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Fighting COVID-19 with Innovation – A Race Against Time
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Fighting COVID-19 with Innovation – A Race Against Time

Pam Cheng EVP, President Global Operations & IT AstraZeneca Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information Technology (IT), guiding the company’s manufacturing, supply chain, procurement, and IT across 18 countries and leading a team of over 19,000. Under her leadership, AstraZeneca Global Operations has transformed significantly driving top performance across the business while delivering value back to the enterprise. The next phase of transformation includes the convergence of operational excellence and digital innovation, building the ‘Factory of the Future’. Before AstraZeneca she spent 18 years in global manufacturing, supply chain, and commercial…

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Panel: Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?
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Panel: Looking at the Big Picture: Where is Our Industry Going, and How Should We Get There?

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 — Moderators: Pat Yang Chairman at Acepodia & Founding Board Director at Sana Biotechnology Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech,…

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Disrupting Quality Standards (or Beliefs) Through Digitalization
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Disrupting Quality Standards (or Beliefs) Through Digitalization

 The current state of digital transformation in life science How to disrupt the quality standards: Digital transformation roadmap and the situation ongoing at SBL Digital transformation’s Value proposition: Improve quality, productivity, and for unparalleled client experience Samsung Biologics’ P4 plan and vision: We’re building the future Sam MacHour SVP & Chief Quality Officer Samsung Biologics Prior to joining Samsung Biologics in 2019, Sam spent more than 32 years supporting large MedTech, Bioscience and Biopharmaceutical companies achieve business operational excellence and gain leadership in the areas of Research & Development, Quality, Compliance, Regulatory, Operations and product commercialization. Sam’s experience covers…

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Accelerating Delivery of New Medicines
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Accelerating Delivery of New Medicines

Examine approaches to accelerate the pace of biopharmaceutical development across multiple platforms and modalities Clinical development velocity can affect CMC approaches, and what we’ve learned through this experience How does acceleration impact our quality, regulatory, and development functions? Understanding acceleration effects on process monitoring and analytics throughout the product lifecycle Discuss what steps we, as an industry, will need to take together to make this the new normal — John Pinion EVP Translational Sciences, Chief Quality Operations Officer Ultragenyx Pharmaceutical John Pinion has over 26 years of global experience leading biologic, small molecule pharmaceutical, gene therapy and device operations across…

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Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain
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Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain

How our “new normal” is affecting our critical materials procurement and how do we adapt for the future? Examining how the proposed nationalization of our supply chains will affect risk management and operations planning What does post-COVID19 Supply Chain robustness look like? How do novel modalities (mRNA, Cell & Gene Therapy) with already existing supply chain challenges cope with these new global constraints? How will high volume ultra cold chain products affect existing specialized ultra cold chain logistics? Seismic shifts and emerging fault lines create lasting affects, what are they and how do they shape our industry in the years…

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Industrialization of Drug Discovery: Manufacturing and Discovery Reimagined Through Artificial Intelligence
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Industrialization of Drug Discovery: Manufacturing and Discovery Reimagined Through Artificial Intelligence

Illustrating how AI is already changing the small molecule side of the pharmaceutical industry in both drug discovery and R&D Extrapolating from these examples to suggest biopharmaceutical manufacturing applications Drawing parallels from the industrialization of biologics manufacturing. How far away are we, and what should we as an industry be doing now to get ready? Discussing what small pilot programs and early test cases might look like, and the timelines involved in moving from proof of concept to industry-wide applications — Tina Larson Chief Operating Officer Recursion Pharmaceuticals Tina M. Larson is Chief Operating Officer at Recursion Pharmaceuticals. Recursion is…

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Digital Transformation in the Biopharmaceutical Industry – A Conversation with Randy Erwin of Cloudleaf
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Digital Transformation in the Biopharmaceutical Industry – A Conversation with Randy Erwin of Cloudleaf

 At the 2019 edition of the Biomanufacturing World Summit series last November in San Diego we spoke with Randy Erwin of Cloudleaf about how biopharmaceutical manfuacturers are embracing Industry 4.0 solutions to their unique challenges. Randy Erwin VP Sales Cloudleaf Cloudleaf’s mission is to create significant value across the end-to-end supply chain network by dramatically increasing visibility of product flow and condition. Customers increase revenues, reduce operational material losses, and enhance the reliability of operations. Our supply chain Visibility Platform delivers complete, real-time views and insights across the ecosystem from suppliers through production and distribution to customers. Using IoT,…

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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies
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Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies

With no standardized methods in analytical development of cell and gene therapies, we must define our own best practices Looking at the evolution and industrialization of analytical development in biologics over the past 20 years: what did we learn and how can we leverage it now? With the current speed of evolution, what new tools will emerge to help us solve these complex challenges The high cost of analytical development and need for greater efficiency begs the question how do we get to where we need to be… And where do we need to be? — Stacey Ma EVP Technical…

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Keynote: When Your Process Equipment is a Raw Material and Your Raw Material is a Human: The Adaptation of Biotechnology CMC Skills to Cell Therapy
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Keynote: When Your Process Equipment is a Raw Material and Your Raw Material is a Human: The Adaptation of Biotechnology CMC Skills to Cell Therapy

CMC/Operations disciplines have an important role in the commercialization of powerful new cell therapies Well understood development principles can be applied, though there are challenges It is important to identify when to draw on experience and when to adapt/grow to address gaps Comparability is key in an emergent technology space, but may be limited by product understanding Growing development skills to advance important new medicines — Alison Moore Chief Technology Officer Allogene Therapeutics Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously…

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

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

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

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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Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy
LIFE SCIENCES

Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy

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

 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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