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LIFE SCIENCES

The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing
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The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing

November 22, 2023

— John TomtishenVP OperationsCellares John Tomtishen is Vice President of Operations at Cellares Corporation. At Cellares, John is responsible for Cellares’ IDMO business, supporting partnership activities, and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm and address industry bottlenecks to accelerate access to life saving cell therapies. John has extensive experience in cell and gene therapies, biologics, and vaccines with diverse roles in Business Operations, CMC/Technical Operations, R&D, Supply Chain, Engineering/Facilities, and Operational Excellence. While at Novartis Pharmaceuticals, John had an integral role in the filing and approval of the first CAR…

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Unleashing the Potential: Leading the Future of Biologics Market Supply
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Unleashing the Potential: Leading the Future of Biologics Market Supply

November 22, 2023

— Dave StewartSVP, Operational and Process Technology, Large Scale Business UnitFUJIFILM Diosynth Biotechnologies Dave Stewart, Senior Vice President Operational and Process Technology, Large-Scale Business Unit, is a proven leader in the biologics manufacturing industry, with a focus on building diverse, multi-disciplinary teams that drive customer deliverables. He brings a servant-leadership mindset and more than two decades of biotech leadership experience to cultivate accountability, collaboration and agility – assembling engaged, high-performing teams and partnerships built on trust. Dave is responsible for ensuring a consistent operations and equipment model, performance and incorporating emerging capabilities across the large-scale network at FUJIFILM Diosynth Biotechnologies (FDB)…

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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined
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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined

November 27, 2023

— Brian TaylorHead of Biopharma SolutionsSmartLabs — SmartLabs provides teams of all sizes enterprise-grade labs customized within weeks for any stage of research or modality and can be reconfigured within days as your research evolves. Outsource your infrastructure and avoid the extensive costs of traditional lab builds while your own teams accelerate your research in a private lab. www.smartlabs.com

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Opportunities and Challenges of GMP Manufacturing of RNA-LNPs
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Opportunities and Challenges of GMP Manufacturing of RNA-LNPs

November 22, 2023

— Martin RabelSr. Field Application ScientistPrecision NanoSystems Inc. Martin Rabel, Dipl.-Pharm., Ph.D. currently works as a Senior Field Application Scientist for Precision NanoSystems ULC supporting clients in Central Europe, Middle East, and Africa (EMEA). He obtained his pharmaceutical license as well as a postgraduate diploma from the Friedrich-Schiller-University Jena working on Bacterial Nanocellulose (BNC) nanoparticles for gene delivery applications. His Ph.D. research focused on the development of animal-free simulation models for the development of complex diagnostic nanoparticles (IONP) and other nanomedicines as well as nanoparticle characterization and manufacturing methods. He joined Precision NanoSystems ULC in 2019 as Field Application Scientist….

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Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine
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Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine

May 25, 2023

 As Novartis begins its journey to become a focused innovative medicines company, the Operations organization is evolving to make this ambition into a reality. A few years ago, we undertook a systematic approach of improving and optimizing our manufacturing capabilities. We brought in best practices, methodologies and tools to streamline processes, eliminate waste, reduce costs, improve quality and efficiency. We recognize that we have embarked on a continuous journey and we are happy to share how far we have come on: Operational Excellence: Embedding operational excellence to improve productivity and deliver high-quality medicines Innovation: Expanding platform capabilities in RNA,…

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Our Journey in Next Generation Manufacturing: What We Can Achieve Together
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Our Journey in Next Generation Manufacturing: What We Can Achieve Together

May 25, 2023

 Where our organizations are heading as a community of pharmaceutical manufacturers Our current and future capabilities by geography, people, and technology Practical leadership approaches that empower us to tackle challenges and set ambitious goals for the future Next generation platforms that will change how we work and succeed Examples from Pfizer that illustrate these pursuits in action — Jim Cafone SVP Global Supply Chain Pfizer Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice President, Global Supply Chain, Jim oversees global demand forecasting, demand and supply planning, worldwide logistics, and inventory management for…

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Quality and Compliance from the Regulators’ Perspective
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Quality and Compliance from the Regulators’ Perspective

May 25, 2023

What are regulators looking for when they engage with QA/QC executives and other senior leaders? How can industry facilitate these interactions? Thinking about your processes and facilities from the point of view of the inspector: What are you taking for granted based on familiarity or habit or tradition that would not apply to a fresh pair of eyes? Highlighting best practices to make ongoing documentation a powerful quality and compliance tool for the future Using compliance as a starting point: What does exceeding expectations look like, and how should pharmaceutical manufacturers stay ahead of that moving target in perpetuity? —…

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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?
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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?

May 25, 2023

Discuss how today’s pipeline and technologies are reshaping biomanufacturing Looking at the technologies that enable next generation manufacturing processes Review case studies and strategies for rapid manufacturing scale up for leading products Focus on the necessity of investing in people and robust strategies to support the workforce and culture Show opportunities that allow for successful navigation in the future of manufacturing, including leveraging legacy and culture as drivers of change Chris Horan Chief Technical Operations Officer Artiva Biotherapeutics Christopher Horan spent nearly 14 years at Genentech, a member of the Roche Group, where he held several leadership positions across technical…

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Leading Through Transformations and Integrations – The Evolution of Global Product Development and Supply
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Leading Through Transformations and Integrations – The Evolution of Global Product Development and Supply

May 25, 2023

Karin Shanahan, EVP, Global Product Development and Supply at Bristol Myers Squibb joins us to discuss how she is leading one of the world’s largest manufacturing operations through rapid transformation, while integrating cutting-edge technology into BMS. Among the highlights, Karin will discuss: How GPS delivers value to the enterprise through the Product Development and R&D interface. The integration of Cell Therapy into GPS and how the company is working to improve predictability long-term. Establishing a competitive advantage for BMS from within GPS – an operational model built to last. Karin will also include successful examples of GPS’s evolution to support…

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Fireside Chat: The New Normal and Beyond: How to Design the Fit for Purpose Technical Operations Organization of the Future
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Fireside Chat: The New Normal and Beyond: How to Design the Fit for Purpose Technical Operations Organization of the Future

May 25, 2023

The Pharma/BioPharma ecosystem is rapidly evolving with new technology and innovative business models People and how we organize and empower them is at the core of competitive advantage We must consider geography, education and culture in training and retaining our most important asset With an increase in new modalities such as cell therapy, there is a new generation of Tech Ops professionals to train and nurture We need to examine how automation and AI might change workforce activities, productivity and workflow The Message:  The Tech Ops organization of the future is being built today, your success depends on how we…

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Managing Innovation and Variability in a Growth Environment
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Managing Innovation and Variability in a Growth Environment

May 25, 2023

 How the pandemic impacted the structure and responsiveness of our global networks Responding to new geographic fluctuation of demand by disease states and patient delivery The challenges and opportunities posed by new product innovation and managing lifecycles — Andy Wirths SVP Supply Americas AstraZeneca Andrew (Andy) Wirths is a senior pharmaceutical operations leader with over 30 years’ experience in the industry spanning small and large molecule manufacturing. Andy joined AstraZeneca in 2015 and is currently Senior Vice President, Americas Supply, where he is responsible for overseeing the manufacturing operations of 8 sites in North and South America. Previously Andy…

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Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics
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Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics

May 26, 2023

With rapidly evolving science driving new therapeutic modalities, what is the role of a CDMO? The challenges of process development with accelerated approvals Building a manufacturing network to address tomorrow’s needs What are the implications of the IRA legislation on the future of biotherapeutic manufacturing? — Spencer Fisk Chief Technology Officer Resilience Inc. Spencer has more than 30 years of experience in Manufacturing and CMC product development. While at Rubius, Spencer built the technical functions to design and deliver the RED™M manufacturing platform, including clearance of 4 IND’s over 4 years. He also led the acquisition and re-fit of their…

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Transforming a Global Development & Product Supply Network for Delivering a Multi-Modal Portfolio – It’s More than Flexible Facilities
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Transforming a Global Development & Product Supply Network for Delivering a Multi-Modal Portfolio – It’s More than Flexible Facilities

May 26, 2023

Re-designing your organization to leverage capabilities across modalities In agile ways Designing technology platforms as you design products Laying the foundation for change during a pandemic builds flexibility and resilience in employees, setting the course for new ways of working and breaking down silos Strengthening a culture of inclusion and driving diversity in leadership ranks — Jens Vogel SVP & Global Head of Biotech Bayer Pharmaceuticals Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of professional and leadership experience in the…

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Panel: How will the Way People, Processes, and Technologies Interact Change in the Next Ten Years?
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Panel: How will the Way People, Processes, and Technologies Interact Change in the Next Ten Years?

June 5, 2023

Discussing some of the forces and factors that are changing the way we operate Debating how these influences will continue to evolve, and how they will shape our organizations Technological progress is a given, but will there also be fundamental changes to our people and our processes in the next decade, or should we expect incremental modifications rather than a sea change? Thinking about Risk Management: How should we brace ourselves for the unexpected in a global business environment whose only constant factor is change? — Joanne Beck Chief Technology Officer Aerium Therapeutics Dr. Joanne Beck is currently Chief Technology…

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The Vertex Story: Serial Innovation in Manufacturing
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The Vertex Story: Serial Innovation in Manufacturing

May 26, 2023

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 — Morrey Atkinson SVP & Head, 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 network. In…

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A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients
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A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients

May 25, 2023

Highlighting what industry will need to do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably, and affordably Providing 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 Exploring the role that new technologies will play in achieving that transformation — Jennifer Baxter VP, Small Molecule Science and Technology Merck Jennifer Baxter has over 20 years of experience in pharmaceutical development and manufacturing activities. During her tenure at Merck, Jennifer has worked in research & development,…

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Designing the Next-Generation Advanced Therapeutics Manufacturing Process
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Designing the Next-Generation Advanced Therapeutics Manufacturing Process

June 13, 2023

Richard D. Braatz Edwin R. Gilliland Professor of Chemical Engineering MIT Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at MIT, where he conducts research into advanced biopharmaceutical manufacturing systems. In this role, he leads process data analytics, mechanistic modeling, and control systems for several projects on campus, including those focused on monoclonal antibody, viral vaccine, and gene therapy manufacturing. Dr. Braatz received an M.S. and Ph.D. from the California Institute of Technology and was the Millennium Chair and Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before…

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