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Key Insights from the Journey of Cultural Transformation
HUMAN RESOURCES, VIDEO, HUMAN RESOURCES

Key Insights from the Journey of Cultural Transformation

February 6, 2020

Beyond the buzzwords: Sharing lessons learned from a multi-year, global, culture transformation journey Discussing the role of upper management in shifting the culture of an organization Exploring the role of HR and evolution of HR practices to impact organizational culture — Fenella Chisholm SVP, Global People & Organization Novartis Fenella Chisholm is SVP and Global Head People & Organization for the Novartis Institutes for BioMedical Research (NIBR). In this role, Fenella partners with leadership across the 6000 strong global early discovery science unit to operationalize the Novartis People strategy in service of the vision to Reimagine Medicine and deliver better…

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The LEGO Leadership Playground
HUMAN RESOURCES, VIDEO, HUMAN RESOURCES

The LEGO Leadership Playground

February 3, 2020

Mobilizing your organization’s unique culture: Embracing transformation and fresh perspectives Realign your workforce by using creative collaboration What strategies matter most during times of change? Creating a framework for all employees to unlock their potential — Patrick Curry Head of Partnering & Operations, Americas The LEGO Group Pat has been with the LEGO Group since 2012 and is currently the Head of Partnering & Operations for the Americas. In this capacity he serves as the People Operations lead for the LEGO Group’s Americas Hub in Enfield, CT, and as the Strategic People Partner for the Americas Market Group. Prior to…

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Go Beyond Engagement – Transform Your Culture into Competitive Advantage
HUMAN RESOURCES, VIDEO

Go Beyond Engagement – Transform Your Culture into Competitive Advantage

February 3, 2020

Architect the most effective culture based on your specific strategic objective Assess where your culture is today relative to where you need it to be in the future Activate custom programs and employees to not only withstand disruption but to become a disruptor in your market — Jennifer Stoll Principal Strategist CultureIQ Jennifer Stoll is a Principal Strategist at CultureIQ, with over 15 years’ experience in consulting and project execution. Areas of particular focus for Ms. Stoll include workforce culture, employee engagement, survey data analysis, text analytics, and specialized offerings such as Total Rewards Optimization. In her role as Principal…

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Engineering Cold Chain Solutions to Support Ebola Clinical Trials – A Conversation with Dan Littlefield of Modality Solutions
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Engineering Cold Chain Solutions to Support Ebola Clinical Trials – A Conversation with Dan Littlefield of Modality Solutions

January 10, 2020

At the 2019 edition of the Biomanufacturing World Summit series last November in San Diego we spoke with Dan Littlefield of Modality Solutions. Dan recently worked with the National Institute of Health to support clinical trials to help fight Ebola in the Democratic Republic of Congo. In this interview, Dan talks about some of the challenges of working in an unusual environment, and how Modality Solutions’ experience designing and implementing bespoke cold chain solutions contributed to an important project. — Dan Littlefield Principal Modality Solutions Daniel J. Littlefield is a founder of Modality Solutions. He has helped establish Modality Solutions…

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The Future of Biomanufacturing: Leveraging Flexible Networks, Quality Culture and Cutting Edge Innovation
LIFE SCIENCES, VIDEO, LIFE SCIENCES

The Future of Biomanufacturing: Leveraging Flexible Networks, Quality Culture and Cutting Edge Innovation

January 10, 2020

 How biomanufacturing can address the dichotomy of small volume precision medicines and high volume blockbuster drugs Building flexible global manufacturing networks to meet our industry’s evolving needs Leveraging cutting edge innovation to maximize process intensification and augment flexibility Creating high performance teams and building and maintaining a culture of quality, reliability and innovation as key differentiator and foundation for continued success Please note: Q&A appears in this separate video: — Jens Vogel President & CEO, BI Fremont Inc. Boehringer Ingelheim Biopharmaceuticals GmbH Dr. Jens Vogel is President and CEO of Boehringer Ingelheim Fremont Inc., the US arm of Boehringer…

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LIFE SCIENCES, VIDEO, LIFE SCIENCES

Keynote: The Successful History of Biologics Manufacturing Provides Foresights and Strategies for New Bio Modalities

November 25, 2019

Establishment of broad communities of practitioners in both manufacturing and process development accelerated maturation of both disciplines Convergence of these process and manufacturing technologies was driven by excellence and capacity in selected CMOs Manufacturing portability has provided remarkable stories of win-win capacity-exchange between proprietary companies Process convergence has resulted in remarkable progress in process yields and cost improvement Intro to Vir Bio: Capacity and cost improvements in bio-manufacturing facilitate global access to medicines for Infectious Disease — Michael Kamarck Chief Technology Officer Vir Biotechnology Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global…

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Digital Transformation for Biopharmaceutical Manufacturers – A Conversation with Amos Dor of Applied Materials
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Digital Transformation for Biopharmaceutical Manufacturers – A Conversation with Amos Dor of Applied Materials

November 27, 2019

At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Amos Dor, Applied Materials’ Pharma General Manager & CTO. Industry 4.0 solutions are transforming the way biopharmaceutical manufacturers do business, and Amos offered his insights into some of the challenges they are facing and the decisions they need to make as they bring these powerful new tools into existing operations. — Applied Materials provides pharma manufacturers an opportunity to leverage decades of experience in increasing productivity. SmartFactory Rx™ is a suite of advanced manufacturing software which enables pharma companies to achieve…

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Digital Transformation and the Smart Factory – A Conversation with Laks Pernenkil of Deloitte Consulting LLP
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Digital Transformation and the Smart Factory – A Conversation with Laks Pernenkil of Deloitte Consulting LLP

November 26, 2019

 At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Laks Pernenkil, Principal | Life Sciences Operations with Deloitte Consulting LLP. Laks shared his insights into digital transformation in general, and specifically how the ‘Smart Factory’ will change the way biopharmaceutical companies operate. — Deloitte Life Sciences Innovation starts with insight and seeing challenges in a new way. Amid unprecedented uncertainty and change, life sciences stakeholders are looking for new ways to transform their organizations using digital innovation and technologies. Deloitte’s team of thinkers and doers can help you imagine,…

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Cell and Gene Therapies and the Dawn of the Next Chapter of Biopharmaceutical Production
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Cell and Gene Therapies and the Dawn of the Next Chapter of Biopharmaceutical Production

November 26, 2019

What are some of the unique challenges and opportunities in commercializing live modalities like CAR-T? Weighing the pros and cons of centralized versus decentralized production models for these new treatments Discussing how our industry’s quality culture informs these new products from R&D right through to the patient Offering lessons learned from the first generation of cell and gene therapies. How will their example inform what we are doing now? Setting timelines for the future: What are we going to be able to do next year, five years from now, and ten years from now? What are we doing to get…

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Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Compliance, Quality, and Risk – A Conversation with Jack Garvey of Compliance Architects

November 25, 2019

At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Jack Garvey, Compliance Architects’ co-founder and CEO. Jack has chaired the Quality stream of content for several Biomanufacturing World Summits, and he has deep insights to offer biopharmaceutical manufacturers looking to communicate with regulators and build their organizations to better address the issues of Compliance, Quality, and Risk. — Jack Garvey CEO Compliance Architects Jack Garvey is the Founder and Chief Executive Officer of Compliance Architects®, a leading consulting and advisory firm specializing in innovative quality and compliance solutions for FDA-regulated…

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Improving Product Quality During Technical Transfers
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Improving Product Quality During Technical Transfers

November 25, 2019

The definition of Technology Transfer and its many applications Planning for tech transfer the “right way,” using “Calculated Risk Reduction” and other tools to ensure all bases are covered Common pitfalls and best practices – what to do, and what not to do Ways to ensure optimal planning and execution using actionable tools — Eric Good Director, Compliance ProPharma Group Dr. Eric Good is an energetic leader with extensive U.S. and international manufacturing, project management, Consent Decree and quality systems experience with Fortune 500 Companies. Dr. Good has 29 years of award winning high-performance. He is an active leader in…

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Manufacturing Autologus Ex Vivo Genetically Modified Cell Therapies have Challenges, but the Future is Bright
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Manufacturing Autologus Ex Vivo Genetically Modified Cell Therapies have Challenges, but the Future is Bright

November 21, 2019

Review the supply chain Examine the contributors of costs Solution for industrial scale viral vector manufacturing Cell processing and viral transduction hubs Rapid analytics for product testing Brighter future for patients with fitter cell therapies — Joseph Tarnowski SVP, Cell & Gene Therapy, R&D Medicinal Science and Technology GSK Prior to his current role in CGT, Joe was the Senior Vice President of Biopharm CMC R&D. Before joining GSK in June, 2010, Joe was the Senior Vice President, Biologics Manufacturing and Process Development in the Technical Operations division of Bristol-Myers Squibb Co. in New Brunswick, NJ. Joe was responsible for…

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Scaling Gene Therapy Manufacturing: What is Our Goal?
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Scaling Gene Therapy Manufacturing: What is Our Goal?

November 21, 2019

Highlighting the scale-up opportunity for dramatic patient benefit through the lens of a patient Outlining the inextricable link between manufacturing and the patient experience for autologous cell therapies Considering the different scaling goals: commercial viability, reliability, patient access, etc. — Derek Adams Chief Technology and Manufacturing Officer bluebird bio Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial…

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The Centenarian and the Start Up: How Merck is Realizing its Biomanufacturing Revolution
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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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