White Paper

Strategies for Accelerating the Development of Modified Release Oral Forms

Tuft’s Center for the Study of Drug Development partners with Quotient Sciences for study on Translational Pharmaceutics.

  • Dr. Joseph DiMasi
  • December 16, 2019

Quotient Sciences recently announced that the Tuft’s Center for the Study of Drug Development (CSDD) published a white paper on our Translational Pharmaceutics platform. The results of the Tufts CSDD study showed that when compared to traditional development paradigms, Translational Pharmaceutics can reduce development times by more than 12 months and create total financial benefits of more than $200 million per approved new drug.

This month we caught up with Joseph A. DiMasi, Ph.D., the principal investigator of the study and the director of economic analysis at Tuft’s CSDD. We wanted to find out a little more about the CSDD, his experience, and the research and methodologies that went into this important analysis of Translational Pharmaceutics.

Our Q&A with Joseph DiMasi:

Question: Can you tell me a little bit about your background and your role at the Tufts Center for the Study of Drug Development?

Joseph: I have a Ph.D. in economics, and my research focus has been on the economics of drug development. Specifically, I have been the principal investigator for a series of studies that establish benchmarks for new drug development, costs, risks, and durations. I have also examined drug development competitive dynamics, drug pricing, and new drug development rates of return on investment.

Question: You and your team have extensive experience analyzing R&D trends, costs and innovations in the pharmaceutical and biotechnology industries. Can you summarize what you see as the “norm” for drug developers today?

Joseph: The landscape for drug development is far more complex today than when I first started investigating the pharmaceutical industry over three decades ago. At that time, drug development was dominated by several dozen firms who generally conducted nearly all development activities in‐ house. Now, outsourcing of preclinical development, clinical trials and manufacturing is widespread. In addition, licensing‐in investigational compounds and joint development with other firms has become much more common. The industry has also developed strong relationships in discovery and development with academia and non‐profits. I expect that the use of CROs and CDMOs will continue to grow and that risk‐sharing arrangements between drug sponsors and these organizations, as well as with academic medical centers and non‐profits will expand.

Question: What was your interest in studying Quotient Sciences and assessing the economic impact of our Translational Pharmaceutics platform?

Joseph: Since the founding of our Center in 1976, we have had an abiding interest in assessing the effects of legislative, regulatory and industry‐driven initiatives to improve the efficiency of drug development. Therefore, examining the economic impact of platforms that have the potential to improve R&D efficiency by speeding up the development process and bringing new therapies to patients sooner fits well with our mission.

Question: Can you talk about the methodology that went into completing this study?

Joseph: We conduct periodic research on the cost, risk, and duration of new drug development for standard drug development paradigms. This gives us benchmark results for the entire process from discovery to regulatory marketing approval. Similarly, the published economic literature provides data on average net revenues attained by new drugs over their product lifecycles. Given the framework provided by these studies, we can model the financial impact on drug sponsors of the widespread application of new approaches that can shorten development times during any part of the process. In this particular case, the assumption is that flexible dosing design and real‐time manufacturing results in the initiation of pivotal trials sooner, on average, than is the case for traditional drug development programs, while also assuming that the length and out‐of‐pocket costs for development phases remains the same. The benefit, then, is derived from reductions in times costs (the cost of the delay between when R&D investments are made and when returns can be earned), and from earning sales sooner than is otherwise the case.

Question: Can you describe the results that were garnered from your study and the significance of these results?

Joseph: Data on the duration of 19 completed Translational Pharmaceutics projects were compared to benchmark durations as determined by independent industry consultants for three types of drug product development programs (first‐in‐humans to proof‐of‐concept, modified release formulations, and enhanced solubility formulations). This analysis suggested time savings for the three types of projects of, on average, between 12 and 15 months. The model developed by CSDD indicates that time savings of this magnitude in initiating pivotal trials results in total financial benefits on the order of $200 million in total from lower time costs and increased net present values of net returns per approved new drug when applied across a broad portfolio of investigational drugs and all indications pursued. Financial benefits will be lower or higher if the time savings are lower or higher than these estimated averages. The model indicates total financial benefits of approximately $17 million per approved new drug per month of reduced development time.

Thank‐you to Joseph and his colleagues for contributing to this blog article.

 

If you’d like to learn more about Translational Pharmaceutics please contact us today. You can also read the white paper by downloading a copy of it here.

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