Quality Executive Partners, Inc. (QxP®)

This issue of Pharma Focus Asia Magazine is the one to read! Christine Feaster has the CDMO/Sponsor relationship covered for all who are interested.

TRANSFORM YOUR QUALITY CULTURE WITH QXP At Quality Executive Partners, Inc. (QxP®), we understand that a strong quality culture is the backbone of successful pharmaceutical operations. Our expert consultants partner with you to develop and sustain a quality culture that ensures patient safety, compliance, and operational excellence. Discover how our tailored approach can transform your organization and give you a competitive edge in the market. Quality Culture starts at the top – choose Quality Executive Partners – we start with Quality too. https://lnkd.in/euxFUPvN #pharma #biopharma #biotech #qualityassurance #consultants

MEET BRIAN DUNCAN – QxP'S SOLID ROCK Brian Duncan is the chief operating officer for Quality Executive Partners, Inc. (QxP®), providing operating oversight for all global consulting engagements. Brian graduated from the U.S. Air Force Academy and then completed his bachelor’s degree in chemistry at the University of Texas at San Antonio. Since 2014, he has held various executive leadership positions with QxP and Virtuosi®. Brian is a seasoned leader, with extensive experience in senior and executive roles in the pharma industry. He has also worked with dozens of global pharma companies developing, deploying, and managing various strategic programs. These programs focus on remediation, mergers and acquisitions, site expansions, global standards alignment, education, and local capability enhancements. In addition, he has developed and led the daily execution of six successful warning letter and consent decree programs. All programs resulted in full resolution within record time (typically 12 months or less) with results that were sustained for several years at the local, regional, and global levels. To learn more about the businesses Brian leads, visit: QxP at https://lnkd.in/ebGq3txn Virtuosi at https://lnkd.in/enb6EcpV #pharma #biopharma #biotech #qualityassurance #consultants

AI ADVANCEMENTS IN PHARMA A big thanks to Manu Kumar Shetty MD., Anubha Gupta, and Pharma Focus Asia Magazine for shedding light on AI’s evolving role in drug development. The article addresses the challenges of integrating AI, especially with the need for vast human data, and offers solutions like generative models to predict drug efficacy and safety. This matters because the future of drug development hinges on embracing AI to navigate complex biological data more effectively. Contact QxP to learn how we can help you stay on top of these innovations: https://lnkd.in/ekHSJuCQ #pharma #biopharma #biotech #qualityassurance

We’re thrilled to see Pharma Focus Asia Magazine feature an insightful article by our own Christine Feaster, SVP of Strategic Operations at QxP! In this piece, Christine outlines the essential considerations for CGT/ATMP companies when selecting a CDMO partner...and more. A big thank you to Pharma Focus Asia for highlighting Christine's expertise! - Read the full article below. - Learn how QxP can help guide your CGT and CDMO journey with expert insights and tailored solutions: https://lnkd.in/eazke3Gz #pharma #biotech #qualityassurance #cdmo #india

MEET CRYSTAL MERSH – QxP'S VISIONARY LEADER Crystal Mersh is the founder, president, and CEO of Quality Executive Partners, Inc. (QxP®). With 25 years of senior-level experience at companies like Novartis, Mylan, Sanofi, and Allergan, Crystal has brought a revolutionary approach to consulting, delivering long-term transformational change to the pharma industry since founding QxP in 2012. Crystal has extensive experience in remediation, consent decree management, warning letter resolution, and continuous quality improvement. Her strategic quality planning and operational leadership have consistently brought turnaround results to critical compliance situations, including comprehensive quality remediation and organizational redesigns, all while maintaining and enhancing business operations. She has led QxP in numerous global engagements, specializing in regenerative medicine and immunotherapies, and has committed QxP to influencing regulatory and industry standards in the pharma industry while setting the platinum standard in life sciences education. The development and growth of Virtuosi® are a key part of Crystal’s vision for leading-edge pharma education. To learn more about the businesses Crystal leads, visit: QxP at https://lnkd.in/eQjWvCyW Virtuosi at https://lnkd.in/eQh8PcsU #pharma #biopharma #biotech #qualityassurance #consultants

TOP 10 PHARMA R&D SPENDERS Thank you, Joanna Sadowska, PhD, EMBA for sharing these insights! The fascinating animation below highlights the top R&D spenders in the pharmaceutical industry from 2005-2023. With global R&D spending exceeding $300 billion in 2023, it's clear that innovation is driving the industry forward. R&D investment not only fuels the development of life-changing therapies but also reflects the evolving focus and priorities of leading pharma companies. QxP: https://lnkd.in/exj9rArn #pharma #biopharma #biotech #qualityassurance #innovation

AI IN PHARMA: TRANSFORMING BIOMARKER DATA AI is changing the way the pharmaceutical industry processes biomarker data, bringing a new level of speed and precision to drug development. This technology is uncovering valuable insights, leading to more targeted therapies and better patient outcomes. Thanks to Tobias Guennel and Pharma Focus Asia Magazine for the informative article linked below. At Quality Executive Partners, Inc. (QxP®), we can help guide your team in evaluating #AI solutions to determine what fits best with your business goals. Visit our website to learn how we can support your decision-making process!  https://lnkd.in/erWVS-K9 #artificialintelligence #pharma #biopharma #biotech #qualityassurance

USP <1062>: OPTIMIZING TABLET MANUFACTURING Thanks to the team at Natoli Engineering Company, Inc. for this helpful article. USP Chapter <1062> provides vital guidelines for standardizing the tablet compression process, focusing on factors like powder flow, material characteristics, and compression pressure. This chapter equips R&D formulation scientists with the tools to identify the right formulations, reducing risks such as capping and optimizing the manufacturing process. By addressing the complexities of compressibility, compactibility, and tableting performance, USP <1062> helps companies produce robust tablets that meet quality standards. At QxP, our consultants have deep expertise in applying these guidelines to enhance your tablet production efficiency and compliance. Check out our website and contact us for more info: https://lnkd.in/g62kjpYa #pharma #biopharma #biotech #qualityassurance #consultants

FDA GUIDANCE ON RISK ANALYSIS FOR COMBINATION PRODUCTS The FDA’s draft guidance on Use-Related Risk Analysis (URRA) emphasizes the importance of managing risks in drug-device combination products. This guidance promotes early risk analysis to optimize design and safety throughout a product's lifecycle. Let Quality Executive Partners help you stay ahead of regulatory expectations and ensure your combination products meet the highest safety standards. Learn more at: https://lnkd.in/gXUGAjyU #pharma #biopharma #biotech #qualityassurance #consultants