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Biopharmaceutical Manufacturing

How CDMOs are Contributing to the Ongoing Future of Medicine — A Conversation with Nick Maragos of Northway Biotech
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How CDMOs are Contributing to the Ongoing Future of Medicine — A Conversation with Nick Maragos of Northway Biotech

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Nick Maragos of Northway Biotech to talk about how biopharmaceutical manufacturers are increasingly partnering with CDMOs to advance the future of medicine, how that working relationship is evolving over time, and what CDMOs need to do to continue to grow and meet the needs of the industry. With special reference to Northway Biotech’s own example, Nick talks about how companies can ensure they are compatible, what the working relationship needs to be, and what factors need to be included in any informed decision-making before and during a partnership. Give this episode a listen!

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Martin Müller & Søren Thuesen Pedersen of Novo Nordisk — Collaboration Among Industry Peers to Move the Life Sciences Forward
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Martin Müller & Søren Thuesen Pedersen of Novo Nordisk — Collaboration Among Industry Peers to Move the Life Sciences Forward

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Martin Müller and Søren Thuesen Pedersen of Novo Nordisk to talk about opportunities biopharmaceutical manufacturers have to work together to lower costs, standardize equipment, build win-win scenarios for procurement and supply chain, and similar initiatives where competitive advantage and IP are not at stake, but costs and compliance and other performance metrics can be improved through joining forces and agreeing on things collectively rather than each company having to reinvent its own wheel on every issue. Building upon their earlier presentation that covered much of the same content, we discuss what would that collaboration look like in real terms? What does getting started look like, and how can interested companies join the ongoing conversations and deliberations? For all that and more, give this episode a listen!

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Where Cell and Gene Therapies are Going — A Conversation with Diluks De Silva of Compliance Architects
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Where Cell and Gene Therapies are Going — A Conversation with Diluks De Silva of Compliance Architects

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Diluks de Silva to talk about Cell and Gene Therapies. For many years we have been hearing these and other Advanced Therapy Medicinal Products (ATMPs) are moving towards commercialization, and each individual therapy that has been approved is heralded as a pioneer to be celebrated and studied for lessons learned and best practices. This year something like 40 cell and gene therapies came to market, and by every indication this is just the start of a whole new generation of medicine about to help patients around the world. What does that look like on the ground? What is the industry doing to prepare itself for what comes next? How do you control things like cost and scalability while you are still inventing how to manufacture the new therapies in the first place? How are these innovations pairing with medical devices, and what does that mean for the future of medicine? There is so much good work being done, and so much still to do. As always, the experts at Compliance Architects have a comprehensive understanding of where the industry is, where it is going, and what needs to happen to ensure everyone’s success. For everyone looking for the updates that matter most on this exciting frontier of medicine, give this episode a listen!

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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

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

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

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

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

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

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

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

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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