FDA Registered 503B Outsourcing Facility

888-508-5032

Meet Epicur’s Advisory Council: Talking Veterinary Oncology Trends with Phil Bergman

Share on facebook
Like & Share
Share on twitter
Tweet
Share on linkedin
Share

With almost 30 years in the field and a specialty in veterinary oncology, Phil Bergman plays an important role on Epicur’s Advisory Board. He has an up-close view of the critical role proper medication plays in patient treatment. We recently discussed with Phil what trends he is seeing in oncology and his hopes for 503B in the veterinary industry.

We’re glad you could join us today, Phil. Tell us about your background in the industry.

I’m a veterinary oncologist and have been in the field now for almost 30 years. I did my oncology residency at Colorado State and then my Ph.D. at a human cancer center to learn about the advancements I could bring back to veterinary medicine. I worked at the Animal Medical Center for several years, then was the Chief Medical Officer for a group called BrightHeart Veterinary Centers, which became part of VCA in 2011. Now, my primary job is running clinical studies. I manage all the various FDA and other studies that we do as an organization for VCA. I also truly enjoy seeing patients. Typically, on Mondays, I continue to see patients at one of our specialty centers.

What areas are clinical trials focusing on right now? Any big trends?

I think the biggest trend that is happening currently is the move toward more immune-based cancer therapeutics. I’ve learned over the last 30 years, if you can harness the immune system in a way that works with you, instead of against you, that can be more impactful than any chemotherapy that’s out there.

We’ve been working on several immunotherapy approaches and one is very close to getting government approval. It uses checkpoint inhibitors that essentially take the brakes off your immune system. Cancer cells have gotten so smart that they touch our T cells and tell them to turn off, so they won’t attack the cancer cells. Biologists have figured out how cancer cells go touch that T cell, and we now have designed drugs to prevent that from happening.

As you would guess, we worry about autoimmune conditions when you do that. To date, they’ve generally been tolerable in people. More importantly, sometimes we see 30-50% complete disappearance of tumors, and those patients are cured just by simply giving them a drug that takes the brakes off their immune system.

The other big change that has happened, which is part of what led me to Stokes and now Epicur, was that an increasing amount of cancer therapeutics were either untenable due to financial pressures, or the doses didn’t work for us. I research stuff like crazy, and when I started looking at compounding it became obvious to me that all compounders were not created equal. That’s when I learned what Stokes Healthcare was doing through Epicur and was just continually impressed with their quality. When I learned that Stokes Healthcare was getting 503B designation with Epicur, that further proved to me that they were the partner of choice. They make sure the drug that you’re prescribing for your patient is the right drug, and more importantly, the dose is consistent every time.

It sounds like dosage plays a key role in treating patients. What are the risks when dosages aren’t exact?

We’ve learned in oncology through a number of studies that, for certain oncology medications, the heterogeneity of the dose that gets delivered is quite remarkable. Some studies show when you order a dose at X amount, depending on the compounders that you use, that dose is sometimes as low as 40% of what you prescribed. In opposite situations, it can be as high as 150%.

With underdosing, you don’t have toxicity. It probably does nothing against the cancer though because it is so low. With higher dosages, you’re inducing some measure of toxicity and hurting your patient unnecessarily.

Why do you think it’s difficult for veterinarians to keep up with 503B information? What do you think are the biggest misconceptions for veterinarians when it comes to 503B?

Unfortunately, veterinarians are not really regulated when it comes to compounding options. I think a lot of veterinarians just don’t examine the information that describes issues related to various compounders. It’s hard enough to keep up with everything, especially as a primary care doctor, and I have immense respect for them.

I barely can keep up with all the things happening in oncology, but you think about it from a primary care veterinarians’ perspective, they have to cover everything – not just one specialty. I think a lot of veterinarians aren’t clear on 503A versus 503B. Most of this is because 503B is referred to as an outsourcing facility and that’s a difficult term to understand in our field. When it’s called an outsourcing facility, that can cause issues, plus there is a lot of misinformation to veterinarians saying 503B is dangerous, which is false.

Do you have a simplified way to describe 503B to colleagues to help them understand the benefits of 503B?

I have a very similar elevator pitch, whether it’s to my clients or a fellow veterinarian. Just yesterday, I had a discussion with a client where we were considering chemotherapy for their pet. I shared with them that I have several partners we can use, from a small pharmacy that’s not far from where they live, or Epicur, which is my preference. The small pharmacy may be 10% cheaper, but I shared with that client that I have immense confidence the drug I’m ordering from Epicur is going to be the appropriate drug and more importantly, at the appropriate dose. The guidelines that Epicur follows guarantee that it’s within a certain range of that dose that’s prescribed. To me, that 10% is the best money that you can spend because I know that your pet will be treated appropriately.

That’s the same schpiel I use when I do CE talks for primary care veterinarians. When people are presented with the value proposition that quality is going to cost you on average 10% more, it gets a lot of traction with clinician scientists. The trick is getting that traction in other areas of veterinary care. Epicur, and 503B outsourcing as a whole, is still fairly new to veterinarians even though Stokes is such a well-known name in the industry.

What are you hoping to see next in 503B outsourcing?

There is a growing interest from other players in the space to become 503B, which I think legitimizes why Epicur was very much a leader in that regard. Epicur was early to that game, and I hope the success they’ve seen in oncology continues across other specialties and into the primary care setting.

I sense that it’s a question of time, especially as we get more clarity around beyond use dating and specifics from the FDA about what we can and can’t do when it comes to bulk compounding. I think clarity in those areas will help create traction because of the challenges to revenue streams veterinarians are seeing with online delivery pharmacies. To have a 503B outsourcing facility send you bulk material in advance that you can prescribe confidently, and conveniently send home with your client, will outweigh the benefits of the online pharmacy. It can also further strengthen that bond for the client and patient to the veterinarian. It’s another revenue stream that’s not marginalized away from the veterinarian.

Thanks for sharing your insights with us, Phil!


For more guidance on why 503Bs make a difference in veterinary medicine, download our white paper:

The Importance of cGMP (503B) Compounded Drugs

Featured Posts: