Three Top-of-Mind Issues Facing Pharma Manufacturing – A Conversation with Jack Garvey of Compliance Architects
April 11, 2022
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Discussing the common pitfalls observed during establishment of initial GMP programs in the areas of quality systems, materials management, supplier qualification, etc. How are companies adopting organizational changes and leveraging digital systems to avoid these pitfalls? Important factors to consider when assessing build vs. buy for early-phase clinical production, and considerations for scaling a GMP program up and/or out Illustrating the importance of establishing clear process requirements and conducting informal and formal facility fit assessments using real-world examples — Chris Mansur President, Azzur Consulting Azzur Group Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes…
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Using innovative thinking to realize a future more “immune” to supply chain disruptions Incentivizing improvements to the pharmaceutical manufacturing infrastructure that enhance the reliability of manufacturing and supply Delivering on the promise of advanced manufacturing to provide reliable, available, high-quality drugs for patients — Michael Kopcha Director, Office of Pharmaceutical Quality, CDER FDA Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise…
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How the pandemic impacted the structure and responsiveness of our global networks Responding to new geographic fluctuation of demand by disease states and patient delivery The challenges and opportunities posed by new product innovation and managing lifecycles — Linzell Harris SVP Global Supply Chain and Strategy AstraZeneca Linzell Harris is senior vice president of Global Supply Chain and Strategy for AstraZeneca, with overall responsibility for the development and execution of the end to end supply chain platform and product supply strategies. In addition, he is responsible for ensuring the strategic development of network designs and supply chain capabilities supporting the…
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How do you define a supply chain? The what, the who, the where and the how Risk categorization Impact, probability and detectability Risk approach Detection, prevention/mitigation and response Near-miss lessons learned — Ken Kent SVP, Chemical Development and Manufacturing Operations Gilead Ken is the Senior Vice President of Chemical Development and Manufacturing Operations. He is responsible for Gilead’s entire drug substance supply and oversees process R&D functions in Foster City and Edmonton, as well as internal and outsourced manufacturing. He played a critical role leading CDMO in sourcing ingredients and scaling up production of remdesivir drug substance, to speed up…
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Discussing how the business model change accelerates Highlighting transformation needs in business setup, technology and ways of working Impact on Development and Manufacturing of different modalities How does Bayer gets prepared for such opportunities and challenges? — Wolfram Carius EVP Pharmaceuticals Bayer AG Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for nearly three years. Before that, he worked for…
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Moderna pre-pandemic times: Sciences, Platform, and Company History Moderna’s preparation COVID-19. Operations insight for an unprecedented scale-up Execution against the plan. Overcoming challenges Moderna’s future operations — Juan Andres Chief Technical and Quality Officer Moderna As Chief Technical and Quality officer, Juan Andres is responsible for Technical Development, product supply at pre-clinical, clinical and commercial stages and quality across Moderna globally (i.e. CMC); chemistry, manufacturing and controls Mr. Andres was previously the Global Head of Technical Operations (Manufacturing and Supply Chain) for over 25,000 Novartis employees across all of its divisions. In this role, he had responsibility for all of…
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Our new purpose: we chase the miracles of science to improve people’s lives Our race to make available breakthrough treatments & vaccines for patients supported by diverse modalities: accelerate product launches and optimize our asset performance Our ambition to develop a network of Factories of the Future Our response to COVID: Operating with a global Supply Chain in a changing environment impacted by COVID and leveraging our assets to fight against the pandemic — Brendan O’Callaghan EVP, Global Industrial Affairs Sanofi Brendan O’Callaghan leads an international network of manufacturing and distribution sites. His ambition is to enable successful commercialization of…
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Explaining the difference between a partial and complete electronic batch record (EBR) Demonstrating that partially digital but disconnected batch record management is as inefficient as paper for managing production data Showcasing how fully digitized batch records enable smarter, faster manufacturing, so manufacturers can make immediate performance gains at every step Illustrating how today’s technology is configurable to a variety of manufacturing scenarios to create a complete, beginning-to-end EBR that other solutions do not — Brian Curran SVP of Strategic Growth MasterControl Brian Curran joined MasterControl in 2002 to direct and expand MasterControl’s product development efforts. He has more than 25…
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Managing risk and unpredictability in a highly innovative environment Adapting to change Partnership skills as a differentiator Developing the culture to thrive Talent strategies in a competitive and changing marketplace — Manel Luis Interim Pharma Operations Lead Executive Director, Strategy and Business Operations | Global Manufacturing Operations Global Product Development and Supply Bristol-Myers Squibb Manel Luis leads Strategy and Business Operations for Global Manufacturing Operations at BMS since 2020. This includes Network Strategies, Governance and Forums, and facilitation and representation of GMO in strategic and Enterprise level initiatives. Since June 2021, Manel is the Interim Lead for the Pharma Network…
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Science Will Win: Pfizer’s 5-point plan and industry pledge to finding solutions to the global health crisis Pushing the boundaries of what’s possible: Moving at Lightspeed Hope Changes Lives: The development, manufacture, and distribution of the COVID-19 vaccine and oral treatment Key takeaway: Making the Impossible Possible — John Kelly VP, Quality Operations and Environment, Health & Safety, Pfizer Global Supply Pfizer Inc. John F. Kelly is Vice President, Quality Operations and Environment, Health & Safety, responsible for leading the overall Quality function for Pfizer and for leading global EHS across the Company. John is a member of the PGS…
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Discuss the current Quality 4.0 environment and address common roadblocks and keys to success How we are applying what we’ve learned to help companies transition to continuously monitor the health of each component of the quality system with predictive and behavioral analytics Leveraging real-time actionable data to establish a collaborative, proactive and preventive culture Ensuring quick results and getting the most value of your investments in Quality 4.0 initiatives — Jaime Velez Co-Founder Operations & Quality Systems Improvement Experts (OQSIE) Jaime is the co-founder of Operations & Quality Systems Improvement Experts (OQSIE), a management and technical consulting company focused on…
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Outline how small molecule manufacturing is being reshaped within the broader transformation of a world-leading biopharmaceutical and vaccine manufacturer Discuss how today’s pipeline and technologies are reshaping this future and how to remain agile for future changes Review case studies and strategies for rapid manufacturing commercialization Focus on the criticality of investing in people and how culture has to evolve as an enabler of transformation — Ger Carmody SVP, Global Pharmaceutical Operations Merck Ger Carmody is responsible for global pharmaceutical and packaging operations comprising approximately 4000 colleagues and internal 9 manufacturing sites. His organization supplies drug substance and drug product…
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How the pandemic has impacted innovation, technology, people and our ways of working and thinking Understanding current capabilities and where we need to be collectively headed as a community of pharmaceutical manufacturers Strategies that compel and empower us to move beyond past constraints and set new, ambitious goals for the future Thinking beyond the data to find purpose and meaningful connections for people — Arleen Paulino SVP Global Manufacturing Amgen Arleen Paulino, Senior Vice President, Manufacturing, leads Amgen’s commercial manufacturing organization. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018,…
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Offering an overview of the public-private partnership that facilitated and accelerated the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics During the pandemic our industry faced crisis and achieved the seemingly impossible. What drives an extraordinary performance? Building stronger bonds of communication, collaboration, and coordination between industry partners and regulators to serve patients better Discussing which parts of our experience with Operation Warp Speed can be built into our industry’s long-term future — Carlo de Notaristefani Lead, Manufacturing & Supply Chain Advisor Operation Warp Speed An international operations executive with global technical, operational, and P&L experience, Carlo has…
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Highlighting what should the industry do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as molecular complexity increases in the future for small molecules, blurring the boundaries between small and large molecules — Sanat Chattopadhyay EVP…
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Sharing Vertex’s track record for serial innovation in manufacturing to create transformative medicines for people with serious diseases and high unmet medical needs Highlighting Vertex’s success with small molecule continuous manufacturing in Cystic Fibrosis Transforming manufacturing in cell and genetic therapies for Sickle Cell Disease, Beta Thalassemia, and Type 1 Diabetes — E. Morrey Atkinson SVP and Head of Commercial Manufacturing and Supply Chain Vertex Pharmaceuticals As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply…
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