I am passionate about quality and innovation in the pharmaceutical industry. I have spent over a decade working and leading cross functional teams implementing quality and laboratory management systems, creating quality departments and strategies. I strive to be a change agent to drive quality departments to excellence in compliance with cGMP standards. My background and heart is in Microbiology where I enjoy executing and studying environmental monitoring performance qualifications as they relate to real time cleaning studies. I am a certified Six Sigma Green Belt with a knack for problem-solving.

Brian Kear is the Global Business Development Lead for Mettler Toledo’s laboratory software division. During his 16 years with the organization, he has worked side by side with industry leading pharmaceutical, chemical, and forensics agencies to design, implement, and optimize data systems for instruments traditionally thought of as “simple”. He currently holds a B.S. in Computer Science and Information Systems as well as an MBA. This combination of education and IT experience, prior to joining the laboratory world, allows him to consistently understand the core needs of a business while simultaneously addressing the IT concerns that surround data in our current environment.

Geoffrey is the Software Operations Manager for Catalent’s Global Laboratory Automation team and has a background in laboratory informatics, laboratory operations, and IT quality/validation.  He has experience implementing laboratory systems, ranging from specialized benchtop instrumentation to multi-site LIMS and chromatography systems, working with a variety of different laboratories and systems.  His approach focuses on the way that software can improve workflows, standardize processes, and reduce risk.

Experienced Quality professional with over 12 years’ experience, specialized in Quality Control Microbiology in the pharma industry. Experience with implementation and validation of several different computer systems, focusing on development of MODA-EM for the QC lab and integration with processing equipment and external monitoring systems for automatic data migration.

Don Rainville serves as the Global Innovation Hub Lead at Accenture Scientific Informatics Services (ASIS), collaborating with clients spanning various sectors to formulate their Digital Lab Strategy. He capitalizes on the assets developed within the ASIS Innovation Program to exemplify potential outcomes, emphasizing digital concepts such as the self-documenting lab, right-first-time lab mentor, citizen data scientist, and robotic assistance, among others—with a primary focus on solving problems. These innovative demonstrations are accessible to industry pioneers through three distinct innovation hubs located in Orlando, Dublin, and Singapore.

Luke has 20 years of experience managing software products & operations, including a current focus on architecting an end-to-end framework for CMC information. In his role at QbDVision, he oversees the core business operations, including teams for product development, customer deployments, and market expansion. Before joining QbDVision, he developed, grew, and led key business units focusing on software development and business consulting across various industries.

John  now leads 20/15 Visioneers with happiness and determination.  He studied Biochemistry at Penn State and did undergraduate research in the Richard Frisque Virology Lab. After graduating John worked for several organizations including his own, as a Biochemist before heading to Merck and Co. Inc. where he spent 10 years working in the lab and eventually moving into computational chemistry and scientific data.  John then joined GSK as Director of Discovery Informatics and Philadelphia Site Head as well as the IT Head of the Structural Biology Domain. In 2007 he went to Accelrys (Biovia) as Global Presales and the Services Organization…

Karen is an experienced Senior Principal Engineer with a demonstrated history of working in the pharmaceuticals industry. She´s skilled in International Project Management, Requirements Analysis, Databases, Software Documentation, and Software Development.  She is a strong engineering professional with a Master focused in Information Technology from Virginia Tech.

He is recently retired  from the Pharmaceuticals & Life Sciences consulting practice within the Accenture Scientific Informatics Services business unit.  He has delivered strategic advisory services to many of the world’s top life sciences organizations.  Prior to joining Accenture, he was Partner, Pharma & Life Sciences Practice at LabAnswer. Pat served as the Chief Operating Officer for LabVantage Solutions, and prior to joining LabVantage, he served as the General Manager of the LIMS business unit within Applied Biosystems.

Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from training effectiveness, GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA…

Chinmoy Roy is a biopharmaceutical consultant with over 40 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation. He was one of the architects for designing and implementing the largest paperless biologics manufacturing plant in the world. He was a member of ISPE’s Data Integrity Special Interest Group (S.I.G). He travels the world to train industry personnel in the areas of his subject matter expertise of CSV and Data Integrity as well as to conduct data integrity audits. His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineering and a Master’s degree in Computer Science.

Kumar Subramanyan, Head of Modelling & Analytics, at Unilever R&D, leads a global team of data scientists, focused on delivering analytics capabilities and solutions to enable data driven decision making to drive product innovation across Unilever’s multiple product categories. This team works closely with the R&D teams in the major business categories along with relevant functional teams such as IT and Marketing and an eco-system of external partners to deliver leading edge analytic solutions and capabilities to the business.

Mark Fish is a Managing Director in Accenture’s Scientific Informatics Services Business. Mark has over 20 years of experience in various leadership roles delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and precision medicine, digital transformation, agile software development and analytical quality control automation.

Rob was a Quality Control microbiologist for 10 years in pharma before transitioning to the laboratory informatics space. He has run and supported implementations and validations of software at numerous organizations globally and now heads the delivery team for the MODA EM solution.

Mark is an independent consultant who specialises in data integrity, laboratory informatics, computer systems validation, and Quality. He has 35 years of experience in the pharmaceutical industry in QC Labs, computer systems validation and lab informatics at Eli Lilly. Mark co-lead Eli Lilly’s data integrity remediation program for QC Laboratories worldwide …

Lloyd F. Colegrove retired as the Director of Data Services and the Director of Fundamental Problem Solving, where top chemists and engineers work on complex, often multi-effect, plant problems. He focused his efforts working to establish the Data Services group that has developed and deployed novel analytics applications to improve data-based decision making in chemical operations. He was also the Analytics Platform Director for Dow’s Manufacturing and Engineering’s Industry 4.0 program.