Related Experiment Video
Updated: Dec 19, 2025
10:43
Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
Published on: June 27, 2014
20.4K
The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and
Joseph A DiMasi1, Michael Wilkinson2
1Tufts Center for the Study of Drug Development, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA, 02111, USA. joseph.dimasi@tufts.edu.
Therapeutic Innovation & Regulatory Science
|June 6, 2020
Summary
Accelerating drug development with an integrated platform significantly boosts financial returns for pharmaceutical companies. This approach enhances innovation incentives by reducing time-to-market and maximizing intellectual property protection.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Health Economics
Background:
- Faster drug development accelerates patient access to novel therapies.
- Reduced development timelines offer significant financial advantages to drug developers.
- Integrated platforms can streamline early-stage drug development processes.
Purpose of the Study:
- To quantify the financial gains associated with accelerated drug development using an integrated platform.
- To compare the financial impact of an alternative early-stage drug development paradigm against traditional methods.
- To provide a real-world financial analysis of quicker drug development.
Main Methods:
- Utilized data from a drug development and manufacturing services organization for 19 drug product development projects.
- Estimated development time reductions for three key activities: first-in-human to proof-of-concept (FIH-PoC), modified release (MR), and enhanced solubility (ES) formulation development.
- Established a traditional drug development paradigm as the base case for financial impact assessment.
Main Results:
- Integrated development model yielded substantial financial benefits compared to traditional methods.
- Estimated after-tax financial benefits per approved new drug ranged from $230.5M-$290.1M (FIH-PoC), $196.4M-$247.5M (MR), and $102.6M-$275.5M (ES).
- These financial gains are realized through reduced time-to-market and extended intellectual property protection.
Conclusions:
- The integrated drug development model demonstrates significant financial advantages over traditional approaches.
- Accelerated drug development translates directly into enhanced financial returns and innovation incentives.
- This paradigm shift offers a compelling strategy for optimizing drug development investments.
Related Concept Videos
01:11Clinical Trials: Overview
4.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.4K
01:28Preclinical Development: Overview
5.6K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.6K
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
141
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
141
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
119
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
119
01:10In Vitro Drug Release Testing: Overview, Development and Validation
203
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
203
01:20Drug Product Performance: In Vitro–In Vivo Correlation
157
In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
157