BMWS20 Archives - Executive Platforms: Thought Leader Series

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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LIFE SCIENCES, LIFE SCIENCES, VIDEO

Transport Simulation Testing of Your Therapy: A Better Approach Than “Real World” Shipping Tests

December 15, 2020

Accelerated, sequential testing (e.g., ASTM, ISTA) is no longer acceptable by the FDA for drug product testing Real-world testing cannot test the “worst-case” edges of your operating space Real-world testing in the post-COVID-19 world will be difficult and expensive

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LIFE SCIENCES, LIFE SCIENCES, VIDEO

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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LIFE SCIENCES, LIFE SCIENCES, VIDEO

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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LIFE SCIENCES, LIFE SCIENCES, VIDEO

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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LIFE SCIENCES, LIFE SCIENCES, VIDEO

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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LIFE SCIENCES, LIFE SCIENCES, VIDEO

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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LIFE SCIENCES, LIFE SCIENCES, VIDEO

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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BMWS20

Disrupting Quality Standards (or Beliefs) Through Digitalization

Transport Simulation Testing of Your Therapy: A Better Approach Than “Real World” Shipping Tests

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

Accelerating Delivery of New Medicines

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

Fighting COVID-19 with Innovation – A Race Against Time

COVID-19 MAbs at Pandemic Speed, Volumes and COGs

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

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