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capacity

Panel: CDMOs as Critical Partners in the Biopharmaceutical Ecosystem. The Challenges and Trends of CDMO Industry in the Past, Present and Future
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Panel: CDMOs as Critical Partners in the Biopharmaceutical Ecosystem. The Challenges and Trends of CDMO Industry in the Past, Present and Future

November 22, 2023

— Lars PetersenPresident and CEOFUJIFILM Diosynth Biotechnologies Lars is a visionary leader with over 30 years of experience in Life Science including his tenure at FUJIFILM Diosynth Biotechnologies. In 2019 when FUJIFILM Diosynth Biotechnologies acquired the Biogen site in Hillerød, Denmark, he assumed the role of COO for the site, and he most recently served as the Head of the Large-Scale business unit in charge of manufacturing sites in Denmark and Holly Springs, North Carolina, US. Lars has been responsible for the Global Large Scale Commercial operation including full profit and loss accountability as well as the responsibility for over…

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Building Flexible, Scalable and Sustainable Cell Therapy Manufacturing Network to Serve Patients
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Building Flexible, Scalable and Sustainable Cell Therapy Manufacturing Network to Serve Patients

November 24, 2023

— Robert ZamboldiSite Head – US Cell & Gene Therapy, Morris PlainsNovartis Rob Zamboldi is the Site Head and General Manager of Novartis’ flagship cell processing operation in Morris Plains, NJ providing worldwide supply of novel CAR-T therapies. Rob was instrumental in the ramp up of the first to market CAR-T, Kymriah ® of which more than 7,000 treatments have been supplied from his facility. Under Rob’s leadership, he oversaw the turnaround from a single product site into a multi-product manufacturing facility, delivering Novartis’ commercial and clinical products as well as securing multiple third-party contracts as a CMO provider. Rob’s…

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Towards Industrialization of Cell Therapy
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Towards Industrialization of Cell Therapy

November 22, 2023

This discussion will focus on the scientific, technical and cultural transformations required to drive towards true industrialization of cell therapies, including: — Jens VogelSVP & Global Head of BiotechBayer Pharmaceuticals Dr. Jens Vogel is SVP & Global Head of Biotech, Bayer Pharmaceuticals Product Supply, leading biologics operations, development and strategy across five sites, including cell & gene therapy industrialization. Jens has more than 20 years of professional and leadership experience in biologics development, operations, program management and regulatory affairs. Before rejoining Bayer in March 2020, he was President and CEO of Boehringer Ingelheim Fremont and member of BI’s Biopharma Executive…

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A Vision for the Future of mRNA Technology: Moderna’s Plans for the Future of mRNA Manufacturing & Expansion
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A Vision for the Future of mRNA Technology: Moderna’s Plans for the Future of mRNA Manufacturing & Expansion

November 24, 2023

— Luis Mustafa PerezVP Innovation & Operational ExcellenceModerna As the CMC Vice President of Innovation & Operational Excellence at Moderna, Luis leads the CMC Transformation Office, integrating scalable business processes and advance technologies across functional areas to ensure successful launches and secure vaccine supply through sustainable improvements. Luis has a remarkable track record across Biotechnology, Pharmaceutical, Medical Device, and Consumer industries with over 22 years of experience. He has consistently demonstrated his ability to drive innovation, transformation, and deliver substantial business results. Significantly, Luis had the honor of leading the 2022 U.S. launches of Moderna’s first COVID-19 booster and pediatric…

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Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success
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Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success

November 22, 2023

— Kevin SharpSVP, Head of Samsung Biologics America SalesSamsung Biologics Kevin Sharp is the Senior Vice President and Head of Samsung Biologics America Sales. He joined the company in 2017 and has served as the Head of Global Sales and Head of Alliance Management at Samsung Biologics. Kevin has held various commercial and business development positions in pharmaceutical companies in the U.S. throughout his career. Kevin was the Director of Business Development at Contract Pharmacal Corp and served over 9 years at GSK in multiple business development and procurement roles supporting their vaccines, pharmaceutical and consumer healthcare businesses. Kevin has…

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Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics
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Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics

November 22, 2023

mRNA manufacturing offers great benefits and potential for infectious diseases and personalized medicines due to the advantages in flexibility, cost, and speed of development, but there are still challenges to overcome to fully realize the potential, especially when addressing small batch manufacturing. Considering manufacturability and scale-up from the beginning will help to deliver process efficiency and scalability along the spectrum of mRNA products. In this presentation, we’ll discuss how digital technology can help accelerate therapeutic development and strategies to adopt a paper free approach at all stages of development. — Katarina StenkloEnterprise End-to End Solutions LeaderCytiva Katarina works for Cytiva…

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Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing
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Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing

November 22, 2023

— Sarah Stevens, Ph.D.President of Azzur Labs & Azzur Cleanrooms on Demand™Azzur Group 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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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 TomtishenVP OperationsCellares 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…

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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 StewartSVP, Operational and Process Technology, Large Scale Business UnitFUJIFILM Diosynth Biotechnologies 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)…

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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 TaylorHead of Biopharma SolutionsSmartLabs — 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. www.smartlabs.com

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Build vs Buy vs Blend: Comparing Challenges and Opportunities for Early-Phase Biopharmaceutical Manufacturing Options
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Build vs Buy vs Blend: Comparing Challenges and Opportunities for Early-Phase Biopharmaceutical Manufacturing Options

May 26, 2023

Exploring and comparing various options available to the biopharma industry for the manufacturing of clinical batches Looking at: Internal manufacturing, outsourced manufacturing, and hybrid models What are the current challenges and opportunities for these options?  Discussing various considerations including economic and time — Ravi Samavedam Chief Innovation Officer Azzur Group Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Before he was appointed Chief Innovation Officer at Azzur Group, he was President and Chief Operating Officer of Azzur Cleanrooms on Demand™. In 2019, Ravi was the General Manager of Azzur…

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Technical Operations Strategies in an Uncertain Market
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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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Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing
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Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing

January 19, 2023

Current industry challenges and opportunities related to biopharma manufacturing Internal manufacturing capability establishment challenges for biopharma Challenges related to outsourcing of technology and process throughout product lifecycle The Azzur Cleanrooms on Demand™ model Case Studies — Ravi Samavedam Chief Innovation Officer Azzur Group Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Ravi joined Azzur in 2012, and prior to his appointment as CINO of Azzur Group, Ravi was the President and COO of Azzur Cleanrooms on Demand™ and previously served as  General Manager of the Boston-area consulting practice.  Prior…

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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning
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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning

April 8, 2022

Discussing the common pitfalls observed during establishment of initial GMP programs in the areas of quality systems, materials management, supplier qualification, etc. How are companies adopting organizational changes and leveraging digital systems to avoid these pitfalls? Important factors to consider when assessing build vs. buy for early-phase clinical production, and considerations for scaling a GMP program up and/or out Illustrating the importance of establishing clear process requirements and conducting informal and formal facility fit assessments using real-world examples — Chris Mansur President, Azzur Consulting Azzur Group Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes…

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Managing Innovation and Variability in a Growth Environment
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Managing Innovation and Variability in a Growth Environment

April 8, 2022

How the pandemic impacted the structure and responsiveness of our global networks Responding to new geographic fluctuation of demand by disease states and patient delivery The challenges and opportunities posed by new product innovation and managing lifecycles — Linzell Harris SVP Global Supply Chain and Strategy AstraZeneca Linzell Harris is senior vice president of Global Supply Chain and Strategy for AstraZeneca, with overall responsibility for the development and execution of the end to end supply chain platform and product supply strategies. In addition, he is responsible for ensuring the strategic development of network designs and supply chain capabilities supporting the…

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