Accelerating Biopharmaceutical Manufacturing by Focusing on What Matters — A Conversation with Joao Paulo Mattos of Thermo Fisher Scientific
August 17, 2023
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Accelerated, sequential testing (e.g., ASTM, ISTA) is no longer acceptable by the FDA for drug product testing Real-world testing cannot test the “worst-case” edges of your operating space Real-world testing in the post-COVID-19 world will be difficult and expensive
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How our “new normal” is affecting our critical materials procurement and how do we adapt for the future? Examining how the proposed nationalization of our supply chains will affect risk management and operations planning What does post-COVID19 Supply Chain robustness look like? How do novel modalities (mRNA, Cell & Gene Therapy) with already existing supply chain challenges cope with these new global constraints? How will high volume ultra cold chain products affect existing specialized ultra cold chain logistics? Seismic shifts and emerging fault lines create lasting affects, what are they and how do they shape our industry in the years…
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Debating the merits of nimble and flexible facilities versus manufacturing battleships Preparing your pilot plants and manufacturing facilities to move forward with Phase II-III approvals Forecasting requirements for optimizing manufacturing equipment, facilities and partners to increase speed to market Achieving business goals to better manage times of product and economic uncertainty Putting theory into practice: Implementing key metrics to improve manufacturing flexibility — Moderators: Pat Yang Chairman at Acepodia & Founding Board Director at Sana Biotechnology Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech,…
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Pam Cheng EVP, President Global Operations & IT AstraZeneca Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information Technology (IT), guiding the company’s manufacturing, supply chain, procurement, and IT across 18 countries and leading a team of over 19,000. Under her leadership, AstraZeneca Global Operations has transformed significantly driving top performance across the business while delivering value back to the enterprise. The next phase of transformation includes the convergence of operational excellence and digital innovation, building the ‘Factory of the Future’. Before AstraZeneca she spent 18 years in global manufacturing, supply chain, and commercial…
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Vir Biotech has discovered a neutralizing COVID-19 mAb to a unique, highly conserved Coronavirus spike sequence, high barrier to resistance and effector function We have partnered with numerous CDMOs and GSK to move from discovery to the clinic in approximately 6 months World-wide pandemic requirements for an efficacious neutralizing mAb may exceed 20 metric tons – challenging the capacity of industry manufacturing infrastructure — Michael Kamarck Chief Technology Officer Vir Biotechnology Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible…
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Bristol Myers Squibb is a company that has undergone an extensive transformation and as a result, has reinvented itself Once a company consisting of multiple and vastly different business units, it is now the largest diversified specialty global biopharma company Its mission and focus is to utilize innovation to advance the treatment of serious disease and significant unmet medical need This organizational evolution required substantial change for the product development and manufacturing arms of the company Technology, systems, processes, people and culture all needed to be re-evaluated through a “new lens” The presentation will cover this journey including approach, successes,…
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Illustrating how AI is already changing the small molecule side of the pharmaceutical industry in both drug discovery and R&D Extrapolating from these examples to suggest biopharmaceutical manufacturing applications Drawing parallels from the industrialization of biologics manufacturing. How far away are we, and what should we as an industry be doing now to get ready? Discussing what small pilot programs and early test cases might look like, and the timelines involved in moving from proof of concept to industry-wide applications — Tina Larson Chief Operating Officer Recursion Pharmaceuticals Tina M. Larson is Chief Operating Officer at Recursion Pharmaceuticals. Recursion is…
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At the 2019 edition of the Biomanufacturing World Summit series last November in San Diego we spoke with Randy Erwin of Cloudleaf about how biopharmaceutical manfuacturers are embracing Industry 4.0 solutions to their unique challenges. Randy Erwin VP Sales Cloudleaf Cloudleaf’s mission is to create significant value across the end-to-end supply chain network by dramatically increasing visibility of product flow and condition. Customers increase revenues, reduce operational material losses, and enhance the reliability of operations. Our supply chain Visibility Platform delivers complete, real-time views and insights across the ecosystem from suppliers through production and distribution to customers. Using IoT,…
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