Pharma Industry 4.0 Will be Advanced by the Data Enablement of People

The strategic necessity of data enablement has never been clearer; without a solid data footprint, organizations cannot enable advanced technologies like AI. Importantly, and encouragingly, the data enablement of people using effective skilling approaches is receiving significant industry energy and interest. This presentation specifically outlines work by the Life Sciences Advisory Board representatives at a 2026 Data Enablement workshop held at Fujifilm Biotechnologies, Holly Springs, NC, USA that had seven organizations represented and carefully discussed the impact, activities, and skilling journeys of those working as business data stewards.

This presentation will present the business data steward profile produced by the advisory board representatives and bring greater awareness to the work that leading organizations have been doing during 2026 to advance the skilling of their people who have either part time or full time responsibilities as data stewards.

Presented by Malcom Jeffers, Transformation Strategist, Head of Research at the International Academy of Automation Engineering

Malcolm Jeffers is a Transformation Strategist and Head of Research at the International Academy of Automation Engineering. With an educational background in Electronic Engineering and the Social Sciences, he advocates for the thoughtful use of technology to benefit both workers, industries, and nations. His work with Life Science manufacturers over the past twenty years has focused on strategic consulting, workforce development, action-research, and executive coaching, all with the aim of enhancing human capabilities in digital manufacturing. Malcolm is especially passionate about human-centric manufacturing, the cultural enablers for it, and the skills that will be needed by those entering, and already within, a rapidly changing work environment. Along with his colleagues at the IAAE he is committed to supporting leaders seeking to lead proactive and impactful transformations. Additionally, he facilitates the IAAE Life Sciences Advisory Board that has representation from over a dozen pharma, biopharma, and medical device companies. Malcolm lives with his wife and three children in Cork, Ireland. 

Enabling Industry 4.0: FAIR Data, Hybrid Governance, and Capability Enablement

Smart factory initiatives succeed when FAIR data practices, robust governance, and people capabilities are given priority and executed in earnest. This session unpacks fundamentals for manufacturing data, and for operationalising standardisation across people, processes and systems. We’ll show why data standardisation is a multi-faceted team sport—requiring development, engineering, quality, IT and operations to co-design schemas, taxonomies and interfaces—and how a combined top‑down and bottom‑up governance model accelerates adoption while preserving compliance. We’ll cover pragmatic steps taken toward data standardisation through various domain lenses, establishing appropriate governance, and building role-based capabilities through targeted training and coaching. Attendees will leave with a considered Governance approach, measurable capability outcomes, and examples of change levers that embed data as an asset in new‑site delivery. This pragmatic approach helps organisations scale smart factory ambitions from “North-Star” new facility, while empowering people to make safe, data-driven decisions.

Presented by Alan Bateman, Director: Systems Architecture, Digital, and Execution at Johnson & Johnson Innovative Medicines

Alan Bateman is a seasoned leader with over 28 years of experience in pharmaceutical and biopharmaceutical manufacturing. He currently serves as Global Director, Systems Architecture, Digital and Execution for New Sites at J&J Innovative Medicine, where he drives digital strategy and system architecture for greenfield manufacturing initiatives. Throughout his career Alan has held leadership roles spanning validation, project engineering, manufacturing systems and engineering management, and he actively contributes to multiple industry and expert groups. Before joining J&J he worked in Ireland with Project Management Group and AVE/Medtronic, delivering complex capital projects and technical solutions. Alan holds a BEng and MEng in Mechanical Engineering from Munster Technological University. He is based in Cork, Ireland, and lives with his wife Rachael and daughters Freya and Nellie. Known for pragmatic leadership and cross-functional collaboration, Alan focuses on applying digital technologies to accelerate safe, compliant and efficient new-site delivery and mentoring future engineering talent.

Followed by Dan Hill, Director, Process Analytics at Fujufilm Biotechnologies

Dan Hill is a senior digital leader and Process Analytical Technology (PAT) expert with extensive experience developing and executing global digital transformation strategies, within and across CMC and R&D organizations. He is passionate about enabling seamless operations and high productivity through digital application and employee up-skilling and is committed to capturing business value by integrating processes, people, systems, and products with the right data and digital solutions at the right time.

Dan is currently a Director of Process Analytics at FUJIFILM Biotechnologies in Holly Springs, NC. He has served in prior roles at Thermo Fisher Scientific, Biogen, Boehringer-Ingelheim, Cargill North America, and Eli Lilly and Company. Dan earned a Bachelor of Science from Ball State University and an MBA from NC State University. In his spare time, Dan enjoys spending time with his family and running.  

Followed by a live question and answer session