When Nonclinical Studies Need a Test Article Adjustment, Integration Matters
Nature Biomedical Engineering: Development of an Investigational Epigenetic Silencer Therapy to Transcriptionally Inactivate Viral DNA in Chronic Hepatitis B
How Canada's Updates to Clinical Trial Processes Are Shaping New Regulatory Standards by Yewande Oduwole
For sponsors running clinical trials in Canada, regulatory affairs has long been measured by a familiar set of expectations and milestones: a clean clinical trial application, a Notice of No Objection (NNO), amendments and notifications filed on time, and inspection records that hold up under review. That work remains essential.
Biomarker Strategies to Enhance Early-Phase Drug Development
Selecting the right biomarkers early in drug development can provide critical insights into drug activity, safety, and therapeutic response. By integrating biomarker strategies into early-phase studies, sponsors can optimize study design, support patient selection, demonstrate target engagement, and make more informed go/no-go decisions.
What You'll Learn:
- Key biomarker categories and their roles in assessing drug response, safety, and efficacy.
- Disease-specific biomarker strategies for CNS disorders, immuno-oncology, ophthalmology, and metabolic diseases.
- Biomarker considerations across therapeutic modalities, including small molecules, large molecules, and cell and gene therapies.
- Best practices for biomarker selection and fit-for-purpose validation to support reliable data and regulatory requirements.
- How integrated biomarker strategies, bioanalysis, and clinical expertise can support more efficient studies and confident development decisions.
Biomarkers by Disease Indication
Different treatments may require distinct biomarkers when the therapy acts on a unique biological mechanism, target, or pathway. Selecting the appropriate biomarker for your program is essential for robust data collection and analysis.
Multiplex biomarker panels allow for measurement of multiple proteins, cytokines, or metabolites from a single biological sample. These panels accelerate programs by providing comprehensive, multi-pathway insights into target engagement, PD, and early toxicity.
Development of an Investigational Epigenetic Silencer Therapy to Transcriptionally Inactivate Viral DNA in Chronic Hepatitis B
Endpoints News: The Patent Clock Is Already Running. Why Development Speed Is Also a Commercial Strategy
Pharmacokinetics and Analgesic Efficacy of Long-Acting Transdermal Buprenorphine in Miniature Swine
