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biopharmaceuticals

The Quality Equation
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The Quality Equation

November 28, 2022

Do you want to ensure that you never have a surprise regulatory inspection outcome? The equation incorporates all you need to assess the status of your site and is even better for companies with networks of sites Data integrity, quality culture, process capability, management commitment and Quality Management Systems are all assessed to produce actionable data whether you are overseeing a CMO or operate your own network of sites — Brandon Varnau Head, Industrial Affairs Specialty Care Global Business Unit Quality Operations Sanofi Brandon Varnau is Head of Industrial Affairs Specialty Care Global Business Unit Quality Operations for Sanofi. He…

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Biopharmaceutical Industry Trends and the Power of Data — A Conversation with Dan Szot and Chris Andrews of BIOVIA, Dassault Systèmes Company
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Biopharmaceutical Industry Trends and the Power of Data — A Conversation with Dan Szot and Chris Andrews of BIOVIA, Dassault Systèmes Company

December 17, 2021

At the 2021 edition of the Biomanufacturing World Summit series held November 15-16 in San Diego, CA, Dan Szot and Chris Andrews of BIOVIA, Dassault Systèmes Company spoke about where the biopharmaceutical industry is today, how it has weathered the global pandemic, and the crucial role data has played in allowing organizations to understand where they are, what they need, and how things can move forward towards successful outcomes through informed decision-making. — Dassault Systèmes Company BIOVIA solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the…

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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

November 30, 2021

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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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: 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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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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Keynote: The Successful History of Biologics Manufacturing Provides Foresights and Strategies for New Bio Modalities

November 25, 2019

Establishment of broad communities of practitioners in both manufacturing and process development accelerated maturation of both disciplines Convergence of these process and manufacturing technologies was driven by excellence and capacity in selected CMOs Manufacturing portability has provided remarkable stories of win-win capacity-exchange between proprietary companies Process convergence has resulted in remarkable progress in process yields and cost improvement Intro to Vir Bio: Capacity and cost improvements in bio-manufacturing facilitate global access to medicines for Infectious Disease — Michael Kamarck Chief Technology Officer Vir Biotechnology Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global…

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