Does Your Program Need a CMC or CMC Regulatory Expert? Don’t Wait Too Long!

control blog
What to Control; CQAs and CPPs and the Key Variables in the Regulatory Submission
October 27, 2020
breakthrough blog
What It Means to Be “Breakthrough”: The Story Behind The FDA Designation
December 3, 2020

Does Your Program Need a CMC or CMC Regulatory Expert? Don’t Wait Too Long!

einstein image

When a CMC emergency crops up, you grit your teeth, your blood pressure spikes and you pledge to bear down and make the right decision. And that’s exactly why you might make the wrong decision. In today’s biotech industry, (where MONEY and TIME, can make you or break you) it can be harder to bounce back.

When you get subjective about a tough choice, you’re more likely to make a mistake. An independent CMC expert or team of experts can help take emotion out of your decision-making. They can help you create a budget so you have a better understanding of your spending needs. They can also help you form a phase appropriate strategy and even your long term game plan.

The trouble is that many experienced professionals, even those with a strong command of their product and process don’t realize when it is time to call in an outside expert.

But the warning signs aren’t indecipherable. It’s a bit like with the New Year, when people are thinking about resolutions. If you put the same resolution to reach out for help on your list year after year, maybe it means you need help reaching that goal. Here are Five tips for diagnosing when your program could use advice from a CMC or CMC Regulatory expert.

1. Vanishing Resources

What if key resources you had counted on for some relief vanish or never actually materialize as your program matures? That can happen because burn rates can shave down finances for certain non-key departments. If there is a delay in the clinical of safety portion of your program, you may lose budget totally.

2. Authoring a Regulatory Submission

Let’s say you’re about to make an investigational or marketing application submission, and you’ve never done that before. Sometimes problematic or vague guidance’s can apply. Determining the data requirements, for one. Some of your strategy can be pre negotiated. Part of it can be postponed, at a lower cost in money and resources. Are you confident you know what questions to ask?

3. Receive an Out-license Inquiry

Suppose you get an unexpected announcement that there is a suitor or partner. If you invested very little overall or over allocated to the wrong things, your program could present bad curb appeal that could even sour a deal. What now?

4. Limited Budget Approaching a Major Crossroad/Milestone

Perhaps you will soon have to make some decisions, or enter into some agreement with your CMO. You need to line up your budget. Maybe your analytical and process as well. For one thing, your CMO may not necessarily have your long term business plan in mind. How to handle?

5. Hit by a Compliance Issue

There is a cost associated with maintaining regulatory compliance developing a drug. If you fall subject to a compliance issue, but didn’t see it coming, your planning process is likely faulty. A CMC Regulatory expert should be able to help you avoid unpleasant surprises, such as a process that is not scalable, batches that fail or fall out of stability because specifications or methods were note appropriate or justified etc.

On the other hand, an independent expert can also help you avoid gaffes such as spending more than you really need to. A second set of eyes who has seen their share of the atypical and has dealt with it firsthand can be a strong ally. Many people won’t know what to expect or how to avoid the unknown landmines.

Follow our channels!