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Biomanufacturing World Summit

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage
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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
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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
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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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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
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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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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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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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Bringing a Quality Focus to CMO Management
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Bringing a Quality Focus to CMO Management

March 6, 2017

Walter Cespedes led a roundtable lunch and learn discussion about bringing a quality focus to CMO management at the  2016 edition of the Biomanufacturing World Summit. We asked him a few questions about how it went. — Walter Cespedes is a seasoned executive with over 28 years of industry Quality experience. Mr. Cespedes serves as Executive Director, Third Party and Commercial Quality Americas for Teva (Actavis).  Prior to this appointment, he served as VP Corporate Quality for Durata Therapeutics, Inc.  Mr. Cespedes has also held a position as a Senior Director of Corporate Quality Assurance for MEDA Pharmaceuticals. Prior to his…

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The Role of Manufacturing in a Successful Biosimilar Strategy
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The Role of Manufacturing in a Successful Biosimilar Strategy

February 16, 2017

Peter Moesta spoke on November 15th at the 2016 edition of the Biomanufacturing World Summit. His keynote presentation was entitled, The Role of Manufacturing in a Successful Biosimilar Strategy. — Peter Moesta has more than 30 years of experience in the biopharmaceutical industry and a strong understanding of manufacturing and launching complex biologics. Before joining TPI, he was senior vice president of Biologics Manufacturing at Bristol-Myers Squibb, where he oversaw the development, production and worldwide launch of numerous significant biologics, including oncology products Yervoy and Opdivo. Previous to this role, Peter held various leadership positions in biologics development and manufacturing…

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The Role of Process Development in Next Generation Biologics Manufacturing
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The Role of Process Development in Next Generation Biologics Manufacturing

December 13, 2016

Alison Moore delivered the opening keynote on November 15th of the 2016 edition of the Biomanufacturing World Summit entitled, The Role of Process Development in Next Generation Biologics Manufacturing. Dr. Alison Moore is Senior Vice President, Process Development serving both Operations and R&D organizations. Prior to this role, Moore served as senior vice president, Operations Technology. Moore was previously vice president, Process and Product Engineering (P&PE) function, where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management….

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