Heptathlon of Sustainable Meaningful Access to RadioPharmaceutical Therapy (RPT 3.0)

Introduction: Contrary to the prevailing assumption, accessibility of radiopharmaceutical therapy (RPT) is not "just" the last mile of a long journey. There is a massive chasm between "Availability" and "Accessibility".

RPT efforts can be categorized into three domains:

• RPT 1.0: pre-clinical to first-in-human studies

• RPT 2.0: clinical trials, FDA approval, and the quest for availability

• RPT 3.0: from availability to accessibility

Although these three domains constitute a continuum and share many traits, each of these has its own unique characteristics (distinct priorities, community, industrial sponsor, and ecosystem,). Access is the focus of RPT 3.0.

Is addressing "access" in any form and shape beneficial? No!

Methods: Lack of access may result in "pseudo-access" (suboptimal delivery of RPTs of substandard quality from both safety and optimization standpoints). In contra-distinction with "pseudo-access," there is "meaningful access," which attempts to achieve routine personalization of care using core principles of theranostics, such as dosimetry and integration of imaging findings into treatment decisions.

However, "meaningful access" to RPT is not in itself sufficient. This state of access might be temporary; a spark in the darkness with no continuity. Thus, we need to aim to achieve "sustainability" of this "meaningful access".

Achieving the goal of "sustainable meaningful access to RPT" is quite challenging. Here, we describe SEVEN Grand Challenges ahead of us (with no specific order of priority). We refer tothese seven challenges the heptathlon of RPT 3.0 (hept: seven + athlon from the Ancient Greek ἆθλον meaning "contest/event")

Results: • Optimization of RPTs: using theranostic imaging, dosimetry and computational nuclear oncology tools to enable predictive oncology and personalization of therapies, including digital twinning of patients (Theranostic Digital Twin)

• Access Deficiency Discovery: Scientific identification of "lack of access" through multi-disciplinary investigation

• Implementation and Dissemination: Utilizing Systems Science/Engineering to plan and implement a multi-dimensional solution to address the deficiencies in access

• Education: The core component of sustainability is training the next generation of nuclear medicine physicians/physicists/technologists inadvancing the discipline with the aim of helping patients in need

• Collaboration and Sharing: Only a community of physicians and other scientists can satisfy the needs of this complex evolution. The nuclear medicine community should embrace the essence of collaboration and enhance the culture of resource sharing (toward open data and open science)

• Advocacy and Societal Interaction: Active engagement with governmental and non-governmental agencies and exercising responsible advocacy for the patients and their care team are of utmost importance to ensure resources are attracted to the practice of RPT.

• Trustworthy Ecosystem: last, but not least, is the importance of trust as the core tenet of patient care. We need to embrace the principles of trustworthiness and implement them in the ecosystem of radiopharmaceutical therapy and the nuclear medicine community.

Conclusions: These seven grand challenges (heptathlon) are essential for achieving sustainable meaningful access to RPT. Overlooking any of these domains will result in the failure of an RPT 3.0 project. Commitment to address these challenges will inspire the next generation of the nuclear medicine community to continue to embrace the specialty. A bright future for nuclear medicine will be rendered inevitable by this awareness on one hand and scientific and economic prosperity on the other. A modern renaissance in Nuclear Medicine has already sprouted from the lessons of the past, and the heralds of this resurrection are students and trainees enthusiastically entering into our beautiful field.