Target product profile can shorten development time and reduce costs, experts say
BALTIMORE – Sponsors should make use of a target product profile (TPP) document to summarize the key goals of a drug development program early on, and which can later be used as the basis for a product’s labeling, said two experts at the RAPS Global Regulatory Strategy Conference on 6 March.The advantage of using this document is that they can be used prospectively during drug development and “forces you to look ahead,” said Mark Levi, director of regulatory affairs for RTI International. Both Levi and Xi Yang, a nonclinical scientist for RTI International, spoke on the benefits of TPP and said that this document can assist in a constructive dialogue with regulators.
Submission of the TPP is optional, yet according to a 2017 study, TPPs are "vastly underused" based on a review of Summary Basis of Approvals (SBOAs) for drugs and biologics approved by FDA between 2008 and 2015. Of the 808 approvals during that time, the authors found that only 87 (11%) referenced TPPs. (RELATED: Researchers Link Target Product Profiles to Shorter Review Times, Regulatory Focus 17 April 2017)
Levi said sponsors should start the TPP “long before the pre-IND meeting.” FDA issued guidance in 2007 advocating the use of the TPP, but the guidance has since been withdrawn.
Within each discipline, the TPP summarizes the specific studies that will supply the evidence for each conclusion that is a labeling concept. The TPP can include the product’s indications and usage, dosage and administration, dosage form and strength, and contraindications. The TPP can also include information on non-clinical studies and clinical studies.
Levi noted that the TPP is a dynamic document and can be updated as often as necessary when studies are completed.
He noted that “for an efficient drug developed process, the TPP forces you to think ahead. Don’t wait until you have phase 3 trials going on. Pivotal trials can cost millions of dollars apiece before you go to the TPP to find out what you’re missing. If you do the TPP too late, it becomes a gap analysis.”
He added that a gap analysis can cost an additional six months of development time and $500,000 in toxicology studies.
Yang also recommended the use of the TPP to guide the development of nonclinical studies. This information can go in Section 8 of the drug labeling under the section on “use in specific populations.” Or it can appear in the Section 13.2 of the labeling in the section on “animal toxicology and/or pharmacology studies.”
The nonclinical information can address whether the nonclinical data supports the clinical research or the marketing and identifies which findings are adverse and which are reversible and monitorable.
The TPP can also shed light on the clinically relevant safety concerns and the maximum recommended human dose and whether these findings should be in the Investigator’s Brochure or drug label.
RAPS Global Regulatory Strategy Conference
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