Tell us about your background.
I attended Boston University for undergrad to study biochemistry and neurobiology. I first began my clinical trial career at MGH as a CRA working on regulatory and data entry for phase 1/2 hematology oncology trials. I then transitioned to UCSF where I was both a CRA/CRC working on hematology-oncology trials primarily in the immunotherapy and CarT space. I’ve worked on some of the major CarT trials that have led to FDA approval or are in the process of going through approval. After learning extensively about how to run trials at a site level, I was looking to transition to the health-tech space where I could make improvements to how oncology trials were currently being run in the industry.
In your past few roles, you’ve seen the challenges of drug development and discovery upfront, where do you see room for technology enabled infrastructure to support startup biotechs?
Many of the systems that sponsors and sites use are antiquated: large, shared excels which often freeze, word documents that are edited without using the latest version, large safety files being sent through email and getting lost. Essentially, this translates to trials being opened slower, patients who are eligible aren’t enrolled, and safety data being compromised.
Another corner that biotech companies can tackle is patient recruitment which at large institutions relies largely on patients that are seen in clinic. Seldom are patients referred for trials unless a PI has an established relationship with a doctor from another clinic, and even more rarely patients themselves reaching out to a site for potential enrollment. Patients and doctors need to have a better way for to know what trials are actively available to them.
What advice do you have for the founding teams of startup biotechs that are new to clinical development?
There is a reason that clinical research associates, coordinators, and data/regulatory managers experience high levels of burnout – the meticulous and painstaking efforts to ensure patient safety comes at price. My advice to biotech companies is to go directly to the source of who runs trials (onsite coordinators and protocol managers) and do thorough research into the nitty gritty details of each trial process. The FDA cares about those details, and a disconnect between technology and the clinical research industry can prove to be a waste of efforts and resources in the long run.
This is all to say, the clinical research industry could benefit largely from a revamp in their technical systems, and the right combination of persistent and humble minds is key to this success.
What led you to join Vial?
I was looking to join a company where my niche clinical trial site knowledge would be applied directly. I wanted to have the capacity to be creative in the projects I was working on, and Vial fit the bill to a T. Many of the changes that improve a patient’s experience on trials are minute, hidden, and untapped. I feel that with my site knowledge combined with Vial members who have entrepreneurial mindsets, I will be able to make palpable changes in trial workflows.
What are you most excited about over the next year at Vial?
I’ve met so many like-minded and highly competent individuals already at my time with Vial that I’m so excited to see how we revolutionize the clinical trial industry. We are young and ambitious yet humble, and we have the ability to think outside the traditional constraints of the industry status quo. I’m excited to see how all of our ideas manifest in the long run, and I have no doubt that it will be very exciting each step of the way.