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LIFE SCIENCES

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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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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LIFE SCIENCES, VIDEO

Panel: Looking Forward – Where are Biopharmaceutical Manufacturers Going, and How Should We Get There?

July 10, 2017

Talking about the state of the biotech industry today: Which emerging trend will see the most growth? People and technology: How are these forces working together to grow and mature our industry? Discussing challenges in capacity planning, make-buy decisions, and supply chain management What is the next big challenge and the next big opportunity facing our community? Are we ready for it? — Moderator: Patrick Yang, Former EVP, Technical Operations, Genentech Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech and Roche. He was Executive…

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LIFE SCIENCES, VIDEO

Maintaining an Effective Quality Focus in Operations During Mergers and Acquisitions

April 28, 2017

Charlene Banard, Shire Pharmaceuticals’ Senior Vice President of Global Quality, spoke at the 2016 edition of the Biomanufacturing World Summit. In this presentation she shares her thoughts and experiences on maintaining an effective quality focus in operations during mergers and acquisitions. Discussing best practices to establish and maintain a quality focus on each product lifecycle during M&A activity Clarifying who is responsible for what and opening up lines of communication, coordination, and collaboration between teams in transition Balancing phase appropriate applications of quality systems, knowledge and risk management, and product control Offering examples of positive outcomes and explaining what made…

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MANUFACTURING, SUPPLY CHAIN — NA, LIFE SCIENCES, VIDEO

Interview – Frank McCrady, President/CEO of EMCID

April 28, 2017

With nearly 30 years of experience in economic development and banking, Frank McCrady has spent 14 of those years as EMCID’s President and CEO, elevating East Montgomery County through strategic planning to a community ready for growth. Under his leadership, development has soared and sales tax revenue for the 158-square mile improvement district has increased by more than 200 percent, from $2.5 million in 2002 to $7.7 million in 2015. Current retail and entertainment projects underway stand to further financial success for the District and the community in the form of job creation, additional business recruiting tools, expanded services, community…

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MANUFACTURING, LIFE SCIENCES, VIDEO

Digital Manufacturing in the Medical Device Industry

April 28, 2017

In this presentation Dean Kossila, Sr. Principle Business Solution Architect of Medtronic, and Frank Platt, Senior Director of Solution Management and Manufacturing of SAP, speak about: Managing operations in real-time delivers a strategic advantage Plant to enterprise integration speeds information flow Touchscreen operations replace paper based processes Quality management and guided procedures assure compliant manufacturing Automated data collection minimizes errors The growing importance of traceability — Dean Kossila is a senior principle business solution architect for Medtronic. Dean’s primary responsibility is the strategic direction and blueprint design for supply chain and manufacturing solutions globally for Medtronic. Previously, Dean was Sr….

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MANUFACTURING, SUPPLY CHAIN — NA, LIFE SCIENCES, VIDEO

Discover the ROI of Operational Excellence: An Executive Discussion

April 27, 2017

In this keynote presentation at NAMES17, Phil McIntyre, Managing Director of Client Development for Performance Solutions by Milliken, shares his experience with making the most out of a lean journey. — Phil McIntyre has been with Milliken over 29 years in leadership roles encompassing both the business and manufacturing arenas. He successfully led several business units within Milliken & Company to profitable growth and financial sustainability, as well as the Performance Products Division Milliken Performance System implementation. Phil was Director of Cost Improvement, and he also spent time as the Pursuit of Excellence Director responsible for integrating customer needs with…

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Working With Organized Labor to Build Better Businesses Together
MANUFACTURING, SUPPLY CHAIN — NA, LIFE SCIENCES, VIDEO

Working With Organized Labor to Build Better Businesses Together

April 27, 2017

In this interview Shawn Otto, Beam Suntory’s Regional Human Resources and Labor Relations Director, answers questions related to his recent presentation at the North American Manufacturing Excellence Summit: Working With Organized Labor to Build Better Businesses Together Offering an overview of the realities of manufacturing with a unionized workforce Understanding what corporate leadership, shopfloor management, union leadership, and the frontline workers all want and need from one another in a healthy working environment Discussing common stumbling blocks and points of conflict between parties in search of common goals: How do you find win-win scenarios out of what at first seemed…

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MANUFACTURING, SUPPLY CHAIN — NA, LIFE SCIENCES, VIDEO

Interview – Shane Yount on Leadership, Performance, and Developing Your Team

April 27, 2017

  Shane Yount, Principal and Author with Competitive Solutions, sat down for a few minutes at the 2017 edition of the North American Manufacturing Excellence Summit. Be sure to also watch Shane’s full workshop presentation, “Business Bootcamp – Driving Greater Execution, Engagement, and Ultimately Earnings!” for more insights. — Shane A. Yount is a nationally recognized author, consultant, and principal of Competitive Solutions, Inc., an international Business Transformation consulting and software firm. Shane’s team pioneered the acclaimed organizational governance system known as Process Based Leadership® (PBL) – A robust governance methodology designed to create a sustainable cadence of clarity, connectivity,…

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MANUFACTURING, LIFE SCIENCES, VIDEO

Business Bootcamp – Driving Greater Execution, Engagement, and Ultimately Earnings!

April 27, 2017

At NAMES17, Shane Yount of Competitive Solutions asked his audience, “Are you ready to accurately assess your teams, your leaders, and your performance?” For 25 years, Competitive Solutions, Inc. has been taking organizations through Business Bootcamp with some pretty dramatic results. Learn how to: Drive Business Acumen at a tactical level Move accountability from a concept to a practice and elevate expectations of engagement Eliminate hours of meetings a week by recalibrating intent Moving from abstract OPEX tools to business critical necessities What are the eight essential elements of 21st century leaders?

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Impacts of Cultural Change in Under-Performing Facilities
MANUFACTURING, LIFE SCIENCES, VIDEO

Impacts of Cultural Change in Under-Performing Facilities

April 25, 2017

Michael Brice, VP Offset Operations at INX International Ink Co., led a roundtable lunch-and-learn discussion entitled, “Impacts of Cultural Change in Under-Performing Facilities” at the 2017 edition of the North American Manufacturing Excellence Summit. In this video he shares why he chose this topic and how the lunch conversation went. — Michael Brice is a 31-year printing ink industry veteran.  He has served in every capacity:  lab technician, colormatching, manufacturing, inplant technician and management, sales and senior level management.  Mike became Chief Operating Officer of Superior Printing Inks in 2000 and named is President and COO in 2003.  He also…

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