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FSP Engagements Continue to Gain Popularity, Drive Success

PPD

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

For our clients, the ability to outsource these capabilities is a marked improvement compared to hiring, training and maintaining a large workforce to fulfill every aspect of clinical operations — a feat made even more complicated by workloads that can fluctuate widely depending on the number of products under development.

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Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations

Conversations in Drug Development Trends

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.

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Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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Alligator Bioscience recruits new Chief Medical Officer

The Pharma Data

Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc.

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Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes

The Pharma Data

The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools. The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design.

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Five Predictions for the Biopharma and Biotech Industries in 2024

PPD

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.