Automation and Rapid Data Analytics for Quality — A Conversation with Daniel Plotkin of Rapid Micro Biosystems
December 21, 2021
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At the 2021 edition of the Biomanufacturing World Summit series held November 15-16 in San Diego, CA, Dan Szot and Chris Andrews of BIOVIA, Dassault Systèmes Company spoke about where the biopharmaceutical industry is today, how it has weathered the global pandemic, and the crucial role data has played in allowing organizations to understand where they are, what they need, and how things can move forward towards successful outcomes through informed decision-making. — Dassault Systèmes Company BIOVIA solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the…
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How Bayer AG built its Cell & Gene Therapy unit New business model joining best of Biotech and best of Pharma How to build a sustainable pipeline? How to manage complexity and keep focus? What are the “must haves”? what are the learnings on common threats of significant transformations? New ways of working accelerated by COVID-19 pandemic Wolfram Carius EVP, Cell and Gene Therapy Bayer AG Prof. Wolfram Carius is the EVP, Cell and Gene Therapy at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer,…
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Offering an overview of how our industry responded to the global pandemic Highlighting how our organization adapted our existing processes and programs to continue to work under extraordinary circumstances Discussing some of the key takeaways and lessons learned from the past year and a half Where do we go from here? How will AstraZeneca and the biopharmaceutical industry at large move forward from here? What are we doing today to pave the way to those objectives? Pam Cheng EVP, President Global Operations & IT AstraZeneca Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information…
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How learnings from the global pandemic combined with the introduction of new technology will enable the patient-centric manufacturing of the future Highlighting what the industry should do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as…
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Describe the potential for advanced manufacturing Review case studies illustrating the potential of advantages advanced manufacturing Provide resources for product developers Peter Marks Director – Center for Biologics Evaluation and Research (CBER) Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director…
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How has working through a global pandemic impacted the way we do business? Taking stock of how we changed and why we changed. What are some of the net positives? What are some of the things where we do want to return to how things used to be? Reviewing where our organizations were five years ago and where we planned to be today, how much has COVID-19 changed the trajectory of our journeys? What are some of the lessons learned that we plan to take with us into the future? Is the community of biopharmaceutical manufacturers stronger for this experience?…
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Discussing the changing landscape for our industry, from pricing to innovation How Operations leaders must prepare their organizations to succeed in this environment Offering a framework for balancing the need to execute in the short-term with the imperative to invest in innovation for the future Esteban Santos EVP, Operations Esteban Santos serves as executive vice president, Operations. Esteban is responsible for the Operations organization, which encompasses Manufacturing, Process Development, Quality, Engineering and Global Supply Chain. Prior to this role, Santos was senior vice president, Manufacturing, responsible for operations at Amgen’s commercial manufacturing locations in the U.S., Puerto Rico, Ireland, the…
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Discussing the current Quality 4.0 environment and addressing the most common challenge of how to get started Applying what we’ve learned to help companies begin their quality and compliance digital initiatives by leveraging behavioral and predictive analytics Ensuring quick results and getting the most value out of your investments in Quality 4.0 initiatives Jaime Velez Co-founder Operations & Quality Systems Improvement Experts (OQSIE) For the last 15 years Jaime has supported more than one hundred consulting engagements with Life Science companies delivering significant productivity improvements in supply chain and quality systems. He started his consulting career at McKinsey &…
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Highlighting what should the industry do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as molecular complexity increases in the future for small molecules, blurring the boundaries between small and large molecules — Sanat Chattopadhyay EVP…
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Sharing Vertex’s track record for serial innovation in manufacturing to create transformative medicines for people with serious diseases and high unmet medical needs Highlighting Vertex’s success with small molecule continuous manufacturing in Cystic Fibrosis Transforming manufacturing in cell and genetic therapies for Sickle Cell Disease, Beta Thalassemia, and Type 1 Diabetes — E. Morrey Atkinson SVP and Head of Commercial Manufacturing and Supply Chain Vertex Pharmaceuticals As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply…
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Strong wave of innovation and new Biologic therapies resulting in high demands Building flexible global capacities at various scales and multiple global locations to ensure reliable supplies and serve patients’ needs worldwide Business continuity planning, crisis management, pandemic preparedness & implementation of additional specific protection measures Close collaboration, intensive and solution-oriented exchange with customers and partners to ensure global patient supplies Managing diverse and complex challenges through digital transformation Critical success factor: Operational excellence, capacity & capabilities expansion and our peoples dedication — Uwe Buecheler Corporate SVP Biopharmaceuticals Boehringer Ingelheim Uwe Buecheler, Ph. D. joint Boehringer Ingelheim (formerly Dr. Karl…
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Challenges biotech companies are facing as patients expectations are increasing Ensuring the end-to-end supply chain can respond in the face of fierce competition for innovation Leveraging data and analytics to increase value and service to patients Keeping patients central as external factors accelerate need for resiliency — Kimberly Lounds Foster SVP Global Supply Chain Bristol-Myers Squibb Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at Bristol-Myers Squibb, where she oversees the clinical and commercial supply chain. Bristol develops and manufactures products on multiple technology platforms, including small molecules, biologics and cell therapies. Kimberly joined Bristol through the Celgene…
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