Reducing Development Timelines and Costs

Joe DiMasi, director of economic analysis and research associate professor, Tufts Center for the Study of Drug Development (CSDD), discussed research into the impacts of working with single source contractors with Pharmaceutical Technology.

PharmTech: When will the full results of the study be published?

DiMasi: We expect the full study to be published shortly. Currently, we are making minor changes to the paper in response to peer reviewer comments. 

PharmTech: Did the analysis also take into account the costs due to potential risks that might result from relying on a single vendor (e.g., when special products are involved and an outage or compliance problem develops at a contract manufacturing organization? [CMO] facility)? If not, are there plans to address this issue in subsequent work on this topic?

DiMasi: We acknowledge that there are potential risks, but we had no way of quantifying them for the study.

PharmTech: Did you see differences in time reduction for small- versus large- molecule development?

DiMasi: With the caveat that the sample size is small, there actually was, on average, no appreciable difference in time reduction between small and large molecules. The mean time reduction for the monoclonal antibodies (mAbs) is 14.3 weeks, while the mean time reduction for the small molecules is 14.1 weeks.

PharmTech: Why was the time reduction so notable in Phase III compounds, particularly mAbs? 

DiMasi: The time reduction was somewhat above average, but it was mostly a structural aspect of the model with regard to R&D costs. The model assumes that clinical testing for a phase for which manufacturing is contracted with a single vendor can begin sooner than otherwise. That brings ultimate approval closer on the timeline to testing of the earlier phases. So, the model yields lower opportunity costs for all earlier phases. The later you are in the process, the more that earlier phases are affected.

PharmTech: What are your plans for continuing this research?  What additional factors and economic issues will be examined?

DiMasi: We hope to expand the analysis to obtain data on more projects, which will serve to validate our initial analysis and allow for a comprehensive analysis of key variables of interest, such as molecule type, route of administration, and therapeutic class.

PharmTech: Why didn’t the concept of single-source manufacturing take off in the 1990s when the programs were first introduced? Were there any flaws in the basic business models and have they been addressed since?

DiMasi: This is a point that came up in interviews [with subject matter experts] for this research.  The early efforts may have been more ad hoc, and outsourcing companies may have lacked the comprehensive capabilities needed to carry through effectively.

PharmTech: Small-to-mid-sized pharma companies are using single vendors, but large companies might also benefit from leveraging them to achieve improvements. Why haven’t more large pharma companies embraced the concept, and what would be needed to change their established point of view?

DiMasi: Large companies have the resources to keep this entirely in-house. On the other hand, they also have the resources to better manage and leverage their outsourcing activities, and thus to optimize the advantages of single-source manufacturing if they do outsource.

Article Details

Pharmaceutical Technology
Supplement: Partnerships in Outsourcing 2018
February 2018
Pages: s31

Citation

When referring to this article, please cite it as A. Shanley, “Reducing Development Timelines and Costs," Pharmaceutical Technology Partnerships in Outsourcing 2018 Supplement (February 2018).