PDA Good Digitalization in Pharma Conference 2024

Featured Presenters

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  Tara Gooen Bizjak, MBS

  Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

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  Tara Gooen Bizjak, MBS

  U.S. FDA

  CAPT Tara Gooen Bizjak is the Director of the Manufacturing Quality Guidance and Policy Staff in CDER, Office of Compliance, Office of Manufacturing Quality and is an engineering officer in the United States Public Health Service. Tara has been with the FDA for over 20 years, primarily focusing on drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. She started as a field investigator in the New Jersey District and transferred to CDER in 2007. Prior to her current role, she was a senior science policy advisory in the Office of Pharmaceutical Quality in the area of quality metrics and emerging technology, branch chief in the area of drug manufacturing pre-approval inspections and a senior advisor in the Office of Regulatory Affair’s Office of Policy and Risk Management. CAPT Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and Quality Improvement Associate. She received a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Science from Rutgers University.
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  Michael Gerlich

  SBS Swiss Business School

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  Michael Gerlich

  SBS Swiss Business School

  Dr Michael Gerlich is the Head of Center for Strategic Corporate Foresight and Sustainability and Head of Executive Education at SBS Swiss Business School.

  He holds a PhD from ARU, Cambridge, and an MBA from the University of Cambridge. His research and publications lately focus on the societal perception and acceptance of Artificial Intelligence (AI).

  On this topic, he has been invited as an academic speaker around the world and has been interviewed and mentioned by media like Forbes. His teaching experience, next to SBS Swiss Business School, includes institutions like the London School of Economics and Political Science (LSE) and ARU, Cambridge, among others. During his career, he has worked as an adviser to the President and the Prime Minister of Kyrgyzstan, the Cabinet of Ministers in Uzbekistan, and various Ministers of economic affairs in Azerbaijan. Additionally, he held leading positions in the industry.

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  Anke Hossfeld

  Merck KGaA

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  Anke Hossfeld

  Merck KGaA

  Anke Hossfeld is Marketing Director for Automation and Digitalization at Merck Life Science KGaA in Darmstadt, Germany.

  She is responsible for the innovation strategy of new products for microbial QC testing in the pharmaceutical industry using automation, robotics and digitization. Anke started her career in 2008 at Biotest AG as International Product Manager for alternative pyrogen and mycoplasma tests. In 2011, Anke joined Merck KGaA in Darmstadt as Global Product Manager and has since been responsible for the product portfolio, life cycle management and new product developments in various QC applications such as bioburden, sterility, pyrogen and rapid technologies.

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  Nicolas Löffler-Perez

  Data Scientist in Swissmedic 4.0, Swissmedic

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  Nicolas Löffler-Perez

  Swissmedic

  Dr. Nicolas Löffler-Perez is a Data Scientist at Swissmedic, the Swiss Agency for therapeutic products. After obtaining his Ph.D at The Johns Hopkins University, he moved to Switzerland to work on Clinical Machine Leaning in the University Hospital of Zurich and the University of Zurich where he developed a multimodal model for comprehensive analysis of images and reports in the hospital as well as optimization algorithms among other projects. He currently works with the Swissmedic 4.0 Team as the technical lead in multiple AI-based applications including the search of illegal medicinal substances in e-commerce, medicament recognition from images, and document similarity. His work focuses on innovation and the implementation of new technologies within Swissmedic. These solutions are mostly oriented towards the improvement of processes at Swissmedic making the stakeholder's engagement essential for the success of these innovative solutions.

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  Mónica Perea-Vélez

  GSK

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  Mónica Perea-Vélez

  GSK

  Mónica Perea-Vélez currently works as the CMC Advocacy and Policy Director at GSK’s Global Regulatory Affairs. She is a medical biologist by training, holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 15 years of experience in Regulatory Affairs and Quality, with extensive expertise in vaccines product development, registration, and life cycle management. Mónica is currently member of EFPIA and VE trade associations working teams with focus on Life Cycle Management activities globally and in China.

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  Fabian Stutz

  Pharmabotix

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  Fabian Stutz

  Pharmabotix

  Fabian Stutz, a visionary entrepreneur, is the CEO and Founder of Pharmabotix, a pioneering company in robotics & automation solutions for the pharmaceutical industry. He founded Pharmabotix in 2021 to revolutionize pharmaceutical production.

  Under his leadership, Pharmabotix offers innovative solutions like robotized systems for advanced therapies and aseptic solutions, enhancing efficiency and quality while reducing costs.

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  Katja Uhlig

  Fraunhofer Institut

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  Katja Uhlig

  Fraunhofer Institut

  Dr. Katja Uhlig Professional background Since 11/2018 working group leader "Microsystems for in-vitro cell models" at the Fraunhofer Institute for Cell Therapy Immunology (IZI-BB) 2010 - 2018 PostDoc at the Fraunhofer Institute for Cell Therapy Immunology (IZI-BB) / Fraunhofer Institute for Biomedical Engineering (IBMT) 2006 - 2010 PhD student at the Fraunhofer Institute for Biomedical Engineering (IBMT), University of Potsdam Expertise - 26 scientific publications (peer-reviewed), H-index: 20 and approx. 40 conference proceedings - Cell biology (2D/3D culture, manipulation, staining techniques) - Alternative methods (organ-on-chip) - Microscopy - Microfluidics (design and production) - Methods for surface modification and analysis

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  Tod Urquhart

  CIM A/S

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  Tod Urquhart

  CIM A/S

  Tod Urquhart has more than fourteen years of experience working in the field of product traceability including software systems, regulatory compliance, process efficiency, and supply chain visibility.

  He has extensive knowledge of planning, managing, and delivering cross-functional projects with companies such as Pfizer, GSK, Merck, Danone, and the Stevanato Group. Tod is currently a pharma industry advisor working with digitalization systems to deliver process optimization, traceability, and continuous manufacturing. He is also the vice chair of an ISPE Community of Practise [CoP] and the chair of the Filling & Inspection working group which is creating an industry standard for the traceability of parenteral containers.

  Tod has a degree in Chemical Engineering from the University of Cape Town [UCT], and a Master’s in Business Administration from Stirling University.

Presenters

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  Maria Batalha

  ValGenesis

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  Maria Batalha

  ValGenesis

  Maria Batalha is part of the Consulting Services in Product Life Cycle Management at ValGenesis as a Data Science Specialist. She joined ValGenesis in 2021 and was involved in the design of digital solutions for industry 4.0 that included advanced MVDA techniques, prototyping activities with R and R Shiny framework, and machine learning modeling.

  As part of ValGenesis Consulting Services team, Maria has focused her work on the Continued Process Verification framework and implementation.

  Maria has a master's in Bioengineering from Universidade Técnica de Lisboa and before Valgenesis 6 years of experience in industry projects in the field of medical devices and consulting.

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  Scott Deckebach

  Lachman Consultant Services, Inc.

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  Scott Deckebach

  Lachman Consultant Services, Inc.

  Scott Deckebach is a Senior Director in the Lachman Consultant Services, Inc. Compliance Practice and is head of the organization's Data Integrity specialist team. He holds a B.S. in Chemical Engineering and an M.B.A. and has 30 years progressive experience in the pharmaceutical industry including global leadership positions and extensive manufacturing, information technology, quality and compliance, lean/six-sigma and project management experience that covers API, biopharmaceutical and medical device sectors and development through distribution and postmarket. Scott has spent the last 7 years globally leveraging his skills with companies at corporate and site levels developing robust, contemporary and sustainable data governance programs both proactively and in response to regulatory agency citations.

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  Bachmann Dieter, PhD

  Janssen J&J

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  Bachmann Dieter, PhD

  Janssen J&J

  Dieter is Dir. Aseptic Manufacturing at J&J's corporate Sterility Assurance group with a main responsibility for providing standardization, science and education across J&J in the field of aseptic processing technologies. He is a Pharmacist by training with 30+ years of experience and holds a PhD in Pharmaceutical Formulation Technologies. Dieter has worked with small family-owned companies as well as in global business. Since joining Johnson & Johnson in 1998 he held several positions in R&D, Operations and Quality of J&Js Pharma and Medical Device franchises. Alongside business Dieter always engaged in associations work. For 10 years Dieter used to work as a Swiss national delegate on developing monographs for the European Pharmacopeia (EP) at EDQM in Strassburg. He is a frequent presenter and active member of PDA and ISPE. Dieter engages at the German DIN/NA063 and ISO TC198. Since 2019 Dieter is the global convenor for ISO TC198/WG9 Aseptic Processing.

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  Sesethu Dowiasch

  Rockwell Automation

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  Sesethu Dowiasch

  Rockwell Automation

  Sesethu Dowiasch brings with her more than 14 years of experience in automation and digitalization. In her current role, she helps Life Science manufacturers transform their manufacturing operations to bring innovative treatments to patients faster, while improving quality, yield, and product security. Her hands-on background in automation and mechatronics engineering gives her a unique perspective on the impact of converging IT and OT through a solid digital transformation journey. In addition to the strategy development of process control systems and secure network architecture design, Sesethu also supports manufacturers with the vertical and horizontal integration between systems such as Batch, DCS, MES, Historian, IOT, ERP, Cloud, etc. Sesethu also serves as the Co-Chair for the ISPE Women In Pharma community of practice in the DACH region. She is passionate about supporting the Life Science industry because of the positive impact it has on patients’ lives.

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  Bernhard Gerl

  Körber Pharma

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  Bernhard Gerl

  Körber Pharma

  Bernhard Gerl is moderating the Think Tank Ecodesign at the Körber group and is driving sustainability in engineering projects. With many years of experience as a mechanical engineer in the design department, he understands the challenges in developing projects and the balancing of complementary and competing requirements. Integrating environmental considerations increases the complexity even further. He and his team of the Think Tank support all Körber's engineers in making the right decisions during product development towards more sustainable machines and promote a sustainable mindset throughout the group.

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  Timothy W Hsu

  International Expert on Healthcare Industry, UNIDO

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  Timothy W Hsu

  UNIDO

  Before serving as an International Expert on Healthcare to UNIDO, Timothy was the Chief Collaboration Officer of the AFDO/RAPS Healthcare Products Collaborative. There, he led an international public-private partnership between regulatory agencies and industry focused on Medical Devices, AI, Combination Products, Pharma, and Life Sciences.

  He also currently serves on the National Academy of Medicine's AI Code of Conduct Working Team and is an independent reviewer for the Coalition of Health AI (CHAI). Timothy was a member of the AI Initiative’s Core Strategic Team and has also spent several years working with the GMLP, AIO, and AI@POC teams at the Xavier Health Artificial Intelligence Initiative.

  Timothy has served across the clinical, operational, and administrative spectrums in healthcare systems. Timothy was a Product Manager in Clinical Intelligence at Premier Inc., where he was the product owner of Service Line Analytics, Cost Accounting, Patient Analytics, and Clinical Professional Partnerships. He was the strategic healthcare futurist at GBBN Architects. Timothy has a BA in English and Neuroscience from Kenyon College and a master’s in Health Services Administration from Xavier University. He has completed a certificate program in AI & Business Strategy from MIT Sloan and CSAIL.

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  Florian W. Huber

  TissUse

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  Florian W. Huber

  TissUse

  Florian started nearly a decade ago as an engineer in the field of production technology and Industry 4.0. His interest in this field was mostly focused on automation and machine learning. When moving to the field of life science around six years ago he used this experience to develop the first fully automated Multi-Organ-Chip platform. Today, he is responsible for the software development team at TissUse including the fields of robotics and data science.  His passion is to bring the newest developments in Machine Learning and Artificial Intelligence to the field of life sciences and laboratory automation.

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  David Hubmayr

  Takeda

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  David Hubmayr

  Takeda

  David Hubmayr holds a degree in Physics from the Technical University Vienna, Austria, Europe as well as certifications in Data Science. His 10 years`+ experience in the biopharmaceutical industry stretch cross-functional from E2E Quality Assurance to R&D with a proven track record of leading and delivering global Quality and Digital Innovation advancements. In his current role, David is a member of the global Digital Innovation team in Data, Digital & Technology at Takeda, Zurich, Switzerland. David is member of the “CPV-of-the-future” working group and the 2023 PDA Robotics conference Scientific Committee, formerly chairing the PDA “Synthetic Data Generation” task force, publishing on both, the generation of synthetic batch data by Artificial Intelligence and AI-powered continued process verification for bioreactor processes. linkedin.com/in/david-hubmayr

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  Toni Manzano, PhD

  Co-Founder and CSO of Aizon, and Team Leader, AI in Operations (AIO), Aizon and AFDO/RAPS Healthcare Products Collaborative

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  Toni Manzano, PhD

  Aizon and AFDO/RAPS Healthcare Products Collaborative

  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, active collaborator in the AI initiative for AFDO and he teaches AI subjects at the Universities (UAB, URV and OBS), member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and 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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  Marilyn Romieux

  Merck KGaA

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  Marilyn Romieux

  Merck KGaA

  Marilyn Romieux is the Strategy and Execution Director of the Pharma Analysis & QC segment for Merck KGaA. She started as an R&D Scientist in the field of rapid microbiology before moving to a Marketing role where she created a new range of application services designed to support users in developing and implementing microbiology QC methods. Her later assignment as Head of Technical Marketing and Scientific Liaison includes employee education, customer training and application development. With an extensive knowledge of microbiology QC and nearly two decades in serving the pharma industry, she took the role of Strategic Marketing Director for the microbiology QC business in 2020, where one of her assignments was leading the marketing of Merck’s Robotics & Automation offer. She expanded her scope to all Science and Lab Solutions businesses of Merck in January 2022. She graduated in Cell Biology and Biochemistry from the University of Strasbourg, France, and earned her Master’s degree in Life Sciences from AgroParisTech in Paris, France.