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PMWS

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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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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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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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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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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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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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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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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Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients
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Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients

May 19, 2021

Highlighting what should the industry do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as molecular complexity increases in the future for small molecules, blurring the boundaries between small and large molecules — Sanat Chattopadhyay EVP…

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Day Two Chair’s Opening Remarks and Keynote: The Vertex Story: Serial Innovation in Manufacturing
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Day Two Chair’s Opening Remarks and Keynote: The Vertex Story: Serial Innovation in Manufacturing

May 19, 2021

Sharing Vertex’s track record for serial innovation in manufacturing to create transformative medicines for people with serious diseases and high unmet medical needs Highlighting Vertex’s success with small molecule continuous manufacturing in Cystic Fibrosis Transforming manufacturing in cell and genetic therapies for Sickle Cell Disease, Beta Thalassemia, and Type 1 Diabetes — E. Morrey Atkinson SVP and Head of Commercial Manufacturing and Supply Chain Vertex Pharmaceuticals As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply…

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Leading Global Supplies in Times of High Biologic Demands Now and After the Pandemic Crisis
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Leading Global Supplies in Times of High Biologic Demands Now and After the Pandemic Crisis

May 19, 2021

Strong wave of innovation and new Biologic therapies resulting in high demands Building flexible global capacities at various scales and multiple global locations to ensure reliable supplies and serve patients’ needs worldwide Business continuity planning, crisis management, pandemic preparedness & implementation of additional specific protection measures Close collaboration, intensive and solution-oriented exchange with customers and partners to ensure global patient supplies Managing diverse and complex challenges through digital transformation Critical success factor: Operational excellence, capacity & capabilities expansion and our peoples dedication — Uwe Buecheler Corporate SVP Biopharmaceuticals Boehringer Ingelheim Uwe Buecheler, Ph. D. joint Boehringer Ingelheim (formerly Dr. Karl…

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Rethinking our Supply Chain to be Patient-Centric
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Rethinking our Supply Chain to be Patient-Centric

May 19, 2021

Challenges biotech companies are facing as patients expectations are increasing Ensuring the end-to-end supply chain can respond in the face of fierce competition for innovation Leveraging data and analytics to increase value and service to patients Keeping patients central as external factors accelerate need for resiliency — Kimberly Lounds Foster SVP Global Supply Chain Bristol-Myers Squibb Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at Bristol-Myers Squibb, where she oversees the clinical and commercial supply chain. Bristol develops and manufactures products on multiple technology platforms, including small molecules, biologics and cell therapies. Kimberly joined Bristol through the Celgene…

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Reducing Drug Shortages… and High Prices
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Reducing Drug Shortages… and High Prices

May 19, 2021

How hospital systems and philanthropies came together to establish their own supply chain for essential quality generic medicines Living the mission to make quality generic medicines accessible and affordable to everyone Improving the resiliency of the supply of essential medicines used in hospitals, often for critical care, day-to-day and during a pandemic Ensuring a safe and stable supply of essential medicines for U.S. patients — Donna Gulbinski Chief Quality & Regulatory Affairs Officer Civica Rx Donna’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history…

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Keynote: Delivering Excellence While Navigating Transition
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Keynote: Delivering Excellence While Navigating Transition

May 19, 2021

Highlighting how operations and manufacturing can think differently to pivot for crises and global events Preparing for M&A opportunities and adapting for a changing business model Discussing the importance of equity, leadership and people as catalysts of culture and change within the industry as we work to serve patients better — Azita Saleki-Gerhardt EVP, Operations Abbvie Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie, leading a team of scientific, engineering, business, quality, supply chain, security, purchasing and manufacturing professionals responsible for supply and distribution of all AbbVie products, as well as a number of corporate services. Dr. Saleki-Gerhardt…

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Why Executive Platforms Decided to Launch Pharma Manufacturing World as Our Seventh Summit Series
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Why Executive Platforms Decided to Launch Pharma Manufacturing World as Our Seventh Summit Series

July 17, 2019

An Open Letter by Geoff Micks Head of Content & Research Executive Platforms   Those of you who follow us on Twitter or LinkedIn may have already seen the ‘Save the Date’ announcement for Executive Platforms’ newest summit series, Pharma Manufacturing World Summit. The first edition of which will run June 22nd and 23rd, 2020, at the Boston Marriott Copley Place. We are very excited about it, as you can imagine. Or maybe you cannot? It occurs to me that with each of the last six series Executive Platforms has launched, we never made a public announcement explaining our thinking…

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