Tag

cell therapy

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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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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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies
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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies

With no standardized methods in analytical development of cell and gene therapies, we must define our own best practices Looking at the evolution and industrialization of analytical development in biologics over the past 20 years: what did we learn and how can we leverage it now? With the current speed of evolution, what new tools will emerge to help us solve these complex challenges The high cost of analytical development and need for greater efficiency begs the question how do we get to where we need to be… And where do we need to be? — Stacey Ma EVP Technical…

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Keynote: When Your Process Equipment is a Raw Material and Your Raw Material is a Human: The Adaptation of Biotechnology CMC Skills to Cell Therapy
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Keynote: When Your Process Equipment is a Raw Material and Your Raw Material is a Human: The Adaptation of Biotechnology CMC Skills to Cell Therapy

CMC/Operations disciplines have an important role in the commercialization of powerful new cell therapies Well understood development principles can be applied, though there are challenges It is important to identify when to draw on experience and when to adapt/grow to address gaps Comparability is key in an emergent technology space, but may be limited by product understanding Growing development skills to advance important new medicines — Alison Moore Chief Technology Officer Allogene Therapeutics Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously…

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Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy
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Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy

Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing? Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively Bringing a structured approach to your advocacy within your network of industry and trade organization connections Embracing the idea that keeping things simple even in a complex environment generates the best outcomes — Pat Yang Former EVP at Juno Therapeutics, Roche and Genentech Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management…

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Cell and Gene Therapies and the Dawn of the Next Chapter of Biopharmaceutical Production
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Cell and Gene Therapies and the Dawn of the Next Chapter of Biopharmaceutical Production

What are some of the unique challenges and opportunities in commercializing live modalities like CAR-T? Weighing the pros and cons of centralized versus decentralized production models for these new treatments Discussing how our industry’s quality culture informs these new products from R&D right through to the patient Offering lessons learned from the first generation of cell and gene therapies. How will their example inform what we are doing now? Setting timelines for the future: What are we going to be able to do next year, five years from now, and ten years from now? What are we doing to get…

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Scaling Gene Therapy Manufacturing: What is Our Goal?
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Scaling Gene Therapy Manufacturing: What is Our Goal?

Highlighting the scale-up opportunity for dramatic patient benefit through the lens of a patient Outlining the inextricable link between manufacturing and the patient experience for autologous cell therapies Considering the different scaling goals: commercial viability, reliability, patient access, etc. — Derek Adams Chief Technology and Manufacturing Officer bluebird bio Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial…

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