Biotech Leader Spotlight Series

Welcome to Partnology’s Biotech Leader Spotlight Series, where we highlight the remarkable accomplishments and visionary leadership of biotech industry pioneers. This series is about showcasing the groundbreaking strides made by exceptional leaders who have transformed scientific possibilities into tangible realities. Through insightful interviews, we invite you to join us in following the inspiring journeys of these executives who continue to shape the landscape of the biotech industry. This week we are recognizing:

Sherly Mosessian, Chief Scientific Officer

Dr. Mosessian earned her bachelor’s degree in Biochemistry, followed by her Ph.D. from UCLA Department of Molecular and Medical Pharmacology, with publications in tumor signaling, molecular imaging targets and clinical trials of Positron Emission Tomography (PET) probes. She joined the SOFIE team in 2021 as the Vice President of Clinical and Regulatory Affairs leading the clinical development of FAPI diagnostic. She was promoted to Chief Scientific Officer in 2022. Prior to joining SOFIE, she served as a Chief Administrative Officer at UCLA and oversaw the establishment of a current Good Manufacturing Process (cGMP) facility in support of PET radiopharmaceutical production for research and clinical service. She successfully established a pathway at the UCLA Department of Pharmacology to translate PET imaging agents from bench to the clinic in a time and cost-efficient manner.

In addition to her expertise in biomedical research, she has served in an executive leadership capacity in technology, having co-led the establishment of DGIT, the integrated information technology organization in support of the research and education mission of the UCLA School of Medicine. Dr. Mosessian is Armenian and having immigrated to the United States at a young age, values the importance of diversity/inclusion, seeking opportunities and having a strong work ethic.?

INTERVIEW:

Walk me through your career, noting some of the most pivotal moments or decisions throughout:

I completed my Ph.D. at UCLA in the Department of Molecular and Medical Pharmacology, focusing on cancer biology and cancer signaling. As I was about to finish my PhD; I approached one of my committee members with an interest in business and regulatory and he offered me a position within his division. I became director of the preclinical imaging division he was building. This role allowed me to wear many hats, manage a small group and project, and build the division into something strong. Over a few months, I was noticed by others in the department, and recommended for the Chief Administrative Officer (CAO) role, which had been difficult to fill, due to a need for a candidate with both scientific expertise, along with a business and administrative mindset. Despite being young in my career, I was given the opportunity and selected for the role .

This CAO role was exciting as I balanced department administration and business aspects (intellectual property, tech transfer, regulatory, finance, IT, facilities, regulatory, environmental health, and safety) with my passion for science. My expertise from the bench side helped shape some of the department’s key areas of interest and push initiatives toward FDA interactions, approvals, and bringing new radiopharmaceuticals into the clinic. It was an amazing opportunity to have early in my career, and I felt very supported. I was in that role for about five years, overseeing department operations and working on regulatory and clinical development pathways for new pharmaceuticals.?

Eventually, it was time for a transition due to significant funding toward combating cybersecurity breaches in our school. This led to the development of a new IT department, and I assumed the position of CAO to help build this organization from a 12-person department to a 145-member organization over four years. This integration across the School of Medicine and other health sciences schools was incredibly exciting, even though I came from a non-IT background. My scientific expertise helped bring technology to researchers, and I learned much about communication management, change management and building strategic roadmaps.

About five years into this role, the CIO of the division left the organization for an exciting opportunity in a start-up, and I was asked to step into the interim role in addition to my current responsibilities. This was a pivotal moment in my career. It forced me out of my comfort zone serving as the #2 position for a while and stepping into the #1 role by? thinking differently to lead the organization through significant change. In this new role I had to focus less on initiatives and introducing change, but instead had to prioritize communication through multiple channels, build transparency and relationships with my team and key stakeholders, and manage the organization without a permanent leader. This experience taught me that I could tap into my skills to effectively serve in a leadership role by bringing stability to the organization and represent the organization externally to key stakeholders.

Interestingly, I did not get the permanent CIO position after serving as interim CIO. This initially felt like a rejection, but ultimately allowed me to reflect on my true passion for science. I started seeking opportunities to return to the field, and fortuitously, a startup called SOFIE, which had flourished since its inception from UCLA, reached out to me. The CEO offered me a position to lead their scientific pipeline, which was incredibly exciting. I accepted the role of Chief Scientific Officer about two and a half years ago, overseeing the organization’s pipeline and regulatory, quality, and compliance functions.

Could you tell me more about the work you're currently doing at SOFIE?

At SOFIE, I serve as the Chief Scientific Officer, where I wear two hats. One involves overseeing quality regulatory compliance across all our radiopharmacies, and the other focuses on managing our pipeline. Our pipeline primarily consists of radiopharmaceuticals, specifically novel products we have licensed, which we are shepherding through the clinical development pathways. These products are called FAPI (Fibroblast Activation Protein Inhibitor). They have various applications in detecting cancer across different types and even in some non-oncology disease areas, such as fibrotic diseases.

Joining SOFIE presented a greenfield opportunity to establish a program from the ground up. Previously, we did not have clinical development expertise. Assembling a passionate, bare-bones team and learning along the way has been incredibly rewarding. We are a small team on the clinical development side, very focused on outcomes, and moving quickly to make an impact. As a company, SOFIE is a great mix of a flourishing 450 employee organization, while retaining some of its original start-up culture to stay nimble, which I admire the most.?

Could you expand on the programs you’ve worked on, highlighting those you are most proud of or passionate about?

There have been many projects, but the one I would highlight is my first one. This particular project was exciting because radiopharmaceutical companies and academics were faced with new FDA regulations on Positron Emission Tomography (PET) tracers, and we had to help our faculty and researchers find seamless paths to move? their newly developed pharmaceuticals into first-in-human studies. I was asked by our department chair to lay out a process to achieve this in a timely and cost-effective manner.

At the time, I had zero regulatory experience and had never done any FDA regulatory work, which was both exciting and challenging. Fortunately, I was surrounded by incredibly knowledgeable subject matter experts. The project involved bringing together chemists, clinicians, regulatory experts, engineers, and veterinary specialists to determine the necessary studies to support the FDA. We needed to lay out a process that was efficient, cost-effective, and met the FDA's requirements while ensuring our faculty had a smooth process moving their novel radiopharmaceuticals to first in human. This effort resulted in a publication we are very proud of and the successful launch of three products into first-in-human studies within about a year and a half, each costing $50,000 a tracer. This was a significant achievement for us.

What I learned about myself is that while I may not have deep expertise in every subject area, I am a connector and a driver. I selected the right people, guided them, learned from them, and helped them make decisions to move forward and complete the initiative. This connector role has served me very well in my career and continues to be valuable in my current role, particularly with our pipeline program. I’ve learned how to bring the right people together, leverage their expertise, and use my strengths to make something successful.

What do you see as the most promising technologies in biotech over the next 5-10 years?

There are two that come to mind. One, specifically in Nuclear Medicine, is the use of AI to continue maturing our image analysis tools for interpreting images. AI in image analysis has started, but there is still much more that can be done.

The second technology, which is outside my direct field but equally exciting, is the concept of 3D bioprinting. I absolutely love the idea. There have been some successes, but I hope to see it become widely adopted and used routinely for patients. Currently, many patients wait for critical organs, with the only option being the passing of another patient to receive the right organs. The possibility of taking a patient’s cells to create compatible organs is incredible to me. I don't work directly in that field, but it's something I follow closely. It is heartbreaking to know that so many sick people in need of transplants are just waiting for the phone to ring. If 3D bioprinting takes off, it would be an amazing solution.

With the experience and insights you have gained, what advice would you give to young people aspiring to work in the biotech industry?

The biggest lesson I've learned and the advice I would give is to be solution-focused. We often see people who are good at standing on the sidelines, pointing out problems. While identifying problems is important, those who excel at various levels of an organization are always solution-focused. So, being solution-focused and not waiting to have all the right skills before starting something is crucial. I often hear individuals interested in pursuing a career in regulatory or project management say they feel unqualified due to lacking certain skills. My advice is not to limit yourself by feeling you need all the skills to start something. Start small, and the skills will come.

I also suggest never saying something is above your pay grade or not in your job description. Whenever there's an opportunity to help someone or take on a task, even if it seems outside your job description, embrace it to help the team move forward. Having the right attitude and a willingness to help the larger team can make a significant impact. There are always exceptions, and you don't want to be taken advantage of, but I've been fortunate to have incredible mentors, mostly men, who opened doors for me. By doing more, I've been noticed and given more opportunities.?