Best Practices on Building and Implementing a Digital Process Data Strategy
Eric Dahlgren, Director of MST, Alnylam Pharmaceuticals
Matt Wheeler, Validation Manager, Precision BioSciences
Dr. Rahul Kaushik, Senior Vice-President, FibroGen
Margaret Mayo, Process Monitoring Specialist II, bluebird bio
Scott Weiss, VP BD & Innovation, IDBS
About the Session:
Join this session to hear Skyland PIMS customers sharing their challenges and best practices for capturing, analyzing, reporting, and sharing critical manufacturing process data across internal and external teams, sites and partners. Leaders from bluebird bio, Precision BioSciences, Alnylam Pharmaceuticals and FibroGen will take you through their journey in identifying, implementing, and realizing the value of cloud technology to streamline tech transfer and manufacturing processes, efficiently monitor variability, ensure process control, and secure CMO collaboration and stakeholder buy-in.
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Eric is Director of Manufacturing Technical Services at Alnylam Pharmaceuticals, overseeing starting materials, drug substance, and process analytics for late stage and commercial RNAi programs. In addition to RNAi, Eric’s previous experience includes supporting biologics and peptide manufacturing in various roles, including process development and manufacturing technical support. Eric holds a BEng in chemical engineering and mathematics from Vanderbilt University and an MSc in chemical engineering from Worcester Polytechnic Institute.
With 12 years of experience in life sciences, Matt likes to be able to contribute to the fight against disease. He feels energized and privileged to wake up every day and take part in innovative science in the effort to help progress modern medicine. He is supported and surrounded by a group of individuals that are equally driven and passionate about what they do. He explains, “As technology advances into uncharted territory, we collectively find fulfillment in supporting patients and clients with our industry expertise.” Matt has served in roles in microbiology, validation, operations and most recently data management.
Dr Rahul Rajan Kaushik is currently at FibroGen, Inc. where he is Senior Vice President, Pharmaceutical Development, Technical and Manufacturing Operations. Prior to this, he was Executive Director and Head of External Manufacturing at Nektar Therapeutics where he led CMC aspects including technology transfer, GMP manufacturing, process characterization, and process validation of Bempegaldesleukin. Rahul spent over 15 years at Amgen,
Inc. where he adopted several leadership roles within CMC ranging from formulation development, analytical development, process development, technology transfer, process characterization, and PPQ oversight. He also established external partnerships for product development and clinical manufacturing, in addition to leading the team that established an end-to-end, state-of-the-art pilot manufacturing facility. Rahul holds an undergraduate degree in Chemistry from I.I.T. Bombay and a Ph.D in Cell Biology from Stanford University.
Margaret Mayo is a senior process engineer at bluebird bio. She has established and grown bluebird bio’s continued process verification programs at multiple manufacturing partners, helping to realize the vision of commercial gene therapy products. Over the past +6 years, she and her team have made critical contributions toward the pending FDA approval of two of bluebird’s products, anticipated this fall. Margaret holds a BS in biomedical engineering from the University of Rochester and has served overseas as a science teacher with the US Peace Corps.
Scott Weiss is responsible for developing IDBS’ expanding network of technology and channel partners. He joined IDBS in 2004 and has held senior leadership roles in consultancy, product management and strategy. Prior to joining IDBS, Scott spent over 20 years in the pharmaceutical industry, where he led multiple
drug-development programs from conceptualization to entry into clinical trials and has authored over 30 peer-reviewed scientific papers and patents. He obtained his PhD in Psychology from the University of Leeds, specializing in Neuroscience.