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Biopharmaceutical Manufacturing

Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond
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Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond

November 22, 2023

In her role as President, Azzur Labs & Azzur Cleanrooms on Demand™ (COD), Sarah Stevens is responsible for operations and strategy across all Azzur Labs and Azzur COD locations throughout the United States. Prior to joining Azzur, Sarah held senior leadership roles within the CDMO and pharmaceutical service provider space. Sarah holds a Doctorate of Pharmaceutics from the University of Manchester (Manchester, UK), as well as a Master of Business Administration and a Master of Pharmacy from the University of Strathclyde (Glasgow, UK).

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Deliver Products to Patients Faster with a Purpose-Built, No-Code EBR and MES
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Deliver Products to Patients Faster with a Purpose-Built, No-Code EBR and MES

November 22, 2023

Brian Curran oversees the success of MasterControl’s Manufacturing Excellence (Mx) solution in the quest to digitize the 80% of life sciences manufacturing, large and small, that still use paper for their batch records or device history records. Curran has the privilege of working externally with Mx customers and internally across MasterControl from R&D to sales, services, and support to ensure Mx success and adoption.

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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 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 T-cell BLA, Kymriah™ (tisagenlecleucel) for pALL (pediatric acute lymphoblastic leukemia) and DLBCL (diffuse large B-cell lymphoma).

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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 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) and is a key driver in building the world’s largest and most tightly connected CDMO network.

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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 Taylor is the Head of Biopharma Solutions at SmartLabs. 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.

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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 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.

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The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC
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The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC

June 6, 2023

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Teresa Gorecki of Compliance Architects LLC about what pharmaceutical manufacturers should expect from regulators as the pandemic winds down, where we are and where we’re going as the pipeline of Cell & Gene Therapies marches towards commercialization, and a wide range of other industry issues, challenges, and opportunities. This is a great conversation that speaks to a lot of key points of interest for pharmaceutical manufacturers of all shapes and sizes. Give it a listen!

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Technical Operations Strategies in an Uncertain Market

November 30, 2022

 State of the current market and impact on manufacturing cell and gene therapies Key factors to consider when scaling up a facility for advanced medicines Make vs. Buy and the advantages and challenges of both solutions given the current market Moderator: Adam Pfeiffer VP of Strategy Project Farma Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.With 16+ years of life sciences consulting experience, Adam has supported countless drug manufacturers in bringing life-saving therapies…

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Emerson Real-Time Modeling System in Takeda’s Los Angeles Plasma Fractionation Facility
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Emerson Real-Time Modeling System in Takeda’s Los Angeles Plasma Fractionation Facility

March 10, 2023

Expected benefits of integrated scheduling and modeling Building the model Integrating the model with various systems Switching to a new scheduling software in manufacturing — Sean Ganley AGILE Champion III Takeda Sean is part of the AGILE team at Takeda’s Los Angeles plasma manufacturing facility. AGILE, in all caps, is Takeda’s methodology for transforming its manufacturing capabilities. Following his bachelor’s degree in Biology from Occidental College, Sean began his 15-year tenure at Takeda. He has shaped the landscape of fractionation performance measurement and used his data and modeling methodologies to facilitate strategic growth of the site’s fractionation capacity by 120%….

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Realizing Gilead’s 2030 Ambition: Advancing a Diverse Portfolio with a Complex Manufacturing Network
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Realizing Gilead’s 2030 Ambition: Advancing a Diverse Portfolio with a Complex Manufacturing Network

March 15, 2023

Gilead’s ambition is moving from a predominantly virology focused portfolio to a more diverse one with an emphasis on adding oncology and inflammation asset To accomplish this a wide net needed to be deployed to rapidly build a portfolio through external sourcing and internal innovation This has resulted in a diverse set of acquisitions, partnerships, opt-ins, and collaborations across program phases and modalities, resulting in a complex manufacturing network This talk will cover the strategies being deployed across the pillars of Process Development, Supply Chain, Quality, Regulatory, and External Manufacturing to realize Gilead’s 2030 ambition — Art Hewig VP of…

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Sustainability for Process Development to Manufacturing: How Can We Leverage Digital Technology to Capture Quality and Productivity Efficiencies?
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Sustainability for Process Development to Manufacturing: How Can We Leverage Digital Technology to Capture Quality and Productivity Efficiencies?

December 22, 2022

The Control Tower: Providing visibility with actionable insights into the health of your manufacturing Yield Improvement: Process understanding and advanced modeling for significant ROI Digital twin: simulation and improved productivity by employing Smart Scheduling Successful industry 4.0 pharma use cases How to effectively build programs to deploy and maintain technology to continuously improve and capture value — Rick Johnston Sr. Director Applied Materials Rick is a senior technical leader within Applied Materials’ pharmaceutical business unit. He has more than 15 years of experience in building software that solves big data, machine learning, scheduling, forecasting and advanced analytics problems in pharma….

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