Jean René Authelin has an engineer degree in chemical engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engi­neer. In the 90’s he founded the Physical Quality function, dedicated to the API crystallisation, drying, polymorphism… for which he was for 10 years Global Head in Rhone Poulenc Rorer, Aventis and finally sanofi. In, 1988 JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug polymorphism, amorphous solids physics, drug stability, crystallisation, nanoparticles engi­neering and processing, drying, milling; spray drying, fluid bed granulation, roller compaction, and freeze-drying. Jean René Authelin is the author or co-author of 20 publications or book chapters and the co-inventor of 9 patents.

Stefan Schneid is currently a laboratory head in the formulation development department at Bayer in Wuppertal. In this function, he develops formulations and processes for novel biological entities, including antibodies and ADCs, and is involved in development projects from pre-clinical stage up to transfer to commercial production. Previously Dr. Schneid worked as R&D Manager at Syntacoll GmbH in Saal, Germany, where he was responsible for the develop­ment of novel formulations and analytical methods for collagen-based drugs and medical devices for parenteral applications. Until 2010, he was a post-doctoral research fellow in the freeze-drying Focus Group at the University of Erlangen, and also spent one year as a visiting scientist in Prof. Michael Pikal’s lab at the University of Connecticut. Stefan Schneid holds a degree of pharmacy from the University of Munich, and received his Ph.D. in pharma­ceutics from the University of Erlangen in 2009 for his dissertation thesis titled “Investigation of Novel Process Analytical Technology (PAT) Tools for Use in Freeze-Drying Processes”. He developed and optimised the formulation and manufacturing process of various pharmaceutical drugs including proteins, peptides, vaccines and small molecules.

Richard Denk has 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 Denk works at SKAN AG, headquartered in Allschwil as the head of sales contain­ment. Mr. Denk founded the expert Containment group of the ISPE DACH 8 years ago. The Containment Group published the Containment Manual in September 2015. Mr. Denk has spent nearly 20 years with the subject production of highly active/highly hazardous substances and has developed the containment pyramid.

 Sophie Declomesnil is the manager of research and development at LYOFAL (SYNERLAB group) leading collaborative research activity of client projects. Over the past 20 years, she has been working at Lyofal and is responsible for the lyophilisation development of the company focusing on formulation, freeze-drying cycle development and thermal properties of the products and also tech transfer. After graduating in science and engineering in the graduate Agrosup DIJON, a French National Institute of technology for Life, Food and Environmental Sciences, she received a doctorate in biotechnology from the University of Picardie (France).

Franz Bosshammer has a degree in mechanical engineering, as well as a Master of Busi­ness Administration (MBA). Prior to joining NNE Pharmaplan in October 2012, Franz has filled various positions, such as process engineer and sales director in the supplying in­dustry for pharmaceutical, aseptic fill, and finish machines. His latest employment was as general manager at Optima Group Pharma. He started his career in the field of process engineering in 1986. Franz has more than 30 years of experience in development and manufacturing of machines for aseptic pharmaceutical operations, with a special focus on freeze-drying technology. Franz has been engaged in various international fill and finish projects over the course of his career.

Andrea Allmendinger joined Hoffmann-La Roche Basel in 2013, where she currently holds the position of a senior scientist and group leader in the de­partment of ‘Late-stage Pharmaceutical and Processing Development’ for par­enteral products. Her projects include the formulation and process develop­ment of parenteral drug products for clinical PhIII and market. She started with commercial product support focusing on technical transfers of NCEs and NBEs in particular on process characterisation and validation for freeze-dried products. Andrea’s research lately focuses on all aspects of formulation de­velopment of freeze-dried formulations supervising several Master and PhD students. Most recently, she became assistant lecturer at the University of Freiburg in the department of pharmaceutical technology and biopharmacy. Andrea is a pharmacist by training and conducted her studies at the University of Heidelberg in Germany and at the University College London. She holds a PhD in Pharmaceutical technology from the University of Basel where she focused on rheological behaviour of liquid high-concentration protein formula­tions.

Christoph Korpus graduated in pharmacy at the Goethe-University in Frank­furt am Main, Germany. He finished his PhD thesis at the Ludwig-Maximil­ians-Universität Munich under the supervision of Prof. Wolfgang Frieß. His research focused on the lyophilisation process development for Dual Chamber Cartridges. This included energy transfer studies and the analysis of different holder devices. For his 3 month research stay at the University of Connecticut, in the group of Prof. Michael Pikal, he was awarded with a graduate student scholarship from the German Academic Exchange Service. Since 2016, he is leading the liquid formulation stability laboratory at Merck KGaA (Germany) in Darmstadt. His current research focuses on the development of high grade excipients for final formulations.

Andrea Simonetti received a MS degree and a PhD degree in electronic engi­neering from the University of Ferrara, Italy. In his career he has successfully led large scale commissioning, validation and quality projects for worldwide major pharmaceutical regulated companies. Standards, risk management, EU and FDA regulatory compliance are significant interests and responsibili­ties. He has designed and implemented pharmaceutical business plans and strategic development activities by leading and overseeing the activities of international sales teams. He has been also responsible for the strategic direc­tion of business units at global pharma machine manufacturers. Andrea is a frequent speaker at conferences and seminars including ISPE, PDA, BFS IOA. In 2010 he started providing stable educational support to US Food and Drug Administration Office of Pharmaceutical Science. He is a frequent contributor to leading pharmaceutical and engineering associations and his insights have been drawn on for topics ranging from conferences to scientific publications and regulatory dossiers. Most recent publications involve developing Process Analytical Technology strategies for pharmaceutical sytems and innovative Container Closure Integrity Testing methods for parenteral drugs. Andrea is currently working with PDA “Technical Report 27 – Pharmaceutical Package Integrity” and with PDA Prefilled Syringes task force teams.

Dr. Patrick Garidel is currently employed as associate director protein science at Boehringer Ingelheim Pharma GmbH & Co. KG. His activities are focused on the development biologics from the downstream process to drug product (liquid and solid formulations, freeze-drying). His expertise covers: develop­ment of drug delivery system and formulations, packaging/devices, process development, bio-analytic, and protein purification. He is responsible for the establishment of innovative platform technologies for e.g. powder inhalation, gene therapy, in silico based predictive tools for molecule properties, and particle analytics. Additionally, he is interested in the development of new con­cepts and strategies for protein purification, stabilisation, delivery and protein/ colloid chemistry in general. PG studied chemistry and biotechnology at the University of Kaiserslautern and pharmaceutical sciences at the University of Strasbourg. He has a PhD in biophysics. During his academic career, he took over various post doc positions at the Institute for Pharmaceutical Technology and Biopharmacy, physical chemistry at the Martin Luther University Halle/ Wittenberg, DESY, Rutgers University and Hospital for Special Surgery.

Solutions in Swindon, UK. Simon has worked for Catalent for over 20 years within the R&D function in Swindon, focusing on the development of formu­lations for the proprietary Zydis® technology. Zydis is a freeze-dried orally disintegrating tablet (ODT) which, when placed in the mouth, dissolves in 1-2 seconds in contact with the saliva. As part of his role Simon has been responsible for developing suitable freeze-drying cycles at both bench and pilot scale, under the guidance of Quality by Design (QBD). Through this work Simon has gained significant knowledge in the understanding of freeze-drying and the critical process parameters which can affect the finished product. Si­mon holds a HNC in Chemistry from the University of the West of England and a BSc (Hons.) in pharmaceutical science from the University of Greenwich.

After completing his master’s in polymer chemistry at the University of Louvain, Belgium, Bram Jongen acquired a PhD in water soluble polymers used for advanced drug adminis­tration. Bram started working as a technical support manager for Datwyler about 14 years ago, supporting customers in a vast area that spanned from Western European countries to countries like India, Korea, and South Africa. Thereafter, he headed the Global Product Introduction & Support team, a global team of highly experienced and educated people, each having their own expertise in the world of pharmaceutical closures. Bram himself ac­quired profound extractables & leachables expertise. His team managed customer projects of technical nature and supported Datwyler’s product and portfolio management. Since the end of 2012, he has been acting as head of R&D, leading a group that focuses on develop­ing new rubber and new coating materials.

Claudia Kunz received her degree in studies in pharmacy from the University of Wuerzburg. Since 2013, Claudia is a PhD student in the division of pharma­ceutics at the Friedrich-Alexander-University in Erlangen and member of PD Dr. Gieseler’s Freeze-Drying Focus Group. Her research interest is focused on freeze-drying of organic co-solvent systems. This involves thermal analysis of the pre-dried solutions as well as characterisation of the final lyophilisates to establish a link to process and product performance.

Andrea Weiland, Ph.D., is managing director of Explicat® Pharma GmbH, a privately owned company providing technical project management services and pharmaceutical development services to Pharmaceutical Industry (CMC).

Andrea is a pharmacist with a Ph.D. in pharmaceutical technology on biode­gradable microspheres and cyclodextrins (Ludwig Maximilians University Mu­nich). She held several leadership positions within Pfizer, working as project manager in process technology and being responsible for technology trans­fer & process development, mainly on sustained release solid dosage forms. Within R&D she was responsible scientist for pharmaceutical development (Phase I - III, candidate characterization and lyophilisation projects). After joining IDEA AG, a biotechnology company based in Munich, Andrea Weiland held the position of director pharmaceutical development and was responsible for process technology development, drug delivery system development (li­posomes, patches), formulation of recombinant proteins, analytical develop­ment, and clinical supplies manufacture; she also served as IDEA`s QP. She is founder of Explicat Pharma GmbH and managing director since 2005. Hers and her team`s experience cover the development of biopharmaceuticals (e. g. recombinant factor VIII), development of lyoformulations and lyocycles, analytical development and related QA as well as regulatory issues. Expli­cat Pharma has been assigned several projects involving the modern process validation approach, including lyocycle robustness testings. Andrea Weiland is qualified person and a member of AAPS as well as several other professional institutions based in Europe, e.g. APV, DphG, Bay. LAK, A3P.