ISSUE NO. 45 — Discovery Studies: An Agile Approach to Early Data for Quicker Decisions
The early identification of toxicity, and flexibility to explore parameters and characteristics of drug candidates in vivo via early discovery non-GLP studies, allow for improved drug development strategy and faster go/no-go decisions. This data from animal models, and particularly nonhuman primates (NHPs) where their genetic, immunologic, and physiologic similarities to humans make them the model of choice, is an important part of informing decisions about candidate molecules.
Access to early discovery studies’ data accelerates the process of refining candidate molecules and identifying promising therapeutic targets, novel delivery methods, and pharmacodynamic markers.
In Issue 45 of The Altascientist, we explore:
- the characteristics and advantages of non-GLP discovery studies
- emerging trends in drug delivery methods two early-stage biodistribution case studies
Highlights From the 2025 American Society for Mass Spectrometry Conference | By Jean-François Larocque and Benjamin Charron
We were thrilled to represent Altasciences at this year’s American Society for Mass Spectrometry (ASMS) conference in Baltimore. With 6,000 scientists, students, and industry professionals from around the globe in attendance, it was an excellent opportunity to learn about the latest developments in mass spectrometry and share insights with other passionate scientists.
Altasciences at ASGCT 2025: An Open Forum for All Things Gene and Cell Therapy | By Kaylyn Koenig
I recently returned from attending the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting. This was my first conference since joining Altasciences, and I was excited to attend with some of my esteemed colleagues, Nobert Makori (Vice President of Toxicology), Steve Mason (Co-COO), and members of the Business Development team, Derek Storey, Gretchen Green, Todd Hartz, and Mike Zamora.
ISSUE NO. 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs
New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS). CRS is a systemic inflammatory response characterized by the release of pro-inflammatory cytokines from immune cells, which results in fever, fatigue, and possibly multiple organ failure.
In Issue 44 of The Altascientist, we review strategies, including those implemented at Altasciences, for developing, qualifying, and implementing cytokine release assays (CRAs) to assess the safety of test articles in vitro to complement in vivo preclinical safety assessments, in addition to:
- the importance of nonclinical cytokine release evaluation
- customized approaches to CRA use in drug development
- top five aspects to consider before running a CRA
- Altasciences’ case results
- how Altasciences can help
Drugs that are likely to require CRAs as part of derisking their development include, but are not limited to: