Single Clinical Trial Strategy to Accelerate your Drug’s Path to Market
Recent FDA discussions surrounding plausible mechanism and confirmatory evidence frameworks reflect this broader shift. Increasingly, translational success may depend not only on demonstrating that a therapy produced a measurable effect, but also on confirming how that effect emerged within intact biological systems. FDA guidance and recent regulatory discussions increasingly reference mechanistic, pharmacodynamic, and target engagement evidence as important components of confirmatory evidence frameworks.
As spatial biology moves closer to regulated translational and clinical development environments, the challenge is no longer simply generating more molecular data. The next phase of the field will depend on the ability to generate biologically coherent, reproducible, scalable, and clinically actionable mechanistic evidence.
Download the white paper to learn how spatial biology can support the FDA’s Evolving Confirmatory Evidence Framework.
The Future of Small and Large Molecule Bioanalytics—Today
In bioanalysis, the future of small and large molecules offers exciting prospects for advancements in drug discovery, diagnostics, and therapeutics. With the increase of larger substances, emerging technologies, and new analytical approaches, drug developers are faced with both new opportunities to evaluate complex substances, and new challenges to address. Therefore, it’s important to learn which bioanalysis techniques are right for your drug.
In this white paper, you’ll learn about:
- Bioanalysis by molecular size
- Advancements in mass spectrometry
- Visualization and quantification of drug distribution
- The era of spatial imaging
- Novel technologies and adaptions
For more information about emerging technologies revolutionizing the field of bioanalysis, download our whitepaper today.
Validating the efficacy of a compound with spatial imaging
With the ever-changing drug development landscape, pharma and biotech companies have the challenging task to quickly and efficiently generate quality and unique data to file an IND. Spatial bioanalysis is a unique solution that can help you achieve this goal, while also enabling strategic and optimized decision making throughout your process.
Download this spatial bioanalysis white paper to gain insights from industry expert, Corinne Ramos, PhD. Discussion points include:
- Precision medicine development and added value
- Disease heterogeneity: Why is it? Why is it important? How do we visualize it?
Target discovery and development of composite biomarkers
Streamlining the Importing and Exporting of Biological Samples
With the evolving requirements of importing and exporting biological samples, there is a heightened priority to proactively plan, execute, and coordinate procedures. Streamlining this process can help improve logistics, ensure timely execution, and increase workflow efficiencies. Despite the complexity, importing and exporting biological samples can become a seamless and predictable phase in research and development, especially when partnering with the right bioanalytical partner.
Download this white paper to learn from industry expert Mark Vann.