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LIFE SCIENCES

Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond
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Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond

— Sarah Stevens, Ph.D.President of Azzur Labs & Azzur Cleanrooms on Demand™Azzur Group In her role as President, Azzur Labs & Azzur Cleanrooms on Demand™ (COD), Sarah Stevens is responsible for operations and strategy across all Azzur Labs and Azzur COD locations throughout the United States. Prior to joining Azzur, Sarah held senior leadership roles within the CDMO and pharmaceutical service provider space. Sarah holds a Doctorate of Pharmaceutics from the University of Manchester (Manchester, UK), as well as a Master of Business Administration and a Master of Pharmacy from the University of Strathclyde (Glasgow, UK).

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Deliver Products to Patients Faster with a Purpose-Built, No-Code EBR and MES
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Deliver Products to Patients Faster with a Purpose-Built, No-Code EBR and MES

— Brian CurranSVP Manufacturing Excellence SuccessMasterControl, Inc. Brian Curran oversees the success of MasterControl’s Manufacturing Excellence (Mx) solution in the quest to digitize the 80% of life sciences manufacturing, large and small, that still use paper for their batch records or device history records. Curran has the privilege of working externally with Mx customers and internally across MasterControl from R&D to sales, services, and support to ensure Mx success and adoption. Curran joined MasterControl in 2002 to direct and expand MasterControl’s product lines. In 2017 he switched to focus on bringing Mx to market, which happened mid-2019 and now has…

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The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing
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The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing

— John TomtishenVP OperationsCellares John Tomtishen is Vice President of Operations at Cellares Corporation. At Cellares, John is responsible for Cellares’ IDMO business, supporting partnership activities, and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm and address industry bottlenecks to accelerate access to life saving cell therapies. John has extensive experience in cell and gene therapies, biologics, and vaccines with diverse roles in Business Operations, CMC/Technical Operations, R&D, Supply Chain, Engineering/Facilities, and Operational Excellence. While at Novartis Pharmaceuticals, John had an integral role in the filing and approval of the first CAR…

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Unleashing the Potential: Leading the Future of Biologics Market Supply
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Unleashing the Potential: Leading the Future of Biologics Market Supply

— Dave StewartSVP, Operational and Process Technology, Large Scale Business UnitFUJIFILM Diosynth Biotechnologies Dave Stewart, Senior Vice President Operational and Process Technology, Large-Scale Business Unit, is a proven leader in the biologics manufacturing industry, with a focus on building diverse, multi-disciplinary teams that drive customer deliverables. He brings a servant-leadership mindset and more than two decades of biotech leadership experience to cultivate accountability, collaboration and agility – assembling engaged, high-performing teams and partnerships built on trust. Dave is responsible for ensuring a consistent operations and equipment model, performance and incorporating emerging capabilities across the large-scale network at FUJIFILM Diosynth Biotechnologies (FDB)…

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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined
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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined

— Brian TaylorHead of Biopharma SolutionsSmartLabs — SmartLabs provides teams of all sizes enterprise-grade labs customized within weeks for any stage of research or modality and can be reconfigured within days as your research evolves. Outsource your infrastructure and avoid the extensive costs of traditional lab builds while your own teams accelerate your research in a private lab. www.smartlabs.com

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Opportunities and Challenges of GMP Manufacturing of RNA-LNPs
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Opportunities and Challenges of GMP Manufacturing of RNA-LNPs

— Martin RabelSr. Field Application ScientistPrecision NanoSystems Inc. Martin Rabel, Dipl.-Pharm., Ph.D. currently works as a Senior Field Application Scientist for Precision NanoSystems ULC supporting clients in Central Europe, Middle East, and Africa (EMEA). He obtained his pharmaceutical license as well as a postgraduate diploma from the Friedrich-Schiller-University Jena working on Bacterial Nanocellulose (BNC) nanoparticles for gene delivery applications. His Ph.D. research focused on the development of animal-free simulation models for the development of complex diagnostic nanoparticles (IONP) and other nanomedicines as well as nanoparticle characterization and manufacturing methods. He joined Precision NanoSystems ULC in 2019 as Field Application Scientist….

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Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine
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Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine

 As Novartis begins its journey to become a focused innovative medicines company, the Operations organization is evolving to make this ambition into a reality. A few years ago, we undertook a systematic approach of improving and optimizing our manufacturing capabilities. We brought in best practices, methodologies and tools to streamline processes, eliminate waste, reduce costs, improve quality and efficiency. We recognize that we have embarked on a continuous journey and we are happy to share how far we have come on: Operational Excellence: Embedding operational excellence to improve productivity and deliver high-quality medicines Innovation: Expanding platform capabilities in RNA,…

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Our Journey in Next Generation Manufacturing: What We Can Achieve Together
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Our Journey in Next Generation Manufacturing: What We Can Achieve Together

 Where our organizations are heading as a community of pharmaceutical manufacturers Our current and future capabilities by geography, people, and technology Practical leadership approaches that empower us to tackle challenges and set ambitious goals for the future Next generation platforms that will change how we work and succeed Examples from Pfizer that illustrate these pursuits in action — Jim Cafone SVP Global Supply Chain Pfizer Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice President, Global Supply Chain, Jim oversees global demand forecasting, demand and supply planning, worldwide logistics, and inventory management for…

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Quality and Compliance from the Regulators’ Perspective
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Quality and Compliance from the Regulators’ Perspective

What are regulators looking for when they engage with QA/QC executives and other senior leaders? How can industry facilitate these interactions? Thinking about your processes and facilities from the point of view of the inspector: What are you taking for granted based on familiarity or habit or tradition that would not apply to a fresh pair of eyes? Highlighting best practices to make ongoing documentation a powerful quality and compliance tool for the future Using compliance as a starting point: What does exceeding expectations look like, and how should pharmaceutical manufacturers stay ahead of that moving target in perpetuity? —…

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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?
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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?

Discuss how today’s pipeline and technologies are reshaping biomanufacturing Looking at the technologies that enable next generation manufacturing processes Review case studies and strategies for rapid manufacturing scale up for leading products Focus on the necessity of investing in people and robust strategies to support the workforce and culture Show opportunities that allow for successful navigation in the future of manufacturing, including leveraging legacy and culture as drivers of change Chris Horan Chief Technical Operations Officer Artiva Biotherapeutics Christopher Horan spent nearly 14 years at Genentech, a member of the Roche Group, where he held several leadership positions across technical…

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