PDA BioManufacturing Conference 2024

Registration Open

Welcoming

• 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.

Welcome from the Co-Chairs

• 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.

Opening Plenary Part I: Addressing Patients Needs

• 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.

• 09:20 – 09:50

  A Brief Insight Into Life with Multiple Sclerosis

  • Presenter: Karen Somers

    

    Karen Somers
    

• 09:50 – 10:20

  Development of Antibody Drug Conjugates as Specific and Potent Medicinal Products - A Regulator´s Perspective

  • 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.

• 10:20 – 10:50

  ICH Q6 - Quo Vadis

  • Regulatory Presenter: Mats Welin

    

    Mats Welin
    

Networking Coffee Break, Poster Session & Exhibition

Opening Plenary Part II: Addressing Patients Needs

• 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.

• 11:20 – 11:45

  Developing Patient Centric Specification for Commercial Biologics: Real World Case Studies

  • Presenter: Jason Warfel

    

    Jason Warfel
    

• 11:45 – 12:30

  Plenary Discussion

  • 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
    

  • Panelist: Jason Warfel

    

    Jason Warfel
    

  • Panelist: Karen Somers

    

    Karen Somers
    

Networking Lunch Break & Exhibition

Guided Poster Walk

• 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.

Session 1 Track A: Processes for New Entities in Freeze-Drying

• 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.

• 13:45 – 02:10

  Developments in In-Line and Off-Line Analytics Applied to Freeze Drying of Biologicals

  • 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

• 14:10 – 14:35

  Building Robustness into the Primary Drying Phase of Lyophilization: A Modelling Framework and Use Cases for Biopharmaceuticals

  • 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.

• 14:35 – 15:00

  Solving the Deep-Frozen Challenge – Lyophilization of an Oncolytic Virus

  • Presenter: Thomas Kriehuber

    

    Thomas Kriehuber
    

• 15:00 – 15:30

  Q&A

  • 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
    

  • 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

Session 1 Track B: CMC Strategies for Vaccines Biomanufacturing

• 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.

• 13:45 – 14:10

  Vaccines Interest Group Session - Our 2024 journey!

  • 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.

• 14:10 – 14:35

  Patient-Centric Development for Vaccines

  • 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.

• 14:35 – 15:00

  Applying Prior Knowledge and Patient Centric Based Considerations to Specification Setting

  • Presenter: Pepijn Burgers

    

    Pepijn Burgers
    

• 15:00 – 15:30

  Q&A

  • 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
    

Networking Coffee Break, Poster Session & Exhibition

Session 2 Track A: Opportunities for Vaccine Access

• 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.

• 16:00 – 16:25

  Fast Evolving Vaccine Innovation Landscape

  • 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
    

• 16:25 – 16:50

  Building Health Emergency Preparedness by Harnessing the Potential of Vaccine Platforms

  • 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.

• 16:50 – 17:15

  Regulatory Global Convergence, Harmonization, and Reliance

  • 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.

• 17:15 – 17:45

  Q&A

  • 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
    

  • 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.

Session 2 Track B: Innovation in Biomanufacturing

• Moderator: Michael R De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company

  

  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.

• 16:00 – 16:25

  Cell-Free Manufacturing of Proteins

  • Presenter: Matthias Steiger

    

    Matthias Steiger
    

• 16:25 – 16:50

  Application and Utilization of Heat Inactivation as a Downstream Purification Tool in Biomanufacturing Processes

  • Presenter: Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company

    

    Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company
    

• 16:50 – 17:15

  Polysorbate Control Strategies in Biopharmaceuticals

  • 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.

• 17:15 – 17:45

  Q&A

  • Moderator: Michael R De Felippis, PhD, Senior Vice President - Research Bioproduct Research and Development, Eli Lilly and Company

    

    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
    

  • Panelist: Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company

    

    Colette Carmody Culhane, MSc., Senior Advisor, Manufacturing Science and Technology, Eli Lilly & Company
    

  • 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.

Networking Event

Track A: Interest Group Session: Advanced Manufacturing and Applied Process Digitalization (former Biomanufacturing IG)

• Moderator: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

  

  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.

Track B: Interest Group Session: Lyophilization

• Moderator: Anthony Cannon

  

  Anthony Cannon
  

Registration Open

Session 3 Track A: Digital Tools Shaping Future Biomanufacturing

• 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.

• 09:00 – 09:25

  The Key Role of AI in Biomanufacturing and Good Practices to Implement it

  • Presenter: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

    

    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.

• 09:25 – 09:50

  A Regulatory Framework Enabling Digital Innovation in Manufacturing

  • 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.

• 09:50 – 10:15

  Accelerated Process Development using End-to-End Digital Twins

  • 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.

• 10:15 – 10:45

  Q&A

  • 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.

  • Panelist: Toni Manzano, Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and United Nations, professor at the URV

    

    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.

Session 3 Track B: Future Techniques in Freeze-Drying

• Moderator: Sebastian Groel

  

  Sebastian Groel
  

• 09:00 – 09:25

  Sustainable Refrigeration Technologies: Overview and Implementation of Innovative Air-Cooling Technology for Freeze-Drying Processes

  • 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)

• 09:25 – 09:50

  Continuous and Controlled Lyophilization of mRNA-LNPs Based Formulations

  • 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.

• 09:50 – 10:15

  Understanding Thermal Interactions in Biopharmaceutical Freezing: Implications for Nucleation Temperature Distribution

  • Academic Presenter: Roberto Pisano

    

    Roberto Pisano
    

• 10:15 – 10:45

  Q&A

  • Moderator: Sebastian Groel

    

    Sebastian Groel
    

  • 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
    

Networking Coffee Break, Poster Session & Exhibition

Session 4 Track A: Fill & Finish Processing

• 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.

• 11:15 – 11:35

  Discovering Equivalence in Extractables & Leachables Assessments of Single-Use Systems: An Advanced Mathematical Methodology

  • Presenter: Ina Pahl, Senior Scientist, Sartorius Stedim Biotech GmbH

    

    Ina Pahl, Senior Scientist, 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.

• 11:35 – 11:55

  VHP Uptake of Manufacturing Tubing Used for Aseptic Fill-Finish Processes of Biopharmaceutical Drug Products

  • 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.

• 11:55 – 12:15

  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

  • 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

    

    Jeff Gensler
    

• 12:15 – 12:45

  Q&A

  • 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: Ina Pahl, Senior Scientist, Sartorius Stedim Biotech GmbH

    

    Ina Pahl, Senior Scientist, 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.

  • 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

    

    Jeff Gensler
    

Session 4 Track B: Sustainability

• Moderator: Virginie Le Coent

  

  Virginie Le Coent
  

• 11:15 – 11:35

  Sustainability at the EDQM: A Focus on the Ph. Eur. and the 3Rs

  • 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.

• 11:35 – 11:55

  Enhancing Sustainability ESG Scores in BioManufacturing

  • Presenter: Philippe Gadal

    

    Philippe Gadal
    

• 11:55 – 12:15

  Using Sustainable Taxonomy: Recycle, Reuse, Reduce & Re-purpose Water for pharmaceutical Use

  • Presenter: Durga Prasad Madhavapeddi

    

    Durga Prasad Madhavapeddi
    

• 12:15 – 12:45

  Q&A

  • Moderator: Virginie Le Coent

    

    Virginie Le Coent
    

  • 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
    

  • Panelist: Durga Prasad Madhavapeddi

    

    Durga Prasad Madhavapeddi
    

Networking Lunch Break, Poster Session & Exhibition

Interactive Questionnaire

• 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.

Closing Plenary Part I: Innovative Regulatory Strategies for a Globalized World

• 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.

• 13:55 – 14:20

  Title to be Announced

  • Regulatory Presenter: Robin Levis, CBER, U.S. FDA

    

    Robin Levis, CBER, U.S. FDA
    

• 14:20 – 14:45

  Efficiency in Pharmaceutical Life-Cycle Management: Implementing ICH Q12 and Established Conditions

  • Presenter: Thomas Stangler

    

    Thomas Stangler
    

• 14:20 – 14:45

  Simultaneous Submission to Multiple Health Authorities Using Accumulus Synergy Platform - Using CMC Platform Best Practices for Comparability Assessments and Manufacturing Process Validation as Pilot

  • 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).

Networking Coffee Break, Poster Session & Exhibition

Passport Raffle

Closing Plenary Part II: Innovative Regulatory Strategies for a Globalized World

• 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.

• 15:20 – 15:45

  Simultaneous Submission to Multiple Health Authorities Using Accumulus Synergy Platform - Using CMC Platform Best Practices for Comparability Assessments and Manufacturing Process Validation as Pilot

  • 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).

• 15:20 – 15:50

  Title to be Announced
• 15:45 – 16:30

  Plenary Discussion

  • 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
    

  • 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
    

  • Regulatory Panelist: Mats Welin

    

    Mats Welin
    

  • 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
    

Co-Chair Conference Summary

• 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.

Closing Remarks & Farewell

• 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.