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Pharmaceuticals

Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution
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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution

Bolstering our supply chain: Strengthening relationships with industry partners to overcome a global health crisis Making the impossible possible: “Project Lightspeed” and the development, manufacture, and distribution of the COVID-19 vaccine Where do we go from here? Ensuring this experience is a catalyst for change for our industry Key takeaways: upending our conventional ways of working and the resilience of our amazing colleagues — Mike McDermott Chief Global Supply Officer, EVP Pfizer As Chief Global Supply Officer, EVP, Mike McDermott leads all of Pfizer’s internal and external manufacturing and supply chain activities. Mike and the Pfizer Global Supply (PGS) team…

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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence
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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence

Being part of the solution: Launching two medicines in record time during the pandemic Meeting growing complexity head-on Establishing communities of practitioners to re-imagine manufacturing and process development Re-thinking how we collaborate across boundaries — Susanne Hundsbaek-Pedersen Global Head Pharma of Technical Operations Roche Susanne serves as the Global Head of Pharma Technical Operations at Roche, a global biotech company. Roche delivers long-term and sustainable healthcare solutions to serve millions of patients in 150 countries. Pharma Technical Operations spans the world with sites on four continents and covers the value chain from Technical development, CMC to Commercial supplies. She is…

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Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes
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Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes

How the pandemic has impacted innovation, technology, people and our ways of working and thinking How is Amgen transforming biomanufacturing for a faster, more data-savvy future and strengthening the balance of resiliency and efficiency Addressing unmet patient needs and establishing new markets through connected technology and other manufacturing innovations (smart materials, process automation and more) Why building integrated, collaborative, agile, high performance teams are at the heart of revolutionary manufacturing Amgen Ecovation™ – creating value through innovative and sustainable manufacturing operations — Arleen Paulino SVP Global Manufacturing Amgen Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization where…

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TCR² and the Path to Registration: The Road in Scaling a TCR Platform and Organization to Un-Lock a Therapy for Solid Tumors
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TCR² and the Path to Registration: The Road in Scaling a TCR Platform and Organization to Un-Lock a Therapy for Solid Tumors

Walking through how we built our Cell Therapy unit. What did we duplicate? What did we innovate? What did we adapt from others, and how did we make it our own? How are we building a sustainable pipeline, managing complexity, and keeping our focus? What are the “must haves”? What are the learnings on common threats of significant transformations? Lessons learned from the TCR² journey to provide innovative therapies for patients in need — Peter Olagunju Chief Technical Officer TCR² Therapeutics Peter Olagunju serves as the Chief Technical Officer of TCR².  He brings over 20 years of experience in cell…

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Towards Industrialization of Cell Therapy
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Towards Industrialization of Cell Therapy

Cell therapy, such as regenerative therapies based on iPSCs and adoptive cell therapies targeting cancer with CAR-T cells, CAR-NKs or TCRs hold enormous potential for the future of medicine, enabling for the first time curative approaches. However, the field is still in its infancy and CMC remains a critical bottleneck in bringing these therapies to patients on a global scale. This discussion will focus on the scientific, technical and cultural transformations required to drive towards true industrialization of cell therapies, including: The critical challenges in CMC for cell therapies today How more in-depth understanding of cells, their critical quality attributes…

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Fireside Chat: Building the Future from a Distinguished Tenure in CMC
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Fireside Chat: Building the Future from a Distinguished Tenure in CMC

Introducing Prime Medicine and its vision for the future of medicine How are we thinking about the inclusion of novel types of automation into molecular medicine workflows? Examining how we view Talent in the emergent technology space, and how do we best deploy remote and hybrid work? Historically, pharmaceutical manufacturing leaders were predominantly men; however, many important CMC leadership positions are now held by women. Why is this the case, and how do we sustain this pattern? What are the most significant learnings from having achieved success in licensing autologous cell therapies? — Ann Lee Chief Technical Officer Prime Medicine…

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Moderna: The Rise of mRNA Vaccines – CMC Operations During a Once-in-a-Lifetime Pandemic
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Moderna: The Rise of mRNA Vaccines – CMC Operations During a Once-in-a-Lifetime Pandemic

Our journey from a “platform” to a “multi-product” company How we achieved the seemingly impossible What we learned along the way Where we are today and where the journey takes us next — Tara Jones SVP, North America Operations Moderna Tara is responsible for end-to-end operations for DNA, Drug Substance, and Drug Product for global clinical trial materials and commercial product for the North America region.  Prior to joining Moderna she was at Amgen where she led drug substance operations at Amgen Puerto Rico and was responsible for both the mammalian and bacterial drug substance manufacturing operations for multiple commercial…

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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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