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LIFE SCIENCES

Embracing Advanced Manufacturing Processes and Technologies to Build Capability and Competitive Advantage
LIFE SCIENCES, VIDEO

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?
LIFE SCIENCES, VIDEO

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
LIFE SCIENCES, VIDEO

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
LIFE SCIENCES, VIDEO

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
LIFE SCIENCES, VIDEO

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
LIFE SCIENCES, VIDEO

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
LIFE SCIENCES, VIDEO

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
LIFE SCIENCES, VIDEO

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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Leading and Leadership in Lean Bio-Manufacturing Operations
LIFE SCIENCES, VIDEO

Leading and Leadership in Lean Bio-Manufacturing Operations

January 31, 2018

Lean applications in Bio-Manufacturing is both complex and simple Sustaining lean performances in Bio-Manufacturing is both science and art Good versus Great Lean leadership… It matters Successful OE polynomial equation for Lean Bio-Manufacturing = … ? — Jacks Lee is an industry executive with global experiences in biopharmaceutical, small molecule drugs and vaccines. His 25+ years of experiences spans across technical, operational and strategic leadership roles in Science-Technology, Engineering, Quality, Supply Chain and Manufacturing. He currently serves as the Senior Vice President of Merck Manufacturing Division-Global Vaccines Operations. Jacks joined Merck in 2007 as head of Global Technology & Engineering….

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Biotech Business Bootcamp – Treating Cultural Sclerosis…
LIFE SCIENCES, VIDEO

Biotech Business Bootcamp – Treating Cultural Sclerosis…

January 16, 2018

Repetitive engagement survey results with no sustainable action plan for improvement? Meeting mania dominating each and every day? Data, metrics, KPI’s, and scorecards – Thermometers or Thermostats? OPEX tools and governance models that feel abstract and disconnected? Struggling with any of these symptoms? If so, your organization is suffering from Cultural Sclerosis. While not fatal, it is debilitating. Fortunately, we have developed a ‘Sustainable Treatment Plan’ based upon 25 years of work with organizations including GSK, Pfizer, Genentech, Gilead, and Alcon that will drive Clarity, Connectivity and Consistency into both your team and leadership culture. — Shane A. Yount is…

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Breakthrough Designations – How Can Quality Enable Speed to Innovation?
LIFE SCIENCES, VIDEO

Breakthrough Designations – How Can Quality Enable Speed to Innovation?

January 3, 2018

Offering an overview of how breakthrough therapy designations have historically worked and how that process is changing Are we as an industry ready for major changes in how drug development is expedited? Discussing how our organizations’ Quality Culture must be an integral part at all stages of this transition Working with all stakeholders to ensure we do not sacrifice safety and quality as we increase the pace of innovation What should we be doing right now to prepare for the future of these developments? — Christie Bielinski, Vice President of Product Quality Management at Janssen Pharmaceuticals, leads a world-wide organization of quality professionals…

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Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage
LIFE SCIENCES, VIDEO

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage

December 13, 2017

Advantages of smaller more agile organizations’ ability to react to patient, regulatory & market pressures Discussing internal innovations in production technologies and working with external partners to do the same How do we adapt our leadership, organizational structure and people management strategies? Lean implementations as a Smart Risk management tool Leveraging collaborations with big pharma to foster innovation and increase speed to market — Moderator: Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and…

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A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build
LIFE SCIENCES, VIDEO

A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build

December 6, 2017

Investing capital in capacity expansion when a drug is early in development is challenging. There are new manufacturing models that reduce risk and add value to your decisions through a concept called optionality Balancing options and critically evaluated risk against probability of success in to-build decisions Introducing a new biomanufacturing solution that leverages manufacturing ecosystems to reduce the need to build infrastructure Effectively transfer non-value added work from the manufacturing site to service providers with this new manufacturing model — Daniel Palmacci has nearly 20 years of leadership experience in Biologics in the area of manufacturing, technical development, supply chain,…

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Development of Biologics in China for Global Markets: Lessons From Wuhan, China
LIFE SCIENCES, VIDEO

Development of Biologics in China for Global Markets: Lessons From Wuhan, China

November 29, 2017

Discussing the approach required to success in the unique business environment of the region Walking through recent changes in the regulatory and operating environment in China Offering lessons learned by JHL Biotech, a biologics development and manufacturing firm with headquarters in Taiwan and a commercial-scale production site in Wuhan, China Highlighting JHL Biotech’s path to rapidly building and operating two production facilities in Asia, with an emphasis on JHL’s use of modular and single-use technologies to accelerate facility construction and accelerate product timelines — Racho Jordanov CEO & Co-Founder JHL Biotech Inc. Racho Jordanov is Co-Founder, President, and CEO of…

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LIFE SCIENCES, VIDEO

Establishment of Efficient Cell Culture Supply Chain through Partnerships

November 29, 2017

Understanding GMP production of biologic therapies is a long-term commitment throughout the life-cycle of a product Discussing how for CDMOs this includes developing strong relationships with suppliers Demonstrating the importance of a solid supplier partnership, from early stages of technology implementation, is essential for long-term success Illustrating a successful Supplier-CDMO relationship in action using GE Healthcare and FUJIFILM Diosynth Biotechnologies as an example Showcasing how this partnership rapidly added cell culture manufacturing capacity through the implementation of single-use production systems — Jeff Carter Strategic Projects Leader GE Healthcare Dr. Carter has been a supplier to the bio/pharmaceutical manufacturing industry for…

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Redefining Competition: Thinking About Our Industry in a Revolutionary Way
LIFE SCIENCES, VIDEO

Redefining Competition: Thinking About Our Industry in a Revolutionary Way

November 29, 2017

What are we doing today to get ready for the realities of our industry a decade from now? Debating what we will need in terms of leadership, people, technology, territory, and resources to grow into new markets with new products in an ever-changing regulatory landscape Is the answer steady growth, or improving agility and versatility, or some third option? Making the case that our industry needs to work together better as individual actors on a shared stage — Kimball Hall serves as the Senior Vice President and Head of Drug Substance Biologics Manufacturing and is a member of the Genentech…

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LIFE SCIENCES, VIDEO

Leveraging Global Change to Create Strategic Opportunity —and Design a New Future— for Manufacturing and Supply Chain Leaders

November 29, 2017

Discussing the global forces shaping the healthcare environment. How is the industry’s current business model being questioned and the definition of innovation shifting? Understanding how the evolution of patients, consolidation of customers, and pressures on cost will accelerate while new players continue to enter the industry and redefine our paradigms Shedding light on the impact of these changes on manufacturing, quality, and supply chain Making the case that the strategic opportunity for our leaders has never been greater Sharing examples of how Teva is taking a leading role in shaping our new future — R. Ananth (Raghunathan Ananthanarayanan) has more…

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