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BMWS

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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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution
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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution

November 23, 2022

Bolstering our supply chain: Strengthening relationships with industry partners to overcome a global health crisis Making the impossible possible: “Project Lightspeed” and the development, manufacture, and distribution of the COVID-19 vaccine Where do we go from here? Ensuring this experience is a catalyst for change for our industry Key takeaways: upending our conventional ways of working and the resilience of our amazing colleagues — Mike McDermott Chief Global Supply Officer, EVP Pfizer As Chief Global Supply Officer, EVP, Mike McDermott leads all of Pfizer’s internal and external manufacturing and supply chain activities. Mike and the Pfizer Global Supply (PGS) team…

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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence
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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence

November 23, 2022

Being part of the solution: Launching two medicines in record time during the pandemic Meeting growing complexity head-on Establishing communities of practitioners to re-imagine manufacturing and process development Re-thinking how we collaborate across boundaries — Susanne Hundsbaek-Pedersen Global Head Pharma of Technical Operations Roche Susanne serves as the Global Head of Pharma Technical Operations at Roche, a global biotech company. Roche delivers long-term and sustainable healthcare solutions to serve millions of patients in 150 countries. Pharma Technical Operations spans the world with sites on four continents and covers the value chain from Technical development, CMC to Commercial supplies. She is…

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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

November 23, 2022

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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  • NASCES

  • NAFS

  • NAFMS

  • EUSCES

  • BMWS

  • NAFES

  • NASRS

  • NAMES

  • PMWS

  • NAISS

  • NAHRES