Moving promising new medical innovations efficiently through all stages of preclinical and clinical development to become treatments

Through interdisciplinary collaborations, access to advanced technologies, and the support of a uniquely structured system, our physicians, surgeons, and researchers are empowered to do what is needed to drive health care innovations for patients everywhere.

Direct access to FDA-compliant resources expedites medical innovation

Clinicians and scientists produce research and clinical-grade therapeutic materials for clinical studies onsite. Additionally, risk, safety, and efficacy assessment studies are performed onsite in compliance with FDA standards. This enables rapid movement into the clinical trial phase. Research teams have access to early-phase trial support, outpatient clinical care, and study management services, like research, nursing, regulatory submissions, and budget management support for all phases of clinical trials. “From device development to preclinical and clinical studies, and early adoption to physician training, Houston Methodist has developed an institutional environment that has supported successful device development,” said Eric K. Peden, MD, chief of vascular surgery at the Houston Methodist DeBakey Heart & Vascular Center.

At Houston Methodist, we continue to accelerate progress in the fields of oncology, nephrology, trauma, and more.

A partnership leads to rapid device development

Allotrope Medical, saw the need to create a device that could help surgeons decrease the risk of injuries to the ureter, which often occur during abdominal and pelvic surgeries. Approximately 4 million of these surgeries are performed annually in the United States alone

While performing a difficult colon resection, Huang came up with the idea of using an electrical current to locate the ureter, leading him to develop StimSite, a device that easily identifies the ureter by stimulating it with a small current. The muscle contractions produced by the device are proven 100% effective in helping visually identify the ureter during surgeries. StimSite could also aid surgeons in differentiating between healthy and dysfunctional tissues in parts of the body such as the esophagus and anorectal area.

Huang’s company, Allotrope Medical, decided to partner with Houston Methodist to further refine and test StimSite, and they have submitted StimSite to the FDA and anticipate clearance in 2020.

“I was fortunate to be trained at a place that recruits people who like to think differently and are allowed to flourish,” said Huang of his experience at Houston Methodist. "I was privileged to work with physicians who have the mindset for innovation—they…don’t push away a new idea...”.

 

An innovative wearable: Engineering and medicine collide to help trauma patients

Maham Rahimi, MD, PhD, RPVI, has found the perfect place to blend his expertise in biomedical engineering and medicine. After receiving his PhD in biomedical engineering from the University of Texas Southwestern Medical Center, he was drawn to Houston Methodist’s innovative capabilities. With an array of resources available, Rahimi helped to develop a medical device that has the potential to improve patient outcomes across multiple specialties.

In August 2018, Rahimi met Steven Hansen, CEO and cofounder of Odin Technologies, at a networking event. They began collaborating on a wearable known as Valkyrie, a noninvasive device that monitors blood flow in the lower extremities.

In trauma patients, for example, Valkyrie could bypass the need for constant invasive needle injections to monitor muscle compartment pressure, which leads to delayed diagnosis of compartment syndrome, increasing the risk of nerve damage, amputation, and possibly death. Valkyrie can help rehabilitation specialists provide patients with timely assessments while continuing to work with patients on their progress.

“My experience with the Houston Methodist Research Institute has been phenomenal. Since working with Dr. Rahimi, the project has really taken off. Houston Methodist strives to facilitate our needs and provide us with the expertise necessary to produce a product that the end user wants—something designed by healthcare providers, for healthcare providers,” said Hansen.

 

Access to GMP-grade RNA facilitates a new generation of treatments

RNA drugs are an entirely new approach to therapy.  John P. Cooke, MD, PhD, chair of the Houston Methodist Department of Cardiovascular Sciences and medical director of RNA Therapeutics Program, recognized the opportunity for Houston Methodist to lead in this therapeutic arena. His scientific team has developed proprietary processes for the synthesis and purification of good manufacturing practice (GMP)-grade RNA that is reliable and high enough in quality to meet FDA standards. Houston Methodist is the only academic institution in the country that can make clinical grade mRNA products for human use.

Our RNAcore facility entered into an exclusive licensing agreement with VGXI, an industry-leading plasmid DNA contract manufacturer. The ongoing collaboration will provide researchers with a steady source of RNA—supporting the development of new RNA vaccines and therapies.

“The pairing of the RNAcore and VGXI fills a critical product development gap with a GMP manufacturing solution that enables biotechnology companies and groups of academic institutions to drive novel mRNA therapies through FDA approval pathways to market,” said Cooke.

Our researchers and clinicians have already begun exploring the use of RNA therapeutics and strategies for use in clinical applications, such as restoring damaged heart tissue and innovative cancer therapies.

Currently, we have more than 1300 research projects underway and 5218 collaborations across 74 countries, including the United States. For each endeavor and through every phase of discovery and clinical trial, we keep our patients at the center of our medical and academic missions.

With a commitment to patients and overall medical advancement, our researchers and clinicians are deeply dedicated to impacting the future of patient care. We encourage these thinkers to keep questioning in the relentless pursuit of life-altering treatments for patients.

Reference: 1. Houston Methodist Institute for Academic Medicine. Pathways to a Cure. Annual Report: Research & Education. 2018:1-44.