Intro to Biomarkers: Assay Validation/Qualification, Regulatory Guidance and Application
The short course will focus primarily on the discussion of technologies, key issues in assay development and some regulatory considerations of biomarkers to ensure...
Dissolution Best Practices and International Harmonization
This workshop will cover best practices, science-based approaches, rationale of CHP requirements. We will also discuss strategies to partner with our CHP colleagues...
Stats Snax: Bite-sized Statistical Concepts
Stats Snax is a series of short videos (3 – 15 min) that discuss basic statistical concepts that apply to the pharmaceutical industry, using examples from CMC...
Drug Transporters in ADME: From the Bench to the Bedside
Scientists working at every career stage and in every part of the pharmaceutical community, including academia, industry, and regulatory, will come together to discuss...
Patient-Centric Design of Long-Acting Injectable Drug Products
Measurement and Understanding of Immune Response in Context of Clinical Development
This workshop covers key aspects of the assessment of immune response considerations in discovery and pre-clinical studies, from the clinical stages through approval.
Optimizing Extraction Recovery for Volumetric Adsorptive Microsampling (VAMS)
Compared to in-clinic sample collection, in-home sampling has many advantages. It saves time for patients, especially those who may be prohibitively far from a clinic...
Journey of Biomarker from Discovery to Qualification
Noninvasive monitoring of nephrotoxicity is challenging. Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood urea nitrogen, and serum...
Development and Regulatory approval for Toxicogenomics (TGX) biomarker to detect DNA damage-inducing agents
Gene expression biomarkers are now available for application in the identification of genotoxic hazards. The TGx-DDI transcriptomic biomarker can accurately...
Covid-19 Safety Testing Approaches
Rafiq Islam, Executive Director of Bioanalysis describes the approach that Celerion has taken to ensure the safety of our employees and patients via a suite of viral...
Mitigation Strategies for US and EU Supply Chain Risk Introduced by the COVID-19 Pandemic
The current global health crisis has a profound effect on the pharmaceutical supply chain, from raw materials, to clinical supply, to store shelves. This 30-minute...
Is Your Lab Cloud Ready
Originally driven by IT needs, cloud technology adoption is now being led by far reaching business demands.
Computational Studies of SARS-CoV-2 Application of Computational Chemistry and A.I.
The rapid outbreak of the novel severe acute respiratory syndrome 2 (SARS-CoV-2) has reached pandemic level and poses a serious global public health concern. Since the...
What We Need to Learn from Failures in COVID-19 Testing
The COVID-19 pandemic has not only disrupted our lives on all fronts, but it has also exposed our need to focus on the highest quality and safety in testing. With...
The Contribution of SIFT-MS to Breath Analysis and Drug Research
As a direct mass spectrometry, Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) is a novel tool to breath analysis and early-stage drug research. With SIFT-MS, the...