Medical Affairs: The Missing Link To Oncology Drug Adoption

By David Adler, MD, Ph.D., MBA

A successful clinical trial is essential to establishing safety and efficacy, but the value of a development program is ultimately determined by whether clinical evidence drives adoption by physicians and healthcare systems.

After spending a decade leading oncology programs in clinical development, I came to appreciate that successfully advancing a program and generating evidence that will ultimately change clinical practice are related, but not identical, challenges. I increasingly found myself asking not only whether the evidence was sufficient for the next development decision but whether it was answering the questions physicians would eventually ask.

Clinical development already considers patient selection, differentiation, positioning, treatment pathways, and evidence requirements. The challenge is ensuring that these decisions are continuously informed by the perspectives of physicians and scientific experts who will ultimately evaluate and use the drug, as well as by emerging RWE. The missing link is medical affairs.

From my perspective as a senior clinical development leader who has spent much of my career in oncology clinical development, medical affairs should not be viewed as a supportive function. It should be an equal strategic partner, bringing external scientific insight, clinical practice perspectives, and RWE into development decisions throughout the life cycle.

Beyond The Clinical Trial

Working with KOLs, practicing physicians, scientific societies, and patient advocacy groups, medical affairs can provide a continuous external perspective on the clinical environment in which an oncology drug will ultimately be used.

In my experience, discussions with investigators and external scientific experts bring a different perspective. An emerging clinical profile might look promising internally, while an oncologist looking at the same program might immediately ask where the drug would fit in an evolving treatment landscape, which patients would actually receive it, or whether the magnitude of benefit would be sufficient to change practice. Those questions are especially consequential in oncology, where the standard of care can change while a drug is still in development, molecularly defined subgroups can reshape the population most likely to benefit, and clinical value may depend not only on antitumor activity but on the durability of benefit, toxicity profile, combination strategy, and where a therapy fits within an increasingly complex treatment sequence. Those questions — and their answers — are valuable while there is still time to influence the evidence-generation strategy.

Other relevant questions include:

• What are the practical challenges of incorporating a particular drug into the standard of care?
• How does it compare with competing drugs?
• Which patients are most likely to benefit?
• Where does it fit within treatment sequencing?
• What would influence physicians' treatment decisions?
• What evidence would strengthen confidence in its use and support adoption?

RWE adds another important dimension by providing insight into patient populations, treatment patterns, outcomes, healthcare utilization, and the practical experience of using a drug beyond the controlled environment of a clinical trial.

A Strategic Partnership Across The Life Cycle

In early development, medical affairs can engage oncology KOLs and practicing oncologists to challenge assumptions about the clinical opportunity, understand the treatment landscape, evaluate competing approaches, and assess whether promising biology has the potential to translate into meaningful clinical value.

As programs mature, medical affairs can help refine differentiation and positioning while identifying evidence gaps that may influence future clinical decisions.

In late-stage development, the focus increasingly extends to adoption: treatment sequencing, physician expectations, guidelines, reimbursement, and the evidence required to support use in routine clinical practice.

The objective is for medical affairs to ensure that clinical development decisions benefit from a continuous understanding of the external clinical environment, and that medical affairs contributes as an equal strategic partner rather than a parallel supportive function.

Four Areas Of Strategic Focus

The pharmaceutical industry has become extraordinarily sophisticated at generating oncology clinical evidence. The next challenge is ensuring that this evidence translates into clinical value and adoption. Here’s how:

• Prioritize. Bring external clinical and scientific insight into portfolio discussions to help identify opportunities with meaningful potential for clinical differentiation and value. In my experience, an oncology program that looks differentiated against the current standard of care can appear very different when assessed against the therapies, combinations, and treatment sequences likely to define practice by the time the drug reaches routine clinical use.
• Define. Establish and continuously refine the positioning, patient population, and evidence requirements that support the development strategy and future adoption. In oncology, defining a program means looking beyond the target population itself to where the drug would fit in the treatment sequence, how it would differentiate from existing and emerging therapies, and what evidence oncologists would ultimately need to support its use.
• Align. Connect evidence generation with the strategic decisions that matter throughout development, ensuring that evidence remains relevant to clinical practice and real-world use. The critical evidence question can shift from whether a drug has antitumor activity to whether the magnitude and durability of benefit, toxicity profile, and feasibility of combining or sequencing the therapy are sufficient to change clinical practice.
• Integrate. Make medical affairs and clinical development equal strategic partners around major portfolio inflection points, with continuous exchange between internal development evidence and external clinical insight. I have found that bringing internal development data together with perspectives from oncology KOLs and practicing oncologists at major inflection points can expose evidence gaps around patient selection, sequencing, combinations, or comparative context while there is still time to influence the next study.

Medical affairs should play more than a supporting role. Its strategic value lies in connecting the science of clinical development with the reality of clinical practice, helping organizations refine development strategies, strengthen evidence relevance, and increase the probability that a drug will ultimately be adopted and deliver meaningful value to patients.

About The Author:

Professor David Adler, MD, Ph.D., MBA, is a senior oncology drug development and translational medicine leader with more than 15 years of experience spanning pharmaceutical development and academic cancer research. He spent a decade in senior medical and clinical development leadership within Bayer AG’s Global Oncology Clinical Development organization, leading oncology programs from preclinical research into the clinic. He currently serves as chief scientific & medical officer of the PATHORA Institute of Pathology & Tissue Medicine. His work focuses on the strategic decisions that shape the path from scientific discovery through clinical development and help determine whether promising innovations can ultimately become medicines. He also holds academic appointments at the Hebrew University of Jerusalem, Ben-Gurion University of the Negev, and the University of Bonn.