Celine Halioua

I’m excited to share that Linda Rhodes, VMD, PhD, has joined our Board of Directors. There are few people who have the breadth and depth of experience across science, veterinary medicine, and entrepreneurship that Linda does. We’re fortunate to have her as part of the Loyal team.

I have long looked up to Linda and consider her a mentor and a friend. Linda has seen it all — from living and working on a feminist dairy cow commune in California to developing three FDA-approved animal health drugs in five years and sitting on the Board of one of the world largest animal health companies. I am honored to learn from her. 

Linda’s expertise in the science and regulation of developing animal health drugs are invaluable to Loyal. We are at an exciting inflection point — aiming to launch our first product to market next year, LOY-002 for senior dogs. We also continue to develop LOY-001 and LOY-003, the large- and giant-breed therapies in our pipeline. Across our portfolio, we will benefit from tapping into Linda’s experience of bringing novel animal drug therapies to market. 

I’m encouraged by the progress we are making across all aspects of the business toward realizing our mission of helping dogs live longer, healthier lives. And I’m inspired by the trails that Linda has blazed ahead of us. 

Please join me in welcoming Linda to Loyal!

Linda Rhodes joins the Loyal Board of Directors

I’m excited to share that Linda Rhodes, VMD, PhD, has joined our Board of Directors. There are few people who have the breadth and depth of experience across science, veterinary medicine, and entrepreneurship that Linda does. We’re fortunate to have her as part of the Loyal team. I have long looked up to Linda and consider her a mentor and a friend. Linda has seen it all — from living and working on a feminist dairy cow commune in California to developing three FDA-approved animal health drugs in five years and sitting on the Board of one of the world largest animal health companies. I am honored to learn from her.&nbsp;



Linda’s expertise in the science and regulation of developing animal health drugs are invaluable to Loyal. We are at an exciting inflection point — aiming to launch our first product to market next year, LOY-002 for senior dogs. We also continue to develop LOY-001 and LOY-003, the large- and giant-breed therapies in our pipeline. Across our portfolio, we will benefit from tapping into Linda’s experience of bringing novel animal drug therapies to market.&nbsp;



I’m encouraged by the progress we are making across all aspects of the business toward realizing our mission of helping dogs live longer, healthier lives. And I’m inspired by the trails that Linda has blazed ahead of us.&nbsp;



Please join me in welcoming Linda to Loyal!

Our product strategy has always been centered on earning FDA approval. While more challenging, time intensive, and expensive than other approaches, I believe achieving FDA approval is critical to demonstrating the scientific legitimacy of lifespan extension drugs.

Our dog longevity drugs LOY-001, LOY-002, and LOY-003 are all being developed under the FDA Center for Veterinary Medicine’s expanded conditional approval (XCA) pathway. XCA is a new regulatory pathway that allows certain animal drugs to be conditionally approved based on: 

The conditional approval period lasts up to five years while we run the additional studies necessary to demonstrate full efficacy. During that time, veterinarians may prescribe our drug as normal, with full awareness of the conditional nature of the approval. If the drug does not show full efficacy at the end of the conditional period, the drug will be taken off the market.

FDA expanded conditional approval pathway is key to bringing longevity drugs to dogs

One of the underestimated challenges of developing longevity drugs is simply the logistics of demonstrating that a drug definitively extends healthy lifespan. To show a drug is extending lifespan, you must start the dog on the drug sufficiently early and then follow them for the rest of their (hopefully very long!) life. Your study must be large and diverse to not succumb to “noise” — things like variance between dog breeds, healthcare access, environmental factors, and biological luck. As such, our pivotal lifespan extension study STAY will be one of the largest (1,000+ dogs across 55 vet clinics) and longest (~4 years) canine clinical trials ever run. 

The conditional approval pathway is intended for animal drugs that address an unmet medical need and require long or complex studies to complete collection of the effectiveness data needed for full approval. It is extremely complex to run a pivotal lifespan extension study, and as such the FDA has determined that LOY-001, LOY-002, and LOY-003 all meet the criteria for using the conditional approval. 

For a small company like Loyal, it has been crucial that we have a path to market while running our pivotal lifespan extension studies. The conditional approval allows us to bring new medicines as early as possible to older dogs, who need it most — without risking their safety.

The FDA drug approval process emphasizes safety and efficacy

The drugs your vet prescribes to your dog, like the Librela my senior Rottweiler takes for her osteoarthritis, have been tested extensively for their safety and efficacy before earning FDA approval. 

We cannot commercialize any of our products without first earning FDA approval. To do this, we must present extensive data to the FDA in three core areas:

What data we’ll have at conditional approval

Conditional approval has the same strict safety and manufacturing quality requirements as full approval. For a drug that will be given to relatively healthy dogs, like LOY-002, the safety bar is especially high. 

Reasonable expectation of efficacy is just what it sounds like — the process consists of shorter studies that prove reasonable expectation that the drug will have the full efficacy you expect.  

 for LOY-001 included over 2,000 pages of evidence and analysis from various sources, including scientific literature, observational studies, and interventional studies. 

Upon approval, the FDA will publish the Freedom of Information (FOI) summary, which will overview the key safety and efficacy data. This is intended for dog owners and veterinarians to educate themselves on the scientific backing of the drug and make an informed choice on whether to prescribe. 

An overview of the regulatory process to conditional approval and — eventually — full marketing approval

Should the FDA grant LOY-002 conditional marketing approval, veterinarians will be able prescribe the drug. At this point, we won’t yet have full lifespan extension efficacy data. The study to get this data (STAY) will run in parallel with the conditional approval period. 

We must complete and analyze the STAY study (estimated 2029) and submit to the FDA to convert our conditional approval into full approval. If we do not complete the study, or if we do not show pivotal lifespan extension in the treated dogs, the drug will be taken off market — as it should be.  

As with all medicines, the key balance is risk:reward. I’m grateful to the FDA that the conditional approval pathway exists. It allows new companies like Loyal to develop innovative drugs and get them into the hands of veterinarians to better the lives of both dogs and their owners. We take the responsibility of developing a new drug incredibly seriously and will never push forward a drug that our scientists and veterinarians do not truly believe will extend the healthy lifespan of our beloved dogs.

Learn more about expanded conditional approval and the FDA:

What is FDA conditional approval?

Our product strategy has always been centered on earning FDA approval. While more challenging, time intensive, and expensive than other approaches, I believe achieving FDA approval is critical to demonstrating the scientific legitimacy of lifespan extension drugs.



Our dog longevity drugs LOY-001, LOY-002, and LOY-003 are all being developed under the FDA Center for Veterinary Medicine’s expanded conditional approval (XCA) pathway. XCA is a new regulatory pathway that allows certain animal drugs to be conditionally approved based off of:&nbsp;



<ul class="wp-block-list">
<li>Full safety data,&nbsp;</li>



<li>Full manufacturing data, and&nbsp;</li>



<li>Reasonable expectation of effectiveness.&nbsp;</li>
</ul>



The conditional approval period lasts up to five years while we run the additional studies necessary to demonstrate full efficacy. During that time, veterinarians may prescribe our drug as normal, with full awareness of the conditional nature of the approval. If the drug does not show full efficacy at the end of the conditional period, the drug will be taken off the market.







<h2 class="wp-block-heading">FDA expanded conditional approval pathway is key to bringing longevity drugs to dogs</h2>



One of the underestimated challenges of developing longevity drugs is simply the logistics of demonstrating that a drug definitively extends healthy lifespan. To show a drug is extending lifespan, you must start the dog on the drug sufficiently early and then follow them for the rest of their (hopefully very long!) life. Your study must be large and diverse to not succumb to “noise” — things like variance between dog breeds, healthcare access, environmental factors, and biological luck. As such, our pivotal lifespan extension study STAY will be one of the largest (1,000+ dogs across 55 vet clinics) and longest (~4 years) canine clinical trials ever run.&nbsp;



The conditional approval pathway is intended for animal drugs that address an unmet medical need and require long or complex studies to complete collection of the effectiveness data needed for full approval. It is extremely complex to run a pivotal lifespan extension study, and as such the FDA has determined that LOY-001, LOY-002, and LOY-003 all meet the criteria for using the conditional approval.&nbsp;



For a small company like Loyal, it has been crucial that we have a path to market while running our pivotal lifespan extension studies. The conditional approval allows us to bring new medicines as early as possible to older dogs, who need it most — without risking their safety.







<h2 class="wp-block-heading">The FDA drug approval process emphasizes safety and efficacy</h2>



The drugs your vet prescribes to your dog, like the Librela my senior Rottweiler takes for her osteoarthritis, have been tested extensively for their safety and efficacy before earning FDA approval.&nbsp;



We cannot commercialize any of our products without first earning FDA approval. To do this, we must present extensive data to the FDA in three core areas:



<ol class="wp-block-list">
<li>Efficacy — It does what it says it will do; in our case, it extends the lifespan of dogs.</li>



<li>Safety — It’s proven safe for dogs, and any side effects are well-understood and documented.</li>



<li>Manufacturing — It can be manufactured at a consistently high quality, at scale.</li>
</ol>







<h2 class="wp-block-heading">What data we&#8217;ll have at conditional approval</h2>



<ul class="wp-block-list">
<li>Full Target Animal Safety</li>



<li>Full Chemistry, Manufacturing, and Controls</li>



<li>Reasonable Expectation of Effectiveness (RXE)</li>
</ul>



Conditional approval has the same strict safety and manufacturing quality requirements as full approval. For a drug that will be given to relatively healthy dogs, like LOY-002, the safety bar is especially high.&nbsp;



Reasonable expectation of efficacy is just what it sounds like — the process consists of shorter studies that prove reasonable expectation that the drug will have the full efficacy you expect.&nbsp; <a href="https://loyalfordogs.com/posts/loyal-announces-historic-fda-milestone-for-large-dog-lifespan-extension-drug">Loyal’s accepted RXE package</a> for LOY-001 included over 2,000 pages of evidence and analysis from various sources, including scientific literature, observational studies, and interventional studies.&nbsp;



Upon approval, the FDA will publish the Freedom of Information (FOI) summary, which will overview the key safety and efficacy data. This is intended for dog owners and veterinarians to educate themselves on the scientific backing of the drug and make an informed choice on whether to prescribe.&nbsp;



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="235" src="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/04/Conditional-Approval-Schematics-1-1024x235.png" alt="" class="wp-image-1189" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/04/Conditional-Approval-Schematics-1-1024x235.png 1024w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/04/Conditional-Approval-Schematics-1-300x69.png 300w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/04/Conditional-Approval-Schematics-1-768x176.png 768w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/04/Conditional-Approval-Schematics-1-1536x353.png 1536w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2024/04/Conditional-Approval-Schematics-1-2048x470.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">An overview of the regulatory process to conditional approval and — eventually — full marketing approval</figcaption></figure>







<h2 class="wp-block-heading">What data we won&#8217;t have at conditional approval</h2>



<ul class="wp-block-list">
<li>Pivotal, randomized, double-blinded, placebo-controlled study showing lifespan extension.</li>
</ul>



Should the FDA grant LOY-002 conditional marketing approval, veterinarians will be able prescribe the drug. At this point, we won’t yet have full lifespan extension efficacy data. The study to get this data (STAY) will run in parallel with the conditional approval period.&nbsp;



We must complete and analyze the STAY study (estimated 2029) and submit to the FDA to convert our conditional approval into full approval. If we do not complete the study, or if we do not show pivotal lifespan extension in the treated dogs, the drug will be taken off market — as it should be.&nbsp;&nbsp;







<h2 class="wp-block-heading">Regulatory innovation</h2>



As with all medicines, the key balance is risk:reward. I’m grateful to the FDA that the conditional approval pathway exists. It allows new companies like Loyal to develop innovative drugs and get them into the hands of veterinarians to better the lives of both dogs and their owners. We take the responsibility of developing a new drug incredibly seriously and will never push forward a drug that our scientists and veterinarians do not truly believe will extend the healthy lifespan of our beloved dogs.







<h2 class="wp-block-heading">Resources</h2>



Learn more about expanded conditional approval and the FDA:



<ul class="wp-block-list">
<li><a href="https://www.fda.gov/animal-veterinary/resources-you/conditional-approval-explained-resource-veterinarians">Conditional Approval Explained: A Resource for Veterinarians</a></li>
</ul>

Karen Greenwood

Some important news: Loyal has received protocol concurrence from the FDA on our companion dog longevity study. This means that the FDA has reviewed the scientific design of our study and determined that it meets their high quality standards, and will validate whether our drug extends canine lifespan and 

In other words, if our study demonstrates that our dog longevity drug extends healthy lifespan, those results will be sufficient to support bringing the drug to market for dogs across the country. 

_________________________________________

Our concurrence means we fundamentally agree with your proposed design, execution, and analyses…

This is a huge milestone for any drug company, but it’s especially significant because, to our knowledge, this is the first time the FDA has accepted a clinical study intending to show that a drug extends lifespan and healthspan, rather than only proving efficacy against a single, specific disease — which is the case with most drugs on the market today.

Loyal was founded around the audacious idea that we should have drugs explicitly designed and FDA-approved to extend general healthy lifespan. With this milestone we take another big step in the direction of this vision. 

To achieve this milestone, we worked with scientists and statisticians at the 

 CVM— the division of the FDA responsible for overseeing the medicines we give our pets — to interrogate and optimize our study design.

We and the CVM have a shared interest in making sure our study is designed in a way that proves whether our products are effective and safe; both are paramount, scientifically and ethically.

Protocol concurrence is a huge step, but it’s not a guarantee

While we’re energized by this milestone, there’s still a lot of hard and careful work to be done.

Clinical trials are complex, and although we strive always to make scientific, evidence-based decisions in our study design and treatments, we won’t actually know how a drug will perform at scale in the real world until we run the study.

What looks promising and effective in a laboratory must in turn be proven in the field — the real world, where dogs live alongside us, and under the supervision of veterinarians in a clinical setting. This is the purpose of clinical trials.

If the study doesn’t deliver a positive outcome, we won’t — and shouldn’t — get approval. 

Designing a study to prove lifespan extension

Clinical studies are sometimes straightforward and sometimes complex. A study to show whether a new flea and tick treatment works can take much less time to design and conduct, since there are many previous studies showing how to measure the efficacy of these drugs.

Ours has been a much longer process — a total of 553 days, just over 18 months, from first discussion on the program to protocol concurrence.

We believe we’re the first to design and receive FDA concurrence for a clinical study that measures lifespan extension following treatment of the underlying causes of aging, rather than any specific disease.

We’re actively recruiting veterinary practices across the country to run clinical trials later this year. If you’re interested in partnering with us on this groundbreaking study, get in touch with our veterinary team today.

We often are asked why we aren’t working on dog aging supplements.

At Loyal we made the decision from the start that we would seek FDA approval for our aging drugs. It’s a rigorous, expensive, years-long process that sets a very high bar for both safety and efficacy — exactly as it should be.

Supplements have no such obligation, and even if they do run their own studies, there’s no oversight. This is why you’ll see a “These statements have not been evaluated by the FDA” disclaimer in fine print on supplements for dogs and humans alike.

While supplements may not hurt and might help your dog, there’s no process to regulate or validate the claims they make on their label, so you can’t be sure of a supplement’s safety or effectiveness.

And for us, especially when our dogs are involved, that just isn’t good enough.

Be the first to know when we’re recruiting dogs for our study

Karen is Loyal’s Senior Vice President of Regulatory & Strategy, and brings more than three decades of animal pharmaceutical experience to the company. She spent 27 years in 

 before going on to oversee programs at leading animal pharmaceutical companies including 

Loyal’s latest milestone: the first longevity clinical study design supported by the FDA

Some important news: Loyal has received protocol concurrence from the FDA on our companion dog longevity study. This means that the FDA has reviewed the scientific design of our study and determined that it meets their high quality standards, and will validate whether our drug extends canine lifespan and <a href="https://blog-admin.loyalfordogs.com/how-scientists-measure-aging-through-healthspan-frailty-and-quality-of-life/" data-type="URL" data-id="https://blog-admin.loyalfordogs.com/how-scientists-measure-aging-through-healthspan-frailty-and-quality-of-life/">healthspan</a>.



In other words, if our study demonstrates that our dog longevity drug extends healthy lifespan, those results will be sufficient to support bringing the drug to market for dogs across the country. 



_________________________________________



<h2 class="wp-block-heading has-text-align-center has-regular-font-size">Our concurrence means we fundamentally agree with your proposed design, execution, and analyses…</h2>



– FDA CENTER FOR VETERINARY MEDICINE



_________________________________________



This is a huge milestone for any drug company, but it’s especially significant because, to our knowledge, this is the first time the FDA has accepted a clinical study intending to show that a drug extends lifespan and healthspan, rather than only proving efficacy against a single, specific disease — which is the case with most drugs on the market today.



Loyal was founded around the audacious idea that we should have drugs explicitly designed and FDA-approved to extend general healthy lifespan. With this milestone we take another big step in the direction of this vision.&nbsp;



To achieve this milestone, we worked with scientists and statisticians at the <a href="https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine" data-type="URL" data-id="https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine">Center for Veterinary Medicine</a> CVM— the division of the FDA responsible for overseeing the medicines we give our pets — to interrogate and optimize our study design.



We and the CVM have a shared interest in making sure our study is designed in a way that proves whether our products are effective and safe; both are paramount, scientifically and ethically.











<h2 class="wp-block-heading has-large-font-size" id="protocol-concurrence-is-a-huge-step-but-it-s-not-a-guarantee" style="font-style:normal;font-weight:600">Protocol concurrence is a huge step, but it’s not a guarantee</h2>



While we’re energized by this milestone, there’s still a lot of hard and careful work to be done.



Clinical trials are complex, and although we strive always to make scientific, evidence-based decisions in our study design and treatments, we won’t actually know how a drug will perform at scale in the real world until we run the study.



What looks promising and effective in a laboratory must in turn be proven in the field — the real world, where dogs live alongside us, and under the supervision of veterinarians in a clinical setting. This is the purpose of clinical trials.



If the study doesn’t deliver a positive outcome, we won’t — and shouldn’t — get approval.&nbsp;











<h2 class="wp-block-heading has-large-font-size" id="designing-a-study-to-prove-lifespan-extension" style="font-style:normal;font-weight:600">Designing a study to prove lifespan extension</h2>



Clinical studies are sometimes straightforward and sometimes complex. A study to show whether a new flea and tick treatment works can take much less time to design and conduct, since there are many previous studies showing how to measure the efficacy of these drugs.



Ours has been a much longer process —&nbsp;a total of 553 days, just over 18 months, from first discussion on the program to protocol concurrence.



We believe we’re the first to design and receive FDA concurrence for a clinical study that measures lifespan extension following treatment of the underlying causes of aging, rather than any specific disease.



We’re actively recruiting veterinary practices across the country to run clinical trials later this year. If you’re interested in partnering with us on this groundbreaking study, get in touch with our veterinary team today.



→ <a href="https://loyalfordogs.com/for-vets/">Become a clinical trial site</a>











<h2 class="wp-block-heading has-large-font-size" id="why-fda-approval-is-so-important" style="font-style:normal;font-weight:600">Why FDA approval is so important</h2>



We often are asked why we aren’t working on dog aging supplements.



At Loyal we made the decision from the start that we would seek FDA approval for our aging drugs. It’s a rigorous, expensive, years-long process that sets a very high bar for both safety and efficacy — exactly as it should be.



Supplements have no such obligation, and even if they do run their own studies, there’s no oversight. This is why you’ll see a “These statements have not been evaluated by the FDA” disclaimer in fine print on supplements for dogs and humans alike.



While supplements may not hurt and might help your dog, there’s no process to regulate or validate the claims they make on their label, so you can’t be sure of a supplement&#8217;s safety or effectiveness.



And for us, especially when our dogs are involved, that just isn’t good enough.











<h2 class="wp-block-heading has-large-font-size" id="be-the-first-to-know-when-we-re-recruiting-dogs-for-our-study" style="font-style:normal;font-weight:600">Be the first to know when we’re recruiting dogs for our study </h2>



<h2 class="wp-block-heading has-large-font-size" id="be-the-first-to-know-when-we-re-recruiting-dogs-for-our-study" style="font-style:normal;font-weight:600">→ <a href="https://loyalfordogs.com/#join">Join our list today</a></h2>







<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="683" src="http://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-1024x683.jpg" alt="" class="wp-image-735" style="width:695px;height:464px" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-1024x683.jpg 1024w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-300x200.jpg 300w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-768x512.jpg 768w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-1536x1024.jpg 1536w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



Karen is Loyal’s Senior Vice President of Regulatory &amp; Strategy, and brings more than three decades of animal pharmaceutical experience to the company. She spent 27 years in <a href="https://www.pfizer.com/content/animal-health" data-type="URL" data-id="https://www.pfizer.com/content/animal-health">Pfizer’s Animal Health</a> group and <a href="https://www.zoetis.com/" data-type="URL" data-id="https://www.zoetis.com/">Zoetis</a> before going on to oversee programs at leading animal pharmaceutical companies including <a href="https://parnell.com/" data-type="URL" data-id="https://parnell.com/">Parnell</a> and <a href="https://ir.kindredbio.com/" data-type="URL" data-id="https://ir.kindredbio.com/">KindredBio</a>.

I’m excited to share that Blake Scholl, the Founder and CEO of 

, has joined our Board of Directors as our first Independent Director.

Blake’s deep expertise in building and scaling a successful, mission-driven business within a highly regulated industry will be both instructive and valuable for Loyal as we grow. 

Loyal hit a number of key milestones over the last twelve months for LOY001 (an implant for large dog lifespan extension) and LOY002 (a daily, tasty pill for old dog lifespan extension):

We are running towards hopeful FDA approval of our drug programs, and being able to support veterinarians and pet parents in helping their dogs live longer, healthier lives.

Blake’s operational, commercial, and technical expertise brings immense benefit as we build towards bringing the first dog aging drugs to market.  

We’re delighted he’s joining our Board.

Blake Scholl joins the Loyal Board of Directors

I’m excited to share that Blake Scholl, the Founder and CEO of <a href="https://boomsupersonic.com/">Boom Supersonic</a>, has joined our Board of Directors as our first Independent Director.



Blake’s deep expertise in building and scaling a successful, mission-driven business within a highly regulated industry will be both instructive and valuable for Loyal as we grow.&nbsp;



Loyal hit a number of key milestones over the last twelve months for LOY001 (an implant for large dog lifespan extension) and LOY002 (a daily, tasty pill for old dog lifespan extension):



<ul class="wp-block-list"><li>We dosed the first companion dog — Josie, a seven-year-old Mastiff — with one of our aging drugs.</li><li>We manufactured prototypes of LOY001 and LOY002.</li><li>We successfully completed the canine aging efficacy data for our two current drug programs, and submitted the LOY001 efficacy package to the FDA.</li><li>We have over 50 veterinary practices interested in participating in our clinical study of LOY002.</li></ul>



We are running towards hopeful FDA approval of our drug programs, and being able to support veterinarians and pet parents in helping their dogs live longer, healthier lives.



Blake’s operational, commercial, and technical expertise brings immense benefit as we build towards bringing the first dog aging drugs to market.&nbsp;&nbsp;



We’re delighted he’s joining our Board.

Ellen Ratcliff, DVM

Veterinarian pals, listen, I’ve been there. For the better part of two decades, I was a mixed animal practitioner working 80 hour weeks, on call 50% of my life, almost never (

) getting a day off. I was stressed out, overstretched, weary, and just trying to keep my head above water. At the same time I was also bored, fighting stagnancy, and wondering if this was my life from there on out. 

Enter a close veterinary friend who was working in-industry and trying to get me to run clinical studies in my practice. In spite of not feeling like I could add a single new thing to my to do list, and admittedly at least partly due to my inability to say no (

figuring when my head popped off at least I would get some rest in the hospital

That decision changed my practice life for the better, and just happened to also lead me in a new career direction I would have never even otherwise known about. While I am not suggesting everyone pursue a new career, I definitely think practicing veterinarians should consider some of the intangible reasons why participating in clinical trials just might be a good move. Yes, even you (

It can sometimes feel like the day-to-day grind of veterinary medicine is so far removed from your scientist side that you can’t even see it from there with binoculars. Yeah, we have microscopes and fecal samples and ELISA tests. But DOING science can seem like something from our college days. I started being an investigator in research, y’all – something I previously thought was only for academics. I can’t tell you how nice it was to be recognized as a scientist again. Animal health companies need your scientist brain and it makes a gal feel sharp to get to use it.

2. Be a part of something bigger than yourself.

I like being a member of a club or a group of people trying to do something I couldn’t do alone. This is probably why I’m also a veterinarian in the Army Reserve and why we all felt that inexplicable camaraderie in vet school. But in practice life, the stress of staff and clients can really be barriers to that feeling. When you start doing clinical studies in your practice, you become a small part of the mission of the company doing that research. You meet new people working towards that goal and you become an integral part of the team. 

3. Learn a new skill set and a new language.

Are you a whiz at talking about anal glands, atopy, and otitis while telling a technician what fluid rate to set the DKA dog on and asking the receptionist to tell the rat poison dog’s owner to come pick it up, all with one hand tied behind your back? You might be ready to learn a new competency in veterinary medicine. Doing something unfamiliar and stimulating that requires a cobwebby part of your brain feels like a breath of fresh air. The change in scenery on your appointment schedule can really reinvigorate the practice pro. New skills, novel processes, innovative medical care, unfamiliar ways of thinking about a problem you may or may not have even known existed? Fun! 

4. Gain a whole new appreciation for how approved drugs get onto your clinic shelves! 

Spoiler alert – it’s a wayyyy lengthier and more involved process than most of us have any concept about. Veterinary medicine has so few approved drugs compared to human medicine. It can only benefit our profession to have pharmacy shelves with more approved drugs that are extensively studied, found to be effective, but also safe. This just isn’t possible without practicing veterinarians participating in this process. 

Having an inside glance into Good Clinical Practice (GCP) studies and understanding how high the data quality must be and how our personal integrity and attention to detail as the investigator plays into that – pretty nifty. Also pretty cool is getting to use novel therapeutics before they even make it to the shelves. 

5. Novel revenue stream (ok, admittedly this one is tangible).

Doing clinical research in your clinic just might give you the chance to see fewer patients in an hour while making the same income. Or add a few more patients to your schedule and increase your income. That was certainly the case for me. It ended up being an unexpectedly lucrative venture for me as a clinical investigator and the work was interesting, diverse, engaging in a way that made it feel like I had stumbled upon a secret in veterinary medicine. 

It is a fruitful enough endeavor that many practices hire a veterinarian and support staff just to run clinical studies in their practices. Sometimes trial sponsors even help fund this. It can be a great way to grow a practice in a time when vets are losing constant inflow of revenue from online pharmacies and pandemics. 

This is my legit real world experience doing clinical studies as a busy general practitioner. I’d love to find out if any of you have similar experiences or wildly different involvement in this space. So let’s hear it, veterinary colleagues, anyone ready to hear how to dip their tired feet into this pool? 

Dr. Ellen Ratcliff, DVM, brings 17 years of mixed animal practice experience to Loyal as the Director of Clinical Development. She’s a Veterinary Corps Officer in the United States Army Reserve with a wealth of experience in public health and Military Working Dog care. Ellen previously managed clinical development at KindredBio, an animal pharmaceutical company. Ellen completed her DVM at the University of Missouri. She lives at home with her 3 beloved cats and her dog, Sormeh.

Clinical trials in the real world: One practitioner’s perspective

Veterinarian pals, listen, I’ve been there. For the better part of two decades, I was a mixed animal practitioner working 80 hour weeks, on call 50% of my life, almost never (literally never) getting a day off. I was stressed out, overstretched, weary, and just trying to keep my head above water. At the same time I was also bored, fighting stagnancy, and wondering if this was my life from there on out.&nbsp;



Enter a close veterinary friend who was working in-industry and trying to get me to run clinical studies in my practice. In spite of not feeling like I could add a single new thing to my to do list, and admittedly at least partly due to my inability to say no (sound familiar?), I consented to try it (figuring when my head popped off at least I would get some rest in the hospital).&nbsp;



That decision changed my practice life for the better, and just happened to also lead me in a new career direction I would have never even otherwise known about. While I am not suggesting everyone pursue a new career, I definitely think practicing veterinarians should consider some of the intangible reasons why participating in clinical trials just might be a good move. Yes, even you (especially you!) general practitioners.&nbsp;



1. Remember you’re a scientist!&nbsp;



It can sometimes feel like the day-to-day grind of veterinary medicine is so far removed from your scientist side that you can’t even see it from there with binoculars. Yeah, we have microscopes and fecal samples and ELISA tests. But DOING science can seem like something from our college days. I started being an investigator in research, y’all &#8211; something I previously thought was only for academics. I can’t tell you how nice it was to be recognized as a scientist again. Animal health companies need your scientist brain and it makes a gal feel sharp to get to use it.



2. Be a part of something bigger than yourself.



I like being a member of a club or a group of people trying to do something I couldn’t do alone. This is probably why I’m also a veterinarian in the Army Reserve and why we all felt that inexplicable camaraderie in vet school. But in practice life, the stress of staff and clients can really be barriers to that feeling. When you start doing clinical studies in your practice, you become a small part of the mission of the company doing that research. You meet new people working towards that goal and you become an integral part of the team.&nbsp;



3. Learn a new skill set and a new language.



Are you a whiz at talking about anal glands, atopy, and otitis while telling a technician what fluid rate to set the DKA dog on and asking the receptionist to tell the rat poison dog’s owner to come pick it up, all with one hand tied behind your back? You might be ready to learn a new competency in veterinary medicine. Doing something unfamiliar and stimulating that requires a cobwebby part of your brain feels like a breath of fresh air. The change in scenery on your appointment schedule can really reinvigorate the practice pro. New skills, novel processes, innovative medical care, unfamiliar ways of thinking about a problem you may or may not have even known existed? Fun!&nbsp;



4. Gain a whole new appreciation for how approved drugs get onto your clinic shelves!&nbsp;



Spoiler alert &#8211; it’s a wayyyy lengthier and more involved process than most of us have any concept about. Veterinary medicine has so few approved drugs compared to human medicine. It can only benefit our profession to have pharmacy shelves with more approved drugs that are extensively studied, found to be effective, but also safe. This just isn’t possible without practicing veterinarians participating in this process.&nbsp;



Having an inside glance into Good Clinical Practice (GCP) studies and understanding how high the data quality must be and how our personal integrity and attention to detail as the investigator plays into that &#8211; pretty nifty. Also pretty cool is getting to use novel therapeutics before they even make it to the shelves. Very cutting edge, right?



5. Novel revenue stream (ok, admittedly this one is tangible).



Doing clinical research in your clinic just might give you the chance to see fewer patients in an hour while making the same income. Or add a few more patients to your schedule and increase your income. That was certainly the case for me. It ended up being an unexpectedly lucrative venture for me as a clinical investigator and the work was interesting, diverse, engaging in a way that made it feel like I had stumbled upon a secret in veterinary medicine.&nbsp;



It is a fruitful enough endeavor that many practices hire a veterinarian and support staff just to run clinical studies in their practices. Sometimes trial sponsors even help fund this. It can be a great way to grow a practice in a time when vets are losing constant inflow of revenue from online pharmacies and pandemics.&nbsp;



This is my legit real world experience doing clinical studies as a busy general practitioner. I’d love to find out if any of you have similar experiences or wildly different involvement in this space. So let’s hear it, veterinary colleagues, anyone ready to hear how to dip their tired feet into this pool? <a href="mailto:ellen@loyalfordogs.com">Reach out via email</a> or <a href="https://loyalfordogs.com/for-vets/" data-type="URL" data-id="https://loyalfordogs.com/for-vets/">learn more</a> &#8211; I love to talk clinical trials.



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="686" height="452" src="https://blog-admin.loyalfordogs.com/wp-content/uploads/2022/08/dr-ellen-ratcliff-dvm-holding-black-dog-veterinary-medicine-2-1.jpg" alt="" class="wp-image-326" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2022/08/dr-ellen-ratcliff-dvm-holding-black-dog-veterinary-medicine-2-1.jpg 686w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2022/08/dr-ellen-ratcliff-dvm-holding-black-dog-veterinary-medicine-2-1-300x198.jpg 300w" sizes="(max-width: 686px) 100vw, 686px" /><figcaption>Dr. Ellen Ratcliff, DVM, brings 17 years of mixed animal practice experience to Loyal as the Director of Clinical Development. She’s a Veterinary Corps Officer in the United States Army Reserve with a wealth of experience in public health and Military Working Dog care. Ellen previously managed clinical development at KindredBio, an animal pharmaceutical company. Ellen completed her DVM at the University of Missouri. She lives at home with her 3 beloved cats and her dog, Sormeh.</figcaption></figure>

Brennen McKenzie, MA, MSc, VMD

As a veterinarian, my job is to help my patients live the longest, healthiest life possible, and to help my clients choose among different treatment options for their pets. When I consider recommending a medicine for my patients, one of the most important things I need to know is how good the scientific evidence is showing that medicine is safe and effective. A really useful resource to help me determine this is whether or not that treatment has been approved for use in dogs by the FDA.

FDA categories help vets distinguish the evidence available for a product

There are different categories of medicines to choose from, and different degrees of regulatory oversight for each, and this can make understanding the strength of the science behind specific treatments a lot easier. 

In general, vets can choose among medicines in several broad categories:

Some treatments are available “over-the-counter,” meaning they have met the same testing requirements as prescription products, but they can be safely and effectively used without supervision by a veterinarian.

How these categories fulfill the needs of our pets

In general, the strength of the evidence identifying both the benefits and the risks of these treatments is greater the closer to the top of the list they are. For example, it takes a lot more research and data in dogs to achieve FDA approval for a prescription medication to be used in dogs than is required for a human drug used off-label or for a dietary supplement. 

The highest bar for scientific evidence is set by full FDA drug approval. This is a complex process that requires demonstrating to the agency that a drug proposed for use in dogs is safe, for the dogs taking it as well as for the humans around them, and that it is effective, meaning it consistently does what it’s expected to do. Full approval requires showing that a drug can be consistently made to a high standard of quality. 

Of course, no scientific or regulatory process is ever perfect. However, the standard of FDA approval is rigorous, and as a vet I know that an approved prescription drug has been tested extensively and has more scientific evidence to support safety and efficacy than any other category of treatment I could use. 

Conditionally approved prescription drugs

 is a relatively new category which recognizes that for conditions that are serious and have no existing effective treatments, a process that makes new drugs available for vets and dog owners to use sooner is beneficial. 

 explaining conditional approval in more detail

Conditional approval requires nearly all of the same conditions to be met, such as proving safety, manufacturing quality, and so on. The only difference from full approval is the type of proof of effectiveness. Rather than meeting the “substantial evidence” for effectiveness standard, which typically requires a clinical trial in companion dogs, conditional approval requires meeting the standard of a “reasonable expectation of effectiveness” (RXE). This standard can potentially be met with studies that involve fewer dogs and shorter time periods than the clinical trials needed for full approval or with evidence already existing in the scientific literature from studies done in the past. 

 announcing the FDA acceptance of RXE for one of our own products

Many more drugs are approved and available for use in humans than in dogs because the biomedical industry for humans is much larger and better funded than veterinary medicine. The FDA recognizes that many potentially beneficial drugs are available in people, or other species, that will never be put through the approval process for use in dogs due to limitations of time, money, or other factors. Since 1994, the agency has allowed vets to use these drugs under specific conditions, and this is known as “

Extra-label use of drugs approved for humans is one of the most common types of medication used in veterinary medicine. Vets understand that the evidence for safety and effectiveness in our patients is not as strong as it is for approved animal drugs, but these drugs are an indispensable tool in caring for our patients.

As long as we, and our clients, understand the limits of the evidence, we can balance risks, benefits and uncertainty in a rational way and monitor patients appropriately to make sure we are truly helping them.

Dietary supplements are the category with the least oversight and the greatest uncertainty about safety and efficacy. In veterinary medicine, this is not even a formal category. As the FDA explains, “there is no ‘dietary supplement’ regulatory classification for animal food substances and products. They are considered either ‘foods’ or ‘new animal drugs’ depending on the intended use.” 

Essentially, anything that is intended to cure, treat, or prevent disease is considered a drug and should, in principle, go through the full or conditional approval process before being marketed for use in dogs. In practice, though, the FDA does not aggressively enforce this policy.

Why a lack of evidence in supplements matters

As a vet, the importance of this to me is that supplements for pets aren’t required to prove they are safe and effective before, or after, being marketed. Most of these products have never been tested in clinical trials.

There is also no official regulatory monitoring of quality for most dietary supplements. 

, for example, that the labels for many probiotic supplements were inaccurate—often the product didn’t have in it what the label said was in it. Even if a specific supplement might have therapeutic effects, your dog won’t benefit from these if the product you buy doesn’t actually contain the ingredients it’s supposed to have!

I do sometimes recommend dietary supplements if there is some scientific reason to believe they might help and are unlikely to be harmful, but my confidence in these products is much lower than for prescription drugs.

Understanding the levels of regulatory oversight can help vets understand the strength of the scientific evidence and the degree of confidence we can have in the medicines we recommend.

There is always some level of risk in doing anything in medicine, and this has to be balanced against the benefits of what we are considering doing. In a dog who is seriously ill, a medicine that can cure them or greatly relieve their suffering has a lot of potential benefit. The risk of some side effects may well be worth taking in such a case. For a healthy dog in whom we are aiming to prevent illness down the road, we would be a lot less likely to take any significant risks at all with our preventive treatments.

However, as a vet and as a dog owner myself, I can only decide what is best for my patients and my pets if I know what the potential risks and benefits are for the medicines I have available. The levels of regulatory oversight I have described can help a lot in understanding the strength of the scientific evidence and the degree of confidence I can have in the medicines I recommend.

Whenever possible, I will always choose those treatments that have the highest degree of evidence behind them because this gives me the greatest chance of helping the dogs I care for. 

Some veterinary products are regulated by other agencies, such as certain parasite preventatives (EPA) and vaccines (USDA), but FDA is responsible for approving most prescription drugs.

”off- label” is a common term vets use to describe what the FDA more often calls “extra-label” drug use.

Drugs and dietary supplements for dogs: What’s the difference?

Linda Rhodes joins the Loyal Board of Directors

What is FDA conditional approval?

Loyal’s latest milestone: the first longevity clinical study design supported by the FDA

Blake Scholl joins the Loyal Board of Directors

Clinical trials in the real world: One practitioner’s perspective