The Industry Prepares for Cell and Gene Therapy Commercialization — A Conversation with PQE
January 5, 2023
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What are some of the unexpected lessons —good and bad— we have taken away from 2020 and 2021? Discussing examples of innovations created by necessity during the global pandemic that will continue on long into the future Taking this chapter in our working lives as an opportunity to re-evaluate, reconsider, and rethink some of the processes and strategies we had in place before COVID-19 How should we adjust our approach to communication, coordination, mentoring, and management in the emerging ‘new normal’ of work? Has the global pandemic changed the way people think about their personal and professional development? What should…
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Our knee-jerk leadership reaction to the pandemic: from managing change to managing burn-outs! Recovery: how to reboot culture, leading with purpose and agility Defining and adopting next-gen performance and talent management — Pascal Bécotte Managing Director Russell Reynolds Associates Pascal leads Canadian operations for Russell Reynolds Associates and is also a member of the firm’s global Executive Committee. He is a key member of the Healthcare Sector where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. More specifically Pascal…
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Discussing the common pitfalls observed during establishment of initial GMP programs in the areas of quality systems, materials management, supplier qualification, etc. How are companies adopting organizational changes and leveraging digital systems to avoid these pitfalls? Important factors to consider when assessing build vs. buy for early-phase clinical production, and considerations for scaling a GMP program up and/or out Illustrating the importance of establishing clear process requirements and conducting informal and formal facility fit assessments using real-world examples — Chris Mansur President, Azzur Consulting Azzur Group Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes…
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Using innovative thinking to realize a future more “immune” to supply chain disruptions Incentivizing improvements to the pharmaceutical manufacturing infrastructure that enhance the reliability of manufacturing and supply Delivering on the promise of advanced manufacturing to provide reliable, available, high-quality drugs for patients — Michael Kopcha Director, Office of Pharmaceutical Quality, CDER FDA Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise…
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How the pandemic impacted the structure and responsiveness of our global networks Responding to new geographic fluctuation of demand by disease states and patient delivery The challenges and opportunities posed by new product innovation and managing lifecycles — Linzell Harris SVP Global Supply Chain and Strategy AstraZeneca Linzell Harris is senior vice president of Global Supply Chain and Strategy for AstraZeneca, with overall responsibility for the development and execution of the end to end supply chain platform and product supply strategies. In addition, he is responsible for ensuring the strategic development of network designs and supply chain capabilities supporting the…
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How do you define a supply chain? The what, the who, the where and the how Risk categorization Impact, probability and detectability Risk approach Detection, prevention/mitigation and response Near-miss lessons learned — Ken Kent SVP, Chemical Development and Manufacturing Operations Gilead Ken is the Senior Vice President of Chemical Development and Manufacturing Operations. He is responsible for Gilead’s entire drug substance supply and oversees process R&D functions in Foster City and Edmonton, as well as internal and outsourced manufacturing. He played a critical role leading CDMO in sourcing ingredients and scaling up production of remdesivir drug substance, to speed up…
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