The Speaker Roundtable from BMWS23 —A Conversation About Biopharmaceutical Manufacturing Issues and Ideas
February 1, 2024
Tag
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.
Continue reading
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.
Continue reading
This panel analyzes how contract development and manufacturing organizations (CDMOs) have transformed over the years, from being merely service providers to becoming indispensable partners in the biopharmaceutical ecosystem.
Continue reading
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.
Continue reading
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.
Continue reading
This panel discussion, presented in memoriam of Dr. Michael Kamarck, reflects on the last few decades of the industrialization of biologics manufacturing and what the future may hold.
Continue reading
This panel explores how the talent and workforce development in biomanufacturing is changing, what the most important new technologies are, and what current factors are affecting the speed of development and efficient manufacturing.
Continue reading
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.
Continue reading
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.
Continue reading
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.
Continue reading
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.
Continue reading
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 worldwide.
Continue reading
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.
Continue reading
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.
Continue reading
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.
Continue reading
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.
Continue reading
