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LIFE SCIENCES

Reducing Drug Shortages… and High Prices
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Reducing Drug Shortages… and High Prices

May 19, 2021

How hospital systems and philanthropies came together to establish their own supply chain for essential quality generic medicines Living the mission to make quality generic medicines accessible and affordable to everyone Improving the resiliency of the supply of essential medicines used in hospitals, often for critical care, day-to-day and during a pandemic Ensuring a safe and stable supply of essential medicines for U.S. patients — Donna Gulbinski Chief Quality & Regulatory Affairs Officer Civica Rx Donna’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history…

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Keynote: Delivering Excellence While Navigating Transition
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Keynote: Delivering Excellence While Navigating Transition

May 19, 2021

Highlighting how operations and manufacturing can think differently to pivot for crises and global events Preparing for M&A opportunities and adapting for a changing business model Discussing the importance of equity, leadership and people as catalysts of culture and change within the industry as we work to serve patients better — Azita Saleki-Gerhardt EVP, Operations Abbvie Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie, leading a team of scientific, engineering, business, quality, supply chain, security, purchasing and manufacturing professionals responsible for supply and distribution of all AbbVie products, as well as a number of corporate services. Dr. Saleki-Gerhardt…

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Disrupting Quality Standards (or Beliefs) Through Digitalization
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Disrupting Quality Standards (or Beliefs) Through Digitalization

January 11, 2021

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

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

December 1, 2020

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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Accelerating Delivery of New Medicines
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Accelerating Delivery of New Medicines

December 1, 2020

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

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

December 1, 2020

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

Fighting COVID-19 with Innovation – A Race Against Time

December 1, 2020

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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COVID-19 MAbs at Pandemic Speed, Volumes and COGs
LIFE SCIENCES, VIDEO, LIFE SCIENCES

COVID-19 MAbs at Pandemic Speed, Volumes and COGs

December 1, 2020

Vir Biotech has discovered a neutralizing COVID-19 mAb to a unique, highly conserved Coronavirus spike sequence, high barrier to resistance and effector function We have partnered with numerous CDMOs and GSK to move from discovery to the clinic in approximately 6 months World-wide pandemic requirements for an efficacious neutralizing mAb may exceed 20 metric tons – challenging the capacity of industry manufacturing infrastructure — Michael Kamarck Chief Technology Officer Vir Biotechnology Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible…

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BMWS20 – Opening Chairs’ Remarks and Keynote: Reinventing a Biopharma Company for the 21st Century
LIFE SCIENCES, VIDEO, LIFE SCIENCES

BMWS20 – Opening Chairs’ Remarks and Keynote: Reinventing a Biopharma Company for the 21st Century

December 1, 2020

Bristol Myers Squibb is a company that has undergone an extensive transformation and as a result, has reinvented itself Once a company consisting of multiple and vastly different business units, it is now the largest diversified specialty global biopharma company Its mission and focus is to utilize innovation to advance the treatment of serious disease and significant unmet medical need This organizational evolution required substantial change for the product development and manufacturing arms of the company Technology, systems, processes, people and culture all needed to be re-evaluated through a “new lens” The presentation will cover this journey including approach, successes,…

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Industrialization of Drug Discovery: Manufacturing and Discovery Reimagined Through Artificial Intelligence
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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

February 24, 2020

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

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

February 24, 2020

 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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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

February 20, 2020

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
LIFE SCIENCES, VIDEO, LIFE SCIENCES

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

February 19, 2020

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
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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