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LIFE SCIENCES

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

April 8, 2022

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

April 8, 2022

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

April 8, 2022

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

April 8, 2022

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?

April 8, 2022

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

April 8, 2022

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

April 8, 2022

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

April 8, 2022

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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Pharmaceutical Development and Manufacturing — The New Post-Pandemic Realities
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Pharmaceutical Development and Manufacturing — The New Post-Pandemic Realities

April 8, 2022

Discussing how the business model change accelerates Highlighting transformation needs in business setup, technology and ways of working Impact on Development and Manufacturing of different modalities How does Bayer gets prepared for such opportunities and challenges? — Wolfram Carius EVP Pharmaceuticals Bayer AG Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for nearly three years. Before that, he worked for…

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Managing Innovation and Variability in a Growth Environment
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Managing Innovation and Variability in a Growth Environment

April 8, 2022

How the pandemic impacted the structure and responsiveness of our global networks Responding to new geographic fluctuation of demand by disease states and patient delivery The challenges and opportunities posed by new product innovation and managing lifecycles — Linzell Harris SVP Global Supply Chain and Strategy AstraZeneca Linzell Harris is senior vice president of Global Supply Chain and Strategy for AstraZeneca, with overall responsibility for the development and execution of the end to end supply chain platform and product supply strategies. In addition, he is responsible for ensuring the strategic development of network designs and supply chain capabilities supporting the…

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Advancing Pharmaceutical Manufacturing Quality
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Advancing Pharmaceutical Manufacturing Quality

April 8, 2022

 Using innovative thinking to realize a future more “immune” to supply chain disruptions Incentivizing improvements to the pharmaceutical manufacturing infrastructure that enhance the reliability of manufacturing and supply Delivering on the promise of advanced manufacturing to provide reliable, available, high-quality drugs for patients — Michael Kopcha Director, Office of Pharmaceutical Quality, CDER FDA Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise…

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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning
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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning

April 8, 2022

Discussing the common pitfalls observed during establishment of initial GMP programs in the areas of quality systems, materials management, supplier qualification, etc. How are companies adopting organizational changes and leveraging digital systems to avoid these pitfalls? Important factors to consider when assessing build vs. buy for early-phase clinical production, and considerations for scaling a GMP program up and/or out Illustrating the importance of establishing clear process requirements and conducting informal and formal facility fit assessments using real-world examples — Chris Mansur President, Azzur Consulting Azzur Group Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes…

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Global Talent Trends in Pharma Manufacturing
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Global Talent Trends in Pharma Manufacturing

April 21, 2022

Our knee-jerk leadership reaction to the pandemic: from managing change to managing burn-outs! Recovery: how to reboot culture, leading with purpose and agility Defining and adopting next-gen performance and talent management — Pascal Bécotte Managing Director Russell Reynolds Associates Pascal leads Canadian operations for Russell Reynolds Associates and is also a member of the firm’s global Executive Committee. He is a key member of the Healthcare Sector where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. More specifically Pascal…

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Panel: Leadership Strategies to Survive and Excel in a Post-COVID World
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Panel: Leadership Strategies to Survive and Excel in a Post-COVID World

April 21, 2022

What are some of the unexpected lessons —good and bad— we have taken away from 2020 and 2021? Discussing examples of innovations created by necessity during the global pandemic that will continue on long into the future Taking this chapter in our working lives as an opportunity to re-evaluate, reconsider, and rethink some of the processes and strategies we had in place before COVID-19 How should we adjust our approach to communication, coordination, mentoring, and management in the emerging ‘new normal’ of work? Has the global pandemic changed the way people think about their personal and professional development? What should…

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