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Getting To and Through FDA with Jason Mercer

We recently caught up with Jason Mercer, Strategic Program Champion at Facet Life Sciences about what it is like to work at facet and some of his favorite milestones.

Favorite Projects

One of my favorite projects was a combination product; a very unique drug paired with a medical device. Even the folks at FDA were not sure how to classify and how to exactly put this into a scheme for approval. It took about two years to get the product approved, but of course we worked with the company for three or four years before approval by helping them get clinical trials set up and ultimately wrote the NDA for them.  We also helped walk them through the process of the NDA review.

There was another project with a complete response letter, which is a negative thing for a company because it means you didn’t get approved. We were able to help them work through the issues and work with the FDA to ultimately get an approval on the second round. That was a really, really interesting and unique product that was very much the cutting edge of medicine. The types of products we work on are often things that even the FDA hasn’t even seen before.

I’ve continued to help the unique drug/medical device company as they launched this product and am actively reviewing their advertising and promotion materials.

The unique products are always the fun ones. We are working with a company that has a psychedelic compound that they’re studying in the psychiatric space. We’ve helped them to get going with their initial clinical trials. We’ve helped them to write the IND, file it, and work with the FDA during the review and eventual clearance of that IND. This company has just completed their first phase one clinical study and are planning for the next steps as they go forward in a very exciting space.

What Kind of Companies Does Facet Life Sciences Work With?

We really focus on smaller companies. Small could mean anywhere from two or three people to 20. What I find is that these tend to be the risk takers and the ones that are really at the forefront of medicine, willing to go after those targets that might not be just the obvious things but are often the products that move medicine forward.

Usually there’s a scientific founder involved. Sometimes it’s an investment founder who’s partnered up with scientific folks.

Maybe they’re a clinical expert and they’ve done work from within a company as a clinical person, but they haven’t really experienced what it takes from the regulatory side. Other than maybe a couple of meetings with the FDA, they haven’t really been through the process of writing an application and responding to the FDA questions and that sort of back and forth, and considering some of the side issues that come up that may be out of their area of expertise.

People in these small companies wear all the hats and even share them sometimes. It’s not unusual to be meeting with the CEO and the Chief Scientific Officer and then one other person, because that’s the whole company. We’ll oftentimes be working side-by-side with third parties from other disciplines. Sometimes those third parties are partners of Facet’s – folks that we work with on a regular basis that we’ve introduced to our clients to help fill a need that company has.

Small companies tend to be very passionate about their products. They tend to want to move fast because this is usually cutting-edge medicine and there’s usually some special motivation for getting the treatment out to folks. We’re pretty intense about looking for ways to make the pathways efficient for them.

What Do You Like About Working at Facet Life Sciences

This is a fun place to work. There’s a lot of really interesting cutting-edge science and medicine that we get to work with that you might not get to work with if you’re working, for example, within a sponsor company.

We’re a small team. We work closely together with each other. Within our internal team, there’s a lot of camaraderie and, and people are just fun to work with and easily accessible. We’re all virtual, but we definitely do the one-off “Hey, can you help me answer this question?” video chats. Everyone is very collaborative and very much available and on board with helping each other and getting to solutions by collecting our expertise together on questions for the client. That is what makes it a great environment to work in.

Our team has a lot of what I call ancillary experience as well. We work primarily within the regulatory space, but we’ve got folks who have backgrounds in quality, backgrounds in in CMC or manufacturing formulation. There are varied experiences to draw upon that might not be always directly applicable day-to-day but, they help to answer some of those one-off questions that sometimes you just have. “This isn’t really regulatory, but have you ever experienced this?” Because again, when you’re working with small development companies, they’re wearing all the hats within their company, and sometimes they just need people who’ve got some experience in a space to say, “Here’s some experience add the equation that you’re trying to figure it out.”

How is Facet Different?

Facet has a singular focus on smaller clients – smaller companies and that focus really shapes the kinds of products that we work on.

We are looking to be partners with our clients rather than just a vendor, which of course shapes the day-to-day experience that you have when working.  Working for Facet, you don’t get treated like some commodity like you would at a large company.

We are encouraged to attend conferences, webinars and, and continuing education. I don’t think I’ve ever been turned down when I’ve asked for these kinds of opportunities.

What Do You Love Best About Your Work?

I think it’s that ability to really see the cutting edge of science and medicine and really be able to impact what’s going to be the next generation of medicines in some really interesting disease spaces. In some cases, the impact is on some very rare diseases, which are always interesting to be part of. It’s very rewarding.

I love working with small companies and working with a small team. Facet is a small and very collaborative team. I think there’s also a real encouragement of growth within the company and professional growth for each of us, which is also an important part of a career. That’s something that Facet has done a good job of; of making sure that we don’t lose sight of growth and opportunities for learning.

What is the culture like at Facet?

The culture is close-knit and there’s a real focus on everybody’s wellbeing. There’s not a drive you to the bone and burn you out mentality. It’s more about keeping a balance. The nature of this business is that there are times where folks are all hands-on deck and there are long hours. In some companies that’s just par for the course, every day. We really try to make it an exception and make sure that folks have some decompression time after those sorts of intense periods come along. People need that and we don’t want to burn folks out. We’ve got great people and we want to keep them. I think that’s something that’s really felt.

How does the work you do at Facet Life Sciences help Clients Get to and Through the FDA?

My focus is on the high-level strategy.  I help chart the development pathway by making a critical assessment of where a client is starting from and then determining how to get them to their development goal in an efficient way.  I also suggest ways that a company can plan for success in the future.  For example, by including additional trial endpoints in clinical trials, this may enable label expansions, different marketing claims, or help with reimbursement.

I try to help folks think in a strategic sense about how to run an efficient development program that satisfies what the FDA needs and can also satisfy what other folks need after you’re approved.

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