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Regulatory Guidance for Oligonucleotide Bioanalysis in DrugDevelopment pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
We are at the forefront of drugdevelopment in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. About the author Jerry McLaughlin CEO, Life Biosciences, Inc.
First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drugdevelopers not typically experienced in later stages of development.
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drugdevelopment 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 DrugDevelopment Industry in 2024 1.
By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups. These drugdevelopment programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells.
The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinicallydevelop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Figure 2 shows pipelines across modalities for some of the competitive targets today.
Could you give us an overview of IRLAB’s current drugdevelopment pipeline? Top-line data from the Phase IIb study is expected at the beginning of 2025. The third project in clinical phase, IRL757, is in Phase I and is being developed for the treatment of apathy.
At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Drugdevelopment is a long process, and patients are waiting. We will have to support an evolving clinicaldevelopment plan and to keep manufacturing off the critical path.
For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD.
The drugdevelopment landscape continues to grow in complexity and cost. Drugdevelopers should consider several approaches when implementing an FSP partnership that is fit-for-purpose and positioned for optimal performance. In the complex field of clinicaldevelopment, timely delivery is essential.
As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities. However, amid this progress, the complexities of drugdevelopment have never been more apparent.
Co-founder and CEO Dr Dan Williams brings over 20 years of experience in biochemistry and drugdevelopment, with a strong background in research and clinical trials. His expertise has positioned SynaptixBio to advance its drug candidates toward clinical trials.
The new DAP guidance goes into more detail about research programs with “several clinical studies” that are subject to DAP requirements. The draft guidance offers some information for how to think about DAPs under “multi-regional clinical studies,” including “globally conducted clinicaldevelopment programs.”
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