About the Episode
If 2020 was a year of unexpected (and unprecedented) change, 2021 was the year that saw our industry reinforce its focus on patients. In the latest edition of Trial Trends, hosts Libbi Rickenbacher and Kathleen Greenough reflect on the past year, discussing how clinical trials are leveraging new technologies to ensure that the patient perspective remains at the center of clinical research in 2022 and beyond.
Welcome to Trial Trends™, a monthly podcast brought to you by 4G Clinical and hosted by Kathleen Greenough, Senior Director of Client Solutions, and Libbi Rickenbacher, Director of Strategy! The show welcomes guests from all over to tackle big ideas, challenge the status quo, and bring fresh perspectives to the rapidly changing world of clinical trials. Get ready to disrupt the old ways of thinking and discover the newest trial trends! In today’s episode, Kathleen recaps 2021 with co-host Libbi Rickenbacher, Director of Strategy at 4G clinical.
To begin, Libbi and Kathleen provide introductions for each other. Libbi has over 15 years of experience in the life sciences. As part of the 4G Strategy team, she spends much of her time assessing industry trends and new technologies in search of potential product opportunities, collaborations and new partnerships. Kathleen is the VP of Commercial Operations at 4G clinical and was one of the first hires back when 4G was founded. Previously, she specialized in the adoption of clinical operation software at a major biotech company for over a decade and a half. As a leader of the commercial team, she spends much of her time talking to clients and engineering solutions.
The last year has been crazy for the industry as a whole, as the spotlight has been cast on the industry for the first time. The standout lesson learned is that the patient really needs to be put in the center of everything. Now, the voice of the patient and their needs is louder than ever. In 2021, we saw much more conversation around the concept of hybrid trials, and decentralization of trials (DCT) is certainly here to stay. Additionally, telehealth is the norm now as more and more insurance companies are beginning to include it in their policy.
Libbi recently ran a survey uncovering the barriers of decentralized trials from sponsors and CROs. A main component of the survey was that protocol complexity is something sponsors see as a main barrier. Sites have felt the increase in logistical work compared to what they’re used to doing. Many technologies out there are beginning to take root to ensure that we have the oversight for clinical trials. Protocol developers are starting to see the new options offered by current technologies. Segwaying into their predictions for 2022, Libbi shares that the focus will shift towards these new technologies, communication between them and how to prepare to support these complex trials. We are entering a new era of personalized medicine and must be prepared to support and scale it. The general public is becoming more educated and comfortable with the idea of mRNA and cell and gene therapy, which are revolutionizing patient treatment. However, there are obvious improvements and general changes needed.
VP, Commercial Operations
Kathleen Greenough, Vice President, Commercial Operations at 4G Clinical, has 16 years of experience in life sciences spanning Clinical Operations, Finance, and IT. Her wide range of solutions implementation expertise includes RTSM, CTMS, trial costing tools, OLAP financial suites and patient enrollment planning. Kathleen has also spent many years as a Clinical Financial Planner and Analyst at a major biotech in Cambridge, MA, gaining a broad and deep understanding of the challenges inherent in Clinical Development. Specializing in software adoption and a frequent speaker at industry conferences, Kathleen is most in her element when working within a user community to facilitate solutions that are insightful and truly helpful.
Libbi Rickenbacher, Director of Strategy, has over 15 years of experience in the field of life sciences, and is an e-clinical RTSM solutions subject matter expert.
Her experience lies at building and managing accounts, clients, and strategic initiatives. Has a proven record of success in conceptualizing and delivering client focused solutions, standards, and providing oversight and guidance to both internal and external teams. Holds BA in both Neuroscience and Psychology and a Doctorate (PhD) in Neuroscience.