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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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Culture of Quality Excellence Driving Competitive Advantage for Operations
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Culture of Quality Excellence Driving Competitive Advantage for Operations

Why a Culture of Quality Excellence is foundational to achieving manufacturing excellence and leads to competitive advantage for operations. Driving a culture that recognizes the Value of Quality Excellence. How to establish a Culture of Quality Excellence by focusing not only on processes and digital infrastructure but also focusing on Real-world examples of how Quality excellence is translated into manufacturing excellence, including  Vendor Management, Investigational Excellence and End to End QMS. Using Quality data in a proactive and predictive manner in order to deliver value and achieve manufacturing excellence. — RJ Doornbos VP, Global Quality Systems Bristol Myers Squibb As the Head of Global…

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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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Industrialization of CAR-T Therapies – Autologous vs Allogeneic: Common and Uncommon Hurdles
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Industrialization of CAR-T Therapies – Autologous vs Allogeneic: Common and Uncommon Hurdles

Industry evolution at a glance Donor Variability, the greatest source of variability for cell therapies. Thoughts on characterizing and accommodating this variability Process considerations for Autologous CAR and the importance of a good data ecosystem to provide insight and understanding to this highly complex therapeutic modality Brief introduction to Kyverna — Karen Walker Chief Technology Officer Kyverna Therapeutics Karen Walker, Chief Technology Officer, Kyverna Therapeutics.  Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, and several…

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The Quality Equation
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The Quality Equation

Do you want to ensure that you never have a surprise regulatory inspection outcome? The equation incorporates all you need to assess the status of your site and is even better for companies with networks of sites Data integrity, quality culture, process capability, management commitment and Quality Management Systems are all assessed to produce actionable data whether you are overseeing a CMO or operate your own network of sites — Brandon Varnau Head, Industrial Affairs Specialty Care Global Business Unit Quality Operations Sanofi Brandon Varnau is Head of Industrial Affairs Specialty Care Global Business Unit Quality Operations for Sanofi. He…

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Lyell’s Manufacturing Journey – Building Capacity and Capabilities to Support Multiple Cell Therapy Programs
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Lyell’s Manufacturing Journey – Building Capacity and Capabilities to Support Multiple Cell Therapy Programs

Overview of Lyell science, technologies and platforms Developing a manufacturing strategy to control supply, enable scale and deliver multiple modalities Establishing electronic systems and digital ways of working from the start Building Lean principles and execution discipline into the organization early Delivering on the vision and strategy including lessons learned — Stephen Hill Chief Operating Officer Lyell Immunopharma Stephen Hill has served as our Chief Operating Officer since October 2021. He joined Lyell in June 2019 as our Chief Technical Operations Officer. From June 2018 to June 2019, he was Senior Vice-President, Head of Global Biologics Operations and from March…

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Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

The past few years has seen a migration of talent and technology from traditional biopharmaceutical manufacturing to ATMP manufacturing: How has this changed the CMC ecosystem, and are we overbuilding capacity again? Avoiding the dangers of fragmentation. How should we better communicate, collaborate, and consolidate our best ideas so we all succeed? Discussing the reasons to set up a new company today, and imagining how our business ecosystem will continue to grow and evolve Debating which production platforms will best suit the newer modalities Exploring the next steps for existing platforms like mAbs: How do we efficiently serve giant markets…

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The World of Tomorrow: Serving Patients Through Transformational Change
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The World of Tomorrow: Serving Patients Through Transformational Change

How learnings from the global pandemic combined with the introduction of new technology will enable the patient-centric manufacturing of the future Highlighting what the industry should 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…

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Fighting COVID-19 with Innovation – What We Have Achieved, What We Have Learned, and What Comes Next
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Fighting COVID-19 with Innovation – What We Have Achieved, What We Have Learned, and What Comes Next

Offering an overview of how our industry responded to the global pandemic Highlighting how our organization adapted our existing processes and programs to continue to work under extraordinary circumstances Discussing some of the key takeaways and lessons learned from the past year and a half Where do we go from here? How will AstraZeneca and the biopharmaceutical industry at large move forward from here? What are we doing today to pave the way to those objectives? Pam Cheng EVP, President Global Operations & IT AstraZeneca Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information…

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