Guest Blog: Patient-Focused Drug Development Is the Right Way to Drive Impact

Sep 21, 2023

Guest Blog by Jeff Jones, Chief Medical Officer, Cullinan Oncology

As a physician and Chief Medical Officer at Cullinan Oncology, I’ve seen firsthand the struggles many cancer patients face when managing their disease, their fear upon learning the diagnosis, and the challenges that come with understanding increasingly complicated treatment options. With an appreciation for patients’ experiences, I see many opportunities for biopharma to help improve not only care but also the quality of life for patients living with cancer.

Looking at the patient experience holistically means not only understanding patients’ relationships with cancer and potential treatments, but also understanding how our industry can design and execute accessible clinical trials that consider all aspects of a patient’s clinical trial experience. This complete picture is what can set patients up for success in treatment and support research teams as they strive to successfully address unmet needs.

Bench to Bedside and Back
Putting patients first can mean approaching research with the aim of identifying unique patterns within patients and their tumors as well as treatment applications within smaller patient populations. Doing so can accelerate the research process to potentially get novel treatments to patients faster.

In the earliest phases of clinical cancer research, we often treat small numbers of patients to limit exposing patients to potentially toxic treatments with yet unproven benefits. As a result, we must find ways to learn as much from each individual patient’s experience with the treatment. An outlier response or even an unusual adverse event in a single patient can help researchers determine the mechanism driving that isolated finding in a way that’s applicable to a larger patient population. This translational approach helps us learn as we go, understand how tumors respond, and identify broader applications for potential treatments.

While science for science’s sake can be highly rewarding, we need to solve real-world problems, give healthcare providers new tools to produce better outcomes, and design better treatments that ideally impact the broadest patient group. We start small but think big. Clinical observations alone won’t get us there—translational research helps close the loop.

Pursuing More Diverse and Accessible Trials
Enrolling diverse patient populations in clinical trials can also help ensure trials produce the most representative data. By conducting trials where patients actually live as well as where they access their care, we can better understand an investigational therapy’s potential benefit to the broader population. Considering patients’ needs in this way helps us raise our game and create therapies better matched to patients’ specific circumstances.

Historically, many clinical trials have been run out of academic medical centers. However, geographic proximity alone doesn’t ensure access to state-of-the-art care, including access to investigational therapies. If patients in underserved neighborhoods in major metropolitan areas are not able or willing to travel to comprehensive cancer centers, we must bring clinical studies to the hospitals and care centers where they do receive care. Further, if clinical trials are too complex to be conducted in community settings, we should be designing trials that are simpler to implement.

To effectively conduct clinical trials in a community setting, research and development (R&D) leaders must also earn the trust of clinicians. Clinical investigators work directly with patients and provide invaluable data toward developing treatments, but investigators need to know the R&D teams they work with are reliable partners in providing access to novel therapies. Investigators need to be able to pick up the phone and call us whenever they need support.

In some respects, this mandate starts way upstream, during the innovation stage of drug design. For instance, modalities such as bispecifics and monoclonal antibodies are in many respects more community-friendly modalities than cellular therapies that can be administered in many practice settings. When it comes to drug development and discovery, the best time to think about patients is all the time. If we wait until an investigational drug enters late-stage trials to consider the people who are actually taking that medication, it’s way too late.

From the earliest fundamental discovery research, everything we do affects how patients will interact with a cancer drug: safety, efficacy, accessibility, cost, and combinability. Through this patient-centric approach, the heavy lifting we do throughout R&D optimizes clinical trials, eases anxiety, and potentially accelerates approvals, getting treatments to patients faster.

About the Author

Jeffrey Jones, M.D., M.P.H., M.B.A., is the Chief Medical Officer of Cullinan Oncology, a biopharmaceutical company focused on creating new standards of care for patients with cancer. With over 15 years of clinical development experience in academia and industry, Dr. Jones’ expertise spans clinical trial design and recruitment, drug development, medical education, and healthcare management. In his current role at Cullinan Oncology, Dr. Jones manages a diverse pipeline of clinical-stage programs that span multiple therapeutic areas and modalities. Dr. Jones holds an M.B.A. from The Ohio State University Fisher College of Business, an M.P.H. from the University of Texas School of Public Health, and an M.D. from the University of Michigan Medical School, completing his residency in internal medicine at McGill University.

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