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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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In today’s fast-paced world, the ability to rapidly evaluate multiple scenarios and drive smart business decisions can be the difference between success and failure. How do you harness new data sources to boost business planning? Can you quickly analyze the new data and transform it into actionable insights to accelerate your sales and operations planning initiatives? Learn how organizations enable continuous planning to: Make faster and smarter business decisions Evaluate multiple demand signals to improve forecast accuracy Identify new buying patterns and preferences to optimize inventory investments Leverage machine learning to improve performance over time — Mac McGary EVP Logility…
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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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Examine approaches to accelerate the pace of biopharmaceutical development across multiple platforms and modalities Clinical development velocity can affect CMC approaches, and what we’ve learned through this experience How does acceleration impact our quality, regulatory, and development functions? Understanding acceleration effects on process monitoring and analytics throughout the product lifecycle Discuss what steps we, as an industry, will need to take together to make this the new normal — John Pinion EVP Translational Sciences, Chief Quality Operations Officer Ultragenyx Pharmaceutical John Pinion has over 26 years of global experience leading biologic, small molecule pharmaceutical, gene therapy and device operations across…
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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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IoT Connected devices monitor 24/7 inside and outside of facilities Enables immediate response and root cause analysis Enables more thorough pest inspection Provides service transparency and accountability Proactive vs. Reactive pest management Improves audit readiness and compliance — Peter Jardine Head of Marketing and Strategy Bayer Digital Pest Management In his career, Peter has focused on differentiating brands, creating new products and services. He has launched over 20 new products and services in numerous market segments including B2C and B2B. Peter gained pest management experience when he joined Orkin Pest Control as the Sr. Director of Strategy and Innovation and…
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The iterative process of launching a D2C channel from site creation through first delivery in 30 days Leveraging consumer and regional demand insights to drive availability and order customization with less inventory Collaborating through connected systems: Laying the groundwork to strengthen customer relationships — Michael Lindsey SVP, Chief Transformation & Strategy Officer Frito-Lay North America Michael Lindsey is currently the Chief Transformation & Strategy Officer for Frito-Lay North America and Quaker North America. In his role, Michael leads a cross-functional organization tasked with developing the ‘next generation’ of PepsiCo’s Foods operations in NA. He is also responsible for strategic plans…
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Accelerating the organizational pace of change by engaging leadership and teams at every level Transforming inventory, distribution, and production processes to deliver new consumer experiences Reducing supplier and product complexity through a consolidated manufacturing network and strategic sourcing — Lance Kearbey Chief Operations Officer Electrolux Major Appliances Lance Kearbey is the Chief Operations Officer for Electrolux Major Appliances. In this role, he is responsible for Manufacturing, Supply Chain, Quality, Purchasing, Digital Solutions and Project Management Lance began his business career with Electrolux in 1993 as an Industrial Engineer and held various management roles thru 2000. He rejoined Electrolux nine years…
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Investing in the infrastructure to execute a global expansion to create localized value proposition Building the capacity to restructure based on new strategic assumptions Balancing an accelerated scale plan with the need to remain operationally nimble The role of intuitive leadership in driving resource efficiency, product innovation, and sustainable growth — Sanjay Shah Chief Operating Officer Beyond Meat Sanjay has worked with fortune 500 companies as well as startups during his extensive career over 25 years. He has substantive executive experience with exposure to various business cultures and widely divergent professionals with rapid growth organizations in the US and Internationally….
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Enabling a differentiated customer experience through enhanced operations Connecting data across the supply chain for smarter, more agile decision making Optimizing operations across three dimensions: cost, service, and cash — Torsten Pilz SVP and Chief Supply Chain Officer Honeywell Torsten Pilz is Senior Vice President and Chief Supply Chain Officer. Torsten has broad responsibilities for the integrated supply chain, including procurement and driving improvements in plant efficiency and working capital while continuing to enhance quality and delivery. Prior to Honeywell, Torsten served as Vice President, Supply Chain, for SpaceX, where he was responsible for planning, purchasing, material management and logistics….
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Coordinating real-time communication, data, and visibility to ensure continuous operations Synchronizing the supply network to customer demand in times of uncertainty Connecting data to the design and development of new products Leveraging technical and organizational commonalities across sectors to continually improve — Stuart Pann Chief Executive Officer Bossa Nova Stuart Pann is the CEO of Bossa Nova, the leading data service provider for global retailers. Pann is an experienced leader in the supply chain industry and has held operational positions at Fortune100 technology companies. He was most recently Chief Supply Chain Officer at HP Inc. where he managed its strategic…
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Staying aligned with corporate leadership principles to guide network-wide COVID response Scaling and adapting machine learning to manage new COVID-related safety concerns Innovating solutions within Amazon and with partners with short and long-term horizons Continual experimentation and iteration with protocols to usher in the ‘new normal’ — Carletta Ooton VP Product Assurance, Risk & Security Amazon Carletta Ooton is Amazon’s Vice President for Product Assurance, Risk & Security. She oversees the company’s Product Assurance, Food Safety, Trade Services, Product Safety & Recalls, Transportation Risk & Compliance, Dangerous Goods, Global Security Operations and Environmental Assurance & Protection teams worldwide. Her responsibilities…
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Ale Eboli, Head of Supply Chain North America, will discuss strategies undertaken to strengthen agility and resilience in its operations during the pandemic crisis as well as how they are preparing for a future that entails living with COVID-19. However, the virus is not the only global crisis we face – Ale will also share Unilever’s response to tackling the climate emergency and social inequality. — Ale Eboli Head of Supply Chain North America Unilever Ale Eboli, Head of Supply Chain North America for Unilever, oversees a supply chain network consisting of 14 manufacturing sites and 11 distribution centers across…
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