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Biomanufacturing

Unleashing the Potential: Leading the Future of Biologics Market Supply
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Unleashing the Potential: Leading the Future of Biologics Market Supply

November 22, 2023

Dave Stewart, Senior Vice President Operational and Process Technology, Large-Scale Business Unit, is a proven leader in the biologics manufacturing industry, with a focus on building diverse, multi-disciplinary teams that drive customer deliverables. He brings a servant-leadership mindset and more than two decades of biotech leadership experience to cultivate accountability, collaboration and agility – assembling engaged, high-performing teams and partnerships built on trust. Dave is responsible for ensuring a consistent operations and equipment model, performance and incorporating emerging capabilities across the large-scale network at FUJIFILM Diosynth Biotechnologies (FDB) and is a key driver in building the world’s largest and most tightly connected CDMO network.

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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined
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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined

November 27, 2023

Brian Taylor is the Head of Biopharma Solutions at SmartLabs. SmartLabs provides teams of all sizes enterprise-grade labs customized within weeks for any stage of research or modality and can be reconfigured within days as your research evolves. Outsource your infrastructure and avoid the extensive costs of traditional lab builds while your own teams accelerate your research in a private lab.

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Opportunities and Challenges of GMP Manufacturing of RNA-LNPs
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Opportunities and Challenges of GMP Manufacturing of RNA-LNPs

November 22, 2023

Martin Rabel, Dipl.-Pharm., Ph.D. currently works as a Senior Field Application Scientist for Precision NanoSystems ULC supporting clients in Central Europe, Middle East, and Africa (EMEA). He obtained his pharmaceutical license as well as a postgraduate diploma from the Friedrich-Schiller-University Jena working on Bacterial Nanocellulose (BNC) nanoparticles for gene delivery applications. His Ph.D. research focused on the development of animal-free simulation models for the development of complex diagnostic nanoparticles (IONP) and other nanomedicines as well as nanoparticle characterization and manufacturing methods.

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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution
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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution

November 23, 2022

Bolstering our supply chain: Strengthening relationships with industry partners to overcome a global health crisis Making the impossible possible: “Project Lightspeed” and the development, manufacture, and distribution of the COVID-19 vaccine Where do we go from here? Ensuring this experience is a catalyst for change for our industry Key takeaways: upending our conventional ways of working and the resilience of our amazing colleagues — Mike McDermott Chief Global Supply Officer, EVP Pfizer As Chief Global Supply Officer, EVP, Mike McDermott leads all of Pfizer’s internal and external manufacturing and supply chain activities. Mike and the Pfizer Global Supply (PGS) team…

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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence
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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence

November 23, 2022

Being part of the solution: Launching two medicines in record time during the pandemic Meeting growing complexity head-on Establishing communities of practitioners to re-imagine manufacturing and process development Re-thinking how we collaborate across boundaries — Susanne Hundsbaek-Pedersen Global Head Pharma of Technical Operations Roche Susanne serves as the Global Head of Pharma Technical Operations at Roche, a global biotech company. Roche delivers long-term and sustainable healthcare solutions to serve millions of patients in 150 countries. Pharma Technical Operations spans the world with sites on four continents and covers the value chain from Technical development, CMC to Commercial supplies. She is…

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Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes
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Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes

November 23, 2022

How the pandemic has impacted innovation, technology, people and our ways of working and thinking How is Amgen transforming biomanufacturing for a faster, more data-savvy future and strengthening the balance of resiliency and efficiency Addressing unmet patient needs and establishing new markets through connected technology and other manufacturing innovations (smart materials, process automation and more) Why building integrated, collaborative, agile, high performance teams are at the heart of revolutionary manufacturing Amgen Ecovation™ – creating value through innovative and sustainable manufacturing operations — Arleen Paulino SVP Global Manufacturing Amgen Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization where…

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Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy
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Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy

November 29, 2022

How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space? Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards including image selection, and packaging network design Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market considerations changing the way we traditionally work? Talking about access issues including regionalization and localization, IP considerations, and how higher order BSL…

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Culture of Quality Excellence Driving Competitive Advantage for Operations
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Culture of Quality Excellence Driving Competitive Advantage for Operations

November 28, 2022

Why a Culture of Quality Excellence is foundational to achieving manufacturing excellence and leads to competitive advantage for operations. Driving a culture that recognizes the Value of Quality Excellence. How to establish a Culture of Quality Excellence by focusing not only on processes and digital infrastructure but also focusing on Real-world examples of how Quality excellence is translated into manufacturing excellence, including  Vendor Management, Investigational Excellence and End to End QMS. Using Quality data in a proactive and predictive manner in order to deliver value and achieve manufacturing excellence. — RJ Doornbos VP, Global Quality Systems Bristol Myers Squibb As the Head of Global…

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Evolving External Collaboration Models
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Evolving External Collaboration Models

November 21, 2018

Reviewing how our industry’s business partnerships have changed over time. How will this trend continue into the future? Dividing the work and sharing the burden: How should biopharmaceutical companies align their objectives of cost management, risk management, productivity, and growth? Maturing business relationships over time through common culture through two-way communication, collaboration, and cooperation Walking through examples of external collaboration: What works, what does not, and why? — Joanne Beck EVP, Global Pharmaceutical Development & Operations Celgene Corporation Dr. Joanne Beck is EVP Global Pharmaceutical Development and Operations at Celgene where she oversees the company’s Pharmaceutical Development, Global Manufacturing Operations,…

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Accelerating Delivery of New Medicines
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Accelerating Delivery of New Medicines

November 20, 2018

Examining technologies, tools, and platforms to accelerate the pace of biopharmaceutical development How development velocity can affect clinical development and what we learn in this process Examining how acceleration impacts our quality, regulatory, and supply chain functions. How do we all keep pace? Understanding how acceleration affects data monitoring and analytics throughout the product lifecycle Discussing what steps we as an industry will need to take together to make this the new normal — Jerry Cacia SVP, Head Global Technical Development Genentech Jerry is responsible for Roche’s Global Technical Development organization. This scope includes responsibility for developing manufacturing processes and…

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Boosting Traceability and Security in the Supply Chain with Serialization
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Boosting Traceability and Security in the Supply Chain with Serialization

November 19, 2018

What is serialization? Global serialization mandates Impact on manufacturing and the pharma supply chain Implementation challenges Technologies – Now and into the future — George Skillin Sr. Director – Global Engineering Pfizer George Skillin is the Senior Director of Pfizer Global Engineering, where he manages a team of 35 engineering professionals in the Process, Equipment, Automation Engineering disciplines and manages the Global Serialization and Industrial Control System Cyber Security Programs for Pfizer. George joined Pfizer in 2002 taking on a 2+ year international assignment as a member of the Site Leadership Team in conjunction with the design, construction, and start-up…

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

November 8, 2018

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 — Uwe Buecheler Corporate SVP, Biopharmaceuticals Boehringer Ingelheim Uwe Buecheler, joint Boehringer Ingelheim (formerly Dr. Karl Thomae GmbH) in 1991. During his time at Boehringer Ingelheim he held different positions in Biopharmaceuticals in Regulatory Affairs, Biological Safety and…

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Panel: The Global Talent War in Biomanufacturing
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Panel: The Global Talent War in Biomanufacturing

November 8, 2018

Learning about global talent trends influencing the job market for senior executives and those with critical, specialized skill sets Creating effective attraction, retention and development plans for top talent Navigating the generational talent gap in critical functions Understanding which leadership differentiators are needed to make it to Senior Executive and C-Level roles — Sanat Chattopadhyay EVP & President, Merck Manufacturing Division Merck Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada. Sanat oversees a network of 50 pharmaceuticals, vaccines,…

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Ready or Not, Digitization Will Transform Biomanufacturing
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Ready or Not, Digitization Will Transform Biomanufacturing

November 8, 2018

The Amazon-ization of Retail – How an industry-wide disruption unfolds The ongoing digitization of the Biopharma ecosystem – The transformation of drug delivery The Possible? Likely? Inevitable? Impacts on Tech Ops – Recent new roles analysis What it all means for Biomanufacturing leadership — Pascal Bécotte Global Leader – Operations & Supply Chain Practice Russell Reynolds Pascal leads the firm’s global Operations & Supply Chain Officers Practice and is a key member of the Healthcare and Industrial teams. He advises global clients on their overall talent strategy, particularly with respect to leadership assessment and succession planning. With more than 16…

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Digital Transformation with Business Impact for Manufacturers
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Digital Transformation with Business Impact for Manufacturers

March 16, 2017

Chris Dobbrow, the Senior Vice President of Sight Machine, spoke at the Biomanufacturing World Summit in San Diego, CA in November 2016. His presentation was entitled: Digital Transformation with Business Impact for Manufacturers Proving that the most valuable data in manufacturing is from production itself Choosing the right goals and outcomes to make a difference Connecting disparate IT systems together into a unified whole Building a scalable approach for the enterprise, step-by-step: Start small to go big Understanding why data lakes and bespoke projects don’t scale Illustrating successful projects with concrete examples

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