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RAPS: How Will Generative AI Take Your Regulatory and Medical Writing Program to the Next Level?

Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines. Organizations are answering the challenge by evolving their authoring processes and leveraging technology efficiencies. For example, lean authoring techniques that incorporate structured content reuse can streamline the creation of complex regulatory documents. Tools that incorporate generative artificial intelligence (AI) can … Continued

Dose Optimization Considerations for Targeted Radiation Therapies

The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number of companies are now developing TRTs, and GlobalData reports that venture capital deals in the field have grown 550% to $408 million in 2023.1 The … Continued

AIFA makeover: Italy’s leap into 2024

In a long-awaited development, Italy’s Medicines Agency, AIFA, underwent transformative changes on January 30th, 2024. This has been a recurrent topic of discussion, with talks of merging the Scientific Technical Advisory Committee (CTS) and the Price and Reimbursement Committee (CPR). However, the COVID-19 pandemic delayed these plans, leading to a continuous extension of the current … Continued

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