If you’re a clinical-stage company still waiting for FDA approval, the compliance hurdles you face are comprehensive—especially with the Drug Supply Chain Security Act (DSCSA) serialization deadline for manufacturers coming in November. Getting ready for both commercialization and serialization at the same time requires a significant investment in staff, infrastructure, and support.
To navigate the industry sea change, many Phase 3s are turning to
Are most Phase 3 companies aware of DSCSA requirements, including serialization?
To be honest, DSCSA is catching a lot of clinical-stage companies by surprise. Most are focused on their clinical processes and
Are these Phase 3
pharmas starting their serialization planning before they get FDA approval?
Most companies start their planning efforts prior to
How do Phase 3 companies work with CMOs/CPOs and 3PLs?
Once you get a product approved, you’ll be performing business processes as a virtual manufacturer. Without facilities, the product is manufactured and packaged by a CMO or CPO, and picked, packed, and shipped by a 3PL 99% of the time. Connecting to trading partners is much harder than connecting to your own site, so don't underestimate the effort it requires. More importantly, make sure your trading partners are as prepared as you need them to be. Many times, we see they're not ready—especially the smaller specialty
How can Phase 3s address the technical challenges of serialization?
Phase 3 and virtual companies understand the immense challenges but they don’t have the technology infrastructure or IT team to know how to set up and manage data exchanges, how to get their file formats correct, and all the other complex details. That’s why many of them look to a skilled solution partner for help.
Do you recommend aggregation for Phase 3 companies?
I would absolutely suggest implementing aggregation at the onset. There are other things to worry about, like launching your second,
Most Phase 3 products are biologic, anti-cancer-type drugs that are high-dollar, low-volume products. In the grand scheme of things, serialization is not going to be that expensive. Don't try to cut the minimal expense at the risk of having issues a year from now.
Why do you think Phase 3 companies are taking such a proactive approach to serialization?
The virtual and Phase 3-type companies are focused on their product
What’s your advice to companies that might not be ready by the November deadline?
The real message is don't stop working. Make sure you have a strong plan, so even if you're not live and the FDA walks in your building, you can show them a plan, and the fact that you're on your way to completion.
Once companies achieve compliance, are they done?
Compliance needs to be an ongoing focus. You can be out of compliance 30 days later if your software isn’t updated. Our message is simple: work with a partner who will help you stay consistent on software releases so you get all the newest functionality to meet the changes in the regulations on an ongoing basis.
Greg Cathcart is the CEO of