experienced leaders of the industry with curious and motivated leaders of the future, creating a unique opportunity for fruitful and mutually inspiring experience exchange. A hands-on PAT-Workshop, multiple site visits, a networking event, and six talks by industry experts followed by very lively Q&A offered a broad range of activities that catered for all tastes.

Starting on Thursday afternoon, the participants were offered three site visits:

The first site visit was jointly hosted by KORSCH AG and L.B. Bohle M+V GmbH at the production facilities of KORSCH in Berlin. Sebastian Eichler and Andreas Teske from the two partnering companies introduced technological advances in the process equipment for solid dosage forms, including an exclusive augmented reality tour; for the second option,
Sven Filler from Bayer AG gave us insights into project management of fully automated facilities for aseptic fill and finish. Participants could walk through the future facility in an augmented reality tour.
The third group had the chance to learn about the production and packaging processes of pharmaceutical products in the Bayer Supply Center Berlin.

After this exciting kick-off, the participants were assembled at the networking event in the 21st floor high above Berlin, where #ispe dach board members and the sponsors of the event joined to complete the day in a relaxed and informal atmosphere with food and drinks.

Starting with a welcome presentation by Zen-Zen Yen (Bayer AG) the main event was kicked off, followed by Chris Williams (Hoffman-La Roche) and Thiemo Huuk (Go Silico), addressing the topic of manufacturing process development in Biotech. After a coffee break, an introduction into Project Management was given by Michael Kaiser (B.Braun) with Matthias Kress (TechPivot GmbH) continuing with a focus on precision medicines.

Afterwards, Peter Brandstetter (PwC) touched upon the compliance problematic of the emerging technologies and Martin Hellmuth (B.Braun) concluded the day with an impressive talk about Commissioning & Qualification Processes. Vivid discussions accompanied every talk and a great Q&A session made it possible to address the arising questions.

An exciting and collaborative PAT-Workshop, led by Hubertus Rehbaum, complemented the event with a great hands-on experience.

United under the broad topic of ‘Technological Advances in Pharma Industry’, the ISPE D/A/CH YP Future Leaders’ Day 2019 made it possible for every attendee to have a look at the known topics from a different perspective and to connected with like-minded people and industry peers.

We hope you enjoyed this happening as much as we did and hope to see you next year! With the warmest words of the gratitude to our sponsors, Korsch AG, L.B. Bohle, and GoSilico,

FLD2019 Orga Committee: Reinhard Benninghoven, Jan Demmer, Patrick Fabian, Maria Kozyrev, Alexandros Papadopoulos, Hubertus Rehbaum.

Further reading:

Member Spotlight: Zen-Zen Yen

Zen-Zen Yen is a highly active Emerging Leader in the ISPE D/A/CH Affiliate who also is engaged in the Affiliate’s Women in Pharma® initiatives and is serving as a Coach at the upcoming ISPE Student & Emerging Leader Hackathon at 2019 ISPE Annual Meeting & Expo. We talked with Zen-Zen to learn more about her experiences with ISPE and what drives her to continually motivate others.

ISpeak Blog

Workshop “Containment – 2025” at the new FHNW Campus in Muttenz

The ISPE D/A/CH Containment Community of Practice conducted the workshop “Containment – 2025” at the new FHNW Campus in Muttenz from the 13th to the 15th May

Among the participants were experts from the industry, Emerging Leaders and, for free, more than 60 students from different universities.
Moreover, students of the newly founded FHNW Student Chapter of the ISPE participated in the workshop.

As main organizers, Professor Berndt Joost and myself were responsible for the smooth execution of the workshop at the FHNW.

Since half of the participants have never come into contact with industry and containment before, the basics were taught on the first day of the event. The students were very interested and first connections with representatives from the industry were made. On the second day of the workshop, the University of Applied Sciences and Arts Northwestern Switzerland introduced itself and the participants were given insights into the various institutes of the FHNW. The participation and enthusiasm of the participants about modern technologies and instruments were the basis for exciting discussions.
Subsequently, a workshop on the handling of new substances in R&D was held at the FHNW’s Process Technology Center (PTC). The PTC is a pilot plant with state-of-the-art facilities in the fields of biotechnology, natural substances, chemical, (bio-) pharmaceutical and environmental technology. At the evening event, the Pantheon in Muttenz was visited, where the participants got an insight into the history of vintage cars.
On the last day of the event, the results of the workshop from the previous day were discussed. The involvement of numerous experts yielded in high quality discussions. The students and Emerging Leaders benefited greatly from this exchange of experience.

The event enabled the participants to expand their network. Students were able to generate contact with the industry especially regarding a master’s thesis in an industrial setup. This highlights the work and investments of ISPE D/A/CH Affiliate to support young generations. The University of Applied Sciences and Arts Northwestern Switzerland thanks ISPE for holding the event at FHNW and looks forward to further cooperation.

– Mustafa Gündüz – Muttenz Student Chapter Chair

I had a great pleasure to give an overview of the YP Community in Europe and present the ongoing activities in the D/A/CH region

About half of the participants were new to the industry, and keen to understand how to successfully and smoothly transition from the university into the business environment.
I presented how different working groups – Events Planning; Marketing; Training and Mentoring – provide an excellent space for Emerging Leaders to sharpen their soft skills regardless of the university background and collaborate with peers on projects across different industry-relevant topics. There was an overall high interest from students, which proved the need to focus on students groups and formalize the activities for them to make it accessible to join while still studying. Some questions were related on collaborations with the pharmaceutical companies on projects as part of the Master’s thesis, as well as possibilities and criteria for participation in workshops and the annual Hackathon.
This event hopefully gave good ideas to the newcomers how to jump-start the career, and displayed once again how much D/A/CH Affiliate invests into actively developing the young generations. Thank you to the organizers for this opportunity and for bringing in so many new faces!

– Martina Lauš, ISPE Europe YP Chair

A Success Story: Staying centered – Stress & Emotional Intelligence as a project manager

Staying centered – Stress & Emotional Intelligence as a project manager

Webinar by Kelly Keen

4 June 2019, at Celonic Deutschland GmbH & Co. KG, Heidelberg

Entering a former slaughterhouse turned GMP manufacturing facility, myself and Ignacio Pena met Ms. Kelly Keen for the first time in person.
She began with a presentation she gave to the ISPE Board in Dublin on ways she sees the YPs helping us form the Workforce of the Future by expanding affiliations with Universities all over the world, launching STEM programs and expanding the DACH Hackatons to Asia and the US.

The feature presentation traveled through her past as a PM and ISPE YP member with over 30 years’ experience in the industry.

The presentation was organized in four sections:

1.) The effects of stress on mental & physical wellbeing
2.) How genetics play a role in how people perceive and deal with stress, knowing some things are programmed into your DNA
3.) Wellness coping strategies that she has experimented with as a fitness instructor for 30 years
4.) How all this calculates into our emotional intelligence and how we communicate with others.

In the future, our ability to challenge, have empathy and communicate emotionally will set our skills apart from Artificial Intelligence.

Get a glimpse of this stunning personality, sharing inside her mental landscape. Take the chance to learn from her coping strategies tackling immense pressure.

In the fourth episode of the ISPE D/A/CH Emerging Leaders webinar series we will distance ourselves from technical subjects and move to a far more valuable asset, the emotional well-being.
“Staying Centered – Stress & Emotional Intelligence as a Project Manager” is a one-and-a-half-hour lasting journey through Kelly Keen`s experiences, during which the audience got the chance of asking personal questions.

Move deeper into her past and family history in the search for answers, returning with the right set of skills, a mixture of exercise, nutrition and meditation to counteract the physical and mental self-abuse, hopefully making her a better leader, person and partner.

If you are interested in her story, watch the recording of this webinar, freely available for all ISPE members.

Authors: Rudger Heß & Kelly Keen
Lindau, June 12, 2019

Members of the YP ISPE D/A/CH joined the ISPE Hackaton in Dublin

“It’s 2030 and you have just been employed at Jigsaw Inc., a nre company, an innovative new pharmaceutical manufacturer. You are placed in a multi-disciplinary technical team and a Community of Practice to develop a strategy for a new multiproduct manufacturing facility in Dublin.”

As members of the YP DACH, we, Jan Demmer and Patrick Fabian, joined the ISPE YP Hackathon in Dublin which was part of the ISPE Europe Annual Conference 2019. During this event, we were able to meet young colleagues from all over Europe.

The ISPE YP Hackathon is a two-day workshop that is fully organized by dedicated YPs from all over Europe. Going into its third round this year, many different topics were covered – always keeping the future in mind. In this year’s edition, we faced the challenge of creating a new multi-drug manufacturing facility. In multidisciplinary teams and with the help of experienced trainers from the pharmaceutical industry, each team provided background knowledge and innovative ideas.

Novel aspects such as cloud solutions, 3D printing and automation were discussed and challenged during implementation. In addition, the participants improved their skills in cross-functional organization and working within international groups.

Just as in the last years, a focus was set on breaking down silos and innovative problem solving. All set in a fun and encouraging environment.

Not only the fantastic energy of the group, but also the audience was highly motivating. In the end, we had to present our results to members of the “Global Pharmaceutical Manufacturing Leadership Forum” which selected the winning team.

All in all, the great teamwork and sharing of backgrounds was of enormous value to everyone. Outstanding was to us that all groups put the patient at the centre of their presentation.

Most of the YPs travelled at their own expense and made the choice to spent their free weekend. It is tremendous to see how dedicated and passionate all participants were.

We have to thank the Irish YPs for the perfectly organized hackathon. To us, it was a great success.

Acknowledgement: The trip to Dublin of Jan Demmer was supported by ISPE YP DACH affiliate with a travel grant. Thank you very much!

Jan Demmer
Project Engineer
B. Braun Melsungen AG

Fabian Patrick
Junior Consultant Compliance
Arcondis AG

Die YP Future Leaders´ Days 2018

Basel. Die Veranstaltung der Emerging Leaders, die ‘Future Leaders´ Days 2018’, war mit mehr als 80 Emerging Leaders und Studenten ein voller Erfolg.

Die Rückmeldungen waren durchweg positiv.

Ein besonderer Dank geht an die Sponsoren
– F. Hoffmann La-Roche AG (Betriebsbesichtigung, Raum und Catering),
– nne unnd CRB für die Ausrichtung des abendlichen Zusammenseins.

Impressionen >>>

Emerging Leaders gestalten mit

Göttingen. Auf dem diesjährigen Workshop der ISPE D/A/CH „PHARMA 2025: „Modularity, Flexibility, Scalability – New Trends & Experiences in Pharma” bei Sartorius in Göttingen wurde mit spannenden Vorträgen aus der Industrie der Trend zur Modularisierung in der (bio)pharmazeutischen Produktion aufgezeigt und diskutiert.

Mit dabei waren mit Chloe Lang (Sartorius Stedim Data Analytics AB), Dominik Bahiense de Mello (Sartorius Stedim Biotech GmbH) und Robert Geiger (M+W Central Europe GmbH) drei ISPE D/A/CH Emerging Leaders.

Am zweiten Tag der Veranstaltung präsentierte Chloe Lang die Zielsetzung der YPs. Sie stellte vergangene und kommende Veranstaltungen der YPs vor.

Anschließend beantworteten bei einer durch die ISPE D/A/CH Emerging Leaders initiierten und organisierten Podiumsdiskussion Stefan Schafmeister (M+W Central Europe GmbH) und Dr. Michael Atzor (Bayer Pharma AG) grundsätzliche Fragen zu diesem Trend. Die Inputs zum Thema und realisierten Projekten der Befragten und des Fachpublikums führten zu guten Einblicken.

Das Format einer Podiumsdiskussion mit Experten und dem Fachpublikum hat sich bewährt und wird beibehalten, zukünftig in geeignete Workshops integriert.

ISPE Pharma 4.0 Konferenz in Verona

Verona. Teilnehmer aus 19 Ländern trafen sich im Villa Quaranta Hotel in Verona, Italien, um mehr über die Herausforderungen und Möglichkeiten von Pharma 4.0 zu lernen. Die Konferenz wurde von der Italien Affiliate in Zusammenarbeit mit der Special Interest Group (SIG) „From Industry 4.0 to Pharma 4.0“ organisiert. Vertreter von ISPE Arbeitsgruppen und Innovationsleader in Pharmafirmen, CMO’s, Lieferantenfirmen, Consulting Unternehmen und aus dem akademischen Umfeld boten in ihren Präsentationen wertvollen Input. Die Hauptthemen der Konferenz waren End-to-End Integration, Datenintegrität und –analytik, Automation und die Arbeitswelt der Zukunft. Die Besucher konnten ihr Netwerk erweitern und ihre Ideen mit Kollegen und Spezialisten diskutieren.

Eröffnet wurde die Konferenz am Donnerstag morgen mit Keynote Sessions. Uli Kuchenbrod (Vetter Pharma) präsentierte das Pharma 4.0 Maturity Model, welches von der Pharma 4.0 SIG entwickelt wird und welches es den Firmen ermöglicht, ihren momentanen Stand auf dem Weg zu Pharma 4.0 zu evaluieren und ihre nächsten Schritte zu bestimmen. Christian Wölbeling sprach über die (englisch) „Holistic Manufacturing Control Strategy“, welches die Grundlage für pharmazeutische Produktion von morgen legen soll. Alistair Orchard, Vice President Digital Enterprise von Siemens, lieferte Inspiration von Seiten der nicht-pharmazeutischen Industrie 4.0-Welt. Er verdeutlichte die Dringlichkeit, mit welcher Siemens die Entwicklung hin zu neuen Technologien und Geschäftsmodellen vorantreibt. Das Unternehmen erkannte bereits vor mehreren Jahren, dass das Beharren auf bewährten Geschäftsmodellen unter Umständen den Konkurs bedeuten kann und investierte in der Folge mehrere Milliarden US-Dollar in neue Technologien und Produkte. Als beispielhafte Resultate dieser Anstrengungen zeigte Alistair einen automatisierten Entwicklungsprozess für Maschinenteile basierend auf künstlicher Intelligenz. Das Unternehmen ist heute zudem in der Lage, anhand eines „Digital Twins“ komplette Fertigungsstraßen noch vor dem Bau der Anlagen bis ins kleinste Detail zu simulieren.

Nach dieser generellen Einführung wurde das Programm in zwei Tracks aufgesplittet, zwischen welchen sich die Teilnehmer entscheiden mussten: „Quality & Predictive Control“ und „Automation & Industry 4.0 Enabling Technologies“. Oliver Ingold war als Vertreter der YP DACH Gruppe als Co-Chair am “Quality & Predictive Control” Track beteiligt. Die Präsentationen von Francesco Mina (Janssen) und Stefano Gelsomini (LivaNova) zeigten jeweils erfolgreiche Beispiele für den Einsatz von PAT-Technologie zwecks Prozess-Steuerung und Real-Time Release Testing. Bei Janssen sind zudem erste Versuche im Bereich der modellprädektiven Regelung im Gange. Matthias Arnold (Externer Berater Digital Enterprise bei Eppendorf) sprach über die tiefere Vernetzung von Laborgeräten. Dieser Ansatz ist spannend, weil dank der Einführung von continuous manufacturing und kleinerer Batchgrössen (Stichwort personalisierte Medizin) auch die Verwendung von Laborgeräten für die Produktion bald Realität werden könnte. Sehr interessant war zudem Nuala Calnan’s Präsentation zum Thema Unternehmens- und Qualitätskultur. Sie zeigte, dass sich die Qualitätskultur in Produktionsanlagen anhand verschiedener Indikatoren (zum Beispiel CAPA-Effektivität oder Anzahl an Verbesserungs-Vorschlägen von Mitarbeitern) messen lässt. Außerdem konnte sie klar zeigen, dass Anlagen mit einer starken Qualitätskultur und hoher Prozessstabilität signifikant zuverlässiger Produkt in der erforderlichen Qualität liefern. Nuala ist Co-Leader des ISPE Quality Culture Teams, welches kürzlich den Quality Culture Report (Gratis-Download für ISPE-Mitglieder) veröffentlichte. Schließlich zeigte Robert Gärtner, Director of Quality bei Veeva, die Vorteile von Cloud-Lösungen für qualitätsrelevante Systeme wie QMS, DMS und LIMS auf. Während heute in der Cloud schon Daten-Analyse durchgeführt wird (u.a. Release by Exception), könnte in Zukunft auch prädiktive Analyse anhand künstlicher Intelligenz möglich sein.

Nebst Oliver Ingold waren drei weitere Emerging Leaders als Co-Chairs an der Konferenz involviert: Frederico Poli (Italien), Juan José Alba Gil (Spanien) und Abdelghani Meqdad (Frankreich). Die vier YPs hatten gemeinsam einen halbstündigen Workshop im Rahmen des Workforce of the Future Tracks auf die Beine gestellt.

Die vier Organisatoren des YP Workshops: Federico Poli, Abdelghani Meqdad, Juan José Alba Gil und Oliver Ingold

Das Konzept des Workshops funktionierte folgendermassen: Das Ziel war die Entwicklung einer Roadmap zu Pharma 4.0 für vier verschiedene Szenarien von fiktiven Firmen. Die Teilnehmer wurden in Teams von 7 Personen eingeteilt und jedes Team hatte eine der vier Fallstudien zu bearbeiten. Jeder Teilnehmer bekam eine von sieben Rollen in einem Unternehmen zugeteilt: Engineering, Business Unit/Marketing, QA/Regulatory Affairs, IT/OT, Manufacturing & Supply Chain, R&D und Transition Manager. Die Aufgabe der ersten 6 Rollen bestand darin, das Roadmap-Template mit konkreten Ideen (Post-It) zu füllen. Der Transition Manager war dafür zuständig, die 6 Departemente zu koordinieren.

Die Teilnehmer zeigten sehr gute Teamfähigkeit und arbeiteten effizient. Trotz Zeitdruck (schlussendlich blieben nur etwa 15 Minuten für die Erledigung der Aufgabe) wurden interessante Lösungen und schlüssige Roadmaps zu deren Umsetzung entwickelt. Das Ergebnis für die fiktive Firma DermaCare wird in einem Artikel des  Pharmaceutical Engineering Magazins (Ausgabe März-April 2018)  näher beleuchtet.

Roadmap zu Pharma 4.0 für das fiktive CMO ActiChem.

Zum Abschluss der zweitätigen Konferenz wurde die Take-Home Message der Veranstaltung noch einmal wiederholt: Pharma 4.0 und Industrie 4.0 sind nicht nur mit weiterer Automatisierung und Digitalisierung gleichzusetzen. Letztere sind nur eine Folge bzw. ein Mittel zur Umsetzung einer Strategie von Pharma 4.0. Pharma 4.0 steht für den Wandel der Pharma-Firmen und Ihrer Partner zu neuen Businessmodellen, Healthcare-Technologien und Unternehmenskulturen.

Introduction of Thorsten Böhle, YP Chair

Thorsten Böhle is a project engineer for process automation and manufacturing execution systems (MES) at F. Hoffmann-La Roche AG in Basel, Switzerland. He holds a position as sub project manager for Automation & MES in a new late stage development and commercial launch facility for solid dosage forms at Roche’s headquarter. Before joining Roche in 2011, he worked four years as an automation engineer in global engineering at B. Braun Melsungen AG in Germany. In March 2017 Thorsten was elected as chair of the ISPE Emerging Leaders for Germany, Austria and Switzerland (DACH). He lives with his family in Basel. His leisure time he loves to spend in the mountains where he organizes alpine tours for the mountain & ski section of Roche Sports Club.

What made you join the ISPE?

The first time the ISPE caught my attention some years ago. Quite by chance, a colleague had a PE Magazine on his desk and I read about the Facility of the year awards. Before that time I didn’t know in detail what ISPE was about, but screening the issue gave me a broad impression about the variety of activities that ISPE offers: workshops, trainings and “Communities of Practice”.

With respect to my area of responsibility at Roche I found out about specific ISPE events on work-related topics like Pharma 4.0, data integrity, continuous manufacturing and more. When I finally attended an event I was favorably impressed by the different groups of participants. Besides attendees from big pharmaceutical companies you get in touch with people from vendors, regulators and academia. So I realized that ISPE could be a great platform for finding answers to questions that one party alone would not be able to solve. When Marcel Staudt and Gunter Baumgartner introduced the ISPE mission to me, I decided that I definitely wanted to be part of it.

What are your tasks / projects in ISPE?

I am actively involved in ISPE matters since March 2016 when I got to know Robert Landertinger from ISPE DACH who is part of the DACH advisory board. During this time ISPE DACH announced the need of setting-up a Emerging Leader network. The purpose of such kind of group was to attract people at the very beginning of their professional career as well as students and provide a platform that meets their needs and expectations.

With already ten years’ experience in the pharmaceutical industry, I was no longer a YP anymore but saw the advantage in using my experience for establishing a core team in close collaboration with the other founder members. Since March 2017, I am leading the group as Chair.

This team has already some impressive achievements to show: We founded dedicated working groups for marketing and events, provided special trainings for YPs and offer a mentoring program for our members. Furthermore we collaborate with other European Emerging Leader ISPE groups and are about to prepare a European YP event at the ISPE Europe Annual Conference in Rome in March 2018. For this conference I am also part of the program committee and Co-Chair for the presentation train “Pharma 4.0”.

What are your takeaways from your activities within the ISPE?

For me it was an “eye-opener” when I became aware how much expert knowledge is available within the ISPE network. In my daily job as project manager, my team and I have tough negotiations with vendor companies for the best possible technical solutions. This can be a hard business because each counterpart has to focus on economic dependencies as well as project timelines and key milestones. In ISPE those parties sit together on one table and collaborate with each other for the definition of industry standards – the “ISPE Plug & Produce initiative” is a great example for an attempt to harmonize the way how IT and automation systems communicate with each other.

The grand opportunity to find an easy access to expert knowledge, broaden your personal network and actively participating in innovative work groups is the reason why I would particularly encourage students and Emerging Leaders to join our organization.