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.

 

Collaborating for Success Tips for Improving Partnerships Between QA and Clinical Operations at Your Site

Risk-Based Auditing and its Application to GLP Computerized System Validation Procedures

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:

Reuters: Flipping the Drug Development Industry on Its Head

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.

Here at Altasciences, Eryn is responsible for guiding regulatory strategies, conducting gap analyses, and leading interactions with regulatory agencies durA headshot of Eryning early drug development.

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