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Don’t Be Afraid! 5 Keys to Successfully Opening an IND

October 30, 2015 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting

As Halloween approaches, many of us go into a role-playing mode and think of the alter-ego we will assume. Superheroes and vampires are common choices and preparing to spend the night in one of these roles can be fun. In reality, not too many of us actually become a superhero or a vampire, so our role-playing stops at the stroke of midnight when the calendar flips into November.

Imagine, however, that this year you decided to become a biotechnology entrepreneur. This choice is not a one‑night fantasy but is a conscious decision to start or join a new, start-up biotechnology company. What will you do when the calendar flips to November? How do you prevent that choice from becoming a horror story?

As regulatory professionals, we usually are not asked that exact question, but we are asked to advise Sponsors on successful ways to move their lead compounds from the bench into the clinic as expeditiously as possible.

Through our experience working with a wide range of companies and on a wide range of projects, we at IMPACT have noted 5 tactics that are critical to the success of a drug development project prior to the submission of an IND.

Attention to these tactics will help you move your projects along in a manner that will assure you of sweet dreams and few nightmares.


Target Product Profile (TPP) – Nearly every successful drug development program uses a TPP. For some Sponsors, the TPP is a well-crafted document but, for others, it is simply an outline. Obviously, the more thought that is put into the TPP, the more valuable it becomes in the development and strategic management of the program.

The TPP should specify the claims which will be in the label when the drug is approved. While this may sound like a fool’s errand (“How is it possible to know what claims will be made when the product is approved in 15 years?”), it is the most essential development tool available.

Successful drug development professionals realize the best drug development programs “work backwards from the label.” The design of the toxicology package, the direction of the CMC program, and the shape of the clinical program need to be in synchrony with one another, and the most effective way to assure that they are is to have a good TPP.

Clinical Development Plan (CDP) – The CDP sets the clinical strategy of the drug development plan by defining the studies needed to achieve the goals of the TPP.

The CDP is a living document that will be fine-tuned over the course of the drug development program; however, at the time the IND is filed, the CDP should contain the overall approach to evaluating the safety and efficacy of the investigational product.

Clinical Trial Material – A long-standing truism among regulatory professionals is that more INDs are placed on clinical hold due to deficiencies in the CMC section than for any other single reason.

This statement underscores the difficulty of designing a product that can be used in clinical studies from a laboratory starting point. The intended use, route of administration, dosage form, strength, stability, and bioavailability of a clinical preparation are critical factors that are rarely considered in the very simple formulations used in early pharmacology studies.

The pharmaceutical development work performed during the pre-IND period must be systematic, thoughtful, and rigorous.

Pharmacokinetics (PK) – The increased ability of drug development programs to provide detailed PK as part of the preclinical toxicology testing program is one of the most striking advances we have seen over the last 20 years.

Even as recently as 10 years ago, many IND packages were submitted with only a minimal understanding of the PK of the investigational drug product. In contrast, most IND packages now include comparative PK from the toxicology studies and often include even more detailed PK data.

These PK data are extremely helpful in defining minimally effective doses, starting doses for the clinical studies, and proposed clinical stopping criteria. We emphatically recommend to our clients that their preclinical toxicology testing programs include adequate PK assessments.

The Pre-IND Meeting – The Prescription Drug User Fee Act of 1997 (PDUFA II) established the FDA-Sponsor meeting process.

Before PDUFA II, Sponsors had no formal interaction with the FDA prior to the submission of an IND and many well-designed programs were placed on clinical hold for unforeseen deficiencies. This type of delay should not happen now.

The Pre-IND meeting is an important opportunity for Sponsors to discuss the preclinical program with the FDA prior to submission of the IND. Any necessary changes or additions to the preclinical program will be identified by the FDA and can be made prior to submission of the IND

Good Will “Hauntings”

A scary alter-ego for a Halloween party can be a lot of fun and we don’t mind being scared when goblins jump out from behind curtains or when we hear a blood-curdling scream at a party. Leading a drug development program, however, should not make your skin crawl. The 5 silver stakes discussed above will ward off preclinical vampires and nightmares!

The experience of the drug development team at IMPACT is extensive. We are ready to help you move your project from the bench to the clinic – so don’t hesitate to contact us. We can’t wait to work with you!

Category: Regulatory Affairs, Drug Development Consulting
Keywords: Target Product Profile (TPP), Clinical Development Plan (CDP), Drug Product, Pharmacokinetics, Pre‑IND Meeting

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