Conversations with Experts: Dr. Arvind Madan

Elixia sat down with nephrologist Dr. Arvind Madan to discuss the vital role of clinical trials in advancing kidney disease research.

Meet Dr. Madan

My name is Arvind Madan and I am a practicing nephrologist in central Florida. My training takes me back to India for medical school, and after graduating from there I moved to the United States and I did my residency in Internal Medicine in Nassau County, Long Island. I did a Nephrology Fellowship at upstate SUNY Syracuse. And once I finished, I moved to Florida and I joined this group in 2001.

And this is one of the, you know, the premier groups. And we offer a full spectrum of clinical nephrology to our patients, now including clinical trials.

Most Memorable Clinical Trial Story

I think in my mind, the greatest impact that I have seen has happened in the rare disease arena for nephrology. And I noticed that one of my patients in the most recent clinical trials, they had given up on every therapy that they had tried: the side effects were too bad, or the medications were too expensive or the patient could not tolerate what was out there.

So, we put them in our recent clinical trial, and the patient has done dramatically well within three months. But this patient had decline in the kidney function of about 25% in three months, and he's regained most of that back, just with one clinical trial. And in the beginning, the patient was a little skeptical about doing a clinical trial, but since then… since they have seen the improvement, now they are sold on it. And they actually have now identified other patients in their family who have the same problem.

Clinical Trials Bring Us All Together

The research has brought us all together. We have become more patient centric and everybody is very thankful that we have this to offer to our patients. We may have a difference with a partner, but patient care supersedes all that. And research has brought us together and made us better physicians in offering better patient care.

Partnership With Elixia

We have a large patient volume in our clinics and Elixia has great experience in managing high volume trials and rare disease trials. So, the collaboration has been very fruitful for both Elixia and our practice, but more importantly for the patients.

Watch the Interview


Elixia Expands Commitment to Psychedelic Research with Two Psilocybin Trials

 

Elixia is proud to announce our involvement in two groundbreaking psilocybin trials targeting major depressive disorder (MDD) and generalized anxiety disorder (GAD). These trials mark Elixia’s continued dedication to advancing mental health treatment through transformative research initiatives.

The first of the two trials focuses on MDD and is currently in the study start-up phase. Elixia is working with two separate sponsors (Usona Institute and Compass Pathways) on two distinct MDD psilocybin trials, both anticipated to commence in Q1. The second trial, centered on GAD, has seen Elixia collaborate with MindMed for their Phase II trial at Elixia’s Springfield location, with Dr. Susan Smiga overseeing the trial at MindMed’s Woodstock, VT location.

Elixia’s operational prowess is highlighted by our ability to efficiently administer doses to study subjects. We were able to dose three individuals within the span of just five business days at a single location, demonstrating our commitment to streamlined and effective clinical trial management.

“Elixia extends its transformative capabilities in psychedelic research across the East Coast, while staying dedicated to optimizing the patient experience,” says Matthew Collins, Director of Site Operations. “Our entire CNS team is genuinely thrilled to contribute to cutting-edge trials at the forefront of mental health treatment, embodying our commitment to pioneering advancements in holistic well-being.”

Elixia is also working with Reunion neuroscience on an upcoming Phase II psychedelic trial utilizing a novel synthetic psilocybin with patients suffering from postpartum depression. We will be one of approximately 20 sites in the US.

Our company has past experience in psychedelic trials for central nervous system (CNS) indications. Elixia previously collaborated with MindMed on a Phase II trial focused on severe anxiety, which became the largest well-controlled clinical trial of LSD ever conducted, enrolling a targeted 200 subjects.

We remain steadfast in our commitment to optimizing the patient experience while contributing to pioneering advancements in mental health treatment. Elixia’s expertise in clinical trials management positions us as a key player in the evolution of psychedelic research.


Elixia Announces New Clinical Excellence Center

In continuing our mission to improve the speed and efficiency of clinical trials, Elixia is pleased to announce the establishment of the Elixia Clinical Excellence Center (ECEC). The ECEC, which originally opened in June 2023 as the Elixia Health Phase I Unit, is expanding its scope to encompass rare hepatorenal disease studies, behavioral health and central nervous system studies, and sleep studies, as well as early-phase research.

Centrally located in Tampa, Fla., the ECEC is a state-of-the-art premier site providing 24/7 medical coverage for studies in an inpatient setting. Featuring 42 beds, the site provides in-house 24-hour medical coverage and offers highly comfortable accommodations for participants making overnight stays. Clients also gain access to Elixia’s vast and diverse de-identified patient database, powered by our partnerships with the largest health systems in the country.

The ECEC’s clinical trial capabilities include pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, dose response, first time in human safety/tolerance, renal studies, IV infusion studies, and more. The site

is equipped with full pharmacy services, 12-lead ECG, refrigerated centrifuges, secure ultra-low temperature freezers, and backup generator electrical supply. Patient amenities include comfortable exam rooms, a recreation area, and private overnight rooms furnished with TVs and tablets with wifi access.

Hepatorenal Disease

The ECEC reflects Elixia’s in-depth expertise in the overlap of kidney, liver and heart disease. We are partnered with several of the largest nephrology networks in the United States, covering 1,500+ providers across 16 states, This is the largest cardio-renal clinical trials network in the US, giving clients unmatched trial expertise across four key geographical areas. We rank in the top 1% globally for clinical trial enrollment in cardio-renal studies, having conducted 350+ studies in cardiology and nephrology indications.

Behavioral health and CNS

Elixia has extensive behavioral health expertise combined with proprietary technology. Having partnered with the largest network of minority patients in the Northeast, we have the #1 highest representation of minorities in behavioral health across sites, globally. We have conducted 200+ studies conducted in this field. Elixia is also the #1 leader in global enrollment for five CNS pharmaceutical companies.

Sleep study

The ECEC offers in-patient evaluation, diagnosis and care for pediatric and adult patients, examining sleep disorders including sleep apnea, insomnia, restless legs syndrome, narcolepsy and more. The site’s 42 calming and comfortable study bedrooms give patients the amenities of a hotel. Our skilled sleep technologists provide a superior patient experience with adherence to American Academy of Sleep Medicine guidelines.

For more information on the Elixia Clinical Excellence Center, please contact us at (954) 900-1001 or info@elixiacrc.com


An Unmatched Cardio-Renal Network Moving Research Forward

At the heart of Elixia’s pioneering efforts in cardiology and nephrology is our unique and multidisciplinary Cardio-Renal Network. We are ranked among the top 1% globally for clinical trial enrollment in cardio-renal research, with an exceptional national footprint dedicated to cardiology and/or nephrology encompassing 350+ studies to date.

Deep Expertise in Cardio-Renal Overlap

At Elixia, we pride ourselves on understanding of the intricate interplay between renal diseases and complex cardiovascular conditions. This comprehensive insight is the result of close collaborations with some of the largest nephrology networks in the United States. Our network includes more than 1,500 nephrologists across 16 states, culminating in the largest one-of-a-kind cardio-renal clinical trials network in the U.S., spread across four crucial geographical regions.

Elixia’s success is owed not only to our vast network but also our strategic partnerships with pharma giants like AstraZeneca, Bayer, Cara Therapeutics, GlaxoSmithKline and Tricida. These alliances empower Elixia to conduct studies in various therapeutic subcategories within cardiology and nephrology, including anemia, chronic kidney disease, chronic renal failure, end-stage renal disease, hyperparathyroidism, metabolic acidosis, overactive bladder, pruritus, and type 2 diabetes.

Leadership and Vision

The driving force behind Elixia’s extraordinary growth is our CEO, Neal Patel, a healthcare and biotechnology entrepreneur with a profound passion for improving accessibility, particularly in underserved communities. His journey began with the establishment of a private R&D laboratory responsible for developing cost-effective diagnostic tests for cardiovascular indications. Over time, Patel developed one of the largest dedicated cardiology networks on the east coast, culminating in the development of the groundbreaking Cardio-Renal Network.

Under his guidance, Elixia’s Cardio-Renal Network has become the largest dedicated clinical trials footprint in the Southeast and the fastest-growing within the cardio-renal specialty in North America. Patel’s strategic foresight has led to Elixia’s meteoric rise, as the company’s total enterprise value has more than quadrupled, our workforce has tripled, and we have garnered numerous accolades for our work in various therapeutic areas.

Pioneering Clinical Trial Solutions

Elixia has always been at the forefront of delivering innovative clinical trial management solutions. Our integrated and technology-forward approach has introduced a new suite of capabilities to enhance the efficiency of clinical trials.

The Elixia Cardio-Renal Network is a testament to the power of innovation, dedication, and strategic collaboration in the field of clinical trials. As we continue to expand our reach and expertise in cardiology and nephrology, Elixia is poised to make a significant impact on the treatment and understanding of complex cardiovascular and renal diseases.


Elixia Surges with Remarkable Expansion in Sites

As a trailblazer in patient recruitment and clinical trials management, Elixia is making waves in the healthcare industry with our phenomenal growth over the past year. We have achieved new milestones that solidify our position as a leader in our specialized therapeutic areas of cardiology/nephrology, behavioral health, and infectious disease.

In just 12 months, Elixia has seen enrollment capacity triple and has doubled our network of clinical trial sites. The company now boasts a total of 21 strategically located sites. This exceptional growth is a testament to Elixia’s commitment to advancing medical research and improving patient outcomes.

One of the most notable achievements for Elixia has been our recent expansion in nephrology studies. We have successfully secured partnerships with the largest nephrology sites in three key states: Michigan, Missouri and Florida. This highlights the company’s dedication to advancing renal research.

Elixia’s innovative approach to patient recruitment and clinical trials management has set us apart in the industry. We eliminate traditional trial bottlenecks with a singular combination of specialized clinical expertise and an agile operating model with reproducible processes to deliver startup and enrollment at uncommonly remarkable speed. Elixia holds the record for enrolling the most patients in the shortest amount of time for any global trial in the last 50 years. Our expansion in sites will allow us to continue that level of performance.

“We are thrilled to announce these remarkable achievements,” says Neal Patel, CEO of Elixia. “Our team’s dedication and hard work have allowed us to not only to double our network and triple our enrollment capacity, but also expand our potential to transform patient lives. We look forward to continuing Elixia’s mission of accelerating medical research with a positive impact worldwide.”


Elixia Enters Phase I Clinical Trials Market

Elixia Health, a leading provider of clinical trials management, analysis and patient recruitment services, announces the opening of its Phase I Unit for clinical research, which began operations on June 1. The 40-bed inpatient private research site is located in Tampa, Fla., near a Level 1 trauma center hospital. The facility provides in-house 24-hour medical coverage and comfortable accommodations for study participants, including those making overnight stays.

Elixia Health’s Chief Scientific Officer, Dr. Harry Alcorn, is serving as administrator of the Phase I Unit. With over 20 years of Phase I experience, Dr. Alcorn has been the principal investigator on more than 150 protocols and sub-investigator on more than 250 protocols. He designed and created the U.S. Renal Network, the first network of Phase I renal research sites in the country.

“Our new unit, equipped with cutting-edge facilities and a seasoned team, is precisely focused on the underserved areas of renal and hepatic patient trials,” said Dr. Alcorn. “Our entry into the Phase I market underlines Elixia’s intent to catalyze breakthroughs that may pave the way for new, FDA-approved medications.”

The Elixia Health Phase I Unit’s clinical trial capabilities include pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, dose-response, first-time-in-human safety/tolerance, renal studies, IV infusion studies, and more. The site’s research areas cover a number of specialty populations (renal, hepatic, cardiovascular, diabetic, and gastrointestinal patients), as well as healthy males, females, and seniors.

The Phase I Unit is equipped with full pharmacy services, 12-lead ECG, refrigerated centrifuges, secure ultra-low temperature freezers, and backup generator electrical supply. Patient amenities include comfortable exam rooms, a recreation area, and private overnight rooms furnished with TVs and tablets with wifi access.

“This step is more than an expansion; it’s a clear message that Elixia is prepared to address and resolve the challenges of today’s clinical research needs,” added Jim Crissy, the company’s Chief Operating Officer. “By combining our cutting-edge infrastructure with Dr. Harry Alcorn’s esteemed leadership, we aim to set new standards in Phase I clinical research.”