PDA Good Digitalization in Pharma Conference 2024

Featured Presenters

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  Anke Hossfeld

  Merck KGaA

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  Anke Hossfeld

  Merck KGaA

  Anke Hossfeld is Global Product Manager at Merck KGaA in Darmstadt, Germany, responsible for innovation and new product development for the In-Process-Testing in Pharmaceutical Industry. Anke worked as a Technical Assistant in the pharmaceutical field prior to her study of Food Science with a focus on Marketing and Sales. In 2008 she joined the Biotest AG and became International Product Manager for alternative Pyrogen and Mycoplasma testing. In 2011 Anke joined Merck KGaA in Darmstadt as Global Product Manager and has been responsible for different product portfolios including bioburden applications & rapid technologies.

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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

  I am the CEO & Head of Sales with Pharmabotix AG, a company that provides clients with innovative robotics and automation solutions for the pharmaceutical industry. From building an effective team to maintaining a large customer network, I am adept at driving business development while delivering exceptional service to customers with a direct communications approach. I am passionate about trying new ideas and providing honest feedback on feasibility to ensure customer satisfaction.

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  R. Tod Urquhart

  Eagas SLU

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  R. Tod Urquhart

  Eagas SLU

  Tod Urquhart is the Founder and CEO of Eagas SLU a company specialising in the field of product traceability.  Tod is a subject matter expert having more than twelve years’ experience of in planning, managing, and delivering cross functional traceability projects for pharmaceutical regulatory compliance as well as product traceability.

  During 2021, Tod has been retained by the Stevanato Group to fulfil the role of “Traceability Lead”.  In this role he is responsible for the development and implementation of the container traceability concept. The project covers a range of areas from working with the key stakeholders, creating new solutions to simplify the integration of unique containers in the key processes to the creation of a common standard for the pharmaceutical industry.

Presenters

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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

  AFDO/RAPS

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  Timothy W Hsu

  AFDO/RAPS

  Before becoming the Director of Health Technology Initiatives at AFDO/RAPS Healthcare Products Collaborative, 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 in varying capacities under the Xavier Health Artificial Intelligence Initiative. Timothy has served across the clinical, operational, and administrative spectrums in healthcare systems ranging from pediatric, academic, research, and community hospitals. His roles in healthcare systems have included work in strategy, planning, perioperative, service line, and population health divisions. Hsu was 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 market research strategist for healthcare market futures 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 Romeux

  Merck KGaA

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  Marilyn Romeux

  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.