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Target Product Profile Development

Creating the strategic blueprint guiding development to deliver patient value.

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An analysis demonstrated that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

The global effort to develop and distribute a SARS-CoV-2 vaccine in months is a triumph for the pharmaceutical industry. It is also unprecedented. Never in the history of drug development has a proposed vaccine gone from concept to regulatory approval in a matter of months.

A key tool in that effort was a Target Product Profile (TPP) for COVID vaccines. Shortly after the discovery of the virus, the World Health Organization, in consultation with various stakeholders such as the manufacturing and scientific communities, developed a TPP for COVID vaccines. It laid out the roadmap for developing the vaccine and the acceptable criteria to be met to protect patients from the devastating effects.

As the name suggests, “Target Product Profile,” also known as the TPP, refers to the targeted or intended profile a pharmaceutical/biotechnology product or technology. The profile provides the product’s desired characteristics or features defining the value proposition, and key differentiators aimed at providing a competitive advantage to the product.

The TPP is a dynamic multidisciplinary strategic development process tool embodying the notion of beginning with the goal in mind.

A detailed target product profile, when created early in the development program and updated as new information becomes available throughout the drug development process, can be extremely helpful in mapping out the strategic marketing and scientific pathway.

The target product profile is utilized on multiple levels in an organization

Blueprint for drug development

Shared vision and strategy in company

Business tool to determine asset value and capital needed

Critical path tool with regulatory agencies

Early drug discovery compass

Define the key quality attributes for manufacturing

Foundation for commercial value

Early evaluation for reimbursement

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