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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?

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

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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Big Future for Small Molecules: How Merck is Reshaping the Manufacture of Small Molecules Within a Broader Manufacturing Transformation

Outline how small molecule manufacturing is being reshaped within the broader transformation of a world-leading biopharmaceutical and vaccine manufacturer Discuss how today’s pipeline and technologies are reshaping this future and how to remain agile for future changes Review case studies and strategies for rapid manufacturing commercialization Focus on the criticality of investing in people and how culture has to evolve as an enabler of transformation — Ger Carmody SVP, Global Pharmaceutical Operations Merck Ger Carmody is responsible for global pharmaceutical and packaging operations comprising approximately 4000 colleagues and internal 9 manufacturing sites.  His organization supplies drug substance and drug product…

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Quality 4.0: Making the Shift to Continuously Monitor the Health of your Quality Management System
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Quality 4.0: Making the Shift to Continuously Monitor the Health of your Quality Management System

Discuss the current Quality 4.0 environment and address common roadblocks and keys to success How we are applying what we’ve learned to help companies transition to continuously monitor the health of each component of the quality system with predictive and behavioral analytics Leveraging real-time actionable data to establish a collaborative, proactive and preventive culture Ensuring quick results and getting the most value of your investments in Quality 4.0 initiatives — Jaime Velez Co-Founder Operations & Quality Systems Improvement Experts (OQSIE) Jaime is the co-founder of Operations & Quality Systems Improvement Experts (OQSIE), a management and technical consulting company focused on…

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Moving at the Speed of Science
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Moving at the Speed of Science

Science Will Win: Pfizer’s 5-point plan and industry pledge to finding solutions to the global health crisis Pushing the boundaries of what’s possible: Moving at Lightspeed Hope Changes Lives: The development, manufacture, and distribution of the COVID-19 vaccine and oral treatment Key takeaway: Making the Impossible Possible — John Kelly VP, Quality Operations and Environment, Health & Safety, Pfizer Global Supply Pfizer Inc. John F. Kelly is Vice President, Quality Operations and Environment, Health & Safety, responsible for leading the overall Quality function for Pfizer and for leading global EHS across the Company.  John is a member of the PGS…

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Network Strategy and Operations for an Innovative Pipeline
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Network Strategy and Operations for an Innovative Pipeline

Managing risk and unpredictability in a highly innovative environment Adapting to change Partnership skills as a differentiator Developing the culture to thrive Talent strategies in a competitive and changing marketplace — Manel Luis Interim Pharma Operations Lead Executive Director, Strategy and Business Operations | Global Manufacturing Operations Global Product Development and Supply Bristol-Myers Squibb Manel Luis leads Strategy and Business Operations for Global Manufacturing Operations at BMS since 2020. This includes Network Strategies, Governance and Forums, and facilitation and representation of GMO in strategic and Enterprise level initiatives. Since June 2021, Manel is the Interim Lead for the Pharma Network…

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Is Your Electronic Batch Record Truly Complete?
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Is Your Electronic Batch Record Truly Complete?

Explaining the difference between a partial and complete electronic batch record (EBR) Demonstrating that partially digital but disconnected batch record management is as inefficient as paper for managing production data Showcasing how fully digitized batch records enable smarter, faster manufacturing, so manufacturers can make immediate performance gains at every step Illustrating how today’s technology is configurable to a variety of manufacturing scenarios to create a complete, beginning-to-end EBR that other solutions do not — Brian Curran SVP of Strategic Growth MasterControl Brian Curran joined MasterControl in 2002 to direct and expand MasterControl’s product development efforts. He has more than 25…

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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients
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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

Our new purpose: we chase the miracles of science to improve people’s lives Our race to make available breakthrough treatments & vaccines for patients supported by diverse modalities: accelerate product launches and optimize our asset performance Our ambition to develop a network of Factories of the Future Our response to COVID: Operating with a global Supply Chain in a changing environment impacted by COVID and leveraging our assets to fight against the pandemic — Brendan O’Callaghan EVP, Global Industrial Affairs Sanofi Brendan O’Callaghan leads an international network of manufacturing and distribution sites. His ambition is to enable successful commercialization of…

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Creating and Maintaining a Resilient Supply Chain: Lessons Learned from a Pandemic
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Creating and Maintaining a Resilient Supply Chain: Lessons Learned from a Pandemic

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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Idea to Performance: The Impossible Journey
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Idea to Performance: The Impossible Journey

Moderna pre-pandemic times: Sciences, Platform, and Company History Moderna’s preparation COVID-19. Operations insight for an unprecedented scale-up Execution against the plan. Overcoming challenges Moderna’s future operations — Juan Andres Chief Technical and Quality Officer Moderna As Chief Technical and Quality officer, Juan Andres is responsible for Technical Development, product supply at pre-clinical, clinical and commercial stages and quality across Moderna globally (i.e. CMC); chemistry, manufacturing and controls Mr. Andres was previously the Global Head of Technical Operations (Manufacturing and Supply Chain) for over 25,000 Novartis employees across all of its divisions. In this role, he had responsibility for all of…

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