『GxPodcast』のカバーアート

GxPodcast

GxPodcast

著者: i-Pharm GxP
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The GxPodcast by i-Pharm GxP is a podcast that shares conversations of thought leadership and perspectives on GxP solutions in the life sciences industry. i-Pharm GxP ensures patient access to life-saving therapeutics through human-centric partnerships, projects, and solutions.Copyright 2023 All rights reserved. 生物科学 科学
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  • Quality Culture and Excellence with Chris Lewis
    2024/05/17

    Get ready for Episode 7 of the GxPodcast!

    This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma.

    Prior to joining Umoja in 2021, Chris served in various Quality leadership roles at Amgen, Sandoz/Novartis, AstraZeneca Biologics, and AveXis/Novartis Gene Therapies, helping to bring life-changing clinical and commercial biologic, small molecule, and gene therapy products to patients and their families around the world. To enable the manufacture of these products, Chris has had the honor and privilege of supporting the startup of five separate cGMP manufacturing facilities, including the building of teams and organizations focused on establishing and maturing an effective quality culture and best serving one another to best serve patients together.

    Outside of Umoja, Chris has a passion for supporting growth in the local biotechnology community, serving as the current President of the Mountain States PDA Chapter and as a Mentor in the Colorado BioScience Institute’s Mentor Program.

    Tune in to hear us talk all things innovation and purpose. Looking at the automation of cell and gene manufacturing, industry regulations, and the power of purpose.

    #GXPodcast

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    1 時間 3 分
  • Offshoring and Risk Management with Eckart Schwarz
    2024/04/19

    It's time for Episode 6 of the GxPodcast!

    This week, we were joined by Eckart W Schwarz, MD, President and Founder of a bespoke Life Science Consultancy, and expert in solutions and drug management. Eckart has 30+ years experience in leadership, designing and delivering global strategic and operational solutions.

    Eckwart has had an impressive career, from spearheading groundbreaking initiatives at GSK, including the establishment of a pioneering offshore R&D Capability Center in Bangalore, India, to the creation of innovative regulatory affairs delivery platforms.

    During his extensive work in leadership, Eckwart has been working on a vast collection of degrees from across the globe, including D.Sc. Hon Dr of Science, MD / M.B.,Ch.B. British Medical Degree, and FFPM (Hon) – 2022 Hon Fellowship, Faculty of Pharm. Med..

    Tune into this new episode to listen to the insightful conversations we shared about the globalisation of drug treatment, tech breakthroughs, biopharmaceutical work and much more.

    #GxPodcast

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    49 分
  • Compliance By Design with Carlos Yuraszeck
    2024/03/14

    We're on episode 5 of the GxPodcast already!

    In this episode, we're joined by a prominent figure in the pharmaceutical and biotechnology industries for nearly three decades, focusing on quality, compliance, and the manufacturing of advanced therapeutic products.

    Throughout his journey, Carlos Yuraszeck has been instrumental in developing effective Quality Systems aimed at enabling Compliance by Design across the GxP spectrum.

    Most recently, as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos was responsible for various functions, including MS&T, Cell Manufacturing, and Engineering.

    At Celgene, Carlos played a pivotal role in launching a groundbreaking treatment for Multiple Myeloma, contributing to the company's evolution into one of the most successful biotech companies. His expertise extends beyond product development to include building and running manufacturing facilities, understanding regulatory requirements, and collaborating with overseeing agencies. This unique combination of skills allows him to guide therapies from concept to patient treatment.

    Prior to Celgene, Carlos held positions at Pfizer, Pharmacia, and Merck, where he gained experience in Quality Assurance, Quality Control, Validation, and Corporate Compliance. #GXPodcast

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    1 時間 19 分
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