Here at the Camargo 505(b)(2) blog, we are adding a new voice to mix in with the technical writing. These candid takes will be given by our experts in drug development and sprinkled in with the usual fare. Camargo Counsel is a venue for straightforward talk and advice related to drug development and 505(b)(2).
With that, we begin Camargo Counsel:
The Cost of Wrong
At the risk of dating myself, Fram® Oil Filters had a television commercial with a timeless message which is applicable to so many areas of life. In my mind’s eye I can still see and hear the mechanic wiping his hands with the towel, picking up the oil filter and saying with a shrug, “you can pay me now, or you can pay me later.” The cost of not taking care of your car is quantifiable … major repair or replace the car.
It is interesting that more than 40 years after I first saw that commercial, it still resonates with me, especially when I am speaking with incredibly intelligent, forward-thinking drug developers who are in situations where the cost of not doing it “right” can have huge consequences.
Wrong, as Defined for Drug Development
The cost of doing it wrong in drug development simply defined is: the increased or unnecessary cost of development, increased time to approval, or both. These costs can be amplified in 505(b)(2) drug development because the (b)(2) regulation is in place to limit the requirements for drug development. Not taking full advantage of these strategies is as sad as that mechanic seemed to be all those years ago.
Some common activities and decisions that increase the cost of doing it wrong are:
- Choosing the wrong or less optimal Listed Drug can increase the cost of development or cause delays in approval due to patent issues.
COST: $$$ and time due to running studies that did not need to be run. Time and $$$$$$ due to a 30 month stay in the review or waiting for a patent to expire when there may have been a different strategy that could have been employed.
- Running studies (nonclinical or clinical studies) prior to discussing the development program with the FDA can increase the cost of development since the study on which you have spent your precious money may not be useful or as useful in the approval process as it could have been with some slight changes.
COST: $$ due to running studies that did not need to be run or $$$$ and time having to rerun studies since the completed study was not optimally designed.
- Taking the wrong strategy to the FDA in the Pre-IND meeting can increase cost, time or both for drug development. Many sponsors underestimate the criticality of the Pre-IND meeting, especially when developing a 505(b)(2) drug and thus believe that any consultant will work out and that “as long as we are close, then we will be fine.” It is important to understand that FDA can only react to what you have provided and the questions you have asked in the Pre-IND meeting request letter and meeting package. It is equally important to understand that once FDA has put something in writing (requirements for drug development), it is not that simple to get the Agency, investors, or potential partners just to ignore what has been previously written in the regulatory record by the FDA as official minutes (although Camargo has been successful doing this a “pay me later” price).
COST: $$$$$ and time due to running studies that did not need to be run. This usually means lost credibility with the FDA due to applying the wrong strategy. Other times, it can be too aggressive and not supported or too conservative and running a larger development program than is necessary.
The Results of Wrong
No pharmaceutical company, no matter how large, can afford to do it wrong. The cost is simply too high. My expert recommendation (and that of the Fram Oil Filter mechanic) is to take care of your valuable asset and do it right the first time.
So, how do you do it right? Here are some simple concepts:
- You get what you pay for. In other words, find a consultant or partner that has done it before, recently, and has a good track record of successful strategy development and interactions with the FDA. There are no guarantees around the size of the development program that will be required, but there are clear consequences of not doing it right.
- Value is critical. Monetary price is not the only consideration. With proper strategy implemented, the monetary price tag will likely be less than without it. Consider that the elimination of one nonclinical study that would have otherwise been conducted or one clinical trial or getting to the market 6 months earlier than expected is of significant value and outweighs the cost of the services of an appropriately experienced consultant.
- Culture can make or break a relationship. Consider that a consultant that has other business objectives may be limited in the strategy development and that you may “get lost” in the enormity of an organization, you may not get the right attention (everyone reading this knows what I am talking about when I say, “you don’t want the D-team.”)
Our Experience with Those Who Have Employed Wrong
At Camargo, we have had sponsors who need help come to us after the initial FDA interactions. We can have some effect on this outcome, but not the full effect that we could have had if we had been involved from the beginning. We have had sponsors shy away from us due to perceived cost and then come back again when their program is in jeopardy. And we have sponsors who want to take full care of their asset and make a conscious decision to minimize the total cost of development and avoid the costs of doing it wrong by working with our Camargo team, with experience in leading more than 1100 Agency meetings. Ultimately, as the oil filter commercial implies, you can pay a little now or you can do it wrong and pay a lot more later.
Contact us to learn more about working with us and doing it right.
Author: K. Gary Barnette, Ph.D., Senior Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services