Preparing for Your First IND Submission: The Devil is in the Details - When preparing an IND submission, an open mind and ability to - BioPharm International

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Preparing for Your First IND Submission: The Devil is in the Details
When preparing an IND submission, an open mind and ability to


BioPharm International
Volume 21, Issue 1

TIMING YOUR PRE-IND MEETING

The pre-IND meeting offers an invaluable opportunity to familiarize the FDA with your company, the investigational drug, the benefits and medical need for it, and your understanding of the agency's requirements. This meeting is usually scheduled three to nine months before the IND submission. The closer you schedule it to the actual submission, the more thoroughly you should understand the biological process and possess the data to support it. Conversely, if you think you could benefit from FDA feedback earlier in the process, you should schedule the meeting far in advance of the submission. You could emerge from the meeting with valuable advice about patient populations, additional animal studies, and precisely what the reviewers will be looking for. The agency is accustomed to both kinds of meetings.

In either case, you should have in hand a protocol, a clear idea of the indication for the drug, and GLP animal studies to support the indication. You should also have manufactured the drug under GMP-like conditions for clinical studies, have qualified analytical testing in place, and allow for at least six months of stability studies after manufacture.

REGARD THE FDA AS A PARTNER

Some companies unreasonably dread meeting with the FDA, seeing it as an obstacle whose knee-jerk reflex is to say no. Protecting the public is a top priority for them, but they do so as highly knowledgeable, experienced scientists who may have more knowledge than you about your process. For example, a biotech start-up had included a compound in the downstream purification process to maintain product integrity. During a very early pre-IND meeting, an FDA reviewer asked if such a class of compounds had been used. When the company said yes, the reviewer pointed out that this caused a serious problem. The company removed the compound from the process. Without the pre-meeting and the knowledgeable reviewer, the company would have continued down the wrong path and been stopped later in the process.

CHECK YOUR EGO—AND BUSINESS CASE—AT THE DOOR

The objective of the pre-IND meeting should be to share with the FDA exactly what you have: scientific results, supporting data, and understanding of the quality and regulatory requirements. In addition to supplying the "hard" data, you should also be cognizant of the "soft" side—the quality of your interactions with the agency, especially in this crucial first meeting. Don't be arrogant about the science or argumentative about issues that the agency raises. Because the review panels are assembled on an ad hoc basis, the discussion can sometimes feel like a PhD oral exam, but the intention is to arrive at a clear understanding of the issues. Similarly, the state of your funding has no place in the pre-IND meeting. Stick to the scientific and regulatory issues.

REMEMBER THE GOAL

Having pursued rigorous science from the beginning, created the IND documentation throughout your progress, and benefited from the pre-IND meeting feedback, you are ready to submit the final application with all of its attendant and detailed documentation. Within 30 days of receiving your submission, the agency will either accept your clinical protocol and let you begin trials or it will ask for additional information for review. Even if you have taken great care every step of the way, it is likely that at some point either following the pre-IND meeting or the submission you will have to do some further work—conduct more basic research experiments to better understand your product, develop additional analytical tests, conduct additional animal studies, or modify your clinical design. Such requests are opportunities to fine-tune your product and protocol on your way to an IND that will take you successfully through Phase 2. In fact, the best way to get the most out of the IND submission process is to see it as a way of helping you produce the best product you possibly can.

Conrad J. Heilman, Jr., PhD is senior vice president, and Joseph J. Villafranca, PhD is senior vice president, both at Tunnell Consulting, King of Prussia, PA, 610.337.0820,


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