Beware the Unfamiliar Approach: Preclinical Implications for Cell & Gene Therapy Innovation

Roughly one decade ago, scientists made significant improvements in viral vectors’ ability to deliver genetic therapeutics. Those therapies use genetic material like DNA to manipulate a patients’ own cells. Cellular (cell) therapies transfer cells into the patient whether they are the patients’ own cells or cells derived from another location or donor cells.    Because…

Who brings what to the table? Artivion’s Deepal Stevenson, M.S. shares her insights on the client / CRO relationship for effective, efficient preclinical studies and reports.

Life science companies of all shapes and sizes rely on preclinical contract research organizations (CROs) to generate the data and reports required to bring their innovations to market.   To do this effectively, and in a capital efficient manner, each entity needs to understand what they need from the other, when they need it, why…

Q&A with an Industry Leader – What’s One Area Especially Ripe for Acceleration in Preclinical Work? Hint: It’s Not the OR.

As we shared recently, our colleagues at Within3 are using technology to accelerate pharma and medtech innovation in some very interesting ways. Their platform improves life science teams’ engagement in asynchronous applications like advisory boards, helps teams find the right KOLs anywhere on the globe and helps teams make the most out of medical congresses…

Preclinical Implications for 3D Printed and Bioresorbable Medical Technologies

The phrase “personalized medicine” has been thrown about by so many for so long in healthcare as to defy definition: or require post graduate work in any one of dozens of specific clinical or technological fields.   For the sake of brevity, 3D printing and bioresorbable material technologies are actively realizing personalized medicine in the…

Orthopaedic Innovators: Do Not Underestimate the Importance of Process in “Medtech Innovation: From Unmet Clinical Needs to Clinical Solutions”

Join GCMI’s Dr. Emily Blum, Evan Goldberg, PhD and John Tipton for an ORS Innovation Network Webinar August 31, 2022   “For over 60 years, the Orthopedic Research Society (ORS) has been the leading research society supporting engineers, orthopaedic surgeons, biologists, veterinarians, and clinicians in pursuit of a world without musculoskeletal limitations.”   GCMI and…

Rooted in Cardiology: Let’s talk preclinical and cardio innovation at TCT 2022

Founded by Cardiologists In the late 1990s, Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., was looking for accessible resources, including preclinical support, needed to support innovation in care for cardiovascular physicians and their patients.   In 1999, his collaboration with other Atlanta area interventional cardiologists and cardiothoracic surgeons resulted in the development…

High Demand, Regulatory Support and Importance of Advance Planning Highlight the 2022 State of the Preclinical Ecosystem

As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to travel for business, medical technology innovation and critical supporting service providers are not only working through pent up demand for delayed projects from 2020 and 2021, but also striving to advance technologies that reduce cost…

When clinical relevance calls for on-the-fly preclinical protocol deviation

How GCMI and T3 Labs is supporting Dr. Lindon Young’s novel therapy to significantly reduce cardiovascular reperfusion injuries.    During events such as myocardial infarction (heart attack) and surgical procedures involving angioplasty, bypass surgery, or heart transplantation, reactive oxygen species (ROS) can be generated, which cause organ and blood vessel damage. ROS is generated from…

Recording & Insights: An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE)

Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study are first in human devices, devices that require Class III premarket approvals, some Class II devices, or a de novo device or…

Are you a life science innovator seeking funding in the next 12 months? Applications are open for PitchRounds at AdvanSE 2022.

Our colleagues at Southeast Life Sciences are now accepting applications for Pitchrounds at AdvanSE 2022.   They’re seeking the southeast’s most promising life science innovators across multiple life science categories including biopharma, medtech, diagnostic, digital health and agriculture biotechnology technologies.   Along with Southeast Life Sciences, we encourage those seeking early rounds of six figures…