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Competition versus coalition
In the most high-stakes cases, the right choice in comparator sourcing can determine market shape as much as market share. What is the best way forward when all competitors want to prove their superiority and avoid being outdone? Dave Callaghan speaks to Terry Walsh, former head of global externalisation packaging, labelling, distribution and comparators at GlaxoSmithKline, about how to find the best option to help ensure a well-run trial.
Assistance, acceleration and augmentation
AI is set to play a significant role in regulatory and medical writing in the very near future. Dr Barry Drees of Trilogy Writing & Consulting, using his more than 30 years of experience, discusses the history of medical writing, the challenges facing his company in implementing AI industrywide, and why computer-augmented reports are necessary.
Ghost writer
Medical writers have tried just about every technique to speed up the process of producing clinical study reports, but strict schedules and inspirational project management can only get you so far. The development of contextual AI could allow sponsors to automate the most laborious aspects of drafting regulatory submissions and free their expert communicators to do what they do best. Kerry Taylor-Smith speaks to the Pistoia Alliance’s Dr Nick Lynch about how robot writers can help get products to market faster.
Alive and well
Emerging stem cell and gene therapies provide unique challenges in a number of areas, including vendor selection and procurement. Emma Green speaks to Jacqueline Barry, chief clinical officer of the Cell and Gene Therapy Catapult, about the key considerations when conducting these trials, and the types of support that manufacturers can receive to ensure a smooth trial process.