Articles in this Issue

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  Transforming Sterility: Cutting-Edge Solutions in Sterile Drug Manufacturing

  Sterile drug product manufacturing is a complex yet vital aspect of the pharmaceutical industry, essential for producing safe and effective medications. Over time, advancements and innovations in this field have revolutionized manufacturing processes, ... read more
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  AI in Drug Development-Slashing Trial Time and Cost

  Traditional drug development processes are plagued by exorbitant costs and prolonged timelines, presenting formidable barriers to innovation in the pharmaceutical industry. The urgent need for transformative solutions has never been more apparent, as the ... read more
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  Navigate Future Risks to Clinical Trial Supply

  The complexity of clinical trials has increased in recent years, bringing new challenges and risks that could impact success. In this article, Robert Feltz, Director of Analytical and Formulation Services at Sharp Clinical, shares his unique insights into the ... read more
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  How Optimized Trials Are Revolutionizing Clinical Research Accessibility

  The efficiency of clinical research is far from ideal. Developing a new drug takes 7 to 13 years, and 85% of clinical trials fail to meet their timelines. Less than 15% of trial participants are from minority groups, and patient dropout rates can reach up to ... read more
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  Can GenAI Address the Soaring Costs of Pharma Medical Writing?

  The pharma industry is rapidly coming to appreciate the substantial scope of Generative AI to transform medical writing, for regulatory documentation, safety report summaries, and more. In response, some companies have begun to grow GenAI capabilities in-... read more
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  Reducing Waste with Intelligent Automation Accelerates Clinical Trial Success

  Although clinical trials are advancing the development of novel treatments, a lack of robust supply chain management is hindering clinical trial success. With a median waste level of 50% for investigational medicinal product (IMP) kits across clinical trials, ... read more
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  The Next Generation of Clinical Trial Patient- Reported Outcomes: Ambient Data

  Technology is integrated into clinical trials in various ways, and as the trial landscape continues to develop, so does the role of technology. The transition from paper to electronic patient reported outcomes (PROs) demonstrates how clinical trial assessments... read more
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  Addressing Oncology Trial Challenges: Solutions for Complexity and Recruitment Struggles

  Only 3-5% of adult cancer patients in the U.S. and fewer than 1 in 20 globally participate in clinical trials, largely due to stringent eligibility criteria. This low enrollment highlights the complexities of oncology trials with multifaceted treatments and ... read more
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  Strategic Outsourcing - A Partnership for Success

  When pharmaceutical companies are bringing a drug product to market, there are several factors that need to be considered to gain competitive advantage including speed, cost effectiveness, flexibility, and risk. Streamlining pharmaceutical development is also ... read more
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  Revolutionizing Clinical Trial Participation: The Power of Innovative Payment Solutions

  The disease does not discriminate across lines of access to clinical research and trials, healthcare, financial concerns or a patient’s individual circumstances. Within medical research, clinical trials stand as the benchmark for advancing healthcare and ... read more
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  A Quarterly Review of New Drug Applications April – June 2024

  This quarterly review of New Drug Applications contains data for applications approved during the second quarter of 2024, which includes new molecular entities (NMEs) and new biologics. A total of 37 applications were approved by the FDA during these three ... read more
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  Someone’s Got to Do It

  Is anyone a fan of the television series “Dirty Jobs”? Hosted by Mike Rowe, the series was first aired on the Discovery Channel on November 7, 2003, and featured 179 episodes. The show highlighted various difficult and unusual jobs, showcasing the demanding ... read more