Target Product Profile

Target Product Profile (TPP) is a new concept to me. However, it may not be a new term at all. Recently, I was asked to review a TPP and I searched the website to find out what TPP means and what are included in TPP. The description of the clinical development programs has to include some information related to biostatistics such as what to measure (primary or secondary endpoint), what the expected treatment difference, how many subjects we need...... Below is a description about TPP cited from a white paper (http://www.diahome.org/content/community/TPP_White_Paper.doc). While TPP is typically used for better communication with regulatory authorities, it may also be used in other purpose. For example, WHO had a TPP for the Advance Market Commitment (AMC) for Pneumococcal Conjugate Vaccines (http://www.who.int/immunization/sage/target_product_profile.pdf).

"A Target Product Profile (TPP) is a document, prepared by the sponsor, to facilitate clinical drug development and enhance constructive dialogue between the sponsor and reviewing Division at the Food and Drug Administration (FDA). A TPP is written and updated during the investigational phases of development in order to capture the goals of clinical drug development as statements of proposed claims for a prescription drug or biologic product. In the TPP, each proposed claim should be annotated to the specific study or other source of data that is intended to support the key sections and statements in the TPP. In essence, the TPP embodies the notion of "beginning drug development with the end in mind"; that is, the sponsor specifies the proposed claims that are the goals of drug development, documents the specific studies that are intended to support the key claims, and then uses the TPP to facilitate a constructive dialogue with FDA."

FDA actually had a draft guidance on TPP (http://www.fda.gov/CDER/GUIDANCE/6910dft.htm)

The garget product profile, if utilized during the development phases, should facilitate labeling discussions during the review cycle. Labeling discussions will be further enhanced if the applicant and FDA provide their rationale for key elements or proposed changes in drfat labeling. To pursue this principle, the applicant and FDA will provide verbal or written rationale for revisions to draft labeling.