Richard Denk studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment, and eight years ago he founded the expert containment group of the ISPE DACH. The containment group published the Containment Manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

Simone is a Regulatory Expert at Merck Life Science and provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on Single-Use Technology (SUT). Over the last years, Simone supported biopharmaceutical drug manufacturer’s implementation of SUT in their manufacturing process.

With her deep understanding of SUT market needs and industry trends, she acts as a subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in Microbiology. 

Walid El Azab is an industrial pharmacist, a qualified person and a Lean Six Sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance and process validation. Finally, he leads audits at manu­facturer sites and workshops to improve processes and inspection readiness level. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilisation and EU GMP Annex 1 guideline revision. He is a plan­ning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions), and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is secretary of the Belgium Qualified Person Association.

Matthias Angelmaier has a bachelor’s degree in industrial and mechanical engineering as well as a master’s degree in business development. He joined Syntegon Technology GmbH in 2009. During his first 3 years, he was a project manager for handling complex customer projects. Since 2012, he is the globally responsible product manager for barrier systems, isolator and process technology. His expertise includes process engineering, sterilization, bio-decontamination, aseptic and high-potent Isolator applications, glove testing systems as well as topics related to advanced aseptic processing. He is a frequent speaker on international symposia and conferences including organizations like ISPE and PDA

Dr. Silvia Aldi is a cell and gene therapy bioprocessing and translational research expert. Currently, she is a cell and gene product manager at SKAN AG, where she leads the product development strategies for the manufacturing of cell and gene therapies.

She has more than 10 years of expertise in R&D management in academic settings, working in the top research centre worldwide (Karolinska Institutet in Sweden and Weill Cornell Medicine in USA), where she gained extensive scientific knowledge in cell and gene processes.

Silvia worked for six years at Karolinska Institutet as assistant professor and research coordinator, where she coordinated international and interdisciplinary research programs focused on the validation of drug targets for cardiovascular diseases and medical device for the diagnosis of autoimmune disease.

She has a master's degree, a BS in cell and molecular biology, and received her PhD in molecular medicine from the University of Siena, Italy.

Ruthger van Zwieten received his PhD in gene and cell therapy from the University of Lausanne, Switzerland and developed the research plan for a pharmaceutical company before transitioning into business development roles in natural sciences companies. He has been with Picarro since November 2019 and has intimate knowledge of the Picarro H2O2 CRDS pharma analyzer which has a major role in the filling of biopharmaceuticals.

Ken Nagai works as a deputy general manager of the total design and project department for Airex, an isolator/decontamination equipment company for the pharma and ATMP industry. His responsibility includes project management, international expansion, new business creation, strategic planning, and production improvement for the organisation. Previously, he experienced new business development in a $10B organisation as a product line manager. He also worked in a consultancy, applying the Toyota production system to many different manufacturing organisations as a consultant. Ken has a bachelor’s degree from the University of Tokyo and an MBA from University of Notre Dame.