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Biomanufacturing

Manufacturing Strategies for Sustainable Global Growth: Building a Global Sustainable Supply Operation for the Future Leveraging Digital and Innovation
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Manufacturing Strategies for Sustainable Global Growth: Building a Global Sustainable Supply Operation for the Future Leveraging Digital and Innovation

November 21, 2023

As Senior Vice President, Global Biologics Operations, Per leads the global biologics operations network, which includes five internal manufacturing sites across four countries, as well as the external biologics supply network. Since April 2020, Per has also served as co-lead for the COVID-19 vaccine program, AZD1222, during which he has led the rapid establishment and start-up of a complex manufacturing network of more than 20 partners across more than 15 countries.

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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity
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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity

November 21, 2023

Ralf Altenburger joined the Technical Operations Leadership Team at Roche/Genentech in July 2015 as Head of Pharma Technical Regulatory. Additionally, in Oct. 2021 he assumed the role of Global Head Cell and Gene Therapy. Ralf has more than 20 years of experience in the pharmaceutical industry and joined Roche in 2009 leading global functions in Technical Development.

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Accelerating the Pace of Progress for Innovative Biologic Products
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Accelerating the Pace of Progress for Innovative Biologic Products

November 22, 2023

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

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Our Journey in Next Generation Manufacturing: What We Can Achieve Together
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Our Journey in Next Generation Manufacturing: What We Can Achieve Together

November 22, 2023

As Senior Vice President of Global Technology & Engineering group in Pfizer Global Supply, Roberto leads a group of highly capable Subject Matter Experts and is responsible for capital projects, implementation Integrated Facility Management and Global Reliability programs, technical support for major investigations, Phase III clinical supply sites, technology transfers, implementation of process development and disruptive technology supporting over 35 Pfizer sites and 200 Contract Manufactures globally.

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Towards Industrialization of Cell Therapy
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Towards Industrialization of Cell Therapy

November 22, 2023

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.

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Strengthening our Industry: Intersection of Innovation, Customer Experience, and Proactive Resilience
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Strengthening our Industry: Intersection of Innovation, Customer Experience, and Proactive Resilience

November 22, 2023

Federico Feldstein is Vice President, Head of Janssen Supply Chain Quality at Johnson & Johnson. In this capacity, Federico is responsible for providing strategic direction and oversight for all areas of Quality for both Large and Small Molecule products as well as Advanced Therapies, such as CAR-T. In his role, Federico is focused on product launches and reliability and the overall compliance profile of our internal manufacturing sites, as well as our external partners.

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Unlocking the Power of Gene Therapy to Accelerate Healthcare Transformation
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Unlocking the Power of Gene Therapy to Accelerate Healthcare Transformation

November 22, 2023

As Spark Therapeutics’ Chief Patient Supply Officer, Chris Stevens leads a team of dedicated professionals working together in manufacturing and technical operations, supply chain, quality and compliance to deliver transformational therapies for patients globally. Chris is also responsible for capital investments, engineering, EHS, real estate and facilities management across the enterprise.

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Global Talent Trends in Pharma and Biotech Technical Operations
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Global Talent Trends in Pharma and Biotech Technical Operations

November 22, 2023

Pascal leads operations for Russell Reynolds Associates in New York and Canada. He works closely with top healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment of directors, CEOs, and other senior executives. Within the healthcare industry, Pascal specializes in biotech and pharma technical operations, including process development, manufacturing, quality, engineering, and supply chain leadership.

Shannon Knott is a member of Russell Reynold’s Leadership and Succession Practice, and is based in Durham, NC. She specializes in executive transition and development, partnering with clients to build more effective and aligned leadership teams. Shannon leverages more than two decades of experience in executive education program development and strategy to provide market-leading insights. Shannon has a passion for leadership development and individual growth, and supports clients in creating future-focused, comprehensive succession processes.

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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 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 completed the Executive Development Program at the Northwestern University Kellogg School of Management to enhance his business and leadership capabilities.

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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

Katarina works for Cytiva in the Manufacturing capacity solutions business unit. She has worked over 20 years in the industry and has extensive expertise in developing end-to-end manufacturing solutions that includes process workflows, process equipment, automation, consumables, and facilities. Her focus over the last few years has been developing and designing solutions for the manufacture of new product modalities such as viral vectors, plasmids, and mRNA therapies.

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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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