Integrating Drug Supply Issues with Strategic Preclinical and Clinical Development

Abstract

The clinical research phase accounts for almost one-half of all the development costs for a new drug. As a result, activities that attempt to coordinate and link the manufacturing, preclinical, and clinical aspects of a program can have a significant impact on the time required to develop a product. There are a number of key activities in each discipline where critical information needs to be shared and activities need to occur in parallel. Since each discipline 's priorities must occur together; synchronous convergence of the activities need to be coordinated. Early in the development process a company needs to consider the market, where the studies will be pedormed, supply requirements and shipping logistics, and how this will all be orchestrated to achieve the end result, an approved product.

Decision-Support Tool for Assessing Biomanufacturing Strategies under Uncertainty: Stainless Steel versus Disposable Equipment for Clinical Trial Material Preparation

“…Nonclinical usage addresses quality control and validation issues, such as the need for in‐process samples, release and stability samples, and retain samples. Projections of investigational product requirements can be made assuming a 25−300% excess over the actual subject usage is necessary for nonclinical uses (Bernstein and Hamrell, 2000). The values selected for the manufacturing product demands were assumed to follow a discrete normal distribution.…”

Modelling biopharmaceutical manufacture: Design and implementation of SimBiopharma

“…Manufacturing issues must therefore be addressed early in the development process to ensure sufficient supplies are produced to the correct standard, enabling deadlines for clinical trials and product launch to be met (Clemento, 1999;Byrom, 2000;Savage, 2000). Bulk drug manufacture must also support additional critical steps, such as process and assay development, stability programs, pre-clinical testing and registration samples (Clemento, 1999;Bernstein & Hamrell, 2000). Manufacturing decisions are further complicated by the need to comply with stringent current good manufacturing practices (cGMP), as well as the unique process validation requirements of biotech facilities.…”