PDA BioManufacturing Conference 2024
Shaping the Future of Biomanufacturing
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Dear Colleagues,
As global health challenges like infectious diseases and cancer evolve, the pharmaceutical biomanufacturing sector continues to innovate and adapt. This industry's advancements attract significant interest from investors, regulators, and other stakeholders, underscoring the importance of staying informed about the latest developments.
Join us in Gothenburg, Sweden, on 24-25 September 2024, for a two-track, face-to-face conference.
The event will explore new technologies including the application of AI, digital twins, development approaches, CMC strategies, and regulatory frameworks, supporting rapid access to vaccines and biotherapeutics from upstream processes to final filling and lyophilization.
The PDA Biomanufacturing Conference 2024, themed "Shaping the Future of Biomanufacturing", is the ideal venue for exploring these innovations. Now in its sixth year, this event offers a comprehensive program focused on emerging trends, regulatory areas, and key technologies.
We are kicking off this year’s conference with a keynote presentation from a patient perspective and we will continue the discussion on addressing patient needs and offer unique networking opportunities with industry professionals, academics, and regulatory representatives from organizations like the U.S. FDA, MHRA, Medical Products Agency Sweden, Paul-Ehrlich-Institut, EDQM, and CEPI.
Session highlights will feature case studies, expert views on biopharmaceutical innovations, advanced modeling, manufacturing capacity, and sustainability as well as special attention will be given to new regulatory strategies for sustainability reporting.
Another reason to join is the two sessions from our PDA Interest Groups, including Lyophilization IG and Advanced Manufacturing, and Applied Process Digitalization IG, showcasing the latest advancements in these areas.
Check out the agenda which is intended to initiate and support discussion and professional exchange through the diversity of scientific presentations. Meet exhibitors, listen to poster sessions, and enjoy the networking opportunities.
We are looking forward to seeing you in Gothenburg.
Sincerely,
The Co-Chairs
Sabine Hauck, Consultant
Elisabeth Vachette, Sartorius
SCIENTIFIC PROGRAM PLANNING COMMITTEE
- Sabine Hauck, Consultant
- Elisabeth Vachette, Sartorius
- Andrea Arsiccio, Coriolis
- Adithya Balasubramanian, ten23 health
- Bianca Bohrer, PSM
- Cristiana Campa, GSK
- Michael De Felippis, Eli Lilly
- Sebastian Groel, Daiichi-Sankyo
- Virginie Le Coent, BioMerieux
- Julian Lenger, Bayer
- Yves Mayeresse, GSK
- Mic McGoldrick, MSD
- Maria Papathanasiou, Imperial College London
- Josh Eaton, PDA
- Falk Klar, PDA Europe
- Sabine Hartmann, Manager Programs & Events, PDA Europe
Featured Exhibitors
- AM Instruments
- Franz Ziel GmbH
- HOF Sonderanlagenbau GmbH
- HOF Sonderanlagenbau GmbH
- Inprocess-LSP
- Refolution
- Smithers
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Member Price
€ 2.250GovernmentMember Only
€ 1.080
Health AuthorityMember Only
€ 1.080
Early Career ProfessionalMember Only
€ 1.080
StudentMember Only
€ 1.080
AcademicMember Only
€ 1.080
Non-Member
€ 2.550
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Tuesday, 24 September CEST
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Registration Open
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Welcoming
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Committee Member: Falk Klar, PhD, Parenteral Drug Association
Falk Klar, PhD, Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.
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Welcome from the Co-Chairs
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Co-Chair: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare. -
Co-Chair: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare.
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Opening Plenary Part I: Addressing Patients Needs
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Moderator: Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, is currently a Technical R&D Advisor and Senior Fellow at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation. She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors.
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A Brief Insight Into Life with Multiple Sclerosis
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Presenter: Karen Somers
Karen Somers
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Development of Antibody Drug Conjugates as Specific and Potent Medicinal Products - A Regulator´s Perspective
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Regulatory Presenter: Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics” in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunosera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt.
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ICH Q6 - Quo Vadis
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Regulatory Presenter: Mats Welin
Mats Welin
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Networking Coffee Break, Poster Session & Exhibition
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Opening Plenary Part II: Addressing Patients Needs
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Moderator: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS
Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS
Elisabeth Vachette is Sustainability Business Partner for the BioProcessing division at Sartorius Corporate. Since joining Sartorius Stedim Biotech in 2000, she has been responsible for quality, production, engineering and product management providing a broad view of the functionalities of single-use solutions development, marketing, qualification and manufacturing. Current responsibilities include Sustainability Strategy and Operational targets for supporting Sartorius Sustainable transformation. She is actively engaged in several industry groups like BPOG, BPSA, Econsense, ... She is an active member of the scientific committee as co-chair for the PDA BioManufacturing conference and is member of the BPSA board of directors.
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Developing Patient Centric Specification for Commercial Biologics: Real World Case Studies
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Presenter: Jason Warfel
Jason Warfel
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Plenary Discussion
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Moderator: Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS
Elisabeth Vachette, MA, BPS Sustainability Business Partner, Sartorius Stedim FMT SAS
Elisabeth Vachette is Sustainability Business Partner for the BioProcessing division at Sartorius Corporate. Since joining Sartorius Stedim Biotech in 2000, she has been responsible for quality, production, engineering and product management providing a broad view of the functionalities of single-use solutions development, marketing, qualification and manufacturing. Current responsibilities include Sustainability Strategy and Operational targets for supporting Sartorius Sustainable transformation. She is actively engaged in several industry groups like BPOG, BPSA, Econsense, ... She is an active member of the scientific committee as co-chair for the PDA BioManufacturing conference and is member of the BPSA board of directors. -
Regulatory Panelist: Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics” in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunosera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt. -
Regulatory Panelist: Mats Welin
Mats Welin
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Panelist: Jason Warfel
Jason Warfel
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Panelist: Karen Somers
Karen Somers
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Networking Lunch Break & Exhibition
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Guided Poster Walk
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Moderator: Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH
Bianca Bohrer, Dipl Ing, Managing Director, PSM GmbH
Ms. Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Kiaserslautern. Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and as a manufacturing manager for parenteral applications, she was able to further deepen these skills. Since September 2014 she has been Head of Quality Control, since 2019 Managing Director of PharmBioTec GmbH, a non-profit research institute, and since 2020 Managing Director of PSM GmbH - a §13-AMG contract manufacturers for aseptic products.
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Session 1 Track A: Processes for New Entities in Freeze-Drying
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Moderator: Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG
Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG
Dr. Julian Lenger is a pharmacist by training with expertise in established and novel freeze-drying technologies as well as formulation development and analytical characterization of biotherapeutics and small molecules. Since 2020, he is driving formulation and process development for early pipeline development projects at Bayer AG in Wuppertal, Germany, as Head of Laboratory in Drug Product Development for parenteral drugs. Before joining Bayer, Julian spent four years as PhD student at the Ludwig-Maximilians-Universität München (University of Munich, Germany) in the group of Prof. Dr. Gerhard Winter at the chair of pharmaceutical technology. Here he successfully investigated and published several papers on novel technologies like microwave-assisted freeze-drying or controlled ice nucleation. Previously, Julian studied Pharmacy at the Christian-Albrechts-Universität zu Kiel (University of Kiel, Germany) and Trinity College Dublin, Ireland. Besides Julian is an active member in societies and consortia like Parenteral Drug Association (PDA) and BioPhorum.
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Developments in In-Line and Off-Line Analytics Applied to Freeze Drying of Biologicals
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Presenter: Paul Matejtschuk, PhD FRSC CChem , Section Head Formulation Science , MHRA
Paul Matejtschuk, PhD FRSC CChem , Section Head Formulation Science , MHRA
Biography: Paul Matejtschuk PhD, CChem, FRSC leads the Formulation Science Section at the Medicines and Healthcare products Regulatory Agency, at their South Mimms laboratories, in the UK, whose mission is to safeguard the quality of biological medicines. He has over 20 years experience of developing freeze drying and formulation conditions for a wide range of biological materials including those developed on behalf of the WHO as International Reference Standards for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions and his research interests include Process Analytical Technology in freeze drying, the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. Paul Matejtschuk (0000-0002-4646-800X) - ORCID Paul has over 35 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk). Email: paul.matejtschuk@mhra.gov.uk
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Building Robustness into the Primary Drying Phase of Lyophilization: A Modelling Framework and Use Cases for Biopharmaceuticals
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Presenter: Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma
Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma
Andrea Arsiccio is a Senior Scientist at Coriolis Pharma, where he works on projects dealing with the development of lyophilized formulations, lyophilization process development and the implementation of innovative modelling concepts. He received a master's degree in Chemical Engineering from Politecnico di Torino in 2016 followed by a PhD degree in 2020. During his PhD he investigated the freeze drying process, with a special focus on the formulation of biopharmaceuticals. He subsequently worked as a Postdoctoral scholar at the University of California in Santa Barbara and at Politecnico di Torino, and during this time his research focused on molecular dynamics simulations. His main interests and expertise are in the fields of freeze drying, protein folding and aggregation, and molecular dynamics simulations.
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Solving the Deep-Frozen Challenge – Lyophilization of an Oncolytic Virus
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Presenter: Thomas Kriehuber
Thomas Kriehuber
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Q&A
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Moderator: Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG
Julian H. Lenger, PhD, Head of Laboratory Parenteral Drug Development, Bayer AG
Dr. Julian Lenger is a pharmacist by training with expertise in established and novel freeze-drying technologies as well as formulation development and analytical characterization of biotherapeutics and small molecules. Since 2020, he is driving formulation and process development for early pipeline development projects at Bayer AG in Wuppertal, Germany, as Head of Laboratory in Drug Product Development for parenteral drugs. Before joining Bayer, Julian spent four years as PhD student at the Ludwig-Maximilians-Universität München (University of Munich, Germany) in the group of Prof. Dr. Gerhard Winter at the chair of pharmaceutical technology. Here he successfully investigated and published several papers on novel technologies like microwave-assisted freeze-drying or controlled ice nucleation. Previously, Julian studied Pharmacy at the Christian-Albrechts-Universität zu Kiel (University of Kiel, Germany) and Trinity College Dublin, Ireland. Besides Julian is an active member in societies and consortia like Parenteral Drug Association (PDA) and BioPhorum. -
Panelist: Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma
Andrea Arsiccio, PhD, Senior Scientist, Coriolis Pharma
Andrea Arsiccio is a Senior Scientist at Coriolis Pharma, where he works on projects dealing with the development of lyophilized formulations, lyophilization process development and the implementation of innovative modelling concepts. He received a master's degree in Chemical Engineering from Politecnico di Torino in 2016 followed by a PhD degree in 2020. During his PhD he investigated the freeze drying process, with a special focus on the formulation of biopharmaceuticals. He subsequently worked as a Postdoctoral scholar at the University of California in Santa Barbara and at Politecnico di Torino, and during this time his research focused on molecular dynamics simulations. His main interests and expertise are in the fields of freeze drying, protein folding and aggregation, and molecular dynamics simulations. -
Panelist: Thomas Kriehuber
Thomas Kriehuber
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Panelist: Paul Matejtschuk, PhD FRSC CChem , Section Head Formulation Science , MHRA
Paul Matejtschuk, PhD FRSC CChem , Section Head Formulation Science , MHRA
Biography: Paul Matejtschuk PhD, CChem, FRSC leads the Formulation Science Section at the Medicines and Healthcare products Regulatory Agency, at their South Mimms laboratories, in the UK, whose mission is to safeguard the quality of biological medicines. He has over 20 years experience of developing freeze drying and formulation conditions for a wide range of biological materials including those developed on behalf of the WHO as International Reference Standards for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions and his research interests include Process Analytical Technology in freeze drying, the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. Paul Matejtschuk (0000-0002-4646-800X) - ORCID Paul has over 35 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk). Email: paul.matejtschuk@mhra.gov.uk
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Session 1 Track B: CMC Strategies for Vaccines Biomanufacturing
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Moderator: Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, is currently a Technical R&D Advisor and Senior Fellow at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation. She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors.
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Vaccines Interest Group Session - Our 2024 journey!
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Presenter: Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.
Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.
Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board. Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively. She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.
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Patient-Centric Development for Vaccines
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Presenter: Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK
Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK
Dr. Frederic Mathot, Associate Director and Scientific Leader at GSK, holds a PhD in Pharmaceutical Sciences and currently works in the pharmaceutical industry for more than 15 years. His role at GSK Vaccines in R&D involves leading the Drug Product development of nucleic acid-based vaccines and other innovative technologies. His work primarily focuses on the physico-chemistry of biomolecules and drug product formulation. He is also involved in academia, supervising PhD students and lecturing at UCLouvain in Brussels, Belgium. His career includes several patents and he has been recognized with a few awards.
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Applying Prior Knowledge and Patient Centric Based Considerations to Specification Setting
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Presenter: Pepijn Burgers
Pepijn Burgers
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Q&A
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Moderator: Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, is currently a Technical R&D Advisor and Senior Fellow at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation. She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. -
Panelist: Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.
Sabrina Restrepo, PhD, Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.
Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board. Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively. She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio. -
Panelist: Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK
Frédéric Mathot, PhD, Associate Director, Scientific Leader, GSK
Dr. Frederic Mathot, Associate Director and Scientific Leader at GSK, holds a PhD in Pharmaceutical Sciences and currently works in the pharmaceutical industry for more than 15 years. His role at GSK Vaccines in R&D involves leading the Drug Product development of nucleic acid-based vaccines and other innovative technologies. His work primarily focuses on the physico-chemistry of biomolecules and drug product formulation. He is also involved in academia, supervising PhD students and lecturing at UCLouvain in Brussels, Belgium. His career includes several patents and he has been recognized with a few awards. -
Panelist: Pepijn Burgers
Pepijn Burgers
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Networking Coffee Break, Poster Session & Exhibition
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Session 2 Track A: Opportunities for Vaccine Access
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Moderator: Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC
Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC
Mic is currently an Associate Director of CMC Technical Advocacy & Policy at Merck Sharp and Dohme, Corp. His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for the last 30 years. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally. For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets. For the last seven years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for reliance, harmonization and greater access of vaccines to patients.
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Fast Evolving Vaccine Innovation Landscape
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Presenter: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
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Building Health Emergency Preparedness by Harnessing the Potential of Vaccine Platforms
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Presenter: Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)
Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)
Dr. Ramin Sabet-Azad is Chemistry, Manufacturing and Controls (CMC) Lead at CEPI, London, supporting the organisation as CMC subject matter expert in CEPI’s pancoronavirus disease program, protein vaccine program and its adjuvants task force. He is also working towards consensus between industry and regulators around use of Platform technologies for rapid response to outbreaks and health threat. He has a MSc and PhD in Biochemical Engineering from Lund University, Sweden, and several years of industrial experience in manufacturing of vaccines and biochemicals. Most notably, at Bavarian Nordic he worked on the approved MVA smallpox/mpox vaccine, and subsequently led DS process development activities for Mvabea, part of Janssen’s EMA/FDA authorised vaccine regimen for protection against the Ebola Zaire virus.
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Regulatory Global Convergence, Harmonization, and Reliance
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Presenter: Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme
Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme
Navdip Ghai is a Regulatory CMC professional at Merck Sharp & Dohme based in the USA and leads a team supporting HPV (Human Papillomavirus) vaccines in global markets. His career spans over 22 years in Bio-pharmaceutical industry with various roles in technical operations, validation, regulatory affairs, and CMC. He has deep exposure to China regulatory environment having led initial approval and renewals of 2 HPV vaccines in China.
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Q&A
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Moderator: Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC
Mic McGoldrick, Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC
Mic is currently an Associate Director of CMC Technical Advocacy & Policy at Merck Sharp and Dohme, Corp. His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for the last 30 years. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally. For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets. For the last seven years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for reliance, harmonization and greater access of vaccines to patients. -
Panelist: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
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Panelist: Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)
Ramin Sabet-Azad, PhD, CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)
Dr. Ramin Sabet-Azad is Chemistry, Manufacturing and Controls (CMC) Lead at CEPI, London, supporting the organisation as CMC subject matter expert in CEPI’s pancoronavirus disease program, protein vaccine program and its adjuvants task force. He is also working towards consensus between industry and regulators around use of Platform technologies for rapid response to outbreaks and health threat. He has a MSc and PhD in Biochemical Engineering from Lund University, Sweden, and several years of industrial experience in manufacturing of vaccines and biochemicals. Most notably, at Bavarian Nordic he worked on the approved MVA smallpox/mpox vaccine, and subsequently led DS process development activities for Mvabea, part of Janssen’s EMA/FDA authorised vaccine regimen for protection against the Ebola Zaire virus. -
Panelist: Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme
Navdip Ghai, Director - Regulatory Affairs CMC, Merck Sharpe & Dohme
Navdip Ghai is a Regulatory CMC professional at Merck Sharp & Dohme based in the USA and leads a team supporting HPV (Human Papillomavirus) vaccines in global markets. His career spans over 22 years in Bio-pharmaceutical industry with various roles in technical operations, validation, regulatory affairs, and CMC. He has deep exposure to China regulatory environment having led initial approval and renewals of 2 HPV vaccines in China.
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Session 2 Track B: Innovation in Biomanufacturing
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Michael R De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company
Michael R. De Felippis, Ph.D. joined The Lilly Research Laboratories of Eli Lilly (Lilly) and Company in 1990 after receiving his doctoral degree in Biochemistry from The Ohio State University. He is currently a Senior Vice President - Research in the Bioproduct Research and Development division. In this senior scientific leadership position, he is responsible for providing strategic technical direction to the CMC activities for the Lilly biopharmaceutical product portfolio with specific emphasis on characterization of physicochemical properties, analytical development, process and product development, control strategy definition, technology transfer and preparation of CMC-related regulatory documentation to support product licensure in global markets. Dr. De Felippis has lectured and published manuscripts, review articles and book chapters on the subjects of protein and peptide structural characterization, comparability, analytical testing and formulation design/delivery approaches.
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Cell-Free Manufacturing of Proteins
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Presenter: Matthias Steiger
Matthias Steiger
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Application and Utilization of Heat Inactivation as a Downstream Purification Tool in Biomanufacturing Processes
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Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company
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Polysorbate Control Strategies in Biopharmaceuticals
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Co-Presenter: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that, he was Head of Pharmaceutical Services at Lonza Drug Product Services. In this role, he was responsible for pre-clinical Drug Product manufacturing for vials, prefilled syringes, and ampoules. He also leads the packaging & combination product development department and the lab automation group. Roman joined Lonza from Roche. He is a Pharmacist by training and holds a Ph.D. in Pharmaceutical technology from the University of Munich, as well as an MBA and is a lecturer at the University of Basel. -
Co-Presenter: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
Atanas Koulov has more than 15 years of experience in pharmaceutical drug product development from Roche/Genentech, Novartis, and Lonza, where he has held positions with increasing responsibilities up to Senior Director leading a Drug Product Analytical Development & QC organization. Atanas is a co-founder and CSO at Clear Solutions Laboratories, a service organization helping Pharma and Biotech partners tackle challenges related to particle control. His focus areas are DP control strategies, particle contamination and control, forensic chemistry, analytical development, and quality control. He has authored more than 50 scientific publications and book chapters.
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Q&A
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Michael R De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company
Michael R. De Felippis, Ph.D. joined The Lilly Research Laboratories of Eli Lilly (Lilly) and Company in 1990 after receiving his doctoral degree in Biochemistry from The Ohio State University. He is currently a Senior Vice President - Research in the Bioproduct Research and Development division. In this senior scientific leadership position, he is responsible for providing strategic technical direction to the CMC activities for the Lilly biopharmaceutical product portfolio with specific emphasis on characterization of physicochemical properties, analytical development, process and product development, control strategy definition, technology transfer and preparation of CMC-related regulatory documentation to support product licensure in global markets. Dr. De Felippis has lectured and published manuscripts, review articles and book chapters on the subjects of protein and peptide structural characterization, comparability, analytical testing and formulation design/delivery approaches. -
Panelist: Matthias Steiger
Matthias Steiger
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Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company
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Panelist: Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes, PhD, CEO, Clear Solutions Laboratories
Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that, he was Head of Pharmaceutical Services at Lonza Drug Product Services. In this role, he was responsible for pre-clinical Drug Product manufacturing for vials, prefilled syringes, and ampoules. He also leads the packaging & combination product development department and the lab automation group. Roman joined Lonza from Roche. He is a Pharmacist by training and holds a Ph.D. in Pharmaceutical technology from the University of Munich, as well as an MBA and is a lecturer at the University of Basel. -
Panelist: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
Atanas Koulov has more than 15 years of experience in pharmaceutical drug product development from Roche/Genentech, Novartis, and Lonza, where he has held positions with increasing responsibilities up to Senior Director leading a Drug Product Analytical Development & QC organization. Atanas is a co-founder and CSO at Clear Solutions Laboratories, a service organization helping Pharma and Biotech partners tackle challenges related to particle control. His focus areas are DP control strategies, particle contamination and control, forensic chemistry, analytical development, and quality control. He has authored more than 50 scientific publications and book chapters.
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Networking Event
Wednesday, 25 September CEST
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Track A: Interest Group Session: Advanced Manufacturing and Applied Process Digitalization (former Biomanufacturing IG)
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Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV
Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes. -
Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON
Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON
Peter has over 19 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how. Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Advanced Manufacturing and Applied Process Digitalization IG, and Mobile Manufacturing Task Force.
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Track B: Interest Group Session: Lyophilization
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Moderator: Anthony Cannon
Anthony Cannon
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Registration Open
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Session 3 Track A: Digital Tools Shaping Future Biomanufacturing
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Moderator: Adithya Balasubramanian, Director, ten23 health AG
Adithya Balasubramanian, Director, ten23 health AG
With more than 15 years of experience in the biotech industry, including positions at Genentech, Regeneron and Lonza, I am an experienced Business Development Director at ten23 health.
My expertise lies in external collaborations, alliance management, and pharmaceutical development, specifically in the areas of formulation development and in-use stability and compatibility. At ten23 health, my primary focus is to identify new business opportunities for the company, build the ten23 brand and provide strategic and tactical guidance to our Development teams.
I began my career as a Research Associate at Regeneron and Genentech, where I worked on Eyelea (Aflibercept), Praluent (Alirocumab) and Polivy (Polatuzumab vedotin). I played a pivotal role in establishing the technical operations team at ten23 health and Lonza Drug Product Services. I have successfully led multiple CMC programs and collaborated with both small and large pharmaceutical companies at various stages of development.
Above all, my true passion lies in creating innovative solutions that enhance patient outcomes and experiences.
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The Key Role of AI in Biomanufacturing and Good Practices to Implement it
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Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV
Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.
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A Regulatory Framework Enabling Digital Innovation in Manufacturing
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Presenter: Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK
Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK
Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China.
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Accelerated Process Development using End-to-End Digital Twins
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Presenter: Thomas Zahel, PhD, Head of Innovation, Körber Pharma
Thomas Zahel, PhD, Head of Innovation, Körber Pharma
Thomas Zahel is Head of Innovation at Körber Pharma Austria GmbH, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for biopharmaceutical companies. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools.
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Q&A
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Moderator: Adithya Balasubramanian, Director, ten23 health AG
Adithya Balasubramanian, Director, ten23 health AG
With more than 15 years of experience in the biotech industry, including positions at Genentech, Regeneron and Lonza, I am an experienced Business Development Director at ten23 health.
My expertise lies in external collaborations, alliance management, and pharmaceutical development, specifically in the areas of formulation development and in-use stability and compatibility. At ten23 health, my primary focus is to identify new business opportunities for the company, build the ten23 brand and provide strategic and tactical guidance to our Development teams.
I began my career as a Research Associate at Regeneron and Genentech, where I worked on Eyelea (Aflibercept), Praluent (Alirocumab) and Polivy (Polatuzumab vedotin). I played a pivotal role in establishing the technical operations team at ten23 health and Lonza Drug Product Services. I have successfully led multiple CMC programs and collaborated with both small and large pharmaceutical companies at various stages of development.
Above all, my true passion lies in creating innovative solutions that enhance patient outcomes and experiences. -
Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV
Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes. -
Panelist: Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK
Mónica Perea-Vélez, MSc, PhD, CMC Advocacy and Policy Director, GSK
Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China. -
Panelist: Thomas Zahel, PhD, Head of Innovation, Körber Pharma
Thomas Zahel, PhD, Head of Innovation, Körber Pharma
Thomas Zahel is Head of Innovation at Körber Pharma Austria GmbH, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for biopharmaceutical companies. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools.
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Session 3 Track B: Future Techniques in Freeze-Drying
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Moderator: Sebastian Groel
Sebastian Groel
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Sustainable Refrigeration Technologies: Overview and Implementation of Innovative Air-Cooling Technology for Freeze-Drying Processes
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Co-Presenter: Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH
Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH
Fabian Plaum is working in the Sales Management for Freeze-Drying and Freeze-Thaw applications at HOF Sonderanlagenbau GmbH. In 2014 he started his studies for mechanical engineering at HOF and has successfully completed these studies with a Master of Engineering. Additionally, since 2014 he has worked in different areas at HOF, as Mechanical Engineering, Project Management and since 2019 within the sales department at HOF. Within the Sales Management Fabian is responsible for the customer care and the creation of customized concepts for the integration of Freeze-Thaw equipment and Freeze-Dryers into aseptic fill and finish lines. -
Co-Presenter: Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH
Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH
Christian Sonntag Education: 2003 - 2007: University of Applied Sciences, Dresden (Production Technology, Dipl.Ing.) --> 2005: Northern Airzona University, Flagstaff (exchange semester) 2007 - 2008: University of Tennessee, Knoxville (Industrial Engineering, Master of Science) --> Fulbright scholarship Work Experience: 2009 - 2012: Haupt Pharma Wolfratshausen (Assistant of Managing Director) 2012 - 2016: Haupt Pharma Wolfratshausen (Technical Project Manager) 2016 - 2020: Roche Diagnostics GmbH, Penzberg (Process Engineer) since 2020: Roche Diagnostics GmbH, Penzberg (Project Manager CAPEX)
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Continuous and Controlled Lyophilization of mRNA-LNPs Based Formulations
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Academic Presenter: Thomas De Beer, PhD, Professor, Ghent University
Thomas De Beer, PhD, Professor, Ghent University
Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he examined the suitability of Raman spectroscopy as a Process Analytical Technology tool for pharmaceutical production processes. Within his PhD research period, he worked four months at University of Copenhagen in Denmark. After his PhD, he was an FWO funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked 9 months at the Ludwig-Maximilians-University in Munich, Germany. In February 2010, he became professor in Process Analytics & Technology at the Faculty of Pharmaceutical Sciences from the university of Ghent. His research goals include bringing innovation pharmaceutical production processes (freeze-drying, hot-melt extrusion, continuous from-powder-to-tablet processing etc.). More specifically, Prof. De Beer contributes to the development of continuous manufacturing processes for drug products such as solids, semi-solids, liquids and biologicals. Thomas De Beer is also director of Ghent University’s Center of Excellence in Sustainable Pharmaceutical Engineering (CESPE) which is founded in 2016. In 2018, Thomas De Beer became co-founder and CEO of the Ghent University spin-off company RheaVita which provides a continuous freeze-drying technology for the pharmaceutical market.
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Understanding Thermal Interactions in Biopharmaceutical Freezing: Implications for Nucleation Temperature Distribution
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Academic Presenter: Roberto Pisano
Roberto Pisano
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Q&A
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Moderator: Sebastian Groel
Sebastian Groel
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Panelist: Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH
Fabian Plaum, M.Eng., Sales Management, HOF Sonderanlagenbau GmbH
Fabian Plaum is working in the Sales Management for Freeze-Drying and Freeze-Thaw applications at HOF Sonderanlagenbau GmbH. In 2014 he started his studies for mechanical engineering at HOF and has successfully completed these studies with a Master of Engineering. Additionally, since 2014 he has worked in different areas at HOF, as Mechanical Engineering, Project Management and since 2019 within the sales department at HOF. Within the Sales Management Fabian is responsible for the customer care and the creation of customized concepts for the integration of Freeze-Thaw equipment and Freeze-Dryers into aseptic fill and finish lines. -
Panelist: Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH
Christian Sonntag, MS, Senior Project Manager, Roche Diagnostics GmbH
Christian Sonntag Education: 2003 - 2007: University of Applied Sciences, Dresden (Production Technology, Dipl.Ing.) --> 2005: Northern Airzona University, Flagstaff (exchange semester) 2007 - 2008: University of Tennessee, Knoxville (Industrial Engineering, Master of Science) --> Fulbright scholarship Work Experience: 2009 - 2012: Haupt Pharma Wolfratshausen (Assistant of Managing Director) 2012 - 2016: Haupt Pharma Wolfratshausen (Technical Project Manager) 2016 - 2020: Roche Diagnostics GmbH, Penzberg (Process Engineer) since 2020: Roche Diagnostics GmbH, Penzberg (Project Manager CAPEX) -
Academic Panelist: Thomas De Beer, PhD, Professor, Ghent University
Thomas De Beer, PhD, Professor, Ghent University
Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he examined the suitability of Raman spectroscopy as a Process Analytical Technology tool for pharmaceutical production processes. Within his PhD research period, he worked four months at University of Copenhagen in Denmark. After his PhD, he was an FWO funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked 9 months at the Ludwig-Maximilians-University in Munich, Germany. In February 2010, he became professor in Process Analytics & Technology at the Faculty of Pharmaceutical Sciences from the university of Ghent. His research goals include bringing innovation pharmaceutical production processes (freeze-drying, hot-melt extrusion, continuous from-powder-to-tablet processing etc.). More specifically, Prof. De Beer contributes to the development of continuous manufacturing processes for drug products such as solids, semi-solids, liquids and biologicals. Thomas De Beer is also director of Ghent University’s Center of Excellence in Sustainable Pharmaceutical Engineering (CESPE) which is founded in 2016. In 2018, Thomas De Beer became co-founder and CEO of the Ghent University spin-off company RheaVita which provides a continuous freeze-drying technology for the pharmaceutical market. -
Academic Panelist: Roberto Pisano
Roberto Pisano
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Networking Coffee Break, Poster Session & Exhibition
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Session 4 Track A: Fill & Finish Processing
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Moderator: Yves Mayeresse, Director, GSK
Yves Mayeresse, Director, GSK
Yves Mayeresse is director in manufacturing technology inside MSAT by GSK. He has more than thirty years of experience in the pharmaceutical and vaccine sector, he 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. Transfer of product towards different internal and external site. 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 new and established technologies used for the upstream and downstream of primary operations, isolator technology and secondary operations from formulation to freeze-drying. He is an engineer in biochemistry, has written articles about Freeze-Drying science and is a regular speaker for conferences on Freeze-Drying. He is a regular committee member for PDA and former chairman of conference.
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Discovering Equivalence in Extractables & Leachables Assessments of Single-Use Systems: An Advanced Mathematical Methodology
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Presenter: Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH
Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH
After his PhD, Armin Hauk started his professional life in 1995 as analytical scientist in the R&D department of the former Ciba-Geigy in Basle (CH). During his time at Ciba, he was head of a organic trace-analysis lab, GLP & GMP analytics, responsible for impurity profiling, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 he worked as consultant and Qualified Person (QP) for Intertek C&P (CH). Since 2016 he has a position at Sartorius Stedim Biotech as Principal Scientist. Armin is lecturer and trainer in E&L conferences and seminars, and he is member in various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan) Armin is one of the German delegates in the Pharmacopeia expert group 16 of the European Directorate for the Quality of Medicine (EDQM).
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VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products
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Presenter: Dilara Ali, MSc, PhD Student , ten23 health
Dilara Ali, MSc, PhD Student , ten23 health
Dilara Ali is a Ph.D. Student in the packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel, Switzerland. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics, from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Freiburg. During her masters, alongside her studies, she worked on the development of liquid formulations. Her master's thesis investigated single-use material used during aseptic manufacturing. Currently pursuing her Ph.D., she focuses on optimizing disposable manufacturing material in fill-finish operations.
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Frame-by-Frame - End-to-End: How Advanced Risk Profiling Accelerated the Development of a Robust Manufacturing Setup for a Brand New Kindeva Fill-Finish Site
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Co-Presenter: Sebastian Scheler, Mr., Managing Director, Innerspace GmbH
Sebastian Scheler, Mr., Managing Director, Innerspace GmbH
I am passionate about pushing the boundaries of advanced risk assessment technologies to unlock new possibilities for designing and managing manufacturing processes in pharma. I spearhead a dynamic team of life science professionals and software developers. The core focus of my professional work lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to risk assessment. This cutting-edge technology facilitates process improvement, process automation, autogenerated SOPs, and immersive training curricula, empowering organizations to achieve unparalleled levels of efficiency, compliance and safety in drug manufacturing. With a profound background in psychology, I have always been captivated by the intersection of human behavior and technology. My passion for Virtual Reality has culminated in pioneering VR simulator methodologies that push the boundaries of experiential learning, training, and behavior measurement systems. Beyond my leadership at Innerspace, I also serve as trainer for PDA training courses and further development of the PDA/Innerspace official partnership focusing on refining training course delivery and design. -
Co-Presenter: Jeff Gensler, MBA, Vice President - Quality, Kindeva Drug Delivery
Jeff Gensler, MBA, Vice President - Quality, Kindeva Drug Delivery
Jeff is currently Vice President of Quality for Kindeva Drug Delivery (Kindeva). He has more than 30 years of quality leadership in the medical device and combination device industries. In addition, he has experience leading large-scale remediation efforts with a proven track record of successfully leading FDA inspections. Jeff has a depth of knowledge working with FDA and Class I, II, and III medical devices, as well as pharmaceutical and combination products. Prior to joining Kindeva, Jeff held several leadership positions, including vice president of quality assurance and quality control at Zimmer Biomet, in Indiana. Before that, he served as director of quality assurance and regulatory affairs at Dentsply International, in Pennsylvania. Jeff joined Kindeva in 2019 as the site quality operations lead, responsible for all site quality functions. As vice president of quality, he is responsible for ensuring regulatory compliance across the entire Kindeva organization. Jeff earned a B.S. in business administration and strategic management, as well as an MBA with a concentration in quality management from Upper Iowa University. He has also completed Six Sigma Greenbelt certification.
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Q&A
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Moderator: Yves Mayeresse, Director, GSK
Yves Mayeresse, Director, GSK
Yves Mayeresse is director in manufacturing technology inside MSAT by GSK. He has more than thirty years of experience in the pharmaceutical and vaccine sector, he 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. Transfer of product towards different internal and external site. 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 new and established technologies used for the upstream and downstream of primary operations, isolator technology and secondary operations from formulation to freeze-drying. He is an engineer in biochemistry, has written articles about Freeze-Drying science and is a regular speaker for conferences on Freeze-Drying. He is a regular committee member for PDA and former chairman of conference. -
Panelist: Dilara Ali, MSc, PhD Student , ten23 health
Dilara Ali, MSc, PhD Student , ten23 health
Dilara Ali is a Ph.D. Student in the packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel, Switzerland. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics, from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Freiburg. During her masters, alongside her studies, she worked on the development of liquid formulations. Her master's thesis investigated single-use material used during aseptic manufacturing. Currently pursuing her Ph.D., she focuses on optimizing disposable manufacturing material in fill-finish operations. -
Panelist: Sebastian Scheler, Mr., Managing Director, Innerspace GmbH
Sebastian Scheler, Mr., Managing Director, Innerspace GmbH
I am passionate about pushing the boundaries of advanced risk assessment technologies to unlock new possibilities for designing and managing manufacturing processes in pharma. I spearhead a dynamic team of life science professionals and software developers. The core focus of my professional work lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to risk assessment. This cutting-edge technology facilitates process improvement, process automation, autogenerated SOPs, and immersive training curricula, empowering organizations to achieve unparalleled levels of efficiency, compliance and safety in drug manufacturing. With a profound background in psychology, I have always been captivated by the intersection of human behavior and technology. My passion for Virtual Reality has culminated in pioneering VR simulator methodologies that push the boundaries of experiential learning, training, and behavior measurement systems. Beyond my leadership at Innerspace, I also serve as trainer for PDA training courses and further development of the PDA/Innerspace official partnership focusing on refining training course delivery and design. -
Panelist: Jeff Gensler, MBA, Vice President - Quality, Kindeva Drug Delivery
Jeff Gensler, MBA, Vice President - Quality, Kindeva Drug Delivery
Jeff is currently Vice President of Quality for Kindeva Drug Delivery (Kindeva). He has more than 30 years of quality leadership in the medical device and combination device industries. In addition, he has experience leading large-scale remediation efforts with a proven track record of successfully leading FDA inspections. Jeff has a depth of knowledge working with FDA and Class I, II, and III medical devices, as well as pharmaceutical and combination products. Prior to joining Kindeva, Jeff held several leadership positions, including vice president of quality assurance and quality control at Zimmer Biomet, in Indiana. Before that, he served as director of quality assurance and regulatory affairs at Dentsply International, in Pennsylvania. Jeff joined Kindeva in 2019 as the site quality operations lead, responsible for all site quality functions. As vice president of quality, he is responsible for ensuring regulatory compliance across the entire Kindeva organization. Jeff earned a B.S. in business administration and strategic management, as well as an MBA with a concentration in quality management from Upper Iowa University. He has also completed Six Sigma Greenbelt certification. -
Panelist: Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH
Armin Hauk, PhD, Principal Scientist, Sartorius Biotech GmbH
After his PhD, Armin Hauk started his professional life in 1995 as analytical scientist in the R&D department of the former Ciba-Geigy in Basle (CH). During his time at Ciba, he was head of a organic trace-analysis lab, GLP & GMP analytics, responsible for impurity profiling, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 he worked as consultant and Qualified Person (QP) for Intertek C&P (CH). Since 2016 he has a position at Sartorius Stedim Biotech as Principal Scientist. Armin is lecturer and trainer in E&L conferences and seminars, and he is member in various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan) Armin is one of the German delegates in the Pharmacopeia expert group 16 of the European Directorate for the Quality of Medicine (EDQM).
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Session 4 Track B: Sustainability
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Moderator: Virginie Le Coent
Virginie Le Coent
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Sustainability at the EDQM: A Focus on the Ph. Eur. and the 3Rs
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Regulatory Presenter: Emmanuelle F Charton, Head of Division B, European Pharmacopoeia Department, EDQM
Emmanuelle F Charton, Head of Division B, European Pharmacopoeia Department, EDQM
Emmanuelle CHARTON holds a PhD in biochemistry from the Institut National Agronomique de Paris-Grignon. Since 2006 she is Head of Division B in the European Pharmacopoeia department at the European Directorate for the Quality of Medicines and HealthCare (EDQM). The Scientific Secretariat for the elaboration of European Pharmacopoeia texts related to microbiology fall under the responsibility of her division. Her work experience includes QA/QC in a facility for the production of parenteral products and preparation to GMP inspections in a global pharmaceutical company, research and development in biochemistry in a global company selling food and chemicals. She has over 25 years’ experience at the EDQM, including as scientific administrator to the groups of experts in the fields of biology and microbiology and as a supervisor to the corresponding work in the EDQM laboratory.
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Enhancing Sustainability ESG Scores in BioManufacturing
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Presenter: Philippe Gadal
Philippe Gadal
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Using Sustainable Taxonomy: Recycle, Reuse, Reduce & Re-purpose Water for pharmaceutical Use
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Presenter: Durga Prasad Madhavapeddi
Durga Prasad Madhavapeddi
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Q&A
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Moderator: Virginie Le Coent
Virginie Le Coent
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Regulatory Panelist: Emmanuelle F Charton, Head of Division B, European Pharmacopoeia Department, EDQM
Emmanuelle F Charton, Head of Division B, European Pharmacopoeia Department, EDQM
Emmanuelle CHARTON holds a PhD in biochemistry from the Institut National Agronomique de Paris-Grignon. Since 2006 she is Head of Division B in the European Pharmacopoeia department at the European Directorate for the Quality of Medicines and HealthCare (EDQM). The Scientific Secretariat for the elaboration of European Pharmacopoeia texts related to microbiology fall under the responsibility of her division. Her work experience includes QA/QC in a facility for the production of parenteral products and preparation to GMP inspections in a global pharmaceutical company, research and development in biochemistry in a global company selling food and chemicals. She has over 25 years’ experience at the EDQM, including as scientific administrator to the groups of experts in the fields of biology and microbiology and as a supervisor to the corresponding work in the EDQM laboratory. -
Panelist: Philippe Gadal
Philippe Gadal
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Panelist: Durga Prasad Madhavapeddi
Durga Prasad Madhavapeddi
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Networking Lunch Break, Poster Session & Exhibition
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Interactive Questionnaire
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Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare.
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Closing Plenary Part I: Innovative Regulatory Strategies for a Globalized World
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Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare.
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Title to be Announced
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Regulatory Presenter: Robin Levis, CBER, U.S. FDA
Robin Levis, CBER, U.S. FDA
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Efficiency in Pharmaceutical Life-Cycle Management: Implementing ICH Q12 and Established Conditions
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Presenter: Thomas Stangler
Thomas Stangler
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Simultaneous Submission to Multiple Health Authorities Using Accumulus Synergy Platform - Using CMC Platform Best Practices for Comparability Assessments and Manufacturing Process Validation as Pilot
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Presenter: Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
Olga Rovira has an academic background in Industrial Chemistry Engineering from the University of Zaragoza (Spain) and in Structural Molecular Biology from the University of London (UK). Olga is currently working at KONTIVAX, her own Regulatory Affairs (RA) consultancy company, which serves small biotech companies, large multinational corporations as well as partnerships such as CEPI (Coalition for Epidemic Preparedness Innovations) or TBVI (TuBerculosis Vaccine Initiative). Her expertise focuses on RA Chemistry, Manufacturing and Controls (CMC) for vaccines. She has a solid knowledge and understanding of technical development of vaccines throughout the whole development path up to registration and subsequent life-cycle stage and how this relates to worldwide regulatory requirements and expectations. Her experience covers multiple vaccine platform technologies as well as adjuvants (novel and well-established). Olga is member of TOPRA (The Organisation for Professionals in Regulatory Affairs).
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Networking Coffee Break, Poster Session & Exhibition
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Passport Raffle
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Closing Plenary Part II: Innovative Regulatory Strategies for a Globalized World
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Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare.
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Simultaneous Submission to Multiple Health Authorities Using Accumulus Synergy Platform - Using CMC Platform Best Practices for Comparability Assessments and Manufacturing Process Validation as Pilot
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Presenter: Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
Olga Rovira has an academic background in Industrial Chemistry Engineering from the University of Zaragoza (Spain) and in Structural Molecular Biology from the University of London (UK). Olga is currently working at KONTIVAX, her own Regulatory Affairs (RA) consultancy company, which serves small biotech companies, large multinational corporations as well as partnerships such as CEPI (Coalition for Epidemic Preparedness Innovations) or TBVI (TuBerculosis Vaccine Initiative). Her expertise focuses on RA Chemistry, Manufacturing and Controls (CMC) for vaccines. She has a solid knowledge and understanding of technical development of vaccines throughout the whole development path up to registration and subsequent life-cycle stage and how this relates to worldwide regulatory requirements and expectations. Her experience covers multiple vaccine platform technologies as well as adjuvants (novel and well-established). Olga is member of TOPRA (The Organisation for Professionals in Regulatory Affairs).
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Title to be Announced
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Plenary Discussion
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Moderator: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare. -
Panelist: Thomas Stangler
Thomas Stangler
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Panelist: Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
Olga Rovira, Regulatory Affairs Senior Consultant, CEPI
Olga Rovira has an academic background in Industrial Chemistry Engineering from the University of Zaragoza (Spain) and in Structural Molecular Biology from the University of London (UK). Olga is currently working at KONTIVAX, her own Regulatory Affairs (RA) consultancy company, which serves small biotech companies, large multinational corporations as well as partnerships such as CEPI (Coalition for Epidemic Preparedness Innovations) or TBVI (TuBerculosis Vaccine Initiative). Her expertise focuses on RA Chemistry, Manufacturing and Controls (CMC) for vaccines. She has a solid knowledge and understanding of technical development of vaccines throughout the whole development path up to registration and subsequent life-cycle stage and how this relates to worldwide regulatory requirements and expectations. Her experience covers multiple vaccine platform technologies as well as adjuvants (novel and well-established). Olga is member of TOPRA (The Organisation for Professionals in Regulatory Affairs). -
Panelist: Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
Anna Czwarno, Ms.Eng., Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
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Regulatory Panelist: Mats Welin
Mats Welin
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Regulatory Panelist: Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
Steffen Gross, Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics” in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunosera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt. -
Academic Panelist: Maria Papathanasiou, PhD, Associate Professor (UK Senior Lecturer), Department of Chemical Engineering, Imperial College London
Maria Papathanasiou, PhD, Associate Professor (UK Senior Lecturer), Department of Chemical Engineering, Imperial College London
Dr Maria Papathanasiou is a Senior Lecturer (AssociateProfessor) at the Department of Chemical Engineering, Imperial College London. She holds a PhD degree in Process Systems Engineering from the Department of Chemical Engineering at Imperial College London and an MSc from the same department. She completed her undergraduate studies at the School of Chemical Engineering, National Technical University of Athens and she conducted her Diploma Thesis in Food Process Engineering at the Technical University of Berlin. Dr Papathanasiou’s research focuses on the development of Process Systems Engineering tools (modelling, optimisation and control) with application to biopharmaceutical process development, optimisation and control. Her research outputs to date have been acknowledged through over 40 peer reviewed and conference publications, 30 oral presentations at international conferences and 4 international awards, including IChemE’s Junior Sargent Medal (2023). -
Regulatory Panelist: Paul Matejtschuk, PhD FRSC CChem , Section Head Formulation Science , MHRA
Paul Matejtschuk, PhD FRSC CChem , Section Head Formulation Science , MHRA
Biography: Paul Matejtschuk PhD, CChem, FRSC leads the Formulation Science Section at the Medicines and Healthcare products Regulatory Agency, at their South Mimms laboratories, in the UK, whose mission is to safeguard the quality of biological medicines. He has over 20 years experience of developing freeze drying and formulation conditions for a wide range of biological materials including those developed on behalf of the WHO as International Reference Standards for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions and his research interests include Process Analytical Technology in freeze drying, the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. Paul Matejtschuk (0000-0002-4646-800X) - ORCID Paul has over 35 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk). Email: paul.matejtschuk@mhra.gov.uk -
Moderator: Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, Technical R&D Advisor and Senior Fellow, GSK
Cristiana Campa, PhD, is currently a Technical R&D Advisor and Senior Fellow at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation. She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. -
Regulatory Panelist: Robin Levis, CBER, U.S. FDA
Robin Levis, CBER, U.S. FDA
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Co-Chair Conference Summary
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Co-Chair: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare. -
Co-Chair: Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck, Dr, EVP Corporate Development & QM, Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare.
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Closing Remarks & Farewell
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Committee Member: Falk Klar, PhD, Parenteral Drug Association
Falk Klar, PhD, Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.
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Presenters
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Dilara Ali, MSc
PhD Student , ten23 health
Panelist
Presenter
Read BioDilara Ali, MSc
ten23 health
Dilara Ali is a Ph.D. Student in the packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel, Switzerland. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics, from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Freiburg. During her masters, alongside her studies, she worked on the development of liquid formulations. Her master's thesis investigated single-use material used during aseptic manufacturing. Currently pursuing her Ph.D., she focuses on optimizing disposable manufacturing material in fill-finish operations. -
Andrea Arsiccio, PhD
Senior Scientist, Coriolis Pharma
Panelist
Presenter
Read BioAndrea Arsiccio, PhD
Coriolis Pharma
Andrea Arsiccio is a Senior Scientist at Coriolis Pharma, where he works on projects dealing with the development of lyophilized formulations, lyophilization process development and the implementation of innovative modelling concepts. He received a master's degree in Chemical Engineering from Politecnico di Torino in 2016 followed by a PhD degree in 2020. During his PhD he investigated the freeze drying process, with a special focus on the formulation of biopharmaceuticals. He subsequently worked as a Postdoctoral scholar at the University of California in Santa Barbara and at Politecnico di Torino, and during this time his research focused on molecular dynamics simulations. His main interests and expertise are in the fields of freeze drying, protein folding and aggregation, and molecular dynamics simulations. -
Adithya Balasubramanian
Director, ten23 health AG
Moderator
Read BioAdithya Balasubramanian
ten23 health AG
With more than 15 years of experience in the biotech industry, including positions at Genentech, Regeneron and Lonza, I am an experienced Business Development Director at ten23 health.
My expertise lies in external collaborations, alliance management, and pharmaceutical development, specifically in the areas of formulation development and in-use stability and compatibility. At ten23 health, my primary focus is to identify new business opportunities for the company, build the ten23 brand and provide strategic and tactical guidance to our Development teams.
I began my career as a Research Associate at Regeneron and Genentech, where I worked on Eyelea (Aflibercept), Praluent (Alirocumab) and Polivy (Polatuzumab vedotin). I played a pivotal role in establishing the technical operations team at ten23 health and Lonza Drug Product Services. I have successfully led multiple CMC programs and collaborated with both small and large pharmaceutical companies at various stages of development.
Above all, my true passion lies in creating innovative solutions that enhance patient outcomes and experiences. -
Bianca Bohrer, Dipl Ing
Managing Director, PSM GmbH
Moderator
Read BioBianca Bohrer, Dipl Ing
PSM GmbH
Ms. Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Kiaserslautern. Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and as a manufacturing manager for parenteral applications, she was able to further deepen these skills. Since September 2014 she has been Head of Quality Control, since 2019 Managing Director of PharmBioTec GmbH, a non-profit research institute, and since 2020 Managing Director of PSM GmbH - a §13-AMG contract manufacturers for aseptic products. -
Pepijn Burgers
Panelist
Presenter
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Cristiana Campa, PhD
Technical R&D Advisor and Senior Fellow, GSK
Moderator
Read BioCristiana Campa, PhD
GSK
Cristiana Campa, PhD, is currently a Technical R&D Advisor and Senior Fellow at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation. She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors. -
Anthony Cannon
Moderator
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Colette Carmody Culhane, MSc.
Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company
Panelist
Presenter
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Emmanuelle F Charton
Head of Division B, European Pharmacopoeia Department, EDQM
Regulatory Panelist
Regulatory Presenter
Read BioEmmanuelle F Charton
EDQM
Emmanuelle CHARTON holds a PhD in biochemistry from the Institut National Agronomique de Paris-Grignon. Since 2006 she is Head of Division B in the European Pharmacopoeia department at the European Directorate for the Quality of Medicines and HealthCare (EDQM). The Scientific Secretariat for the elaboration of European Pharmacopoeia texts related to microbiology fall under the responsibility of her division. Her work experience includes QA/QC in a facility for the production of parenteral products and preparation to GMP inspections in a global pharmaceutical company, research and development in biochemistry in a global company selling food and chemicals. She has over 25 years’ experience at the EDQM, including as scientific administrator to the groups of experts in the fields of biology and microbiology and as a supervisor to the corresponding work in the EDQM laboratory. -
Anna Czwarno, Ms.Eng.
Regulatory, Manufacturing & Supply Director, Vaccines Europe, Vaccines Europe
Panelist
Presenter
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Thomas De Beer, PhD
Professor, Ghent University
Academic Panelist
Academic Presenter
Read BioThomas De Beer, PhD
Ghent University
Thomas De Beer graduated in pharmaceutical sciences in 2002 at the Ghent University in Belgium. He obtained his PhD at the same university in 2007. For his PhD research, he examined the suitability of Raman spectroscopy as a Process Analytical Technology tool for pharmaceutical production processes. Within his PhD research period, he worked four months at University of Copenhagen in Denmark. After his PhD, he was an FWO funded post-doctoral fellow at the Ghent University (2007-2010). Within his post-doc mandate, he worked 9 months at the Ludwig-Maximilians-University in Munich, Germany. In February 2010, he became professor in Process Analytics & Technology at the Faculty of Pharmaceutical Sciences from the university of Ghent. His research goals include bringing innovation pharmaceutical production processes (freeze-drying, hot-melt extrusion, continuous from-powder-to-tablet processing etc.). More specifically, Prof. De Beer contributes to the development of continuous manufacturing processes for drug products such as solids, semi-solids, liquids and biologicals. Thomas De Beer is also director of Ghent University’s Center of Excellence in Sustainable Pharmaceutical Engineering (CESPE) which is founded in 2016. In 2018, Thomas De Beer became co-founder and CEO of the Ghent University spin-off company RheaVita which provides a continuous freeze-drying technology for the pharmaceutical market. -
Michael R De Felippis, PhD
Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company
Moderator
Read BioMichael R De Felippis, PhD
Eli Lilly and Company
Michael R. De Felippis, Ph.D. joined The Lilly Research Laboratories of Eli Lilly (Lilly) and Company in 1990 after receiving his doctoral degree in Biochemistry from The Ohio State University. He is currently a Senior Vice President - Research in the Bioproduct Research and Development division. In this senior scientific leadership position, he is responsible for providing strategic technical direction to the CMC activities for the Lilly biopharmaceutical product portfolio with specific emphasis on characterization of physicochemical properties, analytical development, process and product development, control strategy definition, technology transfer and preparation of CMC-related regulatory documentation to support product licensure in global markets. Dr. De Felippis has lectured and published manuscripts, review articles and book chapters on the subjects of protein and peptide structural characterization, comparability, analytical testing and formulation design/delivery approaches. -
Philippe Gadal
Panelist
Presenter
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Jeff Gensler, MBA
Vice President - Quality, Kindeva Drug Delivery
Co-Presenter
Panelist
Read BioJeff Gensler, MBA
Kindeva Drug Delivery
Jeff is currently Vice President of Quality for Kindeva Drug Delivery (Kindeva). He has more than 30 years of quality leadership in the medical device and combination device industries. In addition, he has experience leading large-scale remediation efforts with a proven track record of successfully leading FDA inspections. Jeff has a depth of knowledge working with FDA and Class I, II, and III medical devices, as well as pharmaceutical and combination products. Prior to joining Kindeva, Jeff held several leadership positions, including vice president of quality assurance and quality control at Zimmer Biomet, in Indiana. Before that, he served as director of quality assurance and regulatory affairs at Dentsply International, in Pennsylvania. Jeff joined Kindeva in 2019 as the site quality operations lead, responsible for all site quality functions. As vice president of quality, he is responsible for ensuring regulatory compliance across the entire Kindeva organization. Jeff earned a B.S. in business administration and strategic management, as well as an MBA with a concentration in quality management from Upper Iowa University. He has also completed Six Sigma Greenbelt certification. -
Navdip Ghai
Director - Regulatory Affairs CMC, Merck Sharpe & Dohme
Panelist
Presenter
Read BioNavdip Ghai
Merck Sharpe & Dohme
Navdip Ghai is a Regulatory CMC professional at Merck Sharp & Dohme based in the USA and leads a team supporting HPV (Human Papillomavirus) vaccines in global markets. His career spans over 22 years in Bio-pharmaceutical industry with various roles in technical operations, validation, regulatory affairs, and CMC. He has deep exposure to China regulatory environment having led initial approval and renewals of 2 HPV vaccines in China. -
Sebastian Groel
Moderator
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Steffen Gross
Head Section Qualtiy and Non-clinical Evaluation of Antibody Therapeutics, Paul-Ehrlich-Institute
Regulatory Panelist
Regulatory Presenter
Read BioSteffen Gross
Paul-Ehrlich-Institute
Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics” in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunosera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt. -
Sabine Hauck, Dr
EVP Corporate Development & QM, Leukocare AG
Co-Chair
Moderator
Read BioSabine Hauck, Dr
Leukocare AG
Sabine Hauck is Executive Vice President Corporate Development at Munich-based biotech company Leukocare AG. She has 20+ years of experience in the biotech industry, in which she held various positions in pharmaceutical development, quality assurance and regulatory affairs. Her experience spans from small molecules to cell therapies and includes a variety of dosage forms. In the current position, Sabine is responsible for digitalization activities at Leukocare AG as well as for Business Process and Quality Management. In this role, she supports the ongoing digital transformation of the organization related to the algorithm-based formulation development approach at Leukocare. -
Armin Hauk, PhD
Principal Scientist, Sartorius Biotech GmbH
Panelist
Presenter
Read BioArmin Hauk, PhD
Sartorius Biotech GmbH
After his PhD, Armin Hauk started his professional life in 1995 as analytical scientist in the R&D department of the former Ciba-Geigy in Basle (CH). During his time at Ciba, he was head of a organic trace-analysis lab, GLP & GMP analytics, responsible for impurity profiling, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 he worked as consultant and Qualified Person (QP) for Intertek C&P (CH). Since 2016 he has a position at Sartorius Stedim Biotech as Principal Scientist. Armin is lecturer and trainer in E&L conferences and seminars, and he is member in various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan) Armin is one of the German delegates in the Pharmacopeia expert group 16 of the European Directorate for the Quality of Medicine (EDQM). -
Falk Klar, PhD
Parenteral Drug Association
Committee Member
Read BioFalk Klar, PhD
Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe. -
Atanas Koulov, PhD
Chief Scientific Officer, Clear Solutions Laboratories AG
Co-Presenter
Panelist
Read BioAtanas Koulov, PhD
Clear Solutions Laboratories AG
Atanas Koulov has more than 15 years of experience in pharmaceutical drug product development from Roche/Genentech, Novartis, and Lonza, where he has held positions with increasing responsibilities up to Senior Director leading a Drug Product Analytical Development & QC organization. Atanas is a co-founder and CSO at Clear Solutions Laboratories, a service organization helping Pharma and Biotech partners tackle challenges related to particle control. His focus areas are DP control strategies, particle contamination and control, forensic chemistry, analytical development, and quality control. He has authored more than 50 scientific publications and book chapters. -
Thomas Kriehuber
Panelist
Presenter
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Virginie Le Coent
Moderator
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Julian H. Lenger, PhD
Head of Laboratory Parenteral Drug Development, Bayer AG
Moderator
Read BioJulian H. Lenger, PhD
Bayer AG
Dr. Julian Lenger is a pharmacist by training with expertise in established and novel freeze-drying technologies as well as formulation development and analytical characterization of biotherapeutics and small molecules. Since 2020, he is driving formulation and process development for early pipeline development projects at Bayer AG in Wuppertal, Germany, as Head of Laboratory in Drug Product Development for parenteral drugs. Before joining Bayer, Julian spent four years as PhD student at the Ludwig-Maximilians-Universität München (University of Munich, Germany) in the group of Prof. Dr. Gerhard Winter at the chair of pharmaceutical technology. Here he successfully investigated and published several papers on novel technologies like microwave-assisted freeze-drying or controlled ice nucleation. Previously, Julian studied Pharmacy at the Christian-Albrechts-Universität zu Kiel (University of Kiel, Germany) and Trinity College Dublin, Ireland. Besides Julian is an active member in societies and consortia like Parenteral Drug Association (PDA) and BioPhorum. -
Robin Levis
CBER, U.S. FDA
Regulatory Panelist
Regulatory Presenter
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Peter J. Makowenskyj, MEng
Director of Design Consulting, G-CON
Moderator
Read BioPeter J. Makowenskyj, MEng
G-CON
Peter has over 19 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how. Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Advanced Manufacturing and Applied Process Digitalization IG, and Mobile Manufacturing Task Force. -
Toni Manzano
Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV
Moderator
Panelist
Presenter
Read BioToni Manzano
Aizon and United Nations, professor at the URV
Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes. -
Paul Matejtschuk, PhD FRSC CChem
Section Head Formulation Science , MHRA
Panelist
Presenter
Regulatory Panelist
Regulatory Presenter
Read BioPaul Matejtschuk, PhD FRSC CChem
MHRA
Biography: Paul Matejtschuk PhD, CChem, FRSC leads the Formulation Science Section at the Medicines and Healthcare products Regulatory Agency, at their South Mimms laboratories, in the UK, whose mission is to safeguard the quality of biological medicines. He has over 20 years experience of developing freeze drying and formulation conditions for a wide range of biological materials including those developed on behalf of the WHO as International Reference Standards for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions and his research interests include Process Analytical Technology in freeze drying, the relationship between structure and stability in biologicals, thermal analysis and other methods for the characterization of lyophilized proteins. Paul Matejtschuk (0000-0002-4646-800X) - ORCID Paul has over 35 years postdoctoral experience working in both academic and industrial settings in the areas of biologicals, with broad experience across downstream processing, characterization and analysis. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org) and a committee member of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk). Email: paul.matejtschuk@mhra.gov.uk -
Roman Mathaes, PhD
CEO, Clear Solutions Laboratories
Co-Presenter
Panelist
Read BioRoman Mathaes, PhD
Clear Solutions Laboratories
Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that, he was Head of Pharmaceutical Services at Lonza Drug Product Services. In this role, he was responsible for pre-clinical Drug Product manufacturing for vials, prefilled syringes, and ampoules. He also leads the packaging & combination product development department and the lab automation group. Roman joined Lonza from Roche. He is a Pharmacist by training and holds a Ph.D. in Pharmaceutical technology from the University of Munich, as well as an MBA and is a lecturer at the University of Basel. -
Frédéric Mathot, PhD
Associate Director, Scientific Leader, GSK
Panelist
Presenter
Read BioFrédéric Mathot, PhD
GSK
Dr. Frederic Mathot, Associate Director and Scientific Leader at GSK, holds a PhD in Pharmaceutical Sciences and currently works in the pharmaceutical industry for more than 15 years. His role at GSK Vaccines in R&D involves leading the Drug Product development of nucleic acid-based vaccines and other innovative technologies. His work primarily focuses on the physico-chemistry of biomolecules and drug product formulation. He is also involved in academia, supervising PhD students and lecturing at UCLouvain in Brussels, Belgium. His career includes several patents and he has been recognized with a few awards. -
Yves Mayeresse
Director, GSK
Moderator
Read BioYves Mayeresse
GSK
Yves Mayeresse is director in manufacturing technology inside MSAT by GSK. He has more than thirty years of experience in the pharmaceutical and vaccine sector, he 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. Transfer of product towards different internal and external site. 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 new and established technologies used for the upstream and downstream of primary operations, isolator technology and secondary operations from formulation to freeze-drying. He is an engineer in biochemistry, has written articles about Freeze-Drying science and is a regular speaker for conferences on Freeze-Drying. He is a regular committee member for PDA and former chairman of conference. -
Mic McGoldrick
Technical Advocacy and Policy - CMC, Merck Sharp & Dohme Corp. LLC
Moderator
Read BioMic McGoldrick
Merck Sharp & Dohme Corp. LLC
Mic is currently an Associate Director of CMC Technical Advocacy & Policy at Merck Sharp and Dohme, Corp. His background in the life sciences started with degrees in Microbiology, Chemistry, and Medical Technology and has experience with Vaccine and Biologics in the Pharmaceutical field for the last 30 years. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, and post approval submissions globally. For a large portion of this time he led the evaluation of worldwide guidances and the expansion of vaccines into the Emerging Markets. For the last seven years Mic has been working on CMC Policy for Vaccines and Biologics, advocating for reliance, harmonization and greater access of vaccines to patients. -
Ina Pahl
Senior Scientist, Sartorius Stedim Biotech GmbH
Panelist
Presenter
Read BioIna Pahl
Sartorius Stedim Biotech GmbH
Ina Pahl studied Chemistry at the University of Hannover and earned the Ph. D in 1996 at the University of Hannover. She started with Sartorius Stedim Biotech in 1997. Until 2000 she worked in Process Development and as Head of Cross Flow Development in R&D. In parallel she coordinated extractables topics in the product development department and worked with external analytical laboratories. Today Ina is Senior Scientist in the department of Bag Technology where she works in a team whose tasks are to develop and perform extractables studies, and to evaluate the results thereof. The data are used to provide customer information on extractables data for the assessment of material safety of single-use components. She is publishing in the field of analytical chemistry, extractables data of single use components, and sensors. Ina is active member of DECHEMA and ELSIE. -
Maria Papathanasiou, PhD
Associate Professor (UK Senior Lecturer), Department of Chemical Engineering, Imperial College London
Academic Panelist
Read BioMaria Papathanasiou, PhD
Department of Chemical Engineering, Imperial College London
Dr Maria Papathanasiou is a Senior Lecturer (AssociateProfessor) at the Department of Chemical Engineering, Imperial College London. She holds a PhD degree in Process Systems Engineering from the Department of Chemical Engineering at Imperial College London and an MSc from the same department. She completed her undergraduate studies at the School of Chemical Engineering, National Technical University of Athens and she conducted her Diploma Thesis in Food Process Engineering at the Technical University of Berlin. Dr Papathanasiou’s research focuses on the development of Process Systems Engineering tools (modelling, optimisation and control) with application to biopharmaceutical process development, optimisation and control. Her research outputs to date have been acknowledged through over 40 peer reviewed and conference publications, 30 oral presentations at international conferences and 4 international awards, including IChemE’s Junior Sargent Medal (2023). -
Mónica Perea-Vélez, MSc, PhD
CMC Advocacy and Policy Director, GSK
Panelist
Presenter
Read BioMónica Perea-Vélez, MSc, PhD
GSK
Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China. -
Roberto Pisano
Academic Panelist
Academic Presenter
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Fabian Plaum, M.Eng.
Sales Management, HOF Sonderanlagenbau GmbH
Co-Presenter
Panelist
Read BioFabian Plaum, M.Eng.
HOF Sonderanlagenbau GmbH
Fabian Plaum is working in the Sales Management for Freeze-Drying and Freeze-Thaw applications at HOF Sonderanlagenbau GmbH. In 2014 he started his studies for mechanical engineering at HOF and has successfully completed these studies with a Master of Engineering. Additionally, since 2014 he has worked in different areas at HOF, as Mechanical Engineering, Project Management and since 2019 within the sales department at HOF. Within the Sales Management Fabian is responsible for the customer care and the creation of customized concepts for the integration of Freeze-Thaw equipment and Freeze-Dryers into aseptic fill and finish lines. -
Durga Prasad Madhavapeddi
Panelist
Presenter
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Sabrina Restrepo, PhD
Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.
Panelist
Presenter
Read BioSabrina Restrepo, PhD
Merck & Co., Inc.
Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board. Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively. She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio. -
Olga Rovira
Regulatory Affairs Senior Consultant, CEPI
Panelist
Presenter
Read BioOlga Rovira
CEPI
Olga Rovira has an academic background in Industrial Chemistry Engineering from the University of Zaragoza (Spain) and in Structural Molecular Biology from the University of London (UK). Olga is currently working at KONTIVAX, her own Regulatory Affairs (RA) consultancy company, which serves small biotech companies, large multinational corporations as well as partnerships such as CEPI (Coalition for Epidemic Preparedness Innovations) or TBVI (TuBerculosis Vaccine Initiative). Her expertise focuses on RA Chemistry, Manufacturing and Controls (CMC) for vaccines. She has a solid knowledge and understanding of technical development of vaccines throughout the whole development path up to registration and subsequent life-cycle stage and how this relates to worldwide regulatory requirements and expectations. Her experience covers multiple vaccine platform technologies as well as adjuvants (novel and well-established). Olga is member of TOPRA (The Organisation for Professionals in Regulatory Affairs). -
Ramin Sabet-Azad, PhD
CMC Lead, The Coalition for Epidemic Preparedness Innovations (CEPI)
Panelist
Presenter
Read BioRamin Sabet-Azad, PhD
The Coalition for Epidemic Preparedness Innovations (CEPI)
Dr. Ramin Sabet-Azad is Chemistry, Manufacturing and Controls (CMC) Lead at CEPI, London, supporting the organisation as CMC subject matter expert in CEPI’s pancoronavirus disease program, protein vaccine program and its adjuvants task force. He is also working towards consensus between industry and regulators around use of Platform technologies for rapid response to outbreaks and health threat. He has a MSc and PhD in Biochemical Engineering from Lund University, Sweden, and several years of industrial experience in manufacturing of vaccines and biochemicals. Most notably, at Bavarian Nordic he worked on the approved MVA smallpox/mpox vaccine, and subsequently led DS process development activities for Mvabea, part of Janssen’s EMA/FDA authorised vaccine regimen for protection against the Ebola Zaire virus. -
Sebastian Scheler, Mr.
Managing Director, Innerspace GmbH
Co-Presenter
Panelist
Read BioSebastian Scheler, Mr.
Innerspace GmbH
I am passionate about pushing the boundaries of advanced risk assessment technologies to unlock new possibilities for designing and managing manufacturing processes in pharma. I spearhead a dynamic team of life science professionals and software developers. The core focus of my professional work lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to risk assessment. This cutting-edge technology facilitates process improvement, process automation, autogenerated SOPs, and immersive training curricula, empowering organizations to achieve unparalleled levels of efficiency, compliance and safety in drug manufacturing. With a profound background in psychology, I have always been captivated by the intersection of human behavior and technology. My passion for Virtual Reality has culminated in pioneering VR simulator methodologies that push the boundaries of experiential learning, training, and behavior measurement systems. Beyond my leadership at Innerspace, I also serve as trainer for PDA training courses and further development of the PDA/Innerspace official partnership focusing on refining training course delivery and design. -
Karen Somers
Panelist
Presenter
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Christian Sonntag, MS
Senior Project Manager, Roche Diagnostics GmbH
Co-Presenter
Panelist
Read BioChristian Sonntag, MS
Roche Diagnostics GmbH
Christian Sonntag Education: 2003 - 2007: University of Applied Sciences, Dresden (Production Technology, Dipl.Ing.) --> 2005: Northern Airzona University, Flagstaff (exchange semester) 2007 - 2008: University of Tennessee, Knoxville (Industrial Engineering, Master of Science) --> Fulbright scholarship Work Experience: 2009 - 2012: Haupt Pharma Wolfratshausen (Assistant of Managing Director) 2012 - 2016: Haupt Pharma Wolfratshausen (Technical Project Manager) 2016 - 2020: Roche Diagnostics GmbH, Penzberg (Process Engineer) since 2020: Roche Diagnostics GmbH, Penzberg (Project Manager CAPEX) -
Thomas Stangler
Panelist
Presenter
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Matthias Steiger
Panelist
Presenter
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Elisabeth Vachette, MA
BPS Sustainability Business Partner, Sartorius Stedim FMT SAS
Co-Chair
Moderator
Read BioElisabeth Vachette, MA
Sartorius Stedim FMT SAS
Elisabeth Vachette is Sustainability Business Partner for the BioProcessing division at Sartorius Corporate. Since joining Sartorius Stedim Biotech in 2000, she has been responsible for quality, production, engineering and product management providing a broad view of the functionalities of single-use solutions development, marketing, qualification and manufacturing. Current responsibilities include Sustainability Strategy and Operational targets for supporting Sartorius Sustainable transformation. She is actively engaged in several industry groups like BPOG, BPSA, Econsense, ... She is an active member of the scientific committee as co-chair for the PDA BioManufacturing conference and is member of the BPSA board of directors. -
Jason Warfel
Panelist
Presenter
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Mats Welin
Regulatory Panelist
Regulatory Presenter
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Thomas Zahel, PhD
Head of Innovation, Körber Pharma
Panelist
Presenter
Read BioThomas Zahel, PhD
Körber Pharma
Thomas Zahel is Head of Innovation at Körber Pharma Austria GmbH, with outstanding experience in statistics, algorithm development and turning complex challenges into easy concepts for biopharmaceutical companies. His background is in bioprocess engineering and he holds a PhD in applied statistics for process development and validation. He is most passionate about developing new statistical methods and turn them into intuitive data science tools.
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PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA recommends the reservation at the following hotel
Elite Park Avenue Hotel
Kungsportsavenyn
36 - 38
411 36 Gothenburg,
Sweden
PDA Europe has reserved a limited number of rooms until 20 July 2024.
Book your room at the PDA Group Rate using the above-mentioned reservation button.
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The Lufthansa Group airlines bring people together – every day, all around the world.The global route network of Austrian Airlines, Lufthansa, SWISS, Brussels Airlines and Eurowings offers optimal connection and combination options, so you will benefit from quick and direct flights to the event.
You will reach the booking platform via this link https://www.lufthansa.com/de/en/meetings-and-events-delegates and with the event code DEAPILQ. The reduced fares are automatically displayed.
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Book FlightSpecial Deutsche Bahn Train Fares
Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.
Event Ticket one-way and specific train (subject to availability):
- 1st class 89,90€ (seat reservation incl.)
- 2nd class 55,90€
Event Ticket one-way and fully flexible:
- 1st class 112,90€ (seat reservation incl.)
- 2nd class 77,90€
Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.
Book TrainArea Attractions
Elite Park Avenue Hotel is located within walking distance from Liseberg amusement park and the Swedish Exhibition & Congress Centre. Theatres, concerts and the Gothenburg Museum of Art is a short walk from the hotel. Along Avenyn are parks, boutiques, shopping malls, and cozy cafés.
Enjoy the well-equipped gym and relaxation area with saunas and a smaller cooling pool. We can also show you our favourite running routes around Gothenburg.