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Is the TPP for your IND MIA?

You are a small to mid-size biotech company with a molecule you believe has efficacy for the treatment of one or more human disease indications. Your pre-clinical studies appear to have gone well and a suitable, but non-optimized, production process is nearly in place that should generate sufficient drug material to support Phase I dosing studies. Your investors are pushing you to get your molecule into the clinic by filing an IND with the U.S. FDA and/or a Clinical Trial Application (CTA), which contains an Investigational Medicinal Product Dossier (IMPD), for European Medicines Agency (EMA) regulators or both if your management is thinking globally. The multimillion dollar bet at this point is; are you really ready to start assembling the CTD sections of a Phase I clinical trial application?

If you ask us, the answer will be a resounding “no” if you haven’t completed a comprehensive, stage appropriate, target product profile (TPP) review upon which to base your pre-IND regulatory strategy. Many claim there are too many unknowns at this point to possibly generate a useful TPP. From experience, we argue that if you haven’t spent the time to develop a robust TPP as a development management tool, you will surely be overlooking, missing, or underappreciating an issue or issues that will cause program delays and drain available cash as you move forward. Think of the TPP as a dynamic document that provides a clear focus on product development objectives over time. Remember, the landscape is littered with biotechs with good molecules that crashed and burned for lack of a well-thought through regulatory strategy.

At a minimum, you need to perform some competitive intelligence scouting as part of the TPP exercise. A TPP should include a search for information on clinical trials of drugs targeting the same indication. You need to know as much as you can glean from this site in order to evaluate your strategy. For example, if you think your drug will be administered by injection, and someone is already in clinical trials with an orally administered drug, you need to consider the implications related to mode of administration now, not later.

We also recommend you review the relevant FDA Advisory Committee documents to garner information about how the Agency is evaluating drugs targeting your indication(s) of choice or drugs having related modes of action. These committees provide independent expert advice to the Agency. The information provided by industry and the FDA to the various committee’s is available to the public.

If you are thinking about global markets, we recommend you include a review of the European Public Assessment Reports, (EPARs). EPARs are published by the EMA for every medicine granted a central marketing authorization by the European Commission following an assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Beg, borrow or steal the time and resources to put a solid TPP in place before preparing your IND or IMPD. The effort will pay dividends over the life cycle of your product. The first payback will be a clear, well written IND or IMPD that will be accepted by the regulators and launch your clinical trials.

In a future post, we will present our thoughts on how to create project and document management tools for generating your IND or IMPD application. Be sure to subscribe to our RSS feed so you don’t miss it.


Blog article by: Al Doig and Taylor Burtis

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