Delivering optimal medical care to all patients (Medical Affairs Department)
We ensure that new drugs and medical devices, brought to market following clinical trials and approval, continue over the long term to fully deliver the required efficacy and effectiveness in actual clinical practice. This is enabled by the clinical application development area, and at the Research and Development Center, the Medical Affairs Department fulfills that role.
The role of medical affairs
The medical affairs departments of pharmaceutical companies are primarily involved in the post-launch stage and are independent departments, separate from the sales divisions, that does not engage in sales promotion.
The Consensus Statement on Medical Affairs Activities released by the Japan Pharmaceutical Manufacturers Association in April 2019 states: “In order to deliver optimal medical care to all patients, MA should: 1) Generate medical and scientific evidence to fulfill unmet medical needs*1, and disseminate information to HCPs and other stakeholders. 2) Engage in medical and scientific interactions with external experts using high-level and/or the latest scientific knowledge.”
A medical affairs department both brings out the scientific value of post-launch products and plays a role in delivering optimal medical care to patients.
Activity policy of the Medical Affairs Department
Otsuka Pharmaceutical Factory’s Medical Affairs Department was established as an independent department in November 2015*2 and has been part of the Research and Development Center since August 2021. As a result, we now have a structure in which a single department collaborates from research and development through to post-marketing, enabling smooth sharing of the status of new product R&D and clinical challenges.
Otsuka Pharmaceutical Factory upholds “The Best Partner in Clinical Nutrition Worldwide” as its management vision. As the best partner in clinical nutrition, the Medical Affairs Department aims to promote appropriate nutritional management that leads to improved patient outcomes. It is known that many hospitalized patients are in poor nutritional status and that their nutritional status affects survival, complications, and length of stay1. To improve patients’ nutritional status, management that meets the required amount of nutrition is necessary. However, according to nutrition management surveys conducted to date by the Medical Affairs Department, there are issues with hospital nutrition management systems in Japan, and management that meets the nutritional amounts patients need has not been sufficiently adopted 2-7.
The Medical Affairs Department seeks to promote appropriate nutritional management that leads to improved patient outcomes by (1) identifying unmet medical needs, (2) formulating a Medical Plan*3, (3) generating evidence, and (4) disseminating medical and scientific information.
Activities of the Medical Affairs Department
The Medical Affairs Department works to promote appropriate nutritional management in areas such as the perioperative period, renal diseases, and critically ill patients. For each disease area, we identify issues that need to be solved and generate evidence to address them. We also conduct awareness activities based on the evidence generated.
Specifically, to identify unmet medical needs, we conduct surveys of healthcare professionals and large-scale studies using real-world data*4 2-7. In addition to identifying clinical issues through discussions with healthcare professionals, we also hold Medical Advisory Board meetings*5 with participation from multiple external medical science experts, collecting information through discussions of issues in the relevant disease areas. After clarifying the current status and challenges in the target disease areas, we consider a Medical Plan aimed at solving these issues and, as necessary, conduct clinical research leading to their resolution. We present our research results at domestic and international academic conferences and publish them in papers8-14. Furthermore, as part of awareness activities to promote appropriate nutrition management, we hold Medical Education meetings*6 that aim to enhance healthcare professionals’ expertise and skills by providing and discussing the latest information in specific disease areas. Through these efforts, we communicate the importance of nutrition management to more healthcare professionals from a fair and neutral standpoint.
In actual medical practice, there are various unmet medical needs, and advancing healthcare requires research activities aimed at resolving them. At Otsuka Pharmaceutical Factory, beyond the research themes set by the Medical Affairs Department, we support investigator-initiated research*7 and research grant programs offered by academic societies. As the best partner in clinical nutrition, we consider it our mission to promote appropriate nutrition management that leads to improved patient outcomes, and we devote ourselves to our daily work with pride in contributing to the advancement of healthcare.
The activities of the Medical Affairs Department were featured as an advertorial in the general science journal Nature’s special feature “Spotlight: Nutrition.”
Nature.com advertorial- Medical needs for which effective treatments are still unavailable
- The name of the department from the company’s establishment until April 2025 was “Clinical Application Development Department”
- A strategic plan to provide value to healthcare professionals and patients based on scientific evidence
- A collective term for medical data collected in routine clinical practice
- A meeting to obtain medical knowledge and medical needs in specific areas from multiple external medical science experts
- A meeting intended to provide healthcare professionals with the latest medical and scientific knowledge and practical skills
- Research in which researchers conceive the study and prepare a research protocol, conducted under the legal and ethical responsibility of the researchers and their affiliated institutions
- Higashiguchi T, Arai H, Claytor LH, et al. Taking action against malnutrition in Asian healthcare settings: an initiative of a Northeast Asia study group. Asia Pac J Clin Nutr. 2017;26:202–211.
- Maeda K, Egashira F, Ueshima J, et al. A survey of the Nutrition Care Process in Japanese acute care hospitals using a nationwide web-based questionnaire. Asia Pac J Clin Nutr. 2024. ( in press )
- Sasabuchi Y, Ono S, Kamoshita S, Tsuda T, et al. A survey on total parenteral nutrition in 55,000 hospitalized patients: retrospective cohort study using a medical claims database. Clin Nutr ESPEN. 2020;39:198–205.
- Maeda K, Murotani K, Kamoshita S, et al. Nutritional management in inpatients with aspiration pneumonia: a cohort medical claims database study. Arch Gerontol Geriatr. 2021;95:104398.
- Iijima A, Tani M, Kuroda A A database study on nutritional management for dialysis patients after gastrointestinal surgery and on prescribed doses in parenteral nutrition. JSPEN. 2021;3:165–174.
- Fukagara K, Fukushima R Surgeons' perceptions of albumin and the current state of postoperative nutritional management based on a web-based questionnaire survey. The Japanese Journal of Surgical Metabolism and Nutrition. 2021;55:141–150.
- Yasuda H, Horikoshi Y, Kamoshita S. et al. Nutritional management of ICU patients receiving mechanical ventilation: a retrospective cohort study using a medical claims database. Clin Nutr Open Sci. 2022;42:84–98.
- Sasabuchi Y, Ono S, Kamoshita S, et al. Clinical impact of prescribed doses of nutrients for patients exclusively receiving parenteral nutrition in Japanese hospitals: a retrospective cohort study. JPEN J Parenter Enteral Nutr. 2021;45:1514–1522.
- Maeda K, Murotani K, Kamoshita S, et al. Effect of parenteral energy or amino acid doses on in-hospital mortality among patients with aspiration pneumonia: a cohort medical claims database study. J Gerontol A Biol Sci Med Sci. 2022;77:1683–1690.
- Takagi K, Murotani K, Kamoshita S, et al. Dose-dependent effects of amino acids on clinical outcomes in adult medical inpatients receiving only parenteral nutrition: a retrospective cohort study using a Japanese medical claims database. Nutrients. 2022;14:3541.
- Takagi K, Murotani K, Kamoshita S, et al. Clinical impact of lipid injectable emulsion in internal medicine inpatients exclusively receiving parenteral nutrition: a propensity score matching analysis from a Japanese medical claims database. BMC Med. 2022;20:371.
- Wada A, Nakamura M, Kobayashi K, et al. Effects of amino acids and albumin administration on albumin metabolism in surgically stressed rats: A basic nutritional study. JPEN J Parenter Enteral Nutr. 2023;47:399–407.
- Yasuda H, Horikoshi Y, Kamoshita S, et al. Injectable lipid emulsion and clinical outcomes in patients exclusively receiving parenteral nutrition in an ICU: a retrospective cohort study using a Japanese medical claims database. Nutrients. 2023;15:2797.
- Yasuda H, Horikoshi Y, Kamoshita S, et al. Associations between in-hospital mortality and prescribed parenteral energy and amino acid doses in critically ill patients: a retrospective cohort study using a medical claims database. Nutrients. 2023;16:57.
