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BMWS

The Centenarian and the Start Up: How Merck is Realizing its Biomanufacturing Revolution
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The Centenarian and the Start Up: How Merck is Realizing its Biomanufacturing Revolution

November 21, 2019

Discuss how today’s pipeline and technologies are reshaping our biomanufacturing Review case studies and strategies for rapid manufacturing scale up for leading products Focus on the criticality of investing in people and robust strategies to support the workforce and culture Show opportunities that allow for successful navigation in the future of manufacturing, including leveraging legacy and culture as drivers of change — Karin Shanahan SVP, Global Biologics & Sterile Operations Merck Karin is SVP, Global Biologics and Sterile Operations at Merck Pharmaceutical where she holds operational responsibility for manufacturing Keytruda and Gardasil in addition to other in-line and pipeline products….

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Panel: Setting Ambitious Goals to Improve the Biopharmaceutical Ecosystem
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Panel: Setting Ambitious Goals to Improve the Biopharmaceutical Ecosystem

November 20, 2019

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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Technology Roadmap for the Biopharmaceutical Industry
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Technology Roadmap for the Biopharmaceutical Industry

November 19, 2019

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 Illustrating successful projects with concrete examples — Jun Huang Director/Team Leader, Process Monitoring, Automation & Control Pfizer Dr. Jun Huang is Director/Team Leader, with the Process Monitoring, Automation and Control group, part of Pfizer Global Technology & Engineering, based in NJ. He leads a team responsible for the development and implementation of Advanced Analytics, AI/ML, Advanced…

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Leveraging Predictive Technologies to Ensure Supply Chain Health – Case Study
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Leveraging Predictive Technologies to Ensure Supply Chain Health – Case Study

November 19, 2019

Deployed artificial and business intelligence to detect events that may create product availability issues, demand and supply related Implemented an automated management alarm and escalation system, emails and text messages, to accelerate response to supply-impacting events Implemented demand-driven scheduling system to connect production mix with actual demand Connected and integrated data across multiple platforms, e.g. PLCs, ERPs, QMS, LIMS, etc. — 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…

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Global Talent Trends in Biomanufacturing 2019
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Global Talent Trends in Biomanufacturing 2019

November 19, 2019

An update on talent trends: what does it (seem to) take to make it to the top? Should I lead, over the next 10 years, the way I lead over the past 10 years? Culture: what is it (really) and how can we transform it as leaders? — Pascal Bécotte Co-Leader, Corporate Officers Sector (Global Functions) & Global Leader, Operations & Supply Chain Practice Russell Reynolds Associates Dr. Pascal Bécotte co-leads the firm’s global Corporate Officers Sector and leads the global Operations & Supply Chain Officers Practice. Pascal is also a key member of the Healthcare and Industrial Sectors, where…

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Why Executive Platforms Decided to Launch Pharma Manufacturing World as Our Seventh Summit Series
WHITEPAPER, White Paper, LIFE SCIENCES

Why Executive Platforms Decided to Launch Pharma Manufacturing World as Our Seventh Summit Series

July 17, 2019

An Open Letter by Geoff Micks Head of Content & Research Executive Platforms   Those of you who follow us on Twitter or LinkedIn may have already seen the ‘Save the Date’ announcement for Executive Platforms’ newest summit series, Pharma Manufacturing World Summit. The first edition of which will run June 22nd and 23rd, 2020, at the Boston Marriott Copley Place. We are very excited about it, as you can imagine. Or maybe you cannot? It occurs to me that with each of the last six series Executive Platforms has launched, we never made a public announcement explaining our thinking…

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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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Embracing Advanced Manufacturing Processes and Technologies to Build Capability and Competitive Advantage
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Embracing Advanced Manufacturing Processes and Technologies to Build Capability and Competitive Advantage

November 19, 2018

Discussing how the evolution of manufacturing processes and technologies have transformed the biopharmaceutical industry When does new manufacturing capabilities generating product innovations, and when does product development spur advances in manufacturing? Debating the role new tools, tactics, and technology will have in overcoming the ongoing challenges currently facing the sector How should the industry continue to grow and develop the next generation of advanced manufacturing technologies? — Greg Guyer Global Head of Operations Bristol-Myers Squibb Dr. C. Greg Guyer is the Global Head of Operations at BMS. Prior to this he was SVP, Biologics Development & Operations and responsible for…

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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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Leveraging Artificial and Business Intelligence to Drive Productivity Improvement and Compliance
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Leveraging Artificial and Business Intelligence to Drive Productivity Improvement and Compliance

November 8, 2018

Common drivers for success: Leveraging Artificial and Business Intelligence to deploy automated systems to detect abnormal performance Deploying an automated management alarm and escalation system; used emails and text messages to accelerate response to performance-impacting events Creating real-time management dashboards and alerts, tailored for each role Connecting and integrating data across multiple platforms, e.g. PLCs, ERPs, QMS, LIMS, etc. Manufacturing Case Study: 300% productivity improvement in a capacity-constrained environment — Jaime Velez Partner 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…

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Sustainable cGMP Compliance is Spelled with 4C’s
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Sustainable cGMP Compliance is Spelled with 4C’s

November 8, 2018

What do we mean when we talk about Quality Culture, and how has that changed over time? If we could start over from scratch, what would we want Quality Culture in our industry to look like? How do we move forward as leaders in our industry to harmonize the ideal with reality? Discussing the tools, tactics, techniques, and technologies we need to make part of this conversation Setting a challenging goal: What can we do next week to move forward with what we have discussed today? — Anders Vinther Global Head of Quality and Engagement Intarcia Therapeutics Prof. Wolfram Carius…

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An Evolution into Biopharm 4.0
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An Evolution into Biopharm 4.0

November 8, 2018

Building a roadmap towards a digital vision starts with the destination in mind Developing a cohesive strategy based on a modular step-wise approach provides solid groundwork for future growth Gaining efficiencies in scale up and scale out capabilities with a standardized automation platform — Jennifer Staffin Automation Solutions Director GE Healthcare Jennifer is currently driving the architectural vision, definition and direction of GE Life Sciences Bioprocessing and Cell Therapy automation platforms. She has led the GEHC Automation & Digital DCS Design team through multiple customer projects over the past several years. Jennifer has over fifteen years’ experience in the design,…

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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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Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age
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Panel Discussion: Pharma 4.0 – Biopharmaceutical Production in the Digital Age

February 27, 2018

Addressing the state of the biopharmaceutical industry today: Which emerging trend will see the most growth? Embracing modular automation, PAT and continuous processing to increase agility, flexibility and improve efficiencies People and technology: How are these forces working together to grow and mature our industry? IoT- how will cloud based data, data analytics and data integrity evolve compliance and quality towards continuous improvement How will these technologies affect patient and product needs towards more individualized therapies? — Moderator: Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of…

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  • NASCES

  • NAFS

  • NAFMS

  • EUSCES

  • BMWS

  • NALES

  • MDMES

  • NAFES

  • NASRS

  • NAHRES

  • NAMES

  • PMWS

  • NAISS