BMWS17 Archives - Executive Platforms: Thought Leader Series

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…

Uncategorized, VIDEO

Knowing and Protecting Your Assets

February 16, 2018

Discussing options for biomanufacturing capacity management: Effective strategies for capacity utilization Spreading capacity among and across different business partners When is the right time to hedge with CMOs? Understanding the attraction, retention, and development trends for talent assets Illustrating these trends with metrics and examples from AstraZeneca’s own experience — Darren Dasburg currently serves as VP & Head, Learning and Development Global Operation at AstraZeneca. Bringing over 30 years of professional experience in a variety of settings, he was appointed Vice President-Site Head for the Boulder Manufacturing Center in September 2015 when AstraZeneca/MedImmune acquired the former Amgen biologics production facility. Previously,…

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….

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…

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…

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…

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,…

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…

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…

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…

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…

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…

BMWS17

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

Knowing and Protecting Your Assets

Leading and Leadership in Lean Bio-Manufacturing Operations

Biotech Business Bootcamp – Treating Cultural Sclerosis…

Breakthrough Designations – How Can Quality Enable Speed to Innovation?

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

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

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

Establishment of Efficient Cell Culture Supply Chain through Partnerships

Redefining Competition: Thinking About Our Industry in a Revolutionary Way

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

Maintaining an Effective Quality Focus in Operations During Mergers and Acquisitions

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