Preclinical Research
Up Close and Personal with Francis Douville
Francis Douville joined the Altasciences team in 2018, as Senior Vice President, Technical Operations, for our preclinical services.
Making the Most of your CRO Partnership
Partnership
Choosing the right CRO as a partner for your drug development programs is a vitally important step to achieving critical decision making
Quiz – All About Investigational New Drug Submission
Test Your Knowledge —Investigational New Drugs
If you work in, or around, the early phase drug development landscape, you are likely aware of the requirements for an investigational new drug (IND) package.
ISSUE NO. 11 — Navigating the IND Submission Process
There are many challenges associated with early drug discovery and development. With timelines, budget, and market competition being critical factors, advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. In fact, we recommend initiating discussions with a CRO at least six months in advance to ensure that capacity, resource availability, and animal supply are built into your timelines.
In Issue 11 of The Altascientist, we provide a high-level overview of the preclinical component of your drug development program in preparation for regulatory submission, including:
- A submission checklist
- Pivotal toxicology studies
- Small molecules vs. biologics
- Considerations for before you begin (species selection, formulation, test article, bioanalysis, etc.)
- Small and large molecule timelines
- SEND data
- Selecting the right CRO for you
Preparing For Your IND Submission
Your IND application must contain information in the three following areas, as outlined by the U.S. FDA:
Use of Thromboelastography (TEG) in Preclinical Studies
Development of an IL-31-Induced Pruritus Model in Cynomolgus Monkeys
Effect of Housing on Stress-Related Parameters in NHPs
Detection of Peripheral Blood Foxp3+ Regulatory T Cell Population in a Preclinical Setting
Translatability of Non-Human Primate Cytokine Data to In-Life Parameters in Nonclinical
A Multi-Peptide Hybrid LC-MS/MS Assay for the Determination of CTI-1601 in Monkey Tissues Provides Insight into its Disposition and Processing