Bob Buhlmann is the Head of Quality Digital Strategy at AstraZeneca, which he has responsibility for the Digital Transformation, Data Analytics, and GMP Computer Validation and Data Integrity Programs. Mr. Buhlmann has over 32 years of industry experience with specialized interest in Software validation and digital strategies in a variety of settings, including international companies regulated by FDA and other regulatory authorities. Mr. Buhlmann work has included consulting with KMI (Parexel) as well as working in the industry with several pharma and bio pharmaceutical companies. He has participated in preparing responses and corrective actions plans for software and quality system related regulatory observations, developed and implemented global computer validation and data integrity programs, digital transformation programs for quality and has lead several global SAP and other Quality System digital implementation’s. Mr. Buhlmann has a bachelor’s degree in Information Systems and is a member of the PDA and has written articles and given presentations on Data integrity in the pharmaceutical industry.

Ian has over 35 years of experience with software development and implementing computerised systems. He has successfully designed and implemented many quality management and manufacturing solutions for the pharmaceutical industry and other regulated industries. Ian manages the Training Department and also works closely with customers to deliver fully validated customer-focused automated solutions. Recently, Ian has been educating the industry on Industry 4.0 concepts, processes and technologies. Ian regularly presents training courses and seminars on practical approaches to computer validation.

Ben has over 20 years’ of experience in the Pharmacetical industry, predominately in technical services and operations management. Currently, he is Asia Pacific Lean Academy Lead at AstraZeneca, responsible for leading the Academies Experiential Learning/Coaching programs which include Lean Leadership, Leading TPM, Human and Organisational Performance, Digital Transformation, and Design Thinking/Agile Sprint. Previously Ben held the position of Site Technical and Portfolio Lead at AstraZeneca’s North Ryde (Sydney Australia) plant and was part of the Site Leadership team. He has also worked for Global Medical Solutions (as the Operations and Compliance Director), Parnell Life Sciences (as Manufacturing Manager), and Jurox Pty Ltd (Projects and Validation Manager). Previous experience includes Bioanalytical Chemistry and Research and Development. Ben holds a Ph.D. in Bio-medicinal Chemistry, as well as bachelor’s degrees in Science (Hons) and Environmental Science.

Brandi is Founder of The Triality Group, LLC, providing quality, regulatory, and compliance consulting services for Life Sciences companies. She has 20+ years’ of GxP experience with a specialization in computer systems quality and data integrity. Brandi joined ISPE in 2014 and is currently a member of the GAMP Global Steering Committee, serves as Chair of the GAMP Americas Steering Committee, and is Co-Chair of the GAMP Global Software Automation and Artificial Intelligence Special Interest Group.

Dr Brad Watmuff (he/him) is Head of Assay Development at Cortical Labs, where his experience in stem cell neurobiology and in vitro disease modelling is used to explore the fledgling fields of translational gameplay and synthetic biological intelligence. Dr Watmuff’s other research interests include bioinformatic methods for the analysis of novel neuronal data, and outside of the lab likes to advocate for open science – publishing, data sharing, and open-source code. Cortical Labs has been at the forefront of the emerging field of synthetic biological intelligence, with their landmark paper showing that human neurons growing in a dish learn to effect change in a simple video game environment. In this talk, Brad will share updates on the state of this technology, and the drug screening and neuropschyiatric disorder modelling applications this platform will potentially enable.