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

We humans have a lot in common with our dogs. We have co-evolved, shaping each other biologically and behaviorally over thousands of years in an unusually close interspecies relationship. Dogs can 

, though at a faster pace. For as far apart as we are on the evolutionary tree, we are surprisingly alike.

These similarities include many aspects of our health. Like humans, young dogs are most likely to suffer from injuries and infections, while diseases of aging, like arthritis and cancer, afflict both humans and dogs in their later years. Not only the diseases we experience, but also the treatments for them, are often the same for us and our dogs. Clients in my veterinary practice are often surprised when I prescribe the same medications for their dogs that they or their family members take.

Same problems, same treatments (sometimes)

When my mother had a recent bout of pneumonia, she was given doxycycline, which is the same antibiotic I 

often use in dogs with respiratory infections

. One of the most common antidepressants used in people, fluoxetine, is also 

frequently prescribed for behavioral problems in dogs

. Like these examples, many of the drugs I use are approved and manufactured for human use and are employed  

 for my patients because they work in dogs too (and because there often are no drugs specifically for dogs that treat the same problems).

Of course, we’re also different from our dogs in a lot of ways. My dog, Kalani, will never play guitar or write a blog post, and I’m pretty terrible at catching squirrels and chewing rawhide. Our differences also influence our health, from the specific ailments we suffer from to the treatments that make us better. While sometimes drugs made for humans can be useful in dogs, many human medicines can be ineffective or even harmful to our pets. Sharing is not always caring, and you should never give your dog your own medication or take theirs! 

Even common, nonprescription medications can be a hazard to our dogs. For minor pain, we often take drugs like acetaminophen or non-steroidal anti-inflammatories like ibuprofen. These are safe enough in humans to be available without a doctor’s prescription, but 

 because of small, but critical, differences in how our bodies process and eliminate such medicines.

Another example are the common decongestants pseudoephedrine and phenylephrine. Humans can use these to treat a stuffy nose due to allergies or a cold. However, dogs have a much more limited ability to process and eliminate these drugs, and they can experience what amounts to an “overdose” from even small amounts. This can lead to symptoms such as anxiety and agitation or even seizures and heart failure.

Good for the goose, but maybe not the gander

Such differences in biology can also work the other way—side effects seen in humans don’t necessarily happen in dogs. A good example is a common antibiotic used in humans called ciprofloxacin. It isn’t very useful for dogs because they don’t absorb it well, so 

they often can’t get enough into the bloodstream

 to be effective. A few small changes in formulation, however, gave us the drug enrofloxacin, which is a very safe and effective antibiotic for dogs. People will definitely want to stick with cipro, though, because enrofloxacin can cause us to have very unpleasant dreams and even hallucinations! 

Another good example is the drug pimobendan, which is 

widely used to treat heart disease in dogs

. This medication has shown great benefits in terms of delaying the progression of some kinds of heart disease (e.g. mitral valve disease) and extending life for many dogs with heart failure. Pimobendan was originally developed for use in humans in the 1980s, but it is currently only approved in Japan, and it is not commonly used even there. The reason is that despite some promising benefits seen in early studies, 

 showed that the people getting this drug were almost twice as likely to die during the study as those getting a placebo! This is exactly the opposite of the positive effect on survival seen with pimobendan in dogs, and it reminds us that drugs can have very different effects in different species.

Sometimes, drugs originally meant for use in humans turn out to have unacceptable risks. However, this can actually be an opportunity for veterinarians if these risks don’t apply to our patients. An example of this is the antibiotic chloramphenicol. Developed in the 1940s, this drug was one of the first antibiotics. Despite being effective, it is rarely used in humans nowadays because it can sometimes cause severe, irreversible anemia (failure to make red blood cells), and this is typically fatal. Fortunately, dogs don’t experience this problem with chloramphenicol. Its use is still limited because of the need to protect humans from exposure to it, but it can sometimes be a life-saving treatment for antibiotic-resistant infections in dogs.

Humans and dogs are alike in many ways, and these similarities sometimes allow us both to benefit from the same medicines. However, sometimes our differences really matter. Both the benefits and the risks of drugs can differ a lot between dogs and humans. We can’t assume that any given drug will have the same positive or negative effects in dogs that it has in people.

Ideally, every drug should be tested thoroughly for both safety and effectiveness in the species we intend to use it in. This is why there are separate divisions in the Food and Drug Administration for evaluating drugs meant 

. Only such testing can give us confidence in predicting the benefits and the safety of a specific drug in humans or in dogs.

 for reporting suspected problems with animal drugs or medical devices

 on dangers of humans and pets sharing drugs

Some drugs used in humans that aren’t safe for dogs

Same drugs, different species: How the effects of drugs vary between dogs and humans

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