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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Freeze Drying Technology - Exchange Series

24-25 September 2019, Berlin/Germany

  • Julian Gitter

    Julian Gitter

    Ludwig-Maximilians-University Munich

    Julian Gitter graduated in Pharmacy from the Christian-Albrechts-University in Kiel, Germany. He spent a one year internship in a public pharmacy and at the School of Pharmacy & Pharmaceutical Sciences at the Trinity College, Dublin, Ireland under the supervision of Prof. Anne-Marie Healy working on solid dispersions.

    In 2015, he started his PhD thesis at the Ludwig-Maximilians-University Munich under the supervision of Prof. Gerhard Winter. His research focuses on new approaches to optimize freeze drying of biopharmaceuticals. This includes the application of non-aqueous co-solvent systems, the establishment of radiative drying as well as deepening the knowledge about controlled nucleation. 

  • Yves Mayeresse

    Yves Mayeresse

    GlaxoSmithKline Vaccines

    Yves Mayeresse is director in manufacturing technology inside MSAT by GlaxoSmithKline Vaccines. He has more than twenty years of experience in the pharmaceutical sector and has worked for different companies.

    Yves has managed activities such as parenteral production, set-up of new Freeze Drying facilities, design of Freeze Drying cycle and development of new stabilizers for freeze-dried products, and transfer of product towards different internal and external sites. He has worked on the industrialization of new freeze-dried products and then in the technical life cycle management. Now, Yves is focusing on different technologies used for the primary and secondary operations.

    Yves holds an engineering degree in Biochemistry, has written articles about Freeze Drying science and is a regular speaker for conferences on Freeze Drying. Since 2016, he has been the Leader of the PDA Interest Group Lyophilization and coordinates the group’s activities in Europe.

  • Thomas Beutler

    Thomas Beutler

    GEA Lyophil

    Thomas Beutler holds a Dipl.-Ing. degree in electrical engineering.

    In the first seven years of his career, he created hardware and software for packing machines. Since 1997, he has been working in the freeze drying business. At that time, the company belonged to STERIS. The freeze drying business was then taken over by GEA in 2005.

    In 2008, he became responsible for the process design of GEA Lyophil freeze dryers. In 2012, he also took on the responsibility as head of the project management to build a bridge between the engineering department and the needs of project managers.

    Since 2016, Thomas is responsible for the liquid dosage application development of GEA Deutschland.

  • Anthony Cannon

    Anthony J. Cannon, PhD

    Merck & Co. / MSD International

    Tony is currently Regional Director of Global Technical Operations, External Manufacturing for Sterile Products at MSD International located in Lucerne, Switzerland. He is responsible for all technical support of sterile drug products for external manufacturing operations for the European Region. He has held various positions throughout his career in Sterile Drug Product development and manufacturing with a focus on formulation and process development of both liquid and lyophilized parenterals, final container development and optimization, medical devices and drug delivery. 

    He has over 20 years’ in the industry with experience in biologics (plasma products, proteins, peptides, liposomes, vaccines; viral and bacterial), small molecules, nanocrystals, medical devices, reagents, nutriceuticals and cytotoxics, focused on lyophilization development and manufacturing. 

    He has also presented on the fundamental of lyophilization, formulation, process development, thermal characterization, finished product analysis, and scale up and tech transfer at various conferences, seminars and pharmaceutical and biotech companies in North America, Europe and Asia.

  • Sascha_Pfeiffer

    Sascha Pfeiffer

    Lyo Engineering

    Sascha Pfeiffer is a Pharma Quality Engineer with over 10 years' experience in Pharma Engineering in the area of API Fill Finish. Sascha founded Lyo Engineering in 2013 and holds the role of Managing Director.

    Sascha specializes in Quality Assurance Engineering, Technical Transfer as well as plant process optimization.  

  • Ingo Presser

    Ingo Presser, PhD

    Boehringer Ingelheim

    Dr. Ingo Presser is Pharmacists by training and received his PhD in Pharmaceutical Technology working on new online methods for freeze drying processes at the University of Munich.

    He joined the Boehringer Ingelheim in 2003. As Head of Manufacturing Science, he was responsible for the implementation of new products, improvement of production processes and for trouble shooting. From 2007 to 2011, he was Head of an aseptic filling and freeze drying unit within the department of Biopharmaceutical production. In May 2011, he changed into the department of Process Science and took over the responsibility for Clinical Manufacturing & Transfer Pharma.

  • Jochen Strube

    Jochen Strube, PhD

    Clausthal University of Technology - Institute for Separation and Process Technology

    Prof. Dr. Strube is a full Professor of Chemical and Biotechnological Engineering, and Director of the Institute for Separation and Process Technology at Clausthal University of Technology (Germany). He currently leads the German working group of industry and academics for “Plant-based Extraction – Products and Process” of ProcessNet at Dechema e.V. Frankfurt am Main. Since 2006, he has been Director of the Institute for Separation and Process Technology in Clausthal. Jochen received his Dr.-Ing. in 1992 and his Ph.D. in Chemical Engineering from the University of Dortmund in 2000.

  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University then received his Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts.

    For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions.

    Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

  • Matthieu Clavaud

    Matthieu Clavaud, MS

    F. Hoffman - La Roche

    Matthieu Clavaud is a laboratory specialist and received his Masters in Chemistry of Natural Substances from the scientific University of Limoges (France).

    He joined F. Hoffmann-La Roche in Basel in 2006 to validate and maintain new analytical methods (Near infrared, infrared and Raman spectroscopy, chemical imaging) with the help of chemometrics for Process Analytical Technologies (PAT) applications and Quality Control analysis (release and stability testing).

    In 2015, he started a Doctoral training in Biomedical and Pharmaceutical Sciences at the University of Liege (Belgium), Department of Pharmacy, Laboratory of Pharmaceutical Analytical Chemistry.

    In his current role, he is dedicated to applying good manufacturing practices (cGMP) in support of manufacturing processes and lab activities involved with vibrational spectroscopy, develop, validate and maintain methods by vibrational spectroscopy in a regulatory framework, as well as supporting collaborators.

  • Jos Corver

    Jos Corver

    RheaVita

    Jos Corver holds a degree in Applied Physics in the field of Rheology and physical transport phenomena. Leading development and engineering work in various industries enriched his expertise in aerodynamics, powder physics, vacuum deposition techniques, material science and NMR. Having had leading roles in industrialization processes, he also gained expertise in project management and quality and statistical assessment including Design of Experiments, Multiple Regression and FMEA.

    After 12 years within BOC Edwards / IMA Life, he started his own company in 2011, RheaVita. RheaVita strives for innovative improvements in pharmaceutical processing and specifically in freeze drying and the processes supporting this. In parallel, he takes project management roles in semiconductor industry to support his desire to implement cross-over between different industrial fields.

    Jos Corver has published in various areas like pharmaceutical, optical and business literature. He is author of a range of patents on the application of NMR, improvements in freeze drying, color printing and Extreme UV sources. Jos is member of the Board of Directors of the ISL-FD.

  • Raf de Dier

    Raf De Dier, PhD

    Janssen J&J

    Raf De Dier holds a Master’s degree in Chemical Engineering and obtained his PhD at the University of Leuven in Belgium and ETH Zürich in Switzerland.

    He joined Janssen R&D in 2016, where he was responsible for the process development and tech transfer support for liquid and lyophilized drug products in the parenteral fill-finish pilot plant.

    As part of the Manufacturing Science & Technology group, he has also lead various PAT and process improvement projects, with an emphasis on lyophilization.

    Currently, he is Associate Director for Innovation in the Clinical Supply Chain, where he drives the proof of concept evaluation and implementation of new scientific initiatives across the parenteral manufacturing sites of Janssen R&D.

  • Alexis Flaquière

    Alexis Flaquière

    GSK Vaccines
    Alexis Flaquière is Manager, Head of Visual Inspection Center of Competencies at GSK Vaccines, in Global MSAT Manufacturing Technologies department. He had more than 15 years' experience in pharma operations and quality assurance, mostly in productions of parenteral. Currently Alexis is occupying a global function to support and advice sites in Visual Inspection field, such as test kit for process qualification, defect management, control strategy for visible particles.
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    Sabine Hauck, PhD

    Leukocare Biotechnology

    Sabine Hauck is Vice President Research & Development at Munich-based biotech company Leukocare AG. She has experience of about 20 years in pharmaceutical development and has held various positions in the field of pharmaceutical development, quality assurance and regulatory affairs in small to midsize biotech and pharma companies, respectively.

  • Patrick Hess

    Patrick Hess

    Seidenader

    Patrick is a Computer Vision Expert. Solving complex computer vision tasks with modern technologies is Patrick’s passion of the last decade. For the past five years he has been the computer vision team lead in the Seidenader software development department. He has established new technologies in software development, algorithms, testing and AI in the company.

    As a driver of modern machine learning, he collected experience in AI through courses and hands-on training. As a technical enthusiast, his is developing IoT devices with software and cloud services as hobbyist.

    Before he joined Seidenader, he completed various projects as a freelancer, all of which have been related to computer vision. As a hobby, he developed his own open source computer vision software (Vison2u). He studied electrical engineering and applied computer science at the University of Fulda.

  • Kumar Khamar

    Kumar Khamar, PhD

    Sanofi Waterford

    Kumar Khamar is Team Leader, Manufacturing Sciences for Sanofi Waterford in Ireland. He joined Sanofi in 2016 as development scientist working mainly in freeze drying area for process development, scale up, technical transfer activities.

    In his current role as team lead, he is coordinating development activities in the lyo MSAT lab for 30+ products including PFS and network support products.

    Kumar has 12 years research experience in physical science related research areas. Prior to Sanofi, Kumar acquired black belt in lean and six-sigma and worked as scientist in operations at Sun Pharma Ireland.
    He holds a bachelor in pharmacy from India, MSc in Pharmaceutical Aanalysis from Glasgow, UK and PhD in Pharmaceutical Crystallization, solid state from Liverpool, UK.

  • Christian Kolic

    Christian Kolic

    Seidenader

    Christian Kolic is a Product Manager Inspection Machines for Seidenader GmbH in Germany. Christian has over 20 years’ experience in inspection of pharmaceutical products.

    In his current role as product manager, he is responsible for further development and maintenance of the product portfolio and manages activities such as preparation and coordination of market and technology analysis, development and project management for the implementation of new product and service ideas. 

  • Claudia Kunz

    Claudia Kunz, PhD

    Merck KGaA

    Claudia Kunz received her license as a pharmacist from the Julius-Maximilians University in Wuerzburg in 2011. In 2019, she obtained her PhD from the Friedrich-Alexander-University in Erlangen.

    Her research interest was focused on freeze drying from organic co-solvent systems as well as Dynamic Vapor Sorption of freeze-dried products.

    Since August 2018, she has been a principal scientist at Merck KGaA, where she works on the early formulation and process development of New Biological Entities as well as Antibody Drug Conjugates.

  • Stephen Langille

    Stephen E. Langille, PhD

    ValSource

    Stephen Langille received his B.S. in biology from the University of Massachusetts and his Ph.D. in microbiology from the University of Maryland.

    He joined ValSource in 2019 as Senior Microbiology Consultant. Prior to this Stephen has been with the US FDA as a Branch Chief in the Office of Pharmaceutical Quality’s Division of Microbiology Assessment. He has worked on several USP expert committees to develop and improve compendial standards for visible and sub-visible particulate matter in injectable drug products.

  • Benjamin Ledermann

    Benjamin Ledermann, PhD

    GEA Lyophil

    Benjamin Ledermann recently joined the GEA Lyophil GmbH in Huerth as an expert for freeze drying technology. At GEA, he is involved in the development and characterization of a novel controlled nucleation technology and the development of new process analytical tools for the characterization of freeze-dried products. Benjamin studied Biochemistry and received his B.Sc. from the University of Applied Sciences in Mannheim in 2011. For his master studies, he went to the Heinrich Heine University in Düsseldorf and graduated in 2013. After his graduation, he joined the Frankenberg-Dinkel lab (Ruhr-University Bochum and TU Kaiserslautern), where he was awarded a PhD in 2018.

  • Jörg Lümkemann

    Jörg Lümkemann, PhD

    F. Hoffmann - La Roche

    Jörg Lümkemann is pharmacist by training and received his PhD in Pharmaceutical Technology from the University of Münster.

    He joined F. Hoffmann La Roche in Basel in 2001, developing parenteral dosage forms (focus freeze dried products). In his current role, he is responsible for the execution of investment projects and is leading the evaluation and implementation of technical innovations within the development department.

    His team is supporting Roche commercial Manufacturing Sites in the context of technical and product related challenges.

  • Bernhard Luy

    Bernhard Luy, PhD

    Meridion Technologies

    Bernhard Luy is CEO of Meridion Technologies, Germany, a company focussing on the development of process technologies for spray freezing and dynamic freeze drying, and the related manufacture of processing equipment.

    Bernhard Luy received his pharmacy degree from University of Freiburg and  FU Berlin, Germany, and his PhD in Pharmaceutical Technology from Basle University Switzerland ( Prof. Hans Leuenberger).

    Prior to founding Meridion, he held various responsibilities within Glatt GmbH Germany, a privately owned global technology and process equipment provider to the pharmaceutical industry in the area of Solid Dosage Forms. His responsibilities included various development positions, prior to serving as COO of the German Headquarters and CEO of the Swiss operations. 

    He is author and co-author of numerous patents and patent applications in the area of Solid Dosage Forms technology, pharmaceutical product and formulation development, as well as in the area of freeze drying technologies, and author of various publications. 

  • Hanns-Christian Mahler

    Hanns-Christian Mahler, PhD

    Lonza AG
    Since September 2015, Dr. Mahler has been leading the product development organization at Lonza AG. Prior this position, he led the department Pharmaceutical Development & Supplies, Biologics EU at Roche, Basel, Switzerland from 2010 to 2015 and as Head of Formulation R&D Biologics, Roche, Basel, from 2005 to 2010. From 2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase. Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing. Dr. Mahler obtained his venia legendi (German Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), Kansas (Lawrence, US) and Basel (Switzerland). He was elected an AAPS Fellow in November 2013. His work experience includes early- and late-stage/commercial and line extension formulation development, primary packaging and device development, drug delivery, Drug Product process development, process characterization and validation, transfer to clinical and commercial drug product production and production support and preclinical and clinical (phase 1-3) Drug Product GMP manufacturing of parenteral dosage forms of biologics, small molecules, peptides and oligonucleotides.
  • Michael Sasse

    Michael Sasse, MD

    Medical School Hannover

    Dr. Michael Sasse completed his medical studies at the University of Giessen. After two years of training in the Department of Cardiology and Cardiac Surgery of the Max Planck Institute in Bad Nauheim, he moved to the Children's Hospital of Hannover Medical School. Since 1999 he is the chief physician of the pediatric intensive care unit of the MHH. As the founder of the pediatric intensive network in Northern Germany (PIN), he has overseen the same since 2003. Dr. Sasse is head of the Standardization Expert Council (SET) Infusion Management of the MHH. Its aim is to bring together and coordinate all departments of the clinic involved in infusion therapy. In addition to his clinical work on the Children's Intensive Care Unit, his scientific focus is on infection and inflammation research as well as in various areas of infusion management. He heads the department's own Academy of Pediatric Intensive Care Medicine, which covers the further education and training of all areas of pediatric intensive care medicine. Dr. Michael Sasse is a member of the Society for Pediatrics and Adolescent Medicine, the Society for Neonatology and Pediatric Intensive Care Medicine (GNPI), the German Interdisciplinary Society for Intensive Care Medicine (DIVI), the German Council for Revival (GRC), the German Sepsis Society (DSG) and European emergency and intensive care societies.

  • John Shabushnig

    John G. Shabushnig, PhD

    Insight Pharma Consulting, LLC

    John is the founder of Insight Pharma Consulting and is an expert in visual inspection.  He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations.  He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection.  He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.

    John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University.  He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board.  He organized and leads the Visual Inspection Interest Group.  He is also an instructor at PDA's Training and Research Institute.  John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel.  He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection.  He is a co-author of the recently published book Visual Inspection and Particulate Control.

  • Emanuele Tomba

    Emanuele Tomba, PhD

    GSK

    Dr. Emanuele Tomba is a Chemical Engineer working in GSK Vaccines in the Technical Research and Development Drug Product department. His main responsibilities concern the development and transfer of Drug Product manufacturing processes.

    He holds a PhD in process chemometrics and is an expert in process modeling and data analysis. He leads the process modeling Center of Excellence within GSK TRD department, supporting projects on a global basis dealing with modeling and simulations of drug product manufacturing processes, including freeze-drying.