This past week during the American Society of Gene and Cell Therapy’s Annual Meeting in Washington DC, Akron’s Claudia Zylberberg participated on an industry panel, alongside a host of other industry experts, on Target Product Profiles.
For those not familiar with the topic – what are Target Product Profiles?
It goes without saying that every commercial drug approved by the FDA comes with a label and directions for its use. What is communicated to the patient through these is the result of a long development process, throughout which the drug product has gone through multiple iterations – due to both developmental as well as regulatory constraints.
Requirements for a particular drug change throughout the development process. Communicating such specifications to the various development teams is important, yet can be difficult.
A document called the Target Product Profile (TPP) exists for that reason – to provide informations on the drug’s requirements and specifications for every stage of the process, from development, to pre-clinical, and clinical studies, through to the formulation and drug product characteristics.
It is an extremely useful document that provides information and focus to the research and development teams and can, if used correctly, prevent late-stage development failures. It has tangible endpoints. It is also used as a communication tool that reflects the development company’s, manufacturing and regulatory agencies’ requirements for a particular drug product, and can track changes throughout the drug’s development timeline.
Target Product Profiles are defined in FDA’s Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool, issued in 2007.
A full TPP can include up to 17 different sections. Typical sections for a therapeutic product include:
- Indications and usage
- Dosage and administration
- Adverse reactions
- Storage and handling
- Clinical pharmacology
- Non-clinical toxicology
- Clinical studies
- Warnings and precautions
The FDA encourages companies to submit TPPs as a part of their Briefing Documents during all steps of the drug development process.
A TPP should, ideally, be developed at the early stages of the drug development process and kept up to date throughout the entire process. It is a “living” document, one that changes as the drug moves through the various development stages.
A helpful webinar on TPPs given by the FDA can be found here.
For more questions on TPPs, contact us and we’ll be happy to talk.