Reinventing Pharmaceutical Development through AI and Data Science

Full day schedule

1. 8:30
   Coffee welcome
2. 9:00
   APGI Introduction
3. 9:20
   Clarification of AI and terminology, limitations of AI in the pharmaceutical sector
4. 10:00
   AI tools for phase 1 formulation
5. 10:40
   Coffee break
6. 11:10
   Optimising modern drug product development by utilising the benefits of digital tools

   Thorsten Cech - BASF, Germany
7. 11:50
   Smart Formulation: Bringing Artificial Intelligence into Pharmaceutical Compounding

   Fabrice Pirot - University of Lyon, France
8. 12:30
   Lunch break
9. 13:45
   From Formulation to Characterization: AI-Assisted Exploration of Polymer Nanomaterials

   Khalid Ferji - University of Lorraine, France
10. 14:25
    AI-Supported Governance and Compliance in Pharmaceutical Quality Process

    Alexander Kunz - Merck, Germany
11. 15:05
    Coffee break
12. 15:30
    Digital twins in production

    Laurent Morello - Siemens, France
13. 16:10
    Digital twins for Phase 1 clinical trials
14. 16:50
    Conclusion

Confirmed speakers

Thorsten Cech

BASF, Germany

Thorsten has worked in the pharmaceutical industry for some 35 years. He is process engineer by training with focus on pharmaceutical technology. His main profession lies in formulation development, process optimisation, and scale up of oral solid dosage forms. Since 2005, Thorsten is Manager of BASF’s Pharma Application Lab based at headquarters, Ludwigshafen, Germany. In his current position and as exert in pharmaceutical technology, he supports customers globally in the field of product applications, feasibility studies, formulation development, process optimisation, and scale-up. Since several years he is deeply involved in optimising drug product development by implementing digital assistants and computer aided systems.

Thorsten has written several publications, articles, and book chapters and holds various patents in the field of pharmaceutical technology.

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Khalid Ferji

University of Lorraine, France

Full Professor at Université de Lorraine, specializing in polymer chemistry and polymer nano-object formulation, with growing expertise in the application of artificial intelligence to polymer science.

CURRENT RESEARCH:

- Artificial intelligence for polymers.

- Polymer chemistry.

- Controlled radical (photo) polymerization.

- Physical-chemistry of polymer characterization (light scattering) and amphiphiles self-assembly.

- Colloids and nano-objects formulation.

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Alexander Kunz

Merck, Germany

Alexander Kunz is a quality assurance and computerized systems expert with deep experience in validation, IT processes, and regulated GxP environments. He began his career as a GLP auditor in multi-site studies, metabolism, and ecotoxicology before moving into IT and validation leadership roles. Today, he serves as Quality Strategy Lead for Computerized Systems in GLP/GCP/GVP at Merck Healthcare KGaA and within a Growth Assignment, GxP Quality Expert Artificial Intelligence for Group SMARTfacturing (GMP), where he actively drives the adoption of AI in GxP-regulated environments across Merck KGaA. Alexander combines strategic vision with hands-on execution across risk-based audit management, electronic signature compliance, joint cloud provider qualifications, and the development of an AI validation framework. He is also the process owner for Merck’s corporate e-signature tool and was the Topic Leader for Validation and Lifecycle Management in the Annex 22 Technical Workshop. Through his continued work in industry workshops, seminars, and cross-functional initiatives, Alexander has established himself in the industry as a recognized expert in artificial intelligence, computerized systems validation, and lifecycle management. His agile mindset, strong quality focus, and ability to translate complex regulatory expectations into practical approaches make him a valuable driver of innovation and compliance in digital transformation.

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Fabrice Pirot

University of Lyon, France

Fabrice Pirot is a Professor at the Faculty of Pharmacy of Lyon (France), where he has been teaching pharmaceutical technology and biopharmaceutics since 1997. He is also a hospital pharmacist and heads the activities of the Fripharm® pharmaceutical platform at the Hospices Civils de Lyon. He contributes to the work of the French National Academy of Pharmacy as well as the French and European Pharmacopoeias. He is the author and co-author of around one hundred scientific publications.

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