Phase-Appropriate Development: Part#1

FDA-regulated companies are always being told to do more. There are multiple new guidance documents per year, revisions of old rules, new technologies, new tests, new contaminants. It can all be overwhelming. For any company, but especially for early-stage companies, the greatest risk to the program is by doing too much, rather than too little.

Putting in systems that are too advanced or meeting requirements too soon costs time and money and will provide no measurable benefit. FDA and other regulators do not provide “extra-credit” to your application when you do more than needed.

Here are the 5 most common errors we have seen companies make by doing too much.

1. Document Control (ling)

Have you ever been in a 4-hour meeting arguing about whether the document coding system should be SOP-1032, SOP-1032A, SOP-1032_A_1a_Home_Site#1? We have. And this is just the beginning – documentation systems can grow like weeds, choking off the possibility of making the improvements you need to make. A “less is more” approach to documentation, focusing on only the critical essentials can turn what is seen as a burdensome exercise to a flexible, crucial tool that maximizes efficiency in product development.

2. Overthinking analytical requirements

A major source of confusion is what tests are required, when to qualify them and when to validate. A common result is to see full development and validation earlier and earlier in the process, blocking them from change. As a result, companies simply add more and more tests, and more cost and time. Additionally, this creates new regulatory exposure – instead of extra credit, there are more opportunities for aberrant and OOS results. By creating a tight, focused and flexible analytical profile, companies can avoid these traps while obtaining the correct and relevant information about the product.

3. Using processes designed for larger companies

The best people from the best companies work with you. And each one brings process memories with them, such as “Well, this worked when we did it at Large Multi-Billion Dollar Pharma, Inc.” While everyone has the best intentions, this can result in a cumbersome, redundant and burdensome multi-step process. “Right-sizing” systems to fit your phase of development can supercharge the timeline.

4. Too many projects at once

Biopharmaceutical and device/diagnostic development, while high technology, does not have the rapid development cycle that IT has. There are many good opportunities both inside and outside any company, but staff and resources can be stretched thin very rapidly. By having a plan that emphasizes core development, you can maximize the chances for success overall.

5. Too large clinical studies

When finally starting clinical studies, companies want to maximize the return on the effort. A common pitfall is to design too-large or too-complex clinical studies, leading to bitter fights with regulators, extra pre-clinical studies, and more costs and delays. Clinical studies can be designed and focused to get the information that is necessary to advance to the next phase. By right-sizing the number of patients and how the studies are performed, many problems can be avoided up front.

Harmony Consulting can make sure that you are doing the right amount of work and no more! If you find yourself facing any of these issues, give us a call and we can guide you forward to more efficient development.