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Culture of Quality Excellence Driving Competitive Advantage for Operations
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Culture of Quality Excellence Driving Competitive Advantage for Operations

November 28, 2022

Why a Culture of Quality Excellence is foundational to achieving manufacturing excellence and leads to competitive advantage for operations. Driving a culture that recognizes the Value of Quality Excellence. How to establish a Culture of Quality Excellence by focusing not only on processes and digital infrastructure but also focusing on Real-world examples of how Quality excellence is translated into manufacturing excellence, including  Vendor Management, Investigational Excellence and End to End QMS. Using Quality data in a proactive and predictive manner in order to deliver value and achieve manufacturing excellence. — RJ Doornbos VP, Global Quality Systems Bristol Myers Squibb As the Head of Global…

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Industrialization of CAR-T Therapies – Autologous vs Allogeneic: Common and Uncommon Hurdles
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Industrialization of CAR-T Therapies – Autologous vs Allogeneic: Common and Uncommon Hurdles

November 28, 2022

Industry evolution at a glance Donor Variability, the greatest source of variability for cell therapies. Thoughts on characterizing and accommodating this variability Process considerations for Autologous CAR and the importance of a good data ecosystem to provide insight and understanding to this highly complex therapeutic modality Brief introduction to Kyverna — Karen Walker Chief Technology Officer Kyverna Therapeutics Karen Walker, Chief Technology Officer, Kyverna Therapeutics.  Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, and several…

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The Quality Equation
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The Quality Equation

November 28, 2022

Do you want to ensure that you never have a surprise regulatory inspection outcome? The equation incorporates all you need to assess the status of your site and is even better for companies with networks of sites Data integrity, quality culture, process capability, management commitment and Quality Management Systems are all assessed to produce actionable data whether you are overseeing a CMO or operate your own network of sites — Brandon Varnau Head, Industrial Affairs Specialty Care Global Business Unit Quality Operations Sanofi Brandon Varnau is Head of Industrial Affairs Specialty Care Global Business Unit Quality Operations for Sanofi. He…

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Emerson Real-Time Modeling System in Takeda’s Los Angeles Plasma Fractionation Facility
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Emerson Real-Time Modeling System in Takeda’s Los Angeles Plasma Fractionation Facility

March 10, 2023

Expected benefits of integrated scheduling and modeling Building the model Integrating the model with various systems Switching to a new scheduling software in manufacturing — Sean Ganley AGILE Champion III Takeda Sean is part of the AGILE team at Takeda’s Los Angeles plasma manufacturing facility. AGILE, in all caps, is Takeda’s methodology for transforming its manufacturing capabilities. Following his bachelor’s degree in Biology from Occidental College, Sean began his 15-year tenure at Takeda. He has shaped the landscape of fractionation performance measurement and used his data and modeling methodologies to facilitate strategic growth of the site’s fractionation capacity by 120%….

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Realizing Gilead’s 2030 Ambition: Advancing a Diverse Portfolio with a Complex Manufacturing Network
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Realizing Gilead’s 2030 Ambition: Advancing a Diverse Portfolio with a Complex Manufacturing Network

March 15, 2023

Gilead’s ambition is moving from a predominantly virology focused portfolio to a more diverse one with an emphasis on adding oncology and inflammation asset To accomplish this a wide net needed to be deployed to rapidly build a portfolio through external sourcing and internal innovation This has resulted in a diverse set of acquisitions, partnerships, opt-ins, and collaborations across program phases and modalities, resulting in a complex manufacturing network This talk will cover the strategies being deployed across the pillars of Process Development, Supply Chain, Quality, Regulatory, and External Manufacturing to realize Gilead’s 2030 ambition — Art Hewig VP of…

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Sustainability for Process Development to Manufacturing: How Can We Leverage Digital Technology to Capture Quality and Productivity Efficiencies?
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Sustainability for Process Development to Manufacturing: How Can We Leverage Digital Technology to Capture Quality and Productivity Efficiencies?

December 22, 2022

The Control Tower: Providing visibility with actionable insights into the health of your manufacturing Yield Improvement: Process understanding and advanced modeling for significant ROI Digital twin: simulation and improved productivity by employing Smart Scheduling Successful industry 4.0 pharma use cases How to effectively build programs to deploy and maintain technology to continuously improve and capture value — Rick Johnston Sr. Director Applied Materials Rick is a senior technical leader within Applied Materials’ pharmaceutical business unit. He has more than 15 years of experience in building software that solves big data, machine learning, scheduling, forecasting and advanced analytics problems in pharma….

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Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing
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Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing

January 19, 2023

Current industry challenges and opportunities related to biopharma manufacturing Internal manufacturing capability establishment challenges for biopharma Challenges related to outsourcing of technology and process throughout product lifecycle The Azzur Cleanrooms on Demand™ model Case Studies — Ravi Samavedam Chief Innovation Officer Azzur Group Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Ravi joined Azzur in 2012, and prior to his appointment as CINO of Azzur Group, Ravi was the President and COO of Azzur Cleanrooms on Demand™ and previously served as  General Manager of the Boston-area consulting practice.  Prior…

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Establishing a ‘Culture of Data’ in Pharma Manufacturing
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Establishing a ‘Culture of Data’ in Pharma Manufacturing

March 13, 2023

Pharmaceutical manufacturers have worked diligently and successfully to foster a ‘culture of quality’, resulting in fewer overall regulatory citations year over year since 2010. How can better data management and analytics impact not only quality but process improvement and efficiency gains as well? What trends are driving the need to move towards both managing and using data better? The ‘culture of data’ starts with changing old ways of working. What steps do biopharma manufacturers need to take to initiate their transformation? How can manufacturers use manufacturing process data to quickly and proactively improve outcomes? — Vishaka Rajaram Director, Pharmaceutical and…

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