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VIDEO

Fireside Chat: 2023 Is Coming in Hot. Are You Missing These 3 Priorities in Next Year’s Plan?
HUMAN RESOURCES, HUMAN RESOURCES, VIDEO

Fireside Chat: 2023 Is Coming in Hot. Are You Missing These 3 Priorities in Next Year’s Plan?

December 20, 2022

 Indicators already show the economy slowing, and organizations are tightening budgets as a result. What’s the best strategy for HR leaders? Take the lead in finding ways to maximize efficiencies across people and existing program investments. Attend this session to hear how to successfully navigate business challenges by focusing on three key priorities: Tackle mental health issues: Burnout will continue to be a chief cause of job flight, with 88% of working parents suffering from exhaustion and fatigue at work, and 72% of frontline workers saying they’re barely able to manage stress or worse. Address family care gaps – 74% of…

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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution
LIFE SCIENCES, LIFE SCIENCES, VIDEO

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

November 23, 2022

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
LIFE SCIENCES, LIFE SCIENCES, VIDEO

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

November 23, 2022

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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Unlocking the Promise of Gene Therapy
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Unlocking the Promise of Gene Therapy

November 28, 2022

Review the current state of gene therapy Discuss overcoming barriers to product development Make the case for global regulatory convergence Describe FDA actions facilitating gene therapy development — Peter Marks Director – Center for Biologics Evaluation and Research (CBER) FDA Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy…

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

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

November 23, 2022

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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Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes

November 23, 2022

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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Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy

November 29, 2022

How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space? Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards including image selection, and packaging network design Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market considerations changing the way we traditionally work? Talking about access issues including regionalization and localization, IP considerations, and how higher order BSL…

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Fireside Chat: Building the Future from a Distinguished Tenure in CMC
LIFE SCIENCES, LIFE SCIENCES, VIDEO

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

November 23, 2022

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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LIFE SCIENCES, LIFE SCIENCES, VIDEO

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

November 28, 2022

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

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

November 23, 2022

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
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Towards Industrialization of Cell Therapy

November 23, 2022

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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Culture of Quality Excellence Driving Competitive Advantage for Operations
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Culture of Quality Excellence Driving Competitive Advantage for Operations

November 28, 2022

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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