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Alison Moore

Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing
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Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

Assessing Changes in the CMC Ecosystem: Are We Overbuilding Capacity Again?
Uniting for Success: Strategies to Prevent Fragmentation and Foster Collaboration in Biomanufacturing
Pioneering New Ventures: Reasons to Establish a New Company Today and Anticipating Future Growth in the Business Ecosystem
Evaluating Production Platforms for Emerging Modalities: Which Platforms Will Best Serve the Future of Medicine?
Navigating the Future of Existing Platforms: Efficiently Addressing Market Needs for Established Therapies such as mAbs, ADCs, and mRNA-based Treatments

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Welcome Day Panel: The Five Biggest Things Facing Our Shared Biomanufacturing Future
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Welcome Day Panel: The Five Biggest Things Facing Our Shared Biomanufacturing Future

Discussing the most important new technologies in biomanufacturing today, with a special emphasis on what we want to do as our industry matures
Debating how talent and workforce development in our industry is changing, and what we should do about it
Listing the current factors affecting speed of development and efficient manufacturing. How do we continue to improve in a changing business landscape with special reference to IRA and the BIOSECURE Acts?
Understanding the current Regulatory environment with an eye for how things are going to evolve into the future
How can we improve the access of biologic medicines?

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Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development
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Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development

Science outpacing Industrialization of Technology: Reviewing next generation cell and gene therapy platforms/technologies, gene editing technologies to unlock new possibilities.
Manufacturing to Scale: Scaling up to meet demand, comparability challenges, production capacity, AI tools and AAV production will drive speed to market/approval
Regulatory Evolution: evolving regulatory frameworks and innovative products necessitate industry and local and global regulatory collaboration to define efficient pathways to approval
Economic/Global Expansion: expanding access to ATMP’s in new regions, reducing cost of goods via production efficiency, expanding global infrastructure to facilitate access to new patients

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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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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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Panel: Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?
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Panel: Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?

Debating the merits of nimble and flexible facilities versus manufacturing battleships Preparing your pilot plants and manufacturing facilities to move forward with Phase II-III approvals Forecasting requirements for optimizing manufacturing equipment, facilities and partners to increase speed to market Achieving business goals to better manage times of product and economic uncertainty Putting theory into practice: Implementing key metrics to improve manufacturing flexibility — Moderators: Pat Yang Chairman at Acepodia & Founding Board Director at Sana Biotechnology Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech,…

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BMWS20 – Opening Chairs’ Remarks and Keynote: Reinventing a Biopharma Company for the 21st Century
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BMWS20 – Opening Chairs’ Remarks and Keynote: Reinventing a Biopharma Company for the 21st Century

Bristol Myers Squibb is a company that has undergone an extensive transformation and as a result, has reinvented itself Once a company consisting of multiple and vastly different business units, it is now the largest diversified specialty global biopharma company Its mission and focus is to utilize innovation to advance the treatment of serious disease and significant unmet medical need This organizational evolution required substantial change for the product development and manufacturing arms of the company Technology, systems, processes, people and culture all needed to be re-evaluated through a “new lens” The presentation will cover this journey including approach, successes,…

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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: Setting Ambitious Goals to Improve the Biopharmaceutical Ecosystem
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Panel: Setting Ambitious Goals to Improve the Biopharmaceutical Ecosystem

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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Panel: The Global Talent War in Biomanufacturing
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Panel: The Global Talent War in Biomanufacturing

Learning about global talent trends influencing the job market for senior executives and those with critical, specialized skill sets Creating effective attraction, retention and development plans for top talent Navigating the generational talent gap in critical functions Understanding which leadership differentiators are needed to make it to Senior Executive and C-Level roles — Sanat Chattopadhyay EVP & President, Merck Manufacturing Division Merck Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada. Sanat oversees a network of 50 pharmaceuticals, vaccines,…

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The Role of Process Development in Next Generation Biologics Manufacturing
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The Role of Process Development in Next Generation Biologics Manufacturing

Alison Moore delivered the opening keynote on November 15th of the 2016 edition of the Biomanufacturing World Summit entitled, The Role of Process Development in Next Generation Biologics Manufacturing. Dr. Alison Moore is Senior Vice President, Process Development serving both Operations and R&D organizations. Prior to this role, Moore served as senior vice president, Operations Technology. Moore was previously vice president, Process and Product Engineering (P&PE) function, where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management….

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