How GCMI and T3 Labs is supporting Dr. Lindon Young’s novel therapy to significantly reduce cardiovascular reperfusion injuries. During…
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In the words of our customers
“Adopting a protocol that more closely mirrors the actual clinical application in humans, was a high value recommendation brought forth in advance of the in-vivo preclinical work. Working with the great team at T3 Labs has dramatically improved the timeline to test the novel molecules in the clinic, most notably to heart attack patients receiving percutaneous coronary intervention (PCI).”
– Lindon H. Young, Director of the Endocrinology and Introduction to Human Disease and Therapeutics courses in the DO program at the Philadelphia College of Osteopathic Medicine (PCOM)
““Designing and managing the logistic demands of a large animal study is complex and requires much more knowledge than a bench scientist’s,” he said. “That’s where the team at T3 Labs has been exceptional. They fill in all of the translational gaps for our requirements with very high levels of proficiency. The ability to execute cardiac cath lab preclinical programs combined with electrophysiology is exceedingly rare. T3 Labs has the infrastructure and expertise to make it happen.”
– Hee Cheol Cho, PhD, Urowsky-Sahr Scholar in Pediatric Bioengineering, Associate Professor, Departments of Biomedical Engineering and Pediatrics at Emory and Georgia Tech
ALung Technologies granted Emergency Use Authorization by the FDA for their Hemolung® Respiratory Assist System for the Treatment of COVID-19
“A good preclinical partner must be able to adapt to the needs, schedule and budget for a specific project. T3 Labs, now part of GCMI, has been an outstanding partner in supporting ALung throughout many preclinical studies.
“Preclinical work is always filled with unexpected outcomes – some good, some bad. Having a trusted preclinical partner that has the experience, expertise, and flexibility to work with your specific product, team, timeline and budget is of the utmost importance.”
– Jeremy Kimmel, PhD, Vice President of New Technologies for ALung
“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the T3 staff to Europe for research programs that must be done there. The T3 staff handle everything required with the utmost professionalism and consideration.” – Steve Rybka, CEO of Vesalio
“We cannot think of a better Preclinical CRO to work with and as we continue to add new products to the pipeline, we will certainly utilize T3 Labs for preclinical studies.” – Dr. Tom Barrows, President & Chief Science Officer of Cell Constructs
“At T3 Labs they have the perfect setup for what we needed. From the cath lab to fluoroscopy to large animal proficiency, not to mention years of expertise specific to cardiology. The entire staff is excited and interested in our technology.” – Dr. Rebecca Levit, Chief Scientific Officer of CorAmi Therapeutics
“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans.” – Jason White, Senior Director of Product Development at St. Jude Medical
“We needed to conduct the study perfectly to prove to the FDA that our technology really was safe and effective; we learned that we needed to engage the right partners to do that.” – Tyler Wanke, Co-Founder and CEO of Innoblative
“The facilities are top tier. We designed the facilities to make it easy to move from concept through protocol to budgeting and now it happens as efficiently as possible.” – Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc.
Featured Preclinical Stories
Webinar recording: An introduction to the U.S. FDA Investigational Device Exemption (IDE)
“The personnel at T3 Labs has randomized the treatments (test and control agents) and have implemented rigorous study design protocol (e.g. location of area at risk) to enable clear and concise reproducibility of the in-vivo myocardial infarction model to render valid comparisons between the test and control compounds used in the study protocol,” Lindon wrote. “We have completed testing of the first test agent and the results indicate a robust reduction in infarct size (i.e. 70% reduction) in the test compound vs.the control compound group accompanied with significant improvement in post-MI cardiac function.”
A SAFER WAY TO CONDUCT PERICARDIOCENTESIS – A PROCEDURE BEGGING FOR A TECHNOLOGY TO REDUCE MORTALITY
“In our tests supported by GCMI and T3 Labs, we found our device reduces pericardial entry depth by over three times less compared to currently available technologies including the 18 gauge needles on the market.”
GCMI’S SHERRY FARRUGIA AND MIKE FISHER SHARE IN THE PRESIDENTS’ AWARD OF DISTINCTION FROM CTSA FOR TRANSLATIONAL RESEARCH
“Because of this research collaboration between Georgia Tech, Emory, Children’s and GCMI, one of the biggest problems affecting patient safety in hospital settings might finally be solved.”
FEATURED EVENT: AN INTRODUCTION TO THE U.S. FDA’S INVESTIGATIONAL DEVICE EXEMPTION (IDE): A GCMI WEBINAR
The IDE process allows a limited product release to enable the clinical use of a new device. The trial can then study a device’s safety, efficacy, and usability when there are too many unknowns for a general market release. The market release is constrained for use as prescribed in the clinical trial protocol and limited in distribution in approved institutions. All this is intended to mitigate the risk when studying a novel technology. The IDE is a common, critical activity and waypoint in the path to FDA full market approval.
PRECLINICAL SPOTLIGHT: REGENERATING PACEMAKING CELLS FOR TREATMENT OF CARDIAC ARRHYTHMIAS WITH DR. HEE CHEOL CHO
“The more translational we became, the more I understood the lives of the patients who have to live with existing pacemaker technology. “The ability to conduct fundamental and translational studies in small and large animal models in the same location with a highly qualified preclinical staff who understand our needs and our science was the final piece of the puzzle. I distinctly remember flying out of Hartsfield-Jackson that day knowing that this is the place.”
“Mabrouk and Inan worked with Patrick Strane, an engineer at GCMI, to figure out how to prepare the device for human testing. After analyzing the device, they decided to make improvements to its packaging, which made it safer for children and more resilient to stringent hospital cleaning standards.”
From Capstone through CREATE-X and on to the precipice of commercialization: Ethos Medical’s medtech journey for its novel spinal guidance system
In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more than three years and the promising product dubbed Neuraline has evolved to become a new medtech startup: Ethos Medical. The Ethos team leveraged the supporting elements and mentors within the Georgia Tech CREATE-X program—with assistance from GCMI and T3 Labs—to advance development of its needle guidance system.
What is the current state of the preclinical testing landscape in the United States? GCMI Director of Scientific Affairs Evan Goldberg sheds some light on that question in a Q&A with Write2Market’s Paul Snyder.
We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study is the one you have to do twice. Our response to your request for preclinical work may not be the lowest bottom line price. But please know this: all preclinical programs and RFPs are not created equal. Read on.
At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA. Let us convince you.
GCMI is committed to working with innovators to test medical technologies and therapeutics that consistently meet customer needs and regulatory requirements. We maintain Quality Management Systems to ensure compliance and ongoing quality of our deliverables, products and services. Our AAALAC accreditation and GLP experience validate these claims. But you don’t have to take our word for it. Read on.
In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established protocols. What happens if and when a regulatory body returns questions? We won’t turn your project away because it’s too hard, or because we haven’t done it before. We pride ourselves on our interest in your project and our accountability. Read on including a few words from two of our clients.
As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your surgeons’ availability, not the other way around. We work beyond the bankers hours because we know time is of the essence, deadlines must be met and your innovation is not your surgeons’ sole concern. Read on.
Where does preclinical testing enter the design and development phase of new medical technologies and devices? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg share deep dive insights.
“At the end of the day, some testing requirements in the design and development phase simply cannot be done ‘on the bench,’ Evan says. “In design input requirements and confirmation activities within the design and development phase, only cadaveric or small scale in-vivo testing can determine if a device provides appropriate grip or traction for the user, or if it works as intended in a beating heart or vessels with blood flow. Read on.
UNDER PRESSURE: CADAVERIC TESTING YIELDS INITIAL HUMAN ORGAN VALIDATION FOR GT CAPSTONE EXPO WINNERS’ MINIMALLY INVASIVE TREATMENT FOR CARDIAC ARREST
“We needed more detail and more evidence on our technology’s potential beyond a porcine heart,” Jackson told us. “We liked what we saw from our early testing, but the access to a cadaveric testing opportunity and support with the GCMI and T3 Labs team was invaluable to our work. With their help, we proved the system can produce the pressure required while inflating at a rate that would not tear the pericardium.” Read more about the Best Interdisciplinary Team in the Fall 2020 Georgia Tech Capstone Design Expo.
Critical preclinical considerations to include in the project planning phase of a new medical technology
Project planning is the beginning of formal product development process, wherein the identified team enters a design control process that complies with medical device regulatory requirements (in the United States, per the FDA) and business strategy. This phase is all about determining the resources, the timing, and the work that’s required for product success.
Where does preclinical work find its way into project planning for new medical technologies? What are the top considerations for preclinical work in this early development stage? GCMI Preclinical Program Director Evan Goldberg shares his insights in this Q&A.
Design validation ensures that you have made the “right” product – according to the customer’s needs. Design verification ensures that the team has made the product “right” – according to regulatory and engineering requirements.
How does verification and validation in the design and development process “translate” to preclinical?
Find the insights from GCMI / T3 Labs Preclinical Program Director Evan Goldberg tells us in this Q&A. Read more.
GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards for our medtech and life science customers. Read on.
Preclinical studies can be expensive. Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study that is critical, but not always obvious. What are the most common cost types you should consider when planning your preclinical study? Read on.
Quality preclinical research begins with a robust preclinical study protocol. Preclinical study protocols can make or break a study, and are the foundation on which reports required by regulatory bodies are built. Our team of subject matter experts have outlined what to include in a preclinical study protocol. Read on.
The most expensive study is one you have to repeat. 10 things to know before you start your GLP preclinical study.
Think of your GLP study as a final exam. They follow months, if not years, of “course work.” They can make or break your innovative medical product. Like a tuition bill (including your final exam), GLP studies are costly. Be prepared with everything on our list below, BEFORE you start that study. Click here to read.
How do we get preclinical studies right for our customers? Easy access to resources, flexibility, experienced staff, and attention to detail and timelines are the high points. Read more.
“This was a make-or-break moment for us. Having credentialed professionals managing the study, board certified veterinarians on staff and a team who cared about the project as if it was their own, is a distinguishing feature for GCMI/T3 Labs.” – Tyler Wanke, Co-Founder and CEO, Innoblative
“I would highly recommend and strongly endorse T3 Labs as the ‘Go To’ contract research organization to conduct preclinical research studies.” – Dr. Lindon H. Young, Young Therapeutics, LLC
A good preclinical partner must be able to adapt to the needs, schedule and budget for a specific project. T3 Labs, now part of GCMI, has been an outstanding partner in supporting ALung throughout many preclinical studies.
We cannot think of a better Preclinical CRO to work with and as we continue to add new products to the pipeline, we will certainly utilize T3 Labs for preclinical studies.
The T3 Labs team is fluent in our scientific language. Because of this, I’m able to do a much better job and I can entrust them to communicate with the physicians directly.
We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the T3 staff to Europe for research programs that must be done there. The T3 staff handle everything required with the utmost professionalism and consideration.
We are grateful to T3 Labs for providing access to the facilities and resources the team needed to be ready for our first ever preclinical session with a practicing anesthesiologist. There we acquired the customer feedback and functional performance data needed to keep us moving forward efficiently on the complex pathway from concept to commercialization.