Melanie Fortin, Vial’s new Clinical Research Project Manager, discusses her background and what brought her to the Vial team. Melanie joined the Vial team in October 2022. To learn more about opportunities at Vial, visit our careers page and follow us on LinkedIn.
Tell us about your background.
I started as an Optometry Technician in the United States Air Force and after my military commitment, I moved over to Ophthalmology and worked as a technician, scribe and trainer. I became very frustrated with medicine not having all of the answers for patients yet or having a limited number treatments for vision-threatening conditions that may or may not work for every patient. So, I moved into the research field as a Clinical Research Coordinator and Site Supervisor where I have worked on and contributed to more than 25 Ophthalmology clinical trials (Phases 1-4; Anterior and Posterior Segment). When I went back to school for my Masters, I worked in the lab doing bench or basic research. After COVID, I wanted to learn more about the entire process of clinical trials (i.e. what happens before the trial reaches the site?), so I joined a biotech sponsor that was working on new treatments for retinal diseases. Now being at Vial CRO as a Clinical Research Project Manager, I have come “full-circle” and have worked in almost every single role in Ophthalmology clinical research along the way!
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?
Start-up biotech companies are creating cutting edge, novel therapies. That means that they need cutting edge, novel technology to support their trials! Many patients are desperately waiting on some of these new therapies to improve or save their lives or vision. Biotech start-ups need CROs that can provide technology-enabled infrastructure that streamlines and improves the clinical trial process. Some areas that technology can be tapped into to speed up the clinical trial process include: accelerating the study start-up process (need to get the selected trial sites up and running as soon as possible), expediting trial recruitment (technology that can be utilized to reach more potential study participants which results in faster enrollment), and streamlining the technology used during the clinical trial process (integrating the various systems needed into fewer systems or even one system). These technology-enabled solutions result in compiling the data needed for FDA approval faster, which ultimately translates into getting these new treatments into the hands of prescribing providers faster.
What advice do you have for the founding teams of startup biotechs that are new to clinical development?
Hire the best team possible and look for passionate individuals (their passion drives them to work tougher and harder). Ensure that the team you build is complementary and fills in each other’s weaknesses (together we will always be stronger). Foster a working environment that is respectful and collaborative; one that promotes open-communication to spark new ideas and brainstorm solutions to challenges you will encounter. The solutions needed are almost always amongst the right team members, and you just need to give your team an open forum where they feel like their contributions are welcomed and valued to access those solutions. My last piece of advice is, if you have developed an innovative drug, treatment, or medical device, then make sure you are selecting a CRO that is innovative as well. You want to partner with a CRO that is built for delivering faster execution and higher quality outcomes in your trials.
What led you to join Vial?
I have experienced firsthand some of the challenges faced by conducting trials with some of the existing CROs, from both the site’s perspective as well the sponsor’s perspective. Many mid-large sized, multi-therapeutic CROs may have conducted Ophthalmology clinical trials, but a common issue I encountered was a lack of understanding of the true complexity involved in Ophthalmic trials (i.e. terminology, assessments involved, recruitment challenges etc.) and for the current Ophthalmology-based CRO’s, I experienced poor communication, service, and support for site staff. Utilizing these past experiences, I am excited to contribute to making Vial’s Ophthalmology CRO the CRO I always wanted to work with (from both the site side and the sponsor side) so that we can improve the existing clinical trial process.
What are you most excited about over the next year at Vial?
This is such an exciting time in the field of Ophthalmology research since we are so close to providing more answers and new treatments for our patients. I am so grateful to be on the Vial team during this pivotal period so that we can reimagine Ophthalmology Clinical Trials!