Articles in this Issue

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  How the Pandemic Has Changed the Game for CDMOs

  One silver lining of the pandemic is that it has illuminated the vital role of pharmaceutical innovation and generated a newfound respect for the power of science. Yet, amidst a backdrop of supply ... read more
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  Technology Creates New Future for Managed Access

  Peter Karns loves helping team members achieve career objectives and enabling clients to reach business objectives. He works with clients, the CyberGrants team and industry experts to develop and lead... read more
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  Experience-Based Solutions for Challenges on Cell and Gene Clinical Trials

  Cell and gene therapies (CGT) are a heterogenic group of therapies based on the physiological capacities of the cells and the extraordinary advances of genetic technology, which give them new or ... read more
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  Accelerating the R&D Process with Holistic Views of Data

  Per a global report by Statista, in 2020, R&D spending in the pharmaceutical industry totaled nearly $200B globally. For comparison, R&D expenditures totaled $137B in 2012. read more
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  How Can AI Be Used to Ensure Clinical Data Quality is Optimal?

  There is no question that the quality of data is fundamental for a successful clinical trial. Clinical data reported during a trial must be complete and reliable, as it is the foundation for analysis,... read more
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  Pharma Logistics Industry Trends to Expect in 2022

  In nearly every industry across the country, trends are shifting quicker than ever before. The COVID-19 pandemic has kicked innovation and disruption into overdrive, while new attitudes toward work, ... read more
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  Doubling Down on Protocol Amendments and Deviations

  Protocol deviations and amendments are a common occurrence in clinical trials. Indeed, sponsor companies, contract research organizations (CROs) and investigative sites accept them as a disruptive ... read more
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  Decentralized Clinical Trials: Placing the Focus on Patient Centricity

  Patient centricity—also known as patient-centered care—has been a growing force across healthcare. Like the consumer-driven change in other industries, patient centricity upends established models. read more
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  Medicaid Mandate 2022: Striving for Equitable Access to Clinical Trials

  On January 1, 2022, the United States enacted landmark legislation supporting our industry’s ability to sponsor more diverse, equitable, and inclusive clinical trials via the Clinical Treatment Act. read more
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  Be Prepared: The EU Clinical Trial Regulation Rollout is Underway

  January 31, 2022, marked a substantial regulatory shift for clinical trials conducted in the European Union (EU). As of that date, the new EU Clinical Trial Regulation 536/2014 (EU-CTR) begins ... read more
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  HORIZON LINES: A Quarterly Review of NDAs – October-December 2021

  This quarterly review of new drug applications contains data for applications approved for the first time during the fourth quarter of 2021, which includes New Molecular Entities (NMEs) and new ... read more