Tag

business landscape

Welcome Day Panel: The Five Biggest Things Facing Our Shared Biomanufacturing Future
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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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Emerging Trends Impacting Technical Development and Manufacturing
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Emerging Trends Impacting Technical Development and Manufacturing

Jamie Moore is currently Senior Vice President of Technical Development responsible for the CMC development of drug substance and drug product for Gilead’s pharmaceutical and biologic product portfolio. She has over 20 years of experience as a chemist and pharmaceutical scientist working in both large and small Biopharmaceutical companies including CytomX and Roche. At CytomX, she was Senior Vice President on the executive team leading the Protein and Process Sciences, and Manufacturing organizations. Previously she spent a significant portion of her career at Genentech/Roche where she held multiple technical and managerial leadership roles within Pharma Technical Operations including Head of Pharmaceutical Development and Global Head of Manufacturing Science and Technology for Commercial Products. Externally, Jamie is serving as the President- for the Board of Directors for CASSS, an organization that brings together industry, academic and regulatory leaders to resolve scientific challenges impacting CMC development and regulation. She has a B.S. in Chemistry and received her doctoral degree in Chemistry and Chemical Biology from UCSF.

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Fireside Chat: The New CFO Mandate: Building Trust in 2024
FINANCE, VIDEO, FINANCE

Fireside Chat: The New CFO Mandate: Building Trust in 2024

Prior to his current role as Vice President and Industry Principal at Workiva, Steve Soter served as an accounting leader in multiple roles including Vice President and Controller and Director of SEC Reporting and International Accounting. His experience includes multiple acquisitions, debt offerings, an IPO, and the world’s first digital debt and equity offering. Steve is the Executive Advisor of the SEC Professionals Group, and a former member of the US XBRL Data Quality Committee. He began his career in public accounting as an auditor, received his Accounting degree from the University of Arizona, graduating summa cum laude, and received a Master of Accountancy and Information Systems degree from Arizona State University.

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Navigating Market Uncertainty with AI and Data-Driven Forecasting
FINANCE, VIDEO, FINANCE

Navigating Market Uncertainty with AI and Data-Driven Forecasting

Danielle Marceau is a Principal Economist & Senior Director, Analytics at Prevedere. Danielle has an extensive background in modeling, forecasting, research and development, and sharing her industry expertise on economics, leading indicators, and predictive analytics. Her role at Prevedere includes guiding the company’s macroeconomic outlook as well as driving research & development around advanced analytics. Her expertise helps business leaders navigate their company’s future opportunities and risks through econometric modeling and leading indicator analysis. Before her role at Prevedere, Danielle was a senior economist at ITR Economics and received her M.S. in Applied Economics from Southern New Hampshire University.

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