All About RegCMC: Q&A

RegDev recently expanded further into the Regulatory Affairs space with a new Regulatory CMC (Chemistry, Manufacturing, and Controls) expert Carla Hekman . Her goal is to help subject matter experts create a strategy specific to the chemistry, manufacturing, and control (i.e. analytical) aspects of drug/biologic development that will ensure regulatory requirements are met and that the CMC data package compiled over the course of the drug/biologic development will be complete and sufficiently strong to ensure health authorities that the drug/biologic can be consistently manufactured in a manner that the quality expectations will be met.

Keep reading to learn common pain points Carla sees companies struggle with and what the future holds in the RegCMC space.

RegDev: Hi Carla we are excited to have you on the RegDev team! What do you love most about working in RegCMC?

Carla: I was at a conference once where a panel of regulatory health authorities from several countries were presenting.?One of those panelists said something that has always stuck with me:?“As the sponsor, it is your job to understand your product.?You need to understand the process, where the weak points in the process are, fix or mitigate those weak points, and demonstrate that you can produce the same quality product with every run.?Don’t wait for us to find those failure points for you.”?I think watching that scenario develop is what makes RegCMC so much fun.?

I enjoy working with teams from the time when we are all scratching our heads wondering, “What happened that time” to the time when we can say, ?“YES!! We know how to manufacture this drug in a controlled fashion.?We know how it degrades and under what conditions, what impurities are present, where they come from and how to measure them.”?I also love putting it all down on paper so it is clear, easy to understand, and solidly supported.

RegDev: What are the common RegCMC pain points for companies?

Carla: In my experience, the pain points change as development proceeds.?At the pre-IND stage, the challenges revolve around ensuring sufficient manufacturing and document control to make those first batches for non-clinical and Phase 1 clinical studies and assembling that initial IND.

As development proceeds, I have seen companies struggle with how to develop their IND in a way that allows flexibility to change the manufacturing/analytical aspects that are still developing while convincing health authorities that the safety and quality of the products manufactured have not been compromised.

RegDev: What types of support do biotech and pharmaceutical companies need in the Reg CMC space?

Carla: Biotech/Pharma companies can benefit from RegCMC support from pre-IND all the way through to a registration study and postmarketing.?RegCMC can help the technical teams understand and build in flexibility early in the program, when aspects of CMC are changing rapidly, and then build in controls as development progresses and critical control points are identified.

Even after a product is approved, CMC changes will often still be required or desired by a company. ?RegCMC can work closely with the technical team to build a solid, defensible package that is approvable and assures the health authorities that manufacturing is still under control and quality product will continue to be produced.

RegDev: How do you think RegDev can make a difference in the RegCMC space?

Carla: RegCMC as part of RegDev can fill a gap for both pharma and biotech companies that either aren’t ready to hire a full time RegCMC person, or who have a particular project they just aren’t staffed up to complete.?For example, we can help draft the CMC sections for an initial IND, update the CMC information in an IND as development moves into a new phase, help plan out and project manage the CMC module(s) of an NDA/BLA, draft an FDA meeting briefing document, conduct a risk assessment, conduct an NDA/BLA gap analysis, or map out a strategy to get from manufacturing for clinical trials through to process validation.

We are here to help and then step back once that extra set of hands is no longer needed.

RegDev: What do you see in the future of this area?

Carla: Gene and cell therapies are now coming online as major players.?In addition, Guidances are now available from health authorities to help direct the development of these therapies.?These exciting new therapies hold great potential for treating patients with diseases that are currently uncurable.?I look forward with great anticipation to being able to contribute to those products.

What other questions do you have about Regulatory CMC? Add them below!

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