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Lessons from Translational Research on the Natriuretic Peptide Family and Leptin — 538 Proc. Jpn. Acad., Ser. B 95 (2019) [Vol. 95, Review Translational science: Newly emerging science in biology and medicine — Lessons from translational research on the natriuretic peptide family and leptin — † By Kazuwa NAKAO*1, (Edited by Hiroo IMURA, M.J.A.) Abstract: Translation is the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and the public, ranging from diagnostics and therapeutics to medical procedures and behavioral changes. Translational research is defined as the effort to traverse a particular step of the translation process for a particular target or disease. Translational science is a newly emerging science, distinct from basic and clinical sciences in biology and medicine, and is a field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. Advances in translational science will increase the efficacy and safety of translational research in all diagnostic and therapeutic areas. This report examines translational research on novel hormones, the natriuretic peptide family and leptin, which have achieved clinical applications or for which studies are still ongoing, and also emphasizes the lessons that translational science has learned from more than 30 years’ experience in translational research. Keywords: translational science, translational research, natriuretic peptide family (ANP, BNP, CNP), leptin, animal disease model, rare disease The original definition of translation refers to 1. Introduction the process of turning observations in the laboratory, Linguistically, the term “translation” refers to clinic, and community into interventions that im- the conversion of one language to another language. prove the health of individuals and the public, The term is also used to refer to the synthesis of ranging from diagnostics and therapeutics to medical proteins from mRNA in biology. Since the last decade procedures and behavioral changes. Translational of the 20th century, the terms “translational research” research is defined as the effort to traverse a and “translational science” have been used to refer to particular step of the translation process for a the process or concept by which we move from particular target or disease. Translational science is discoveries to applications in medicine.1)–3) Because a newly emerging science, distinct from basic and progress in biology was rapidly applied to medicine in clinical sciences in biology and medicine and is a the 20th century, the term “translation” has become field of investigation focused on understanding the widely used in biology and medicine under the scientific and operational principles underlying each proposal of the National Center for Advancing step of the translational process. Translational Science (NCATS), resulting in diver- Despite rapid and remarkable advances in gence from the original conceptual meaning. medical science, especially in basic science, discov- eries in many steps of the translation process are only *1 Medical Innovation Center, Kyoto University Graduate being introduced to clinical applications after a time- School of Medicine, Kyoto, Japan. † consuming process, and only in extremely rare cases. Correspondence should be addressed: K. Nakao, Medical The process has often been likened to a seemingly Innovation Center, Kyoto University Graduate School of Medicine, 53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan endless trip through a long, dark tunnel. These (e-mail: [email protected]). challenges withstanding, the research field of trans- doi: 10.2183/pjab.95.037 ©2019 The Japan Academy No. 9] Translational science 539 lational science is anticipated to transform discov- Heart eries into clinical applications in medicine and make Atrial Natriuretic Peptide ANP innovative medical technologies a reality. Above all, Brain Natriuretic Peptide BNP advances in translational science will increase the Blood vessel ffi e cacy and safety of translational research in all NO (EDRF) diagnostic, therapeutic, and behavioral applications. C-type Natriuretic Peptide (CNP) Although a multitude of animal models have Adrenomedullin (AM) been developed to emulate various human diseases, Endothelin (ET) there are only a few animal models that mimic Angiotensin II (AII) human disease remarkably accurately, e.g., sponta- Prostacyclin (PGI2) neously hypertensive rats (SHRs)4) and hereditary Thromboxane (TXA2) 5) obese mice, (ob/ob) are very useful for the PTH-related Protein (PTHrP) preclinical steps of translational research on hyper- Fig. 1. Cardiovascular hormones and the cardiovascular system tension and obesity, respectively. Lessons from as an endocrine organ. Members of the natriuretic peptide family research history on SHRs, an excellent animal model are prototype cardiovascular hormones. for hypertension research, led us to investigate the clinical significance of the natriuretic peptide family [atrial natriuretic peptide (ANP), brain natriuretic Leptin peptide (BNP), and C-type natriuretic peptide TNF-α (CNP)] in SHR in the early stages of preclinical Adiponectin research. For translational research on leptin, a Resistin representative adipokine, in addition to obese mouse Adipsin models such as the leptin knockout (KO) ob/ob mice PAI-1 and leptin receptor KO db/db mice, we generated Angiotensinogen leptin transgenic (Tg) “skinny” mice with elevated Free Fatty Acid plasma leptin concentrations similar to those in obese Steroids humans and assessed the functional and therapeutic Fig. 2. Adipocyte-derived factors, adipokines, released from implications of leptin beyond species differences. adipocytes. Adipose tissue is a novel endocrine organ. Leptin is These studies led to establishment of a “proof-of- an adipokine that induces severe obesity when depleted. concept (POC)” that plays a pivotal role in the transitional step from the preclinical stage to clinical Table 1. Translational research on the natriuretic peptide family trials of the translational science spectrum. and leptin achieved or ongoing in Japan This review summarizes the current state of translational research on the natriuretic peptide Application State/Industry Disease and Target family (ANP, BNP, and CNP), which are prototype Achieved/Suntory Congestive heart Therapeutic cardiovascular hormones (Fig. 1), and on leptin, a ANP (Daiichi-Sankyo) failure representative adipokine (Fig. 2 and Table 1). In Diagnostic Achieved/Shionogi Body fluid volume addition, general principles of translational science Heart failure and BNP Diagnostic Achieved/Shionogi are proposed that have accumulated in the course of hypertrophy translational research. Suitable animal disease mod- Ongoing/Chugai CNP Therapeutic Achondroplasia els mimicking human diseases are indispensable in Pharmaceutical the preclinical stage. Target diseases for the initial Therapeutic Achieved/Shionogi Lipodystrophy step of clinical trials could be rare human diseases, Leptin Achieved*/Cosmic Lipodystrophy, Diagnostic and then the target diseases expand from rare human Corporation Adiposity diseases into common human diseases that are *Diagnostic application of leptin for lipodystrophy has been essentially close to rare human diseases in their approved by PMDA after the submission of the manuscript. etiology and pathophysiology.2) fi 2. De nition of translational science and the in the 20th century, and the fields explored by basic translational science spectrum scientists and physicians or clinicians became much 2-1. Definition of translational science. wider, deeper, and more separate. It is very hard for Progress in biology was rapidly applied to medicine medical doctors to be experts in both basic or 540 K. NAKAO [Vol. 95, smoking cessation. Thus, “translation” refers to a Clinical Science Clinician conceptual and practical multistep process. By contrast, “translational research” is defined by NCATS as the endeavor to traverse a particular Clinician /Scientist step of the translation process for a particular target or disease. In the process from discoveries to medical applications in real-world environments, complexity Basic Science Scientist as well as research and operational challenges increase exponentially. Progress of Medicine Translational science is quite distinct in purpose and operation from translational research. Transla- Fig. 3. Effects of progress in medicine on basic scientists, tional research focuses on the specific case of a target clinician-scientists (translational scientists), and clinicians or or disease, whereas translational science is focused on clinical scientists. a general case that applies to any target or disease. Focus areas of translational science are the common preclinical research and clinical research or medicine causes of inefficiency and failure in translational (Fig. 3). From the last decade of the 20th century, research, such as incorrect predictions of the toxicity the terms “translational research” and “translational or efficacy of new drugs, lack of data interoperability, science” have been used to describe the concept of and ineffective clinical trial recruitment. Because the process of moving from a discovery to clinical these causes are the same across targets, diseases, and practice.1)–3) The term “translation” has been widely therapeutic areas, advances in translational science used in biology and medicine (i.e., biomedicine), will increase the efficacy and safety of translational under a proposal of the NCATS, resulting
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