Q&A with Medpace Rheumatology Medical Experts: A Collaborative and Cross-Therapeutic Approach

Medpace's unique, scientifically-driven approach to clinical research gives Sponsors the advantage of early and ongoing insight and guidance from trial design through execution of the study. These highly-qualified Medpace Rheumatologists offer Sponsors deep expertise across a broad spectrum of diseases and technologies.

conditions until she decided to focus on clinical research. Treating patients with autoimmune and rare conditions motivated her to become involved in discovering novel treatments for those in need. Her curiosity in drug development and drug safety led her to pursue a career with Medpace. Dr. Docena has experience conducting clinical research trials as a sub-investigator and medical monitor for osteoarthritis, inflammatory arthritis, and autoimmune connective tissue disorders.

spondyloarthritis/AS, systemic lupus erythematosus, Sjogren's syndrome, scleroderma/systemic sclerosis, myositis, vasculitis, polymyalgia rheumatica, and giant cell arteritis. He has authored or co-authored several publications and presented abstracts at the annual American College of Rheumatology (ACR) meetings. Dr. Head has clinical trial experience as a medical monotor, principal investigator or sub-investigator in several clinical trials covering rheumatology indications.

In this brief interview, we learn more about the expertise that Dr. Docena and Dr. Head bring to Medpace, along with the unique strengths of each Medical Director that complement each other, building a strong medical leadership team in rheumatology.

Tell us about each of your backgrounds: what expertise do you bring to Medpace?

Dr. Head: I have a background in clinical rheumatology, working in a rheumatology group practice for 20 years. I provided inpatient and outpatient care for a wide variety of rheumatologic diagnoses, and I worked with internal medicine and family practice residents during their rheumatology rotations. I also participated as a PI or sub-I in several clinical trials for rheumatology indications. I enjoy learning about new therapeutic mechanisms and the satisfaction of being a part of developing new treatments.

Dr. Docena: Before joining Medpace, I was in clinical practice, first in Detroit and then in Ohio, specializing in rheumatology. During my time in Detroit, I was involved in academic research focused on rheumatology studies and worked collaboratively with other medical specialties in the care of our shared patients. My background in clinical practice and rheumatology research equips me with valuable expertise that I bring to Medpace. I am passionate about contributing to the development of new medications for these populations, especially young females, who desperately need better treatment options and potentially a cure.

What drew each of you to Medpace?

Dr. Head: Knowing I would be a part of the group effort required in new drug development. I also really enjoy the opportunity to learn about new innovations and mechanisms for the treatment of autoimmune disease. Being part of Medpace allows me to continue to use my medical knowledge in collaboration with a team dedicated to developing exciting and innovative treatments in areas of need.

Dr. Docena: Rheumatology research has seen signification advancements, offering more treatment options; however, there remains an unmet need for new treatment options. By being involved in the development of a treatment that could provide patients with a better quality of life and possibly a cure, I could be indirectly helping more people than in clinical practice. My interest in pursuing a nonclinical career while leveraging my medical expertise led me to Medpace, and the headquarters being in my hometown of Cincinnati was a bonus.

Medpace is a global company, providing opportunities to collaborate with colleagues worldwide and gain insights into clinical research aspects in different countries. The company's organic growth globally was intriguing, as it allows me to contribute to diverse global studies and help expand the reach of global trials. When I first came to Medpace, I really liked the feel and culture of the company. I was impressed by the collaborative approach that facilitates strong teamwork across various departments in order to find the best solution. Additionally, Medpace is a full-service CRO with integrated services, including in-house labs, which enhances efficiencies and makes processes more seamless.

How do the differences in your backgrounds help build a strong medical leadership team for rheumatology?

At Medpace, there are two rheumatologists within our medical team of global physicians, bringing over 29 years of combined clinical and industry experience. We understand the current treatment paradigms in rheumatology, so we understand the pipelines, mechanism of action, and the current needs of rheumatology patients. We also make up part of a larger team of specialists with expertise in the area of immunology and inflammatory diseases. This collaboration of in-house specialists positions Medpace to cover a broad spectrum of indications.

We have unique strengths in specific specialties that complement each other, building a strong medical leadership team for rheumatology. We have global and country-specific experience to navigate languages, cultures, and clinical and regulatory environments around the world. We each have experience working with PIs in different areas. Our different connections expand our network with other rheumatologists and potential PIs, which is helpful when working with Sponsors to gauge the landscape of what's happening in different areas.

Illustrate the rheumatology clinical development landscape, highlighting the specific challenges, considerations, and risks involved.

The drug development process is currently changing; historically, the classic perspective for medicine and clinical development was to develop one medication for one disease and defining one disease by organs. For example, there are cardiologists for the heart, dermatologists for the skin, and nephrologists for the kidney. There have been advancements to this mindset, and we now better understand the inflammatory pathway, so we are better at understanding how to develop new drugs that target specific points in the inflammatory pathway. One investigational medicinal product (IMP) can now target several diseases, even diseases that don't belong to the same specialty.

The current landscape for clinical development in rheumatology is overlapping different inflammatory diseases that span different specialties like dermatology and nephrology. The rheumatology space has ongoing new discoveries of inflammatory pathways and mechanisms with potential for developing new treatments. Despite this, several of the diseases have had no new proven effective treatments or the other treatments are not completely effective and/or have significant side effects. So, there are unfulfilled needs and opportunities. Many autoimmune diseases are heterogenous and have a spectrum of different disease manifestations. Often, there is no "one size fits all" treatment. In these cases, a challenge is how to best identify the patients with the disease manifestations/inflammatory pathways that will benefit and respond to the investigational drug's mechanism of action.

Another challenge is many diseases aren't responding to conventional medications and require ongoing treatment with glucocorticoids and other immunosuppressive drugs that cannot be stopped. This can interfere with showing the true benefit of the investigational drug compared to the placebo. The challenge is how do we minimize glucocorticoid and other background treatments in the placebo group while maintaining patient safety in the trial.

Additionally, we don't have enough rheumatologists in clinical development around the world for the number of Sponsors and investors trying to develop new medication for immune indications. Diversity in clinical trials is a challenge and there is a need for increased diversity in rheumatology trials. Minority populations are not properly represented in clinical trials, so we are not creating evidence that specific medication will work for them if they are not included in the trials. There is a history of distrust in minority communities and there is a need for diversity in PIs to help build more trust and encourage patients to enter these trials.

Tell us a little about the cross-functional collaborative approach at Medpace and how this helps accelerate rheumatology clinical development.

Rheumatic diseases can affect several systems and organs in the body, so rheumatology clinical development requires teamwork and collaboration across medical specialties due to the overlap. It is in our nature as rheumatologists to be familiar with teamwork because we are always working to properly care from patients across other specialties, including nephrologists, dermatologists, etc., to address the patient problems and improve quality of life.

This transitions to how we work at Medpace in a multidisciplinary team with medical experts, providing support and interacting frequently with the clinical operations and regulatory teams. Medpace has a consortium of specialists in immunology and inflammatory diseases which includes immunologists, allergists, rheumatologists, dermatologists, gastroenterologists, hematologists, nephrologists, pulmonologists, neurologists, and ophthalmology specialists. This in-house interdisciplinary collaboration allows for appropriate expert oversite throughout each clinical trial.

Additionally, with the boom of cell and gene therapies for rheumatology indications, there are a lot of biotechs working on these advanced therapies in immune diseases. At Medpace, we provide medical leadership working with our internal experts in hematology and cell therapy, including Dr. Greg Hale and Dr. Ann Woolfrey.

What integrated services at Medpace help to support rheumatology clinical trials?

Our comprehensive CRO services are supported by our wholly-owned Central Laboratories, Bioanalytical Lab, Imaging Core Lab, ECG Core Lab, and Phase I Unit, as well as a Clinical Trial Management System that ties all study data together in a single platform.

Medpace's integrated central laboratories (MRL) can perform a variety of disease-specific biomarker panels for the detection and monitoring of SLE, Rheumatoid Arthritis, and other autoimmune indications. MRL's extensive selection of chemistry, immunology, hematology, molecular, and flow cytometry tests include over 50 FDA cleared/CE marked inflammatory biomarkers validated on specialized instrumentation as well as a large menu (>100) of validated ELISA and multiplexed assays.

Imaging expertise and clinical trial experience ensures that imaging components are seamlessly integrated into the complex structure of the overall trial. Medpace Core Labs (MCL) provide a breadth of expertise across a broad spectrum of rheumatology imaging. Notably, we use a web-based image management system with integrated quantitative tools to analyze a wide range of medical imaging modalities such as MRI, CT, PET, x-ray, etc. for confirmation of eligibility, safety, and efficacy evaluations.

Patients with rare rheumatology diseases, such as systemic sclerosis, encounter significant challenges in their daily lives. Reducing these burdens is crucial for recruiting and retaining a committed group of patients into studies. Medpace places patients at the center of the trial to reach enrollment goals, while improving outcomes in terms of study design, participation, adherence, satisfaction, and data collection. Medpace Patient Concierge Services (PCS) provides global travel support to minimize patient burden, facilitate compliance with study visits, and keep the study on track.

From a clinical development standpoint, what new innovations are you most excited about?

There are many innovations in rheumatology that we are excited for that will transform the landscape of rheumatology clinical development. To note a few:

• Specific technologies that can impact several indications, for example cell therapies are used for systemic lupus, lupus nephritis, osteoarthritis, and more.

• Novel monoclonal antibodies directed to interfere with inflammatory pathways or to deplete auto-reactive immune cells.

• Immune effector cell therapies (CAR-T cell therapies) that can use the body's immune cells to treat and give long-term remission to patients with some of our most severe and refractory autoimmune rheumatic diseases.

• The use of oral small molecule kinase inhibitors-these medications come in the form of a pill and are being developed to interfere with multiple inflammatory pathways.

How do you envision rheumatology clinical development evolving over the next 10-15 years?

The immune system is complicated and there are many potential mechanisms and interactions that contribute to developing an autoimmune disease. There is great heterogenicity within the disease groups. In other words, patients with the same disease may have different pathways driving inflammation. Ideally, we will develop biomarkers that can predict which inflammatory pathway to target for the individual patient.

We also hope to develop more curative therapies that offer long-term remission with less side effects, particularly for some of the frustrating, difficult to treat, and unresponsive chronic inflammatory conditions such as systemic lupus erythematosus (SLE) and scleroderma/systemic sclerosis.

Personalized medicine is the future for rheumatology, as it is currently for oncology indications. Based on genetic markers and inflammatory markers, we can choose a more tailored option for the mechanism of action with the least adverse events for that specific condition and patient. With mechanism of action, there is a tendency to develop combined therapies under a single medication that are targeting two different problems. Developing combined therapies is complex but is a promising approach to autoimmune diseases.

What motivates you and your interest in clinical research - specifically in rheumatology?

Every clinician at some point has experienced a refractory case where everything available has been tried and failed to improve the patient. It affects even the most frequent indication with the most drug options available in the market. Treatment options for rheumatic diseases are refractory to whatever we have in the market right now. This is very frustrating to the clinician and of most significance, devastating to the patient and their family. There are numerous medications in the market combining biologics and oral molecules; still after using all those medications, you will find around 20-30% of subjects do not respond to any of those medications. Once patients prove to be refractory to whatever is available in the market, that patient is condemned to only use glucocorticoid, which is the main driver of early mortality in rheumatic diseases and loss of quality of life.

It is motivating to be part of these efforts in clinical research to find new mechanisms and new treatments that will help people with difficult to treat or previously untreatable autoimmune rheumatic diseases.

Medpace Rheumatology CRO

Medpace's expertise and consistent track record of success as a full-service CRO across various therapeutic areas provides the flexibility necessary to meet the unique needs of rheumatology research. Our in-house board-certified rheumatologists have a thorough understanding of the complex conditions that cause these diseases, as well as the medical complications experienced by patients. Experts collaborate across therapeutic areas to create effective and efficient study designs for Sponsors of all sizes.

Public link

Please use the above public link if you want to share this noodl on another website.