| ●Editorial | Kageyama S | 4 | Full text | |
| ●Public Debriefing Session 2012 －Move “Innovation” to the “Market”－ | 5-150 | Abstract | ||
| Organized by：Foundation for Biomedical Research and Innovation | ||||
| Opening remarks by MEXT | Morimoto K | 9 | ||
| Annual Report of Translational Research 2012 | Saruta T | 10-1 | ||
| Overview from the Supporting Organization | Fukushima M | 12-8 | ||
| All Hokkaido Translational Research Project for Advanced Medicine | Sato N | 19-23 | ||
| Clinical research, innovation and education center, based on collaboration between biomedical engineers and clinicians | Yaegashi N | 24-9 | ||
| Advanced center for the establishment and coordination of biomedical innovation development assistance | Saito N | 30-4 | ||
| Establishment of central Japan network for sustainable development of advanced medicine | Mizuno M | 35-9 | ||
| Reinforcement of academic base for development of novel drug and medical treatment | Shimizu A | 40-4 | ||
| Strategic promotion of core center development for TR practice | Myoui A | 45-50 | ||
| Establishment of academic research organization supporting developments of innovative medicine for the next generation | Nakanishi Y | 51-5 | ||
| Development of oncolytic virus therapy using genetically-engineered viruses | Todo T | 56-7 | ||
| Development of cancer immunotherapy targeting γδT cells | Minato N，Sugie T | 58-60 | ||
| Promotion of an investigator-initiated clinical trial of prostate cancer treatment using a novel anti-cancer reagent | Kaneda Y | 61-4 | ||
| Clinical development of BK-UM, a targeting agent for ovarian cancer | Mekada E | 65-7 | ||
| Nanomedicine-based translational research for Acute Myocardial Infarction | Egashira K，Nakano K | 68-71 | ||
| Innovative less invasive nanomedicine for Critical Limb Ischemia | Egashira K，Nakano K，Matsumoto T，Maehara Y | 72-4 | ||
| Development of RNA-based gene drug for the treatment of peripheral arterial disease | Yonemitsu Y | 75-8 | ||
| Questions and answers | 79-80 | |||
| Real-time tumor-tracking proton beam irradiation therapy | Shirato H，Hayashi H | 81-4 | ||
| PET Study using C-11 Methionine | Tamaki N，Shiga T | 85-8 | ||
| Clinical study using a newly developed system for minimally invasive surgery | Yamamoto S | 89-91 | ||
| Pulsed Water Jet：Medical Device to achieve maximal removal and functional preservation | Tominaga T，Nakagawa A | 92-5 | ||
| Translational Research for the fetal electrocardiogram to promote practical application | Kimura Y | 96-8 | ||
| A minute suture device which eliminates ligature | Ono M | 99-101 | ||
| An electrocorticographic implantable wireless system for motor and communication control | Yoshimine T，Hirata M | 102-5 | ||
| Questions and answers | 106-7 | |||
| Intravenous administration of auto serum-expanded autologous mesenchymal
stem cells in spinal cord injury | Yamashita T，Sasaki M | 108-10 | ||
| Intravenous administration of auto serum-expanded autologous mesenchymal stem cells in stroke | Honmou O | 111-3 | ||
| Questions and answers | 114-5 | |||
| Clinical induction of tissue-engineered cartilage realizing the combination of the regenerative cartilage with the regenerative mucosa | Takato T | 116-9 | ||
| Multicenter clinical research using autologous oral mucosal epithelial
cell sheets for total limbal stem-cell deficiency | Nishida K，Oie Y | 120-3 | ||
| Laminin-511 E8 fragment as a culture substrate for human pluripotent stem cells under feeder-free/xeno-free conditions | Sekiguchi K | 124-7 | ||
| Strategic approach for establishment of the pancreatic islet transplantation by academic TR center | ||||
| (i)Clinical application of safe and high active enzymes for cell-isolation | Goto M，Watanabe K | 128-31 | ||
| (ii)Development of clinical islet transplantation with new immunosuppressive protocol | Gotoh M，Anazawa T | 132-5 | ||
| Questions and answers | 136 | |||
| Network construction | Aoki M | 137-40 | ||
| Seeds incubation and development of translational research in academia | Kageyama S | 141-5 | ||
| Expectation of pharmaceutical company for academia | Inagaki O | 146-9 | ||
| Closing remarks | Saruta T | 150 | ||
| ●Proposal | ||||
| Present status & scope of innovation in the academic sector －Where are we now and where should we go?－ | Fukushima M | 151-66 | Full text | |
| ●Translations | ||||
| Guidance for Industry： Preclinical assessment of investigational cellular and gene therapy products [draft guidance] | U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) (trans. by Nishimura H，Oh T，Noguchi Y) | 167-83 | ||
| Guidance for Industry：Potency tests for cellular and gene therapy products | U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) (trans. by Nishimura H，Oh T，Noguchi Y) | 185-96 | ||
| Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products [draft] | European Medicines Agency (EMA), Committee for Advanced Therapies (CAT) (trans. by Nishimura H，Oh T，Noguchi Y) | 197-208 | ||
| ●Articles | ||||
| The application of electromagnetic record to the Clinical Trial-related Documents for the conduct of a clinical trial | Yamaguchi M，Kondo M，Yamamoto M，et al． | 209-40 | Abstract | |
| Application of non-pharmacological physical treatment to treatment-refractory obsessive-compulsive disorder：A critical viewpoint from a psychiatrist | Kuroki T | 241-52 | Abstract | |
| ●Article and translations | ||||
| Two new standards from the Institute of Medicine (IOM)：Clinical Practice
Guidelines We Can Trust and Finding What Worksin Health Care－Standards for Systematic Reviews | Aihara M | 253-8 | Full text | |
| Clinical Practice Guidelines We Can Trust | Institute of Medicine of the National Academies (trans. by Aihara M) | 259-60 | Full text | |
| Finding What Works in Health Care－Standards for Systematic Reviews | Institute of Medicine of the National Academies (trans. by Aihara M) | 261-4 | Full text | |
| ●Instructions for authors［Japanese］＆［English］ | 265-73 | Full text | ||
| ●Editor’s note | Saio T | 275 | Full text | |