Drug development timeline

Many proactive QA measures can and should be installed during all phases of clinical trial activities, such as ensuring that assays used throughout the trials are properly developed and used clinical trial materials are adequately manufactured, packaged, and labeled appropriate communication between research personnel and other clinical departments is maintained and most important, creativity and flexibility are balanced with reasonable drug development timelines. 

Fig. 1 New drug development timeline. (From FDA Consumer Special Report on New Drug Development in the United States, U.S. Food and Drug Administration, Rockville, MD, January 1995.)...

FIGURE 10.3 Schematic of typical drug-development timeline overlaid with points of entry and applications of metabonomics technology. Relative availability of bulk drug is indicated by mass designations (mg, g, kg quantities). (Reprinted from Robertson, D.G., Toxicol. Sci., 85, 809, 2005. With permission.)... 

Because of the accelerated drug development timeline, the procedure used in the final process development piloting campaign was transferred to the production unit virtually unchanged. Only minor modifications to the existing production equipment were made to address electrical code requirements. 

The two key elements of any biotech story are the importance of the medical need and the rationale for why this idea is likely to work when previous efforts have failed. While the time value of money should theoretically be important, given the long timelines for drug development, in practice estimates of successful drug valuations and technical risks usually overshadow the risk-free time cost of money. 

These plans envision composition-of-matter patents on drug molecules for which development timelines and market potentials can be estimated. Product stories are the clearest, most rational plans because profitable sales can be projected and rNPVs calculated. On the other hand, investors usually perceive higher risks because the rNPVs tend to be dominated by single product candidates for which historical failure rates are high. Examples of product stories include Amgen s development of Epogen and Amylin s development of Symlin. 

Steps 1 to 6 are usually referred to as drug discovery, while steps 7 and 8 are referred to as drug development. The timeline for each of drug discovery and development can be as little as 4 years and as much as 7. 

As things stand today, there are no shortcuts in drug development, regarding neither the overall development time—typically 12-15 years—nor the early identification of dropouts. The pharmaceutical industry will continue to have to contend with failure rates and timelines to bring products to market exceeding industry standards by far. 

Figure 3.10 The drug development process. The timeline for drug discovery and development is long, adding to the high cost of drug development. Computational methods have helped to shorten this timeline.

When should stress-testing studies be performed in the development timeline for drug substance and drug product ... 

Accelerated drug development schemes have shifted the need for analytical instrumentation to include criteria for high throughput (quantitative process approaches) and the capability to contribute to an application that produces information for accelerated decision making (qualitative process approaches). The value of sensitivity, selectivity, and detail are still significant however, new parameters dealing with efficiency, productivity, and information content have become the new watermarks for analytical instrumentation in the pharmaceutical industry. These factors have been affected by shorter timelines and the pharmaceutically relevant information required for decision making. 

Excipient and vendor selections can greatly influence the new drag development timeline, product performance, and acceptance of final products. Compendial excipients have composition consistent with monographs published in compendia such as USP-NF these are the better-characterized excipients. These excipients most likely possess desirable qualities and are preferred excipients for pharmaceutical formulations. Non-compendial excipients can also be used for drug products if they are supported by Type IV dmg master files (DMFs) in regulatory dossiers. Overall, a good excipient supplier should 29... 

Preparing a detailed drug development plan, including designation of key points or development milestones, generating a timeline for completion, and defining the critical path... 

One of the primary functions of the project team is to coordinate the various studies necessary for the successful development of a drug candidate and to ensure that the timeline for development is on schedule. As mentioned above, this coordination is usually accomplished by preparing a detailed drug development plan and monitoring the research process. The required studies and the extent of the development plan depend on four criteria of the proposed drug candidate, which are ... 

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