NeuroSense featuring the COO

“What excites me the most is ensuring everything, no matter how many things we have in the air at once, is executed flawlessly”
– Hagit Binder, COO

After 13 years as VP of Marketing and Projects, I realized that what excites me the most is ensuring everything, no matter how many things we have in the air at once, is executed flawlessly and done right the first time. It’s similar to the satisfaction of an air traffic controller managing multiple planes landing and taking off simultaneously, with zero incidents. This is what propelled me to a career in operations and to NeuroSense Therapeutics, where I have been the Chief Operating Officer for two years now.

As the COO, I play a pivotal role in the planning and execution of our clinical studies. The process begins with defining the condition we aim to address, currently focusing on ALS and Alzheimer’s, with plans to expand to Parkinson’s and beyond. We then determine the target population, including the number of participants and the study’s scope. Identifying the optimal locations for the study is also crucial to ensure its success. Each step is integral to shaping a study that aligns with our mission and maximizes its impact.

Before a study begins, I am responsible for designing a request for proposal to the Clinical Research Organizations (CROs). In the request, we bring together all the necessary  information regarding the study and additional services that we wish to engage in. Every small decision has many implications.

Selecting the right collaborators is a challenging task, as it’s not always easy to make direct comparisons. Ultimately, I must choose a CRO that balances an appropriate budget with the right personnel. It’s about finding the optimal combination that aligns with our goals and ensures the success of the project.

It is very important for me to meet the vendors’ project managers in advance and to make sure we have a good connection, because they’re going to be my go-to people on a daily basis. I need to make sure that I have good chemistry with them, and that they understand that we are a startup, where everything needs to be fast, in high quality, and with no compromises on the way. I repeat the same process with different vendors to find the best services for labelling, packaging and distributing to the sites. Ultimately, it is my responsibility to make sure that all the tools we need come together at the sites in order to kick the study off.

The bigger portion of what I do in the study start-up is locating the sites, making the connection with the principal investigators (PIs), understanding their capabilities and their willingness, motivating them to understand our drug and our study, having all the contracts with them, discussing the budget, understanding how many patients they can enroll and what the duration of the enrolment will be. Basically, I am looking for the optimal team to help NeuroSense with the study.

The ideal site is a site where the PI is very engaged, motivated to bring new drugs to their patients, has a large staff filled with caring employees to support the patients and the conduct of the study, is well equipped, and maintains the quality and integrity of the study. I can say that yesterday we met an ALS patient, who told us that the best thing in the study he participated in was the study coordinator and the study nurse. They made such a difference in his experience because they were so caring.

In managing our clinical studies, my focus is on making participation as easy and convenient as possible for patients. This includes minimizing site visits, enhancing the likelihood of receiving active treatment, and addressing logistical challenges like transportation. Recognizing the impact on both patients and their caregivers, I also consider compensation to reduce their financial burden.

Another key aspect of my role is ensuring that all equipment used in the study is standardized. I carefully select vendors who meet the necessary certifications and can provide materials that comply with regulations across different countries. Timely delivery of investigational medicinal products is crucial, and I work closely with logistics’ vendors to manage this effectively. Additionally, I maintain regular communication with our Contract Research Organization (CRO) to ensure smooth operations and address any challenges that arise. The CRO can be helpful to make sure we do everything necessary before getting started with a trial. However, we do not let the CRO hold us back. It is  important that we have our own inhouse clinical research associates (CRA’s) to keep things moving forward. We form connections on our own with clinical sites rather than just relying on our CRO. They see that our therapy is our “baby”, that we care for it, we want it to be managed with the best hands possible, therefore we choose the site that we want to engage with. That makes a big difference in creating a close relationship with the PI.

It is always a boost of motivation to understand that the work that we are doing here is important. It can save lives and families. It can reduce pain, agony and suffering. ALS is a devastating disease, and we have within our power to help.

My tip is to stay alert and proactive every day. Anticipate potential issues before they arise and be ready to address them quickly. It’s about staying ahead of challenges and keeping everything on track, even when unexpected obstacles come up.