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Biomanufacturing World Summit

LIFE SCIENCES, VIDEO, LIFE SCIENCES

The Disease Clearing Potential of CAR T-Cell Therapy for Autoimmune Diseases

Karen Walker, Chief Technology Officer at Kyverna Therapeutics, shares insights into the groundbreaking potential of CAR T-cell therapy to transform the treatment of autoimmune diseases. In this fireside chat, she explores emerging science, early clinical progress, and what this next frontier could mean for long-term disease remission and patient outcomes.

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Shaping Tomorrow: Strategies for Success in Manufacturing and Innovation

Chris Crowell, VP and Global Head of Manufacturing at Kite, a Gilead Company, shares strategies for advancing manufacturing and innovation to drive productivity and reduce cost of goods. He explores how process improvements, modern technologies, and flexible, future-ready capabilities are reshaping biomanufacturing—illustrated through real-world examples of measurable impact.

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Fostering Innovation in the Face of Changes in today’s Healthcare Environment

Moderator Michael Thien, former SVP & Head of Pharmaceutical Sciences, R&D at Takeda, leads a discussion with Pat Yang, Chairman of Taiwan BioManufacturing Corp, and Ran Zheng, CEO of Landmark Bio, on fostering innovation in today’s rapidly shifting healthcare landscape. The panel explores innovative approaches to developing therapies for rare and ultra-rare diseases, integrating digital tools and automation into biomanufacturing, and driving cross-functional innovation amid evolving regulatory and supply chain pressures.

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From Bottleneck to Breakthrough: Digital Tech Transfer for Pipeline Acceleration

Michalle Adkins, Director of Life Sciences Strategy at Emerson, shares how digital-first workflows, automation, and AI are transforming tech transfer from a bottleneck into a competitive advantage. She explores how connected platforms streamline recipe translation, optimize scheduling, and accelerate pipeline throughput by combining intelligent technology with human expertise.

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Creative and Impactful Leadership Through Uncertainty

Pascal Bécotte, Managing Director at Russell Reynolds, and Marie-Noëlle Gagnon, Chief Talent Officer at Cirque du Soleil Entertainment Group, share how Cirque’s creative heritage inspires leadership through ambiguity and change. They explore how open communication, trust, and a strong sense of purpose empower teams to stay resilient and adaptable in high-pressure environments.

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Building Adaptive Technical Operations to Support the Future of Biomanufacturing

Adam Pfeiffer, Senior Vice President at Project Farma; Angela Goodenough, Executive Director of CMC, Analytical Development & Quality Control and Interim Head of Clinical Supply Chain at AnaptysBio; Jeff Davis, VP of Clinical Manufacturing at Gilead; and George Skillin, VP of Client Engagement at Project Farma, share how to build adaptive technical operations that can keep pace with the future of biomanufacturing. They explore how to strengthen internal and external partnerships, maximize innovation and efficiency, and balance quality with speed to market in an increasingly dynamic environment.

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From Partnership to Performance: Driving Agility and Excellence in Biomanufacturing

Rainer Haemmerle, Executive Director of Manufacturing at Boehringer Ingelheim Biopharmaceuticals GmbH, shares how strategic partnerships fuel agility and excellence in biomanufacturing. He explores how collaborative models accelerate new capabilities, strengthen responsiveness from development to commercial scale, and help biopharma companies navigate evolving market and regulatory pressures.

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Evolving External Collaboration Models
LIFE SCIENCES, VIDEO

Evolving External Collaboration Models

Reviewing how our industry’s business partnerships have changed over time. How will this trend continue into the future? Dividing the work and sharing the burden: How should biopharmaceutical companies align their objectives of cost management, risk management, productivity, and growth? Maturing business relationships over time through common culture through two-way communication, collaboration, and cooperation Walking through examples of external collaboration: What works, what does not, and why? — Joanne Beck EVP, Global Pharmaceutical Development & Operations Celgene Corporation Dr. Joanne Beck is EVP Global Pharmaceutical Development and Operations at Celgene where she oversees the company’s Pharmaceutical Development, Global Manufacturing Operations,…

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Accelerating Delivery of New Medicines
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Accelerating Delivery of New Medicines

Examining technologies, tools, and platforms to accelerate the pace of biopharmaceutical development How development velocity can affect clinical development and what we learn in this process Examining how acceleration impacts our quality, regulatory, and supply chain functions. How do we all keep pace? Understanding how acceleration affects data monitoring and analytics throughout the product lifecycle Discussing what steps we as an industry will need to take together to make this the new normal — Jerry Cacia SVP, Head Global Technical Development Genentech Jerry is responsible for Roche’s Global Technical Development organization. This scope includes responsibility for developing manufacturing processes and…

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Boosting Traceability and Security in the Supply Chain with Serialization
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Boosting Traceability and Security in the Supply Chain with Serialization

What is serialization? Global serialization mandates Impact on manufacturing and the pharma supply chain Implementation challenges Technologies – Now and into the future — George Skillin Sr. Director – Global Engineering Pfizer George Skillin is the Senior Director of Pfizer Global Engineering, where he manages a team of 35 engineering professionals in the Process, Equipment, Automation Engineering disciplines and manages the Global Serialization and Industrial Control System Cyber Security Programs for Pfizer. George joined Pfizer in 2002 taking on a 2+ year international assignment as a member of the Site Leadership Team in conjunction with the design, construction, and start-up…

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Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age
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Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age

Addressing the state of the biopharmaceutical industry today: Which emerging trend will see the most growth? Embracing modular automation, PAT and continuous processing to increase agility, flexibility and improve efficiencies People and technology: How are these forces working together to grow and mature our industry? IoT- how will cloud based data, data analytics and data integrity evolve compliance and quality towards continuous improvement How will these technologies affect patient and product needs towards more individualized therapies? — Moderator: Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of…

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Knowing and Protecting Your Assets
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Knowing and Protecting Your Assets

Discussing options for biomanufacturing capacity management: Effective strategies for capacity utilization Spreading capacity among and across different business partners When is the right time to hedge with CMOs? Understanding the attraction, retention, and development trends for talent assets Illustrating these trends with metrics and examples from AstraZeneca’s own experience — Darren Dasburg currently serves as VP & Head, Learning and Development Global Operation at AstraZeneca. Bringing over 30 years of professional experience in a variety of settings, he was appointed Vice President-Site Head for the Boulder Manufacturing Center in September 2015 when AstraZeneca/MedImmune acquired the former Amgen biologics production facility. Previously,…

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Leading and Leadership in Lean Bio-Manufacturing Operations
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Leading and Leadership in Lean Bio-Manufacturing Operations

Lean applications in Bio-Manufacturing is both complex and simple Sustaining lean performances in Bio-Manufacturing is both science and art Good versus Great Lean leadership… It matters Successful OE polynomial equation for Lean Bio-Manufacturing = … ? — Jacks Lee is an industry executive with global experiences in biopharmaceutical, small molecule drugs and vaccines. His 25+ years of experiences spans across technical, operational and strategic leadership roles in Science-Technology, Engineering, Quality, Supply Chain and Manufacturing. He currently serves as the Senior Vice President of Merck Manufacturing Division-Global Vaccines Operations. Jacks joined Merck in 2007 as head of Global Technology & Engineering….

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Biotech Business Bootcamp – Treating Cultural Sclerosis…
LIFE SCIENCES, VIDEO

Biotech Business Bootcamp – Treating Cultural Sclerosis…

Repetitive engagement survey results with no sustainable action plan for improvement? Meeting mania dominating each and every day? Data, metrics, KPI’s, and scorecards – Thermometers or Thermostats? OPEX tools and governance models that feel abstract and disconnected? Struggling with any of these symptoms? If so, your organization is suffering from Cultural Sclerosis. While not fatal, it is debilitating. Fortunately, we have developed a ‘Sustainable Treatment Plan’ based upon 25 years of work with organizations including GSK, Pfizer, Genentech, Gilead, and Alcon that will drive Clarity, Connectivity and Consistency into both your team and leadership culture. — Shane A. Yount is…

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Breakthrough Designations – How Can Quality Enable Speed to Innovation?
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Breakthrough Designations – How Can Quality Enable Speed to Innovation?

Offering an overview of how breakthrough therapy designations have historically worked and how that process is changing Are we as an industry ready for major changes in how drug development is expedited? Discussing how our organizations’ Quality Culture must be an integral part at all stages of this transition Working with all stakeholders to ensure we do not sacrifice safety and quality as we increase the pace of innovation What should we be doing right now to prepare for the future of these developments? — Christie Bielinski, Vice President of Product Quality Management at Janssen Pharmaceuticals, leads a world-wide organization of quality professionals…

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