With drug makers facing mounting development costs, especially for expensive and time consuming oncology research, and tighter budgets companies are increasingly seeking to improve efficiencies.
AZ has now published research in the Journal of Clinical Oncology detailing its attempts. The researchers claim that by altering administrative processes the first patient was enrolled 48 hours after the US Food and Drug Administration (FDA) approved the initial new drug (IND) application. In other trials this has taken up to six months, according to the researchers.
The work was performed by a strategic alliance, which consists of AZ and MD Anderson Cancer Center, that identified the initiation of Phase I trials as a bottle neck in the development of oncology drugs and attempted to improve this step.
To achieve this the partners focused on administrative process, which are handled separately in many drug development alliances between academia and industry, according to the researchers.
Parallel operations
Each party has different timeline priorities, for instance industry must prepare IND documentation and academia has to submit information to institutional review boards (IRB). Approaching these timelines independently can result in delays that could be avoided by greater cooperation.
In particular the partners identified the timing of two events as critical to improving efficiency. Firstly, the researchers changed the standard practices of protocol review by the principal investigator and academic centre regulatory bodies.
Both parties worked collaboratively to develop the protocol and the final draft was shared with MD Anderson’s principal investigator before submission to the FDA. Furthermore, the MD Anderson IRB reviewed the protocol before IND approval.
Conducting the IRB and FDA reviews simultaneously eliminated delays associated with waiting for IND approval. The researchers regard this as a key aspect of Project Zero Delay.
Further gains were made by focusing on the timing of the trial preparations. Personnel from AZ and MD Anderson inspected the site before the FDA approved the IND to improve efficiencies.
In addition AZ completed the administrative steps associated with drug shipment in advance. By doing this the therapeutic was available shortly after the FDA and IRB approved the trial.
The research paper’s abstract is available here.