No one has an ugly baby.
At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. The unfortunate fact is that there are ugly babies. We’ve all been in the position of looking at someone’s baby and biting our tongue because we know that their baby isn’t as beautiful as they think it is.
And that’s appropriate. Because niceties need to exist when talking about a real baby. Such tact isn’t useful when discussing drug development.
Your baby is your drug. If your development program is ugly, even just a little bit, brutal honesty from your advisors is necessary. Your regulatory consultant should never bite their tongue. They should tell you what needs to be, and they should do so early and often.
Sure, the truth hurts. But, hearing the truth and figuring out what to do about it can save you time and money, and possibly lots of both.
The Pressure to Succeed Can Create an Echo Chamber
Time and money are always top priorities for sponsors.
This pressure on a drug development program to succeed sometimes causes the sponsor to minimize important factors and data during the development process. This stance can lead to wasted effort, the wrong path and lost opportunities to succeed.
For instance, in an effort to shave time off their study, a sponsor might decide to submit their NDA with only six months of stability data. They are doing this with full knowledge that, according to FDA guidance, sponsors are required to submit 12 months of stability data.
The top-down pressure to succeed from within the organization may make the sponsor decide that waiting another six months is too long. In their own echo chamber, they’ve convinced themselves that they have an acceptable product that they will present to the FDA, and that the FDA will allow it to proceed, or even approve it. The developers may hold onto this belief despite knowledge to the contrary, talking themselves into believing what they want. In other words, they have an ugly baby and they have no one there to tell them otherwise.
That’s what a good regulatory consultant can do for you. A great regulatory consultant will not only tell you that your baby is ugly, but will also tell you what you can do about it.
It’s Always Time to Hear the Truth About Your Baby
Sponsors need to hear the truth about their drug development program as early as possible. They also need to hear the truth as frequently as possible throughout the development continuum. That’s because knowing the truth can save time and money.
Hearing the truth early in the process helps the sponsor make any necessary changes to their program. Depending on what is wrong with the program, they can work with their regulatory consultant to fix the problem and guide the program towards a trajectory that has a higher probability of success when presented to the FDA.
Hearing the truth late in the process can create nightmares. The program may be so off-course that getting it back on-track may mean spending more time and millions of dollars in order to do things like change protocols, change the program’s design, or conduct more, longer, or bigger studies.
Furthermore, the program may have already gotten so ugly that there is no way to salvage it. As such, if a program needs to be terminated, it should happen as early as possible. The more time that passes, the more money has been spent, and the drug asset becomes more valuable. Late in the game is not the time to hear the truth; especially if the truth results in the loss of a once-valuable asset.
How Beautiful is Your Baby?
To many sponsors, their baby is beautiful and utterly flawless, even though there is evidence to the contrary. Our job is to come in and perform an objective analysis from an external party that may result in us telling them that their baby isn’t so beautiful after all. But our work doesn’t stop there. It is also our job to explain the reasons why the sponsor’s baby isn’t flawless so that they can make the changes necessary to get their baby approved by the FDA.
Fortunately, we do get to tell sponsors that their baby is objectively beautiful. One of the ways that we provide added value is when we can reassure sponsors that they are on the right path and should expect positive outcomes at the FDA.