Skip To The Main Content
Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Europe Freeze Drying Technology

Virtual Conference, 24-25 September 2020

  • 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.

  • 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

    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.

  • Julian Gitter

    Julian Gitter, PhD

    Bayer

    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 2019, he completed his PhD thesis at the Ludwig-Maximilians-University Munich under the supervision of Prof. Gerhard Winter. His research focused 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.

    Since early 2020, he has been Laboratory Head, Formulation Development Parenteral Drug Delivery for Bayer.

     
  • blank-profile

    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.

  • 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.

  • 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.  

  • Kevin Smyth

    Kevin Smyth, CEng, MIChemE

    IPS-Integrated Project Services Ireland Limited

    Kevin is a chartered biochemical engineer with over 30 years’ global experience in the design of biopharmaceutical manufacturing facilities. He led multiple large molecule biologics, vaccines, and sterile fill-finish Projects, from the development of project scope, front-end planning, feasibility studies to detailed design.

    Kevin has extensive biopharmaceutical process design experience, including P&D development, HAZOP chair, FMEA facilitator, regulatory compliance audits, equipment technology evaluation, and compliance with client local and global standards. He possesses excellent technical knowledge and a passion for the development of peers.

    Kevin has worked as a fill-finish subject matter expert (SME) on several global projects and has considerable experience leading fill-finish and biopharmaceutical synthesis facility designs for major pharmaceutical clients.

    Kevin is an active committee member of the PDA and ISPE Ireland Affiliate Committees and regularly chaired and organised technical seminars in Ireland for both organisations.

  • Maria Badal Tejedor

    Maria Badal Tejedor, PhD

    Cepheid

    Maria has recently joined Cepheid as a freeze-drying specialist having a previous working experience as a project manager and formulation scientist in pharmaceutical formulation development of pre-clinic and early clinic drug formulations.

    She has also been involved in the consortium NextBioForm for protein formulation research where the focus of her research was on lyophilization and drying technologies of protein formulations.

    Maria received her Ph.D. degree in surface chemistry which main topic was the study of the sticking and picking phenomena in relation to the surface properties and tableting behavior of the tablet ingredients during compaction.

  • Thomas Frank

    Thomas Frank

    Refolution Industriekälte GmbH

    Thomas Frank is a chemical engineer (Dipl. Ing.) and certificated senior project manager (IPMA level B) with demonstrating experience and network in the field of refrigeration. For over 10 years, he has been working in different fields of industrial refrigeration from process cooling for chemical plants to food storage and environmental simulation.

    Since 2019, he owns Refolution, an engineering office that is using deep knowledge of refrigeration and analytic process understanding to develop new processes in different fields.

    In 2019, Thomas and colleagues from HOF Sonderanlagenbau developed a new process doing dry freezing with only air as a refrigerant. He also supported GEA with their new dry freezing process using a combination of air and CO2 refrigeration.

  • Sebastian Gröel

    Sebastian Gröel

    Ludwig-Maximilians-University Munich

    Sebastian Groel studied Pharmacy at the Goethe University Frankfurt with a scholarship from the “Deutschlandstipendium”.

    During an internship at Merck KGaA, Darmstadt, he gained his first expertise in the field of the lyophilization process of pharmaceutical relevant products. Since 2019, he has been researching on the topic of molecular dynamics of freeze dried products as a PhD student in the group of Professor Gerhard Winter at the LMU Munich.

  • Maik Guttzeit

    Maik Guttzeit, Dipl. Ing.

    Bayer AG

    Maik holds a German Dipl.-Ing. degree in process technology.

    He worked at GEA Lyophil for 20 years where he was responsible for testing and qualification of lyophilizers within the QA department.

    Currently, he is Technology Manager Sterile & Aseptic at Bayer AG. In this role, he is also responsible for standardization of lyophilizers within Bayer AG.

  • Simon Kervyn

    Simon Kervyn, PhD

    Datwyler
    Simon Kervyn graduated as a PhD in organic chemistry and materials from the University of Namur, Belgium in 2012. After research stays at National Institute of Materials Sciences in Tokyo and at UCLA, Los Angeles, he worked at the Coatings Research Institute in Belgium.
    He is now working for Datwyler as manager materials development. In this position he performs customer’s dedicated research to optimize the selection of rubber components to their applications. Furthermore, he works on the development of coated products for the Datwyler portfolio.
  • Daniel Kullmann

    Daniel Kullmann, MSc

    Hoffmann-La Roche

    Daniel Kullmann obtained his B.Sc in Pharmaceutical Sciences from the Ludwig-Maximilians-University Munich in October 2014 and his M.Sc also in Pharmaceutical Sciences from the same university in December 2016.

    In May 2017, he joined the Pharmaceutical Technology group of Prof. Huwyler at the University Basel as a PhD student. His research is focused on novel approaches to facilitate the easy and aseptically safe administration of IV infusions in tropical countries or in emergency situations.

    His PhD research project will be conducted in a close cooperation with the Commercial Product Support, Innovation and Investment section of F. Hoffmann – La Roche Ltd in Basel.

  • Monica Rosa

    Monica Rosa, PhD

    Coriolis Pharma Research GmbH

    Monica Rosa is graduated with a MSc (Pharm) degree in Pharmaceutical Sciences at University of Lisbon (UL), Portugal in 2011. She received her PhD in Chemical Engineering from Instituto Superior Tecnico de Lisboa (IST-UL) in 2016.

    In 2016, she joined the Business Unit Lyophilization of Coriolis Pharma, Germany. As a scientist, Monica was part of project teams for customer projects dealing with liquid and lyophilization formulation development, comparability and stress testing, storage stability study, and others.

    In 2019, she moved to the position of senior scientist in the Business Unit Lyophilization of Coriolis Pharma by managing pharmaceutical development projects. In addition, Monica is sharing her expert know-how to support other scientists and is supervising PhD students and interns.

  • Kristina Sennvik

    Kristina Sennvik, PhD

    GSK

    Kristina Sennvik works as Global Regulatory Affairs (GRA) Manager at GSK Vaccines, Belgium.

    She received her Ph.D. in neuroscience and neurodegenerative disorders from Karolinska Institute, Sweden, then performed post-doctoral research at Rutgers, the State University of NJ, US and at Catholic University of Leuven, Belgium before joining GSK Vaccines.

    Kristina’s current role in GRA includes cross-product CMC responsibilities with focus on secondary operations: formulation, filling and freeze-drying.

  • Geoff Smith

    Geoff Smith, PhD

    De Montfort University

    Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). His research group focusses on pharmaceutical applications for impedance, dielectric and terahertz spectroscopies alongside optical techniques such as laser speckle and optical flow.

    He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), ice interface temperatures, primary drying rates and end points.

    This development marks the first time that impedance spectroscopy has been used to characterize materials within conventional glass freeze-drying vials, without having to insert the electrodes into the product (i.e. the solution under-going freeze-drying).

    This feature of the technology sets it apart from other in-process impedance measurement systems, in which a bulky electrode assembly is inserted into the solution being freeze-dried, to provide a product-non-invasive technology.