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LIFE SCIENCES

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

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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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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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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What Lessons Should Pharmaceutical Manufacturers Take Away from Operation Warp Speed?
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What Lessons Should Pharmaceutical Manufacturers Take Away from Operation Warp Speed?

April 8, 2022

Offering an overview of the public-private partnership that facilitated and accelerated the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics During the pandemic our industry faced crisis and achieved the seemingly impossible. What drives an extraordinary performance? Building stronger bonds of communication, collaboration, and coordination between industry partners and regulators to serve patients better Discussing which parts of our experience with Operation Warp Speed can be built into our industry’s long-term future — Carlo de Notaristefani Lead, Manufacturing & Supply Chain Advisor Operation Warp Speed An international operations executive with global technical, operational, and P&L experience, Carlo has…

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The Things We Can Achieve and Our Shared Journey Along the Way
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The Things We Can Achieve and Our Shared Journey Along the Way

April 8, 2022

How the pandemic has impacted innovation, technology, people and our ways of working and thinking Understanding current capabilities and where we need to be collectively headed as a community of pharmaceutical manufacturers Strategies that compel and empower us to move beyond past constraints and set new, ambitious goals for the future Thinking beyond the data to find purpose and meaningful connections for people — Arleen Paulino SVP Global Manufacturing Amgen Arleen Paulino, Senior Vice President, Manufacturing, leads Amgen’s commercial manufacturing organization. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018,…

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