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

— Per AlfredssonSVP, Global Biologics Operations AstraZeneca and President AstraZeneca ABAstraZeneca 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. Throughout his 24 years within AstraZeneca, Per has significant global experience across all aspects of manufacturing and supply…

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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 AltenburgerGlobal Head, Cell and Gene Therapy, Genentech/RocheRoche 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. Prior to joining Roche, Ralf held roles of increasing responsibility in technical R&D at Merck KGaA and Novartis. He has a PhD in pharmaceutical technology from the Philipp University Marburg, Germany.

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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
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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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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 MarksDirector – Center for Biologics Evaluation and Research (CBER)FDA 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

— Roberto SilveiraGlobal Technology & EngineeringPfizer 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. Roberto Silveira joined Pfizer in 1989 in Brazil and from 1989 to 1994 he held production positions of increasing responsibilities. In 1995, he was transfer to Pfizer…

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Panel: Biotech Manufacturing Industrialization, Talent Development, and Leadership — A Tribute to Our Friend Mike Kamarck
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Panel: Biotech Manufacturing Industrialization, Talent Development, and Leadership — A Tribute to Our Friend Mike Kamarck

November 22, 2023

Over the last few decades we have all witnessed the industrialization of biologics manufacturing, as well as continuous progress in complex medicines such as Cell and Gene Therapy. In this panel we will reflect on where we started, where we are now, and what our future holds. We dedicate this conversation to Mike Kamarck, an exceptional leader of our era whose legacy includes everything we plan to discuss: Alison MooreCMC Executive Dr. Alison Moore is a CMC Executive who most recently served as the Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President,…

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Welcome Day Panel: Planning for Biomanufacturing of the Future: What are the Five Big Things We Need to Talk About?
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Welcome Day Panel: Planning for Biomanufacturing of the Future: What are the Five Big Things We Need to Talk About?

November 22, 2023

— Moderator: Alison MooreCMC Executive Dr. Alison Moore is a CMC Executive who most recently served as the Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President, Process Development, in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR)….

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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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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 A Feldstein, JDVP, Global Head of Supply Chain QualityJohnson & Johnson Innovative Medicines 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. Additionally, Federico has a passion for the people in his organization…

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Quality Reborn – Redefining Education of Quality Business Leaders
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Quality Reborn – Redefining Education of Quality Business Leaders

November 22, 2023

It is time for Quality leaders to transition from a traditional compliance driven role to that of a Quality Business Leader making quality a competitive advantage for companies rather than seen as a cost. To become a successful Quality Business Leader requires mastering the following skills — Anders VintherSVP Pharmaceutical Development & ManufacturingKronos Bio Anders Vinther serves as VP Quality at Kronos Bio. He joined Intarcia Therapeutics in 2018 as VP Global Quality and Engagement, previous to this Anders was the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines…

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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

Chris StevensChief Patient Supply OfficerSpark Therapeutics 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. Since joining Spark in 2017, Chris has effectively led teams in several key areas, initially serving as Head of Manufacturing where he led the development of Spark’s manufacturing network through the filing and launch of Luxturna, the first approved gene therapy for genetic…

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Expanding Scalability Potential of T-Cell Therapies with Allogeneic Approaches
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Expanding Scalability Potential of T-Cell Therapies with Allogeneic Approaches

November 22, 2023

Amy GamberVP, ManufacturingAtara Biotherapeutics Amy has been at Atara Biotherapeutics for 5 years. She is currently the Vice President of Manufacturing, which includes External Manufacturing, Material Sciences, and Manufacturing Science and Technology functions. Prior to her current role, she led the joint team that transitioned the commercialization of the first approved allogeneic T-cell therapy to Atara’s strategic partner, Pierre Fabre. Amy has broad operations experience across multiple regulated industries, including biopharmaceutical, petrochemical, and oil and gas. She specializes in business systems design and implementation and program and project management. Prior to Atara, Amy held a variety of roles at companies…

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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

— Dr. Pascal BécotteManaging DirectorRussell Reynolds Associates 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. Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and trained as an aerospace engineer with the Royal Canadian Air Force. He…

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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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