PDA Good Digital Manufacturing Conference 2025

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.

Tom J.B de Man, MSc

Merck KGaA

Tom de Man is head of the Omics and Machine Learning R&D department at Merck, supporting the BioReliance® services portfolio. His department develops and validates multi-omics bioinformatics algorithms for adventitious agent testing. Previously, Tom has worked at the US Centers for Disease Control and Prevention (CDC) and various academic institutions, which provided him with a broad set of professional skills. His expertise includes comparative genomics, software development, and (GxP) data analysis. Tom has authored over 20 peer-reviewed manuscripts on various molecular and bioinformatics topics, including pathogen detection and characterization. He holds a Bachelor (BSc) as well as Master of Science (MSc) in Bioinformatics.

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.

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.

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.

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.

Toni Manzano

Aizon and United Nations, professor at the URV

Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the CPV of the Future initiative at the PDA, PDA RAQAB member and active and he teaches AI subjects at the Universities (UAB, URV and OBS), collaborator with the United Nations in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.

Mónica Perea-Vélez, MSc, PhD

GSK

Mónica works as Advocacy and Policy Director at GSK’s CMC Global Regulatory Affairs (GRA). She is a medical biologist by training and holds a Masters in Molecular Biology and a PhD in Bioscience Engineering. Mónica has over 17 years’ experience in the pharmaceutical sector where she has held different CMC positions within Regulatory Affairs and Quality Assurance. She has a deep expertise in vaccines product development, clinical trial applications and MAA globally. In her current role, she is responsible for leading GSK’s global LCM and China CMC advocacy and policy activities. Mónica is currently member of EFPIA, IFPMA and VE trade associations working teams with focus on LCM activities globally and in China.

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.