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LIFE SCIENCES

The World of Tomorrow: Serving Patients Through Transformational Change
LIFE SCIENCES, LIFE SCIENCES, VIDEO

The World of Tomorrow: Serving Patients Through Transformational Change

How learnings from the global pandemic combined with the introduction of new technology will enable the patient-centric manufacturing of the future Highlighting what the industry should 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…

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Fighting COVID-19 with Innovation – What We Have Achieved, What We Have Learned, and What Comes Next
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Fighting COVID-19 with Innovation – What We Have Achieved, What We Have Learned, and What Comes Next

Offering an overview of how our industry responded to the global pandemic Highlighting how our organization adapted our existing processes and programs to continue to work under extraordinary circumstances Discussing some of the key takeaways and lessons learned from the past year and a half Where do we go from here? How will AstraZeneca and the biopharmaceutical industry at large move forward from here? What are we doing today to pave the way to those objectives? Pam Cheng EVP, President Global Operations & IT AstraZeneca Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information…

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How to Make the Bio-Revolution a Reality: Building Bayer’s Cell & Gene Therapy Platform
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How to Make the Bio-Revolution a Reality: Building Bayer’s Cell & Gene Therapy Platform

How Bayer AG built its Cell & Gene Therapy unit New business model joining best of Biotech and best of Pharma How to build a sustainable pipeline? How to manage complexity and keep focus? What are the “must haves”? what are the learnings on common threats of significant transformations? New ways of working accelerated by COVID-19 pandemic Wolfram Carius EVP, Cell and Gene Therapy Bayer AG Prof. Wolfram Carius is the EVP, Cell and Gene Therapy at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer,…

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The Transformational Potential of the Advanced Manufacturing of Biologics
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The Transformational Potential of the Advanced Manufacturing of Biologics

Describe the potential for advanced manufacturing Review case studies illustrating the potential of advantages advanced manufacturing Provide resources for product developers Peter Marks Director – Center for Biologics Evaluation and Research (CBER) 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…

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Panel: Looking Backwards, Looking Forwards —How Did the Last Two Years Change Us?
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Panel: Looking Backwards, Looking Forwards —How Did the Last Two Years Change Us?

How has working through a global pandemic impacted the way we do business? Taking stock of how we changed and why we changed. What are some of the net positives? What are some of the things where we do want to return to how things used to be? Reviewing where our organizations were five years ago and where we planned to be today, how much has COVID-19 changed the trajectory of our journeys? What are some of the lessons learned that we plan to take with us into the future? Is the community of biopharmaceutical manufacturers stronger for this experience?…

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A Changing Biopharmaceutical Landscape: How Operations Must Be Front and Center to Enable Business Success
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A Changing Biopharmaceutical Landscape: How Operations Must Be Front and Center to Enable Business Success

Discussing the changing landscape for our industry, from pricing to innovation How Operations leaders must prepare their organizations to succeed in this environment Offering a framework for balancing the need to execute in the short-term with the imperative to invest in innovation for the future Esteban Santos EVP, Operations Esteban Santos serves as executive vice president, Operations. Esteban is responsible for the Operations organization, which encompasses Manufacturing, Process Development, Quality, Engineering and Global Supply Chain. Prior to this role, Santos was senior vice president, Manufacturing, responsible for operations at Amgen’s commercial manufacturing locations in the U.S., Puerto Rico, Ireland, the…

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Quality 4.0: Where Do I Start?
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Quality 4.0: Where Do I Start?

 Discussing the current Quality 4.0 environment and addressing the most common challenge of how to get started Applying what we’ve learned to help companies begin their quality and compliance digital initiatives by leveraging behavioral and predictive analytics Ensuring quick results and getting the most value out of your investments in Quality 4.0 initiatives Jaime Velez Co-founder Operations & Quality Systems Improvement Experts (OQSIE) For the last 15 years Jaime has supported more than one hundred consulting engagements with Life Science companies delivering significant productivity improvements in supply chain and quality systems. He started his consulting career at McKinsey &…

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Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients
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Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients

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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Keynote: Delivering Excellence While Navigating Transition
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Keynote: Delivering Excellence While Navigating Transition

Highlighting how operations and manufacturing can think differently to pivot for crises and global events Preparing for M&A opportunities and adapting for a changing business model Discussing the importance of equity, leadership and people as catalysts of culture and change within the industry as we work to serve patients better — Azita Saleki-Gerhardt EVP, Operations Abbvie Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie, leading a team of scientific, engineering, business, quality, supply chain, security, purchasing and manufacturing professionals responsible for supply and distribution of all AbbVie products, as well as a number of corporate services. Dr. Saleki-Gerhardt…

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Day Two Chair’s Opening Remarks and Keynote: The Vertex Story: Serial Innovation in Manufacturing
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Day Two Chair’s Opening Remarks and Keynote: The Vertex Story: Serial Innovation in Manufacturing

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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Leading Global Supplies in Times of High Biologic Demands Now and After the Pandemic Crisis
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Leading Global Supplies in Times of High Biologic Demands Now and After the Pandemic Crisis

Strong wave of innovation and new Biologic therapies resulting in high demands Building flexible global capacities at various scales and multiple global locations to ensure reliable supplies and serve patients’ needs worldwide Business continuity planning, crisis management, pandemic preparedness & implementation of additional specific protection measures Close collaboration, intensive and solution-oriented exchange with customers and partners to ensure global patient supplies Managing diverse and complex challenges through digital transformation Critical success factor: Operational excellence, capacity & capabilities expansion and our peoples dedication — Uwe Buecheler Corporate SVP Biopharmaceuticals Boehringer Ingelheim Uwe Buecheler, Ph. D. joint Boehringer Ingelheim (formerly Dr. Karl…

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Rethinking our Supply Chain to be Patient-Centric
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Rethinking our Supply Chain to be Patient-Centric

Challenges biotech companies are facing as patients expectations are increasing Ensuring the end-to-end supply chain can respond in the face of fierce competition for innovation Leveraging data and analytics to increase value and service to patients Keeping patients central as external factors accelerate need for resiliency — Kimberly Lounds Foster SVP Global Supply Chain Bristol-Myers Squibb Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at Bristol-Myers Squibb, where she oversees the clinical and commercial supply chain. Bristol develops and manufactures products on multiple technology platforms, including small molecules, biologics and cell therapies. Kimberly joined Bristol through the Celgene…

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Reducing Drug Shortages… and High Prices
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Reducing Drug Shortages… and High Prices

How hospital systems and philanthropies came together to establish their own supply chain for essential quality generic medicines Living the mission to make quality generic medicines accessible and affordable to everyone Improving the resiliency of the supply of essential medicines used in hospitals, often for critical care, day-to-day and during a pandemic Ensuring a safe and stable supply of essential medicines for U.S. patients — Donna Gulbinski Chief Quality & Regulatory Affairs Officer Civica Rx Donna’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history…

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BMWS20 – Opening Chairs’ Remarks and Keynote: Reinventing a Biopharma Company for the 21st Century
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BMWS20 – Opening Chairs’ Remarks and Keynote: Reinventing a Biopharma Company for the 21st Century

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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COVID-19 MAbs at Pandemic Speed, Volumes and COGs
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COVID-19 MAbs at Pandemic Speed, Volumes and COGs

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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