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biopharmaceuticals

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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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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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

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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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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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?

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

 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: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy
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Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy

Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing? Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively Bringing a structured approach to your advocacy within your network of industry and trade organization connections Embracing the idea that keeping things simple even in a complex environment generates the best outcomes — Pat Yang Former EVP at Juno Therapeutics, Roche and Genentech Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management…

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Digital Transformation and the Smart Factory – A Conversation with Laks Pernenkil of Deloitte Consulting LLP
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Digital Transformation and the Smart Factory – A Conversation with Laks Pernenkil of Deloitte Consulting LLP

 At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Laks Pernenkil, Principal | Life Sciences Operations with Deloitte Consulting LLP. Laks shared his insights into digital transformation in general, and specifically how the ‘Smart Factory’ will change the way biopharmaceutical companies operate. — Deloitte Life Sciences Innovation starts with insight and seeing challenges in a new way. Amid unprecedented uncertainty and change, life sciences stakeholders are looking for new ways to transform their organizations using digital innovation and technologies. Deloitte’s team of thinkers and doers can help you imagine,…

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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects
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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects

At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Jack Garvey, Compliance Architects’ co-founder and CEO. Jack has chaired the Quality stream of content for several Biomanufacturing World Summits, and he has deep insights to offer biopharmaceutical manufacturers looking to communicate with regulators and build their organizations to better address the issues of Compliance, Quality, and Risk. — Jack Garvey CEO Compliance Architects Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects®, a leading consulting and advisory firm specializing in innovative quality and compliance solutions for FDA-regulated…

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

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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Improving Product Quality During Technical Transfers
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Improving Product Quality During Technical Transfers

The definition of Technology Transfer and its many applications Planning for tech transfer the “right way,” using “Calculated Risk Reduction” and other tools to ensure all bases are covered Common pitfalls and best practices – what to do, and what not to do Ways to ensure optimal planning and execution using actionable tools — Eric Good Director, Compliance ProPharma Group Dr. Eric Good is an energetic leader with extensive U.S. and international manufacturing, project management, Consent Decree and quality systems experience with Fortune 500 Companies. Dr. Good has 29 years of award winning high-performance. He is an active leader in…

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