Preclinical Research
Key Considerations for Nonclinical AAV Gene Therapy Development
Case Study—Nanosuspension Formulation to Maximize Potency for Preclinical Studies
Top 10 Life Science Resources for Summer 2024
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!
Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ for (Bio)Pharmaceuticals Safety Assessment
CNS-Targeted Therapies Delivery Strategies and Sampling in Non-rodent Preclinical Species: Considerations During Early Phase Discovery to IND-Enabling Regulatory Studies
Optimizing for Success: How Sponsors Can Overcome the Challenges in Early-Phase Drug Development
The Challenges With Outsourcing Drug Development
In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.
The Sinclair Nanopigᵀᴹ—The Other Non-rodent
Five Promising Treatment Areas in Early-Phase Drug Development in 2024
Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings.
ISSUE NO. 39 — Considerations for Nonclinical Dermal Studies: Advancing to Phase I
An increasing number of advanced methods for dermal drug delivery contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor. As a result, new medications and innovative approaches are continually being designed specifically for dermal delivery, creating new marketing opportunities for sponsors, including those developing previously marketed drugs.
Surveys have shown that patients prefer dermal routes of administration, and so dermal and transdermal drug delivery systems (TDDS), also known as patches, can provide greater patient compliance, ease of administration, and convenience—especially for conditions in which chronic use is necessary.
As is the case with all drug products, dermal therapeutics require stringent safety testing and regulatory compliance. By leveraging new methodologies, researchers are paving the way for more effective, patient-friendly options, providing the expertise and resources necessary to navigate this complex but promising landscape.
Issue 39 of The Altascientist explores the nonclinical prerequisites and considerations for advancing dermal programs to Phase I clinical trials—and addresses the challenges of efficiently delivering drugs to the skin's multi-layered structure.
This issue includes:
- species selection
- candidate selection for TDDS
- typical IND programs for dermal indication
- dermal-specific studies, such as phototoxicity and skin sensitization/irritation assessments
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to The Altascientist: Audiobooks on Spotify, Apple Podcasts, or wherever you get your audio content.
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Disrupting the CRO Model: Altasciences Participates in Documentary Series for 2024 Global Health Summit
Altasciences is leading the conversation on change in the drug development industry as part of a new documentary series for the 2024 Global Health Summit, hosted alongside the WHO’s 77th World Health Assembly in Geneva in May. The mini documentary explores transformation in the slow-to-change drug development industry.