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BMWS

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

November 30, 2021

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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The World of Tomorrow: Serving Patients Through Transformational Change
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The World of Tomorrow: Serving Patients Through Transformational Change

November 30, 2021

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

November 30, 2021

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?

November 30, 2021

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

November 29, 2021

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?

November 29, 2021

 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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Disrupting Quality Standards (or Beliefs) Through Digitalization
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Disrupting Quality Standards (or Beliefs) Through Digitalization

January 11, 2021

 The current state of digital transformation in life science How to disrupt the quality standards: Digital transformation roadmap and the situation ongoing at SBL Digital transformation’s Value proposition: Improve quality, productivity, and for unparalleled client experience Samsung Biologics’ P4 plan and vision: We’re building the future Sam MacHour SVP & Chief Quality Officer Samsung Biologics Prior to joining Samsung Biologics in 2019, Sam spent more than 32 years supporting large MedTech, Bioscience and Biopharmaceutical companies achieve business operational excellence and gain leadership in the areas of Research & Development, Quality, Compliance, Regulatory, Operations and product commercialization. Sam’s experience covers…

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Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain
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Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain

December 1, 2020

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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Accelerating Delivery of New Medicines
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Accelerating Delivery of New Medicines

December 1, 2020

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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Panel: Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?
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Panel: Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?

December 1, 2020

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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Fighting COVID-19 with Innovation – A Race Against Time
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Fighting COVID-19 with Innovation – A Race Against Time

December 1, 2020

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

December 1, 2020

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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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

December 1, 2020

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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Industrialization of Drug Discovery: Manufacturing and Discovery Reimagined Through Artificial Intelligence
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Industrialization of Drug Discovery: Manufacturing and Discovery Reimagined Through Artificial Intelligence

February 24, 2020

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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Digital Transformation in the Biopharmaceutical Industry – A Conversation with Randy Erwin of Cloudleaf
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Digital Transformation in the Biopharmaceutical Industry – A Conversation with Randy Erwin of Cloudleaf

February 24, 2020

 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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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies
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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies

February 20, 2020

With no standardized methods in analytical development of cell and gene therapies, we must define our own best practices Looking at the evolution and industrialization of analytical development in biologics over the past 20 years: what did we learn and how can we leverage it now? With the current speed of evolution, what new tools will emerge to help us solve these complex challenges The high cost of analytical development and need for greater efficiency begs the question how do we get to where we need to be… And where do we need to be? — Stacey Ma EVP Technical…

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  • NASCES

  • NAFS

  • NAFMS

  • EUSCES

  • BMWS

  • NAFES

  • NASRS

  • NAMES

  • PMWS

  • NAISS

  • NAHRES