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Pharmaceutical Manufacturing

Can AI Deliver a ‘Real’ Advantage for Life Sciences Manufacturing?
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Can AI Deliver a ‘Real’ Advantage for Life Sciences Manufacturing?

May 26, 2023

Exceed customer expectations, earn stakeholder trust, and positively impact the future of health How an increasing focus on digital transformation is creating opportunities for manufacturers to meet the challenges of disruption and a competitive marketplace Are you making the most of the tremendous volume of data being collected? Leveraging your organization’s data foundation to provide actionable insights that enable improved decision-making and lead to positive outcomes across the manufacturing process — Kim Forte Principal, SCNO Deloitte Consulting LLP Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network Operations practice. Based in New York, she has over 20…

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Establishing a ‘Culture of Data’ in Pharma Manufacturing
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Establishing a ‘Culture of Data’ in Pharma Manufacturing

March 13, 2023

Pharmaceutical manufacturers have worked diligently and successfully to foster a ‘culture of quality’, resulting in fewer overall regulatory citations year over year since 2010. How can better data management and analytics impact not only quality but process improvement and efficiency gains as well? What trends are driving the need to move towards both managing and using data better? The ‘culture of data’ starts with changing old ways of working. What steps do biopharma manufacturers need to take to initiate their transformation? How can manufacturers use manufacturing process data to quickly and proactively improve outcomes? — Vishaka Rajaram Director, Pharmaceutical and…

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Global Talent Trends in Pharma Manufacturing
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Global Talent Trends in Pharma Manufacturing

April 21, 2022

Our knee-jerk leadership reaction to the pandemic: from managing change to managing burn-outs! Recovery: how to reboot culture, leading with purpose and agility Defining and adopting next-gen performance and talent management — Pascal Bécotte Managing Director Russell Reynolds Associates Pascal leads Canadian operations for Russell Reynolds Associates and is also a member of the firm’s global Executive Committee. He is a key member of the Healthcare Sector where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. More specifically Pascal…

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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning
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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning

April 8, 2022

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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Advancing Pharmaceutical Manufacturing Quality
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Advancing Pharmaceutical Manufacturing Quality

April 8, 2022

 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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Managing Innovation and Variability in a Growth Environment
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Managing Innovation and Variability in a Growth Environment

April 8, 2022

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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Creating and Maintaining a Resilient Supply Chain: Lessons Learned from a Pandemic
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Creating and Maintaining a Resilient Supply Chain: Lessons Learned from a Pandemic

April 8, 2022

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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Pharmaceutical Development and Manufacturing — The New Post-Pandemic Realities
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Pharmaceutical Development and Manufacturing — The New Post-Pandemic Realities

April 8, 2022

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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Idea to Performance: The Impossible Journey
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Idea to Performance: The Impossible Journey

April 8, 2022

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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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients
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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

April 8, 2022

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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Is Your Electronic Batch Record Truly Complete?
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Is Your Electronic Batch Record Truly Complete?

April 8, 2022

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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Network Strategy and Operations for an Innovative Pipeline
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Network Strategy and Operations for an Innovative Pipeline

April 8, 2022

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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