Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of progress.” In a remarkable display of agility, medtech affairs and commercial teams, including KOLs, and regulatory bodies found a way to advance and deliver innovations in a time of unprecedented disruption.
If we looked deeper into the development timelines of many of those innovations, particularly those with rigorous preclinical testing requirements, we suspect we would find a significant amount of those preclinical studies were conducted prior to Q1 2020.
What then 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 the following Q&A with Write2Market’s Paul Snyder.
Q: How has preclinical work changed from your clients’ perspective in the past 18 months?
A: Given the industry-wide, intensive budgetary and travel restrictions, very little preclinical testing got done in 2020 compared to the previous 2-3 years. That began to ease this past spring. We are now seeing more requests for GLP studies supporting safety and efficacy data for new medical technologies and devices than at any point in my career. Every preclinical lab is stacked with ongoing studies and RFPs. As such timelines at the labs, including T3 Labs at GCMI, have doubled from request to time scheduled.
Q: What has been critical in enabling you and your team to continue to deliver for your preclinical customers?
A: Flexibility. We can get creative with how procedures are planned, not only to better accommodate our customers’ and their surgeons’ needs, but our own staff’s as well. If we need to start earlier in the day to accommodate just one extra procedure, we will. If we need to stay late if a participant has an early flight the next day, we will. If we need to schedule procedures on weekends, we will.
Q: What can innovators or companies needing preclinical testing support do to ensure their projects proceed unimpeded?
A: Look as far ahead on scheduling and reporting timelines like histopathology as possible. Those labs are slammed just like the preclinical CROs are. Get on their schedule quickly to expedite reports on the back end.
Q: Outside of the pandemic, how would you describe the current state of preclinical research?
A: Consolidation of preclinical cros has been a major factor for those needing preclinical services. This means fewer options, higher prices and a more important than ever need to vet your preclinical partners than ever. I recommend readers to check out “Five questions to ask when selecting a CRO preclinical studies.”
Q: What should those preparing for upcoming preclinical work do now to give their studies the highest probability of success?
A: Given the current state of travel restrictions, especially for international travelers and supply chain challenges to which preclinical work is not immune, identify what you need and have backup plans in place if a resource becomes unavailable. Teleconferencing works well for observing procedures remotely. Facility tours and audits with quality assurance teams also work well in a remote or virtual environment. Taking advantage of those opportunities speeds up the process and opens up calendars.
What else would you like to know? We would love to hear from you via email: info@gcmiatl.org. Please indicate “State of Preclinical Query” in the subject line.
About GCMI
GCMI accelerates the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. We are a trusted, proven industry-leading preclinical CRO for medical device and other medical products. We’re an AAALAC accredited facility that conducts feasibility, proof of concept, safety, and GLP medical device testing for studies in any therapeutic area and in small and large models.
Why GCMI? It’s all about flexibility, accountability, quality, compliance and accreditation, our scientific acumen and commitment to value. Learn more.