Accelerated Drug Development: The Promise Is In The Process

By Jan-Olav Henck, Ph.D., Chief Scientific Officer, Aptuit LLC

In 1993, the FDA issued the call to the pharmaceutical industry to streamline the drug development process from discovery to First In Man. Despite many efforts, the industry standard for the timeline for a drug to advance from discovery to First In Man still remains to be between 18 to 30 months. To address this challenge, Aptuit focused on reducing the length of time needed to advance the Active Pharmaceutical Ingredient (API) to IND submission. Aptuit understood that large pharmaceutical companies were thwarted by siloed disciplines and the very slow exchange of information and collaboration among their many groups. It was also known that smaller pharma companies and emerging biotechs were grappling with limited resources and generally relied on multiple outsourcers. Back in 2007, this knowledge drove Aptuit to initiate Aptuit INDiGO®, a strategic approach that integrated its preclinical, clinical supply and IND preparation capabilities. With Aptuit INDiGO®, a streamlined, accelerated development track could advance the Active Pharmaceutical Ingredient (API) to IND submission in as few as 26 weeks, much less time than the industry standard.

The unique Aptuit INDiGO® initiative is characterized by four primary elements.

1. Artificial barriers between the drug substance (API) and drug product development are eliminated, merging these into a single track.
2. Modern solid state chemistry processes, such as amorphous dispersions, are employed if needed to increase solubility and bioavailability of the test compound.
3. Quality by Design strategies are undertaken in the earliest stages and throughout the development cycle. This aspect of the process allows for the efficient implementation of strategies for successful drug candidates at each stage.
4. Information for patent filings is established even within this early time frame, maintaining the seamlessness and integrity of data throughout.