In May 2024, New Hyde Park, N.Y.-based Northwell Health and the START Center for Cancer Research — a global network of clinical trial sites — established a partnership to bring an early-stage clinical trial site to Northwell’s R.J. Zuckerberg Cancer Center, also in New Hyde Park.
The organizations have since appointed Geraldine O’Sullivan Coyne, MD, PhD, to lead the newly established START unit. She recently helped launch START Dublin after serving for seven years at the National Cancer Institute.
Dr. O’Sullivan Coyne and Richard Carvajal, MD, medical director and deputy physician-in-chief of medical oncology at the Northwell Cancer Institute, spoke to Becker’s about why and how the START partnership will push clinical trial innovation forward.
Editor’s note: Responses have been lightly edited for clarity and length.
Question: What does establishing a START site at Northwell signal about the system’s broader strategy in cancer care and clinical trials?
Dr. Richard Carvajal: The way that our industry delivers cancer care and access to some of these novel therapies is not optimal, and I think that’s widely acknowledged. Access to these therapies are a challenge. At a system like Northwell, we have the opportunity to give our patients access to those therapies without the need for them to travel very far. Developing a robust phase 1 program in a system like Northwell is a high priority for us because [access to these therapies] is so critically important.
Q: Why was partnering with START the right move for Northwell versus building out this capability entirely in-house?
RC: All cancer programs are going to say [trial capability] is a critical piece that they need to develop, but there are different challenges depending on the setting.
In smaller community settings, they’ll have the patients and physicians but maybe lack a little bit of the knowledge required to build infrastructure. On the other end of the spectrum, with our traditional academic centers where there’s deep expertise and a long history of doing trials like this, there’s frequently a lack of efficiency for various reasons.
Together, Northwell and START saw an opportunity to do things differently. We’ve got the community-based oncologists who want to give their patients access to these therapies and then we have the expertise of START— it’s just an incredible marriage and something that hasn’t been done before. With this START-Northwell relationship, the speed, size and scale at which we can do this is so much greater.
Q: How do you envision this shaping Northwell’s role in the regional and national oncology landscape?
RC: As a new model it has a ton of potential for innovation, even above and beyond what START has already been able to achieve. When you think about the complexity of trials, the new therapies that are coming through, the need for inpatient administration, cellular therapy, pediatric cases, neuro-oncology — there’s a huge range of opportunities that this sort of partnership can do. If we can succeed, I would love to see this model exported elsewhere.
Q: Dr. O’Sullivan Coyne, You helped launch START Dublin. What insights from that experience are you applying to the Northwell initiative?
Dr. Geraldine O’Sullivan Coyne: There are elements in parallel to helping launch START Dublin that are equally exciting in this venture. Dublin certainly taught us the importance of embedding early-phase research into an existing hospital ecosystem, looking to work with the infrastructure that’s there while bringing something entirely new to patients. When you combine this type of global expertise with local collaboration, you can launch and scale these types of early-phase units much faster than we ever thought possible. Northwell is similar in that it is a large and trusted healthcare system, but its difference is in the sheer scale and the diversity of the New York population that we believe is a truly uniquely powerful setting for both groups.
Q: What kinds of investments and infrastructure are essential to support early-phase trial operations at scale?
GOC: START has now over 20 years in the oncology drug development setting, but its model focuses in particular on two elements. There’s not only the infrastructure aspect, but for us to carry out our core operational fundamental aspect, we need 100% dedicated staff to be able to produce that type of clinical excellence in the trial setting. This means we have a great deal of investment in the people aspect of this endeavor as well. We provide a lot of structured onboarding and mentorship to ensure very much that we remain committed with our partners to being the stewards of innovation, and being able to also advocate for patients by bringing in these types of trials into the community.
With regards to some of the more mundane aspects of the infrastructure, we know that the units need to have certain areas that are key to the drug development process, while relying on some of the other ancillary or support groups that are part of the hospital. Being integrated in this healthcare system also means that we can potentially take on together trials that would be more delicate or more challenging to carry out in a strictly ambulatory-based setting.
We also have our own pharmacy, with both hazardous and non-hazardous compounding capabilities, which is a key aspect in oncology drug development and something that you do not want to place as an additional burden on hospital resources. While there are some very distinct infrastructure needs of the START units, it’s the partnership with Northwell where we believe we’ll be able to take on these more complex and more delicate trials to the benefit of patients.
RC: Outside of what the START unit should look like, there are a lot of support services that are required to actually run these trials. Similar to what we require for standard of care cancer care, you need easy and rapid access to radiology, interventional radiology, subspecialized pathology, cardiology and other specialists needed to monitor toxicity, ophthalmology, endocrine, etc.
Q: Are there specific tumor types or modalities you’re prioritizing?
GOC: This is going to be an endeavor where we’ll be able to see what the real-world patient needs are as we see what comes through the door, while at the same time being able to serve not only underrepresented groups but also rare tumor populations. We know that about 35% of our trials are focusing on novel modalities: antibody-drug conjugates, bispecific antibodies, cell therapies, radioligand therapies, some cancer vaccines and some precision trials specifically looking to address a particular mutation or molecular alteration.
These types of delicate early phase trials, classically have been available in the more traditional academic medical centers. Northwell has undoubtedly flipped that model by bringing these types of trials into a place where patients live and receive their care. We believe that this will help us remove barriers, be able to reach underrepresented groups, but also ensure that these latest therapies are also tested in real-world populations. It is tremendously exciting for us.
Q: What has been the internal response from Northwell’s oncology teams as this partnership begins?
RC: They cannot wait. Even before START, we’ve significantly ramped up our clinical research enterprise over the past few years. The faculty, staff, patients, everyone has been thrilled with the access that we’ve been able to provide them. This is just going to accelerate it to a different level. Physicians will continue to remain an integral part of patient care and be given the opportunity to participate in the program as well.
Q: What excites you most about the opportunity to bring early-phase clinical trials into a community-based model at Northwell?
RC: The first START unit, which is opening up now, is the Long Island program. The second unit will open up next year in Manhattan. We’re going to be able to drive the field forward in ways that other programs haven’t been able to, at a pace that other places have not been able to do it. We’re going to be able to do novel therapies that have only been done at tertiary, standard academic centers. We’re really innovating here for the benefit of patients, I’m just excited about the whole thing.
GOC: Access at scale is one of the elements that very much comes across as the most tangible potential, which I hope will be to the benefit of all of us and most particularly the patients we serve. We’re going to be busy, but it’s incredibly exciting work and I can’t wait.
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