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If you are interested in, please contact us.
RESEARCH OBJECTIVES
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To analyze regulatory bodies' decision for the authorization of drugs and medical devices
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To analyze regulatory bodies' theoretical framework
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To analyze pharmaceutical companies' clinical development and pharmaceutical affairs strategies
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To investigate the comparative evaluation criteria between divisions in regulatory bodies
EDUCATION
COLLABORATIVE RESEARCH
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in-house collaborative researches
Planning of clinical research protocols
Supporting regulatory aspects of other reseraches
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Othre collaborative researches (seeking)
STUDENTS' CAREER
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Mitsubishi Tanabe Pharma (R&D)
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Shiga University of Medical Science Leading Graduate Program for REDUCING THE BURDEN OF NON-COMMUNICABLE DISEASE (NCD) IN THE ASIAN PACIFIC REGION
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MSD (Sales)
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Yakult Honsha (R&D)
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Chugai Pharmacetical (HTA analyst)
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Graduate School of Pharmaceutical Science, Nagoya City University
＞＞＞ACHIEVEMENTS
Peer-reviewed papers
C/E-19 (Collaborative research)
Iwata R, Mochizuki S, Hasegawa T, Ishii K, Matsumaru N, Tsukamoto K.
Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database.
Ther Innov Regul Sci. 2024 May 6. https://doi.org/10.1007/s43441-024-00660-3
C/E-18 (Collaborative research)
Hino Y, Okada M, Hallgreen CE, De Bruin ML, Doty RE, Matsumaru N, Tsukamoto K.
Regional disparity in first-in-class anticancer drug development in the US, EU, and Japan.
Biol Pharm Bull. 2023. https://doi.org/10.1248/bpb.b22-00868 (Advance online publication)
C/E-17 (Collaborative research)
Maeda H, Uchida M, Kusano M, Tsukamoto K, Yamanoi M.
Characteristics of the Compassionate Use Program in Japan: An Analysis of Expanded Access Clinical Trials from 2016 to 2021.
Clin Pharmacol Ther. 2022. https://onlinelibrary.wiley.com/share/author/PYGZXHJ9FTYVDQKTQAXZ?target=10.1002/cpt.2641
E-16
Sawachi K, Matsumaru N, Tsukamoto K.
Clinical development of anticancer drugs can be enhanced using efficacy data of small population clinical trialsn Japan.
J Clin Pharm Ther. 2022; 47(9):1388-1394. https://doi.org/10.1111/jcpt.13676
E-15
Tajima G, Matsumaru N, Tsukamoto K.
Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan.
J Clin Pharm Ther. 2022; 47(9):1395-1401. https://doi.org/10.1111/jcpt.13677
E-14
Miyazaki T, Komiyama M, Matsumaru N, Maeda H, Tsukamoto K.
Lag Time for New Innovative, First-in-Class, Drug Approval in Japan.
Biol Pharm Bull. 2022; 45(4):477-482. https://doi.org/10.1248/bpb.b21-0089
E-13
Ushijima S, Matsumaru N, Tsukamoto K.
Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi‑regional Clinical Trials.
Pharm Med. 2021 Jul 23. https://doi.org/10.1007/s40290-021-00393-w
E-12
Izuka S, Matsumaru N, Tsukamoto K.
Characteristics of drugs approved in Japan without conducting confirmatory clinical trials.
J Clin Pharm Ther. 2021 Jul 11. https://doi.org/10.1111/jcpt.13487
C/E-16 (Collaborative research)
Ohno S, Chen Y, Sakamaki H, Matsumaru N, Yoshino M, Tsukamoto K.
Burden of caring for Alzheimer’s disease or dementia patients in Japan, US, and EU: results from the National Health and Wellness Survey: a cross-sectional survey.
J Med Econ. 2021 Jan-Dec;24(1):266-278. online first. https://www.tandfonline.com/doi/full/10.1080/13696998.2021.1880801
C/E-15 (Collaborative research)
Ohno S, Chen Y, Sakamaki H, Matsumaru N, Yoshino M, Tsukamoto K.
Humanistic burden among caregivers of patients with Alzheimer’s disease or dementia in Japan: a large-scale cross-sectional survey.
J Med Econ. 2021 Jan-Dec;24(1):181-192. https://doi.org/10.1080/13696998.2021.1877149
C/E-14 (Collaborative research)
Ohno S, Chen Y, Sakamaki H, Matsumaru N, Tsukamoto K.
Factors associated with humanistic burden and indirect cost among patients with cancer in Japan.
J Med Economic. 2020;23(12):1570-1578. https://doi.org/10.1080/13696998.2020.1839234
C/E-13 (Collaborative research)
Shibata S, Matsushita M, Tsukamoto K, Chiba K, Ozaki K, Suzuki T.
A Study on the Description of Anticancer Drug Combination Therapy in the Package Insert in Japan.
BPB Reports Vol. 3 No. 5 p.157-165 2020. https://www3.e-kenkyu.com/bpb-reports-online-journal/papers/61?number=5&volume=3&year=2020
C/E-12 (Collaborative research)
Ohno S, Shoji A, Hatake K, Oya N, Igarashi A.
Cost-effectiveness analysis of treatment regimens with obinutuzumab plus chemotherapy in Japan for untreated follicular lymphoma patients.
J Med Economic. 2020;23(10):1130-1141. https://doi.org/10.1080/13696998.2020.1791890
E-11
Matsumoto T, Matsumaru N, Scuffham P, Neels P, Tsukamoto K.
Alternative New Mono‑scaled Quantitative Benefit–Risk Assessment of Human Papillomavirus Vaccine in Japan
Ther Innov Regul Sci. 2021 Jan;55(1):48-55. https://rdcu.be/b46LU
C/E-11 (Collaborative research)
Matsumaru N, Okada H, Suzuki K, Nachi S, Yoshida T, Tsukamoto K, Ogura S.
Weather Fluctuations may have an Impact on Stroke Occurrence in a Society: A Population-based Cohort Study.
Cerebrovasc Dis Extra. 2020;10(1):1-10. https://doi.org/10.1159/000505122
C/E-10 (Collaborative research)
Ohno S, Chen Y, H Sakamaki, Matsumaru N, Tsukamoto K.
A population-based study of the humanistic burden among cancer patients in Japan.
J Med Economic. in press. https://doi.org/10.1080/13696998.2019.1707213
E-10
Kido K, Tsukamoto K.
Japan's health care system faces a perfect storm (Short Communication)
Int J Health Plann Manage. online first. https://doi.org/10.1002/hpm.2936
E-9
Kikuchi M, Adachi N, Matsumaru N, Tsukamoto K.
Current Landscape of Late-Phase Clinical Trials for Alzheimer’s Disease: Comparing Regional Variation Between Subjects in Japan and North America
Pharm Med. 2019;33(6):511-518. https://link.springer.com/article/10.1007/s40290-019-00306-y
C/E-9 (Collaborative research)
Ohno S, Chen Y, H Sakamaki, Matsumaru N, Tsukamoto K.
Humanistic and economic burden among caregivers of patients with cancer in Japan.
J Med Economic. 2020;23(1):17-27. https://doi.org/10.1080/13696998.2019.1675672
C/E-8 (Collaborative research)
Shibata Y, Miyahara Y, Sadaka Y, Yasue M, Fujimura M, Soda M, Yamamoto M, Kato H, Suzuki A, Tsukamoto K, Hara T, Tsurumi H, Kitaichi K.
Evaluation of the effectiveness of caspofungin against febrile neutropenia and the factors related to the alteration in its plasma concentration.
J Infect Chemother. 2019;25(10):801-805. DOI: 10.1016/j.jiac.2019.04.011
C/E-7 (Collaborative research)
Nakayama H, Matsumaru N, Tsukamoto K.
Safety-related regulatory actions and risk factors for anticancer drugs in Japan.
Pharm Med. 2019;33(1):45–52. https://doi.org/10.1007/s40290-018-0260-8
C/E-6 (Collaborative research)
Nakayama H, Matsumaru N, Tsukamoto K.
Delays in new drug applications and associated factors for orphan anticancer drugs in Japan compared with the United States.
Pharm Med. 2018;32(6):403–412. https://doi.org/10.1007/s40290-018-0257-3
E-8
Tsukamoto K, Cnop M, Mori D, Kume S, Anazawa T, Doi M, Chikazawa K, Matsumaru N.
Future perspectives for the treatment of diabetes: importance of a regulatory framework
Ther Innov Regul Sci. 2019;53(4):535-541. http://journals.sagepub.com/doi/full/10.1177/2168479018795854
E-7
Kido K, Matsumaru N, Tsukamoto K.
Health Technology Assessment in Japan: A pharmaceutical industry perspective
Ther Innov Reg Sci. 2019;53(4):472-480. http://journals.sagepub.com/doi/full/10.1177/2168479018791136
C/E-5 (Collaborative research)
Nakayama H, Matsumaru N, Tsukamoto K.
The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States.
Invest New Drugs. 2019;37(5):1086-1093. https://doi.org/10.1007/s10637-018-0612-y
E-6
Tanaka M, Matsumaru N, Tsukamoto K.
Influence of Breakthrough Therapy Designation in the United States on Oncology Drug Development Timelines in Japan.
Pharm Med. 2018;32(3):201–207. https://doi.org/10.1007/s40290-018-0236-8
C/E-4 (Collaborative research)
Nakayama H, Tsukamoto K.
Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan.
Invest New Drugs. 2018;36(4):702–708. https://doi.org/10.1007/s10637-018-0603-z
E-5
Tanaka M, Matsumaru N, Tsukamoto K.
Influence of Expedited Programs in the United States on Oncology Drug Development in Japan.
Ther Innov Regul Sci. 2019;53(2):199-206. DOI: 10.1177/2168479018769288
E-4
Rokuda M, Matsumaru N, Tsukamoto K.
Identification of Drug Characteristics for Implementing Multi-Regional Clinical Trials Including Japan.
Clin Ther. 2018;40(2):284-295. https://doi.org/10.1016/j.clinthera.2016.01.012
C/E-3 (Collaborative research)
Matsuramru N, Hattori R, Ichinomiya T, Tsukamoto K, Kato Z.
New Quantitative Method for Evaluation of Motor Functions Applicable to Spinal Muscular Atrophy.
Brain & Development. 2018;40(3):172-180. https://doi.org/10.1016/j.braindev.2017.12.003
C/E-2 (Collaborative research)
Soda M, Ito S, Matsumaru N, Nakamura S, Nagase I, Takahashi H, Ohno Y, Yasuda M, Yamamoto M, Tsukamoto K, Itoh Y, Deguchi T, Kitaichi K.
Evaluation of the microbiological efficacy of a single 2-g dose of an extended-release azithromycin by population pharmacokinetics and simulation in Japanese patients with gonococcal urethritis.
Antimicrob Agents Chemother. 2018;62(1):e01409-17. doi:10.1128/AAC.01409-17.
E-3
Onishi T, Tsukamoto K, Matsumaru N, Waki T.
Industry Perspective of Pediatric Drug Development in the United States Involvement of the European Union Countries
Ther Innov Reg Sci. 2018;52(1):49-56. https://doi.org/10.1177/2168479017716718
E-2
Tsukamoto K, Carroll K, Onishi T, Matsumaru N, Brasseur D, Nakamura H.
Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks.
Clin Ther. 2016;38(3):574-581. https://doi.org/10.1016/j.clinthera.2016.01.012
C/E-1 (Collaborative research)
Soda M, Shibata Y, Yasue M, Fujimura M, Takahashi H, Nakamura S, Yamamoto M, Tsukamoto K, Suzuki A, Hara T, Tsurumi H, Itoh Y, Kitaichi K.
Simple HPLC method for the determination of caspofungin in human plasma
Clin Pharmacol Biopharm. 4:137 (2015)
E-1
Tsukamoto K.
Development of Novel Pharmaceutical Agents for Alzheimer's Disease: The Impact of Regulatory Initiatives in Japan and United States.
Clin Ther. 2015;37(8):1652-1660. https://doi.org/10.1016/j.clinthera.2015.02.024
J-5
Tsukamoto K.
Pharmacology and regulatory science foresee drug development.
Folia Pharmacologica Japonica, 148(1): 6-8 (2016)
J-4
Tsukamoto K, Matsumaru N.
Current Approaches for Education and Research of Regulatory Science in Europe and Unites States.
Regulatory Science of Medical Products, 6(2): 163-169 (2016)
J-3
Tsukamoto K, Takenaka T.
Role of Academia in Regulatory Science for Global Drug Development.
Yakugaku Zasshi, 136(4): 543-547 (2016)
J-2
Tsukamoto K.
From a laboratory; Regulatory science should be a practical science.
Farumashia，51(7): 666-668 (2015)
J-1
Tsukamoto K, Takenaka T.
An Analysis of the Current State of Regulatory Science Research and Education in the United States.
Regulatory Science of Medical Products, 5(1): 103-107 (2015)
Presentations
P-23
Tsukamoto K, Ohno S, Chen Y.
HEALTH-RELATED QUALITY OF LIFE OF CANCER PATIENTS IN JAPAN- A POPULATION-BASED NATIONAL HEALTH AND WELLNESS SURVEY STUDY
ISPOR Europe 2019, Copenhagen, Denmark. (2019.11.4)
P-22
Ohno S, Chen Y, Sakamaki H, Tsukamoto K
The health-related quality of life and Economic burden on Cancer Patients in Japan
JSMO 2019, Kyoto, Japan (2019.7) https://doi.org/10.1093/annonc/mdz338.022
P-21
Kikuchi M, Matsumaru N, Tsukamoto K.
Toward Better Conduct of the Multinational Clinical Trials; Comparison of Clinical Assessment Scales By Regions (North America and Japan)
AAIC2017, London, England. (2017.7.17)
P-20
Kido K, Matsumaru N, Tsukamoto K.
Health Technology Assessment in Japan: Current Issues and Challenges
HTAi Annual Meeting 2017, Rome, Italy.（2017.6.19-20）
! You can download the HTA survey form >>> click here
P-19
Matsumaru N, Tsukamoto K, Kato Z.
Developmental change of motor function analyzed with 3D motion capture system and use of iOS device
The 59th Annual Meeting of the Japanese Society of Child Neurology, Osaka, Japan(2017.6.16)
P-18
Matsumaru N, Tsukamoto K, Kato Z.
Developmental Changes of Motor Functions Quantitatively Evaluated using Three-dimensional Motion Capture System
AOCCN2017 (14th Asian and Oceanian Congress of Child Neurology), Fukuoka, Japan(2017.5.13)
P-17
Onishi T, Waki T, Matsumaru N, Tsukamoto K.
Identification of factors for operating pediatric international clinical trials by using ClinicalTrials.gov
The 37th Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeautics, Tottori(2016.12.1)
P-16
Matsumaru N, Kato Z, Tsukamoto K.
Discussions in effect of therapeutic end points' setting for pediatric neuromuscular disease on registered number of patient
The 43th Japan Society of Development Pharmacology and Therapeutics 2016, Tokyo(2016.11.12)
P-15
Matsumoto T, Matsumaru N, Tsukamoto K.
Multiple Risk Assessment of HPV Vaccination (Poster presentation)
2nd Regulatory Science Forum for next-generation researchers, Tokyo(2016.9.17)
! award of excellence student poster presentation
P-14
Aoki S, Kobayashi K, Matsumoto T, Mori D, Onishi T, Waki T, Matsumaru N, Tsukamoto K.
Pattern Analysis of Expand Indication for Antitumor Drug (Poster presentation)
2nd Regulatory Science Forum for next-generation researchers, Tokyo(2016.9.17)
P-13
Adachi T, Matsumaru N, Tsukamoto K.
Discussion on trend of drug approval and reliability of clinical trials for oncology area in US
The 6th Annual Meeting of Society for Regulatory Science of Medical Products, Tokyo(2016.9.9)
P-12
Matsumoto T, Matsumaru N, Tsukamoto K.
Benefit-risk Assessment of HPV Vaccination Program in Japan (Poster presentation)
DIA 2016, Philadelphia, USA(2016.6.27)
P-11
Mori D, Matsumoto T, Onishi T, Waki T, Matsumaru N, Tsukamoto K.
Global Effects of FDA Guidance Requiring Evaluation of Cardiovascular Risk in New Antidiabetic Therapies on Drug Development (Poster presentation)
DIA 2016, Philadelphia, USA(2016.6.27)
P-10
Tsukamoto K, Mori D, Matsumoto T, Onishi T, Waki T, Matsumaru N.
Influence of FDA Guidance on Antidiabetic Drugs Development in Japan (Poster presentation)
DIA EuroMeeting 2016, Hambrug, Germany(2016.4.7)
P-9
Matsumaru N, Kato Z, Katsura T, Hattori R, Shimizu N, Shii Y, Ohnishi H, Kawamoto N, Fukao T, Kato T, Aoki T, Miyamoto K, Akiyama H, Funato M.
Three Dimensional Motion Capture System for Quantitative Evaluation of Motor Functions Applied to Healthy Adult and Spinal Muscular Atrophy Patient with Thyrotropine Releasing Hormone Therapy
ICHG2016 The 13th International Congress of Human Genetics, Kyoto(2016.4.7)
P-8
Matsumaru N, Kato Z, Onishi T, Waki T, Matsumoto T, Mori D, Tsukamoto K.
Discussion on Therapeutic Endpoints in Neuromuscular Disease
The 36th Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeautics, Tokyo(2015.12.9)
P-7
Matsumoto T, Mori D, Onishi T, Waki T, Matsumaru N, Tsukamoto K.
Effect of FDA Guidance on Antidiabetic Drug Development in Japan (Poster presentation)
1st Regulatory Science Forum for next-generation researchers, Funabashi(2015.9.12)
! award of excellence student poster presentation
P-6
Matsumaru N, Kato Z.
Quantitative Evaluation of Motor Functions using Motion Capture System
AOCCN2015 (The 13th Asian and Oceanian Congress of Child Neurology), Taipei, Taiwan(2015.4)
P-5
Onishi T, Waki T, Tsukamoto K.
A State of Pediatric Drug Development in US, EU, and JP. (Poster presentation)
The 135th Annual Meeting of the Pharmaceutical Society of Japan, Kobe(2015. 3.28)
P-4
Waki T, Onishi T, Tsukamoto K.
Effect of Political Initiatives for Facilitating Drug Development in Alzheimer's Disease in the U.S. (Poster presentation)
The 135th Annual Meeting of the Pharmaceutical Society of Japan, Kobe(2015. 3.28)
! award of excellence student poster presentation
P-3
Yamamoto M, Tsukamoto K.
Interdivisional comparison in FDA on treatment of missing data. (Poster presentation)
The 135th Annual Meeting of the Pharmaceutical Society of Japan, Kobe(2015. 3.28)
P-2
Tsukamoto K.
Pharmacology and regulatory science foresee drug development.
The 88th Annual Meeting of the Japanese Pharmacological Society, Nagoya(2015.3.20)
P-1
Tsukamoto K.
New Drug Development for Alzheimer's Disease-Effect of Initiatives by FDA and PMDA
4th Gifu Structure Biology, Medical Science, Theoretical Drug Development Workshop Symposium, Gifu(2015.3.5)
Symposium
2017. 9.22
5th Gifu Innovation Lecture (International Symposium)
Towards Innovative Treatment and Drug Development for Diabetes Mellitus: from bench to bedside
"Saving Pancreatic β cells from Cell Death in Type 2 Diabetes", Cnop M, (Professor, Université Libre de Bruxelles)
"Generation of Functional Mature Insulin-producing Cells from Induced Pluripotent Stem Cells", Kume S, (Professor, Tokyo Institute of Technology)
"Present and future of islet transplantation", Anazawa T, (Assist. Prof. Kyoto University Hospital)
"Experiences in development of bioengineered pancreatic islets", Doi M, (Director of laboratory, Otsuka Pharmaceutical Factory)
"Development and approval of regenerative medical products", Chikazawa K, (Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency)
2016.10.6
4th Gifu Innovation Lecture (International Symposium)
Vaccine Development for Future
"Evaluation of Vaccines, Easy or difficult? Can we apply the Benefit Risk model?", Neels P, (Biomedical Sciences Department, University of Namur - Namur, Belgium)
"Effectiveness of Vaccine - from epidemiological perspective -", Kamiya H, (Infectious Disease Surveillance Center, National Institute of Infectious Diseases)
"HPV vaccination: is it worth it? - Establishing cost-effectiveness of HPV vaccination programs", Scuffham P, (Health Economics, Griffith University - Queensland, Australia)
"Deliver Innovative Recombinant Vaccines Expeditiously", Nakata F, (Director, UMN Pharma Inc.)
"Innovation and regulatory science for adjuvanted vaccines <New mechanism of action and potential biomarkers>", Ishii K, (Laboratory of Adjuvant Innovation, National Institutes of Biomedical Innovation, Health and Nutrition)
2016.2.26
Tufts CSDD & GPU GRS Joint Forum, (Tufts Center for the Study of Drug Development, USA)
2016.2.23
Georgetown University & Gifu Pharmaceutical University Regulatory Science Student Forum, (Georgetown University Center of Excellence in Regulatory Science and Innovation, USA)
2015.10.8
3rd Gifu Innovation Lecture (International Symposium)
What can we do for pediatric drug development ? - Previous, current, and future (provisional) -
"The paediatric regulatory framework for drug development in Europe", Brasseur D, (Paediatrician, Free University Brussels (ULB), Belgium)
"Current Situation of Pediatric Drug Development in Japan: What has been done and what needs to be done", Nakamura H, (Director for Clinical R & D, National Center for Child Health and Development, Japan)
"Actual cases of pediatric drug development - From a pharmaceutical industry's viewpoint", Osakabe M, (Head of R&D Division, Nobelpharma Co., Ltd.)
"For pediatric drug development - we can do 3D motion capture analysis -", Kato Z, (Structural Medicine, The United Graduate School of Drug Discovery and Medical Information Sciences, Gifu University)
"Lessons from Pediatric Clinical Trials", Carroll K, (Research Scientist Navigator, Lurie Children's Hospital -Chicago, USA)
2014.10.10
2nd Gifu Innovation Lecture (International Symposium)
"Novel Regulatory Science Research on the Drug Development for Alzheimer's Disease", Moritoyo T, (Associate Professor, Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital)
"An Overview of CSF Biomarkers of Alzheimer's Disease", Shoji M, (Professor, Department of Neurology, Hirosaki University Graduate School of Medicine)
"Use of Biomarker and Pharmacogenomics in New Drug Development for Alzheimer's Disease", Otsubo Y, (Ministry of Health, Labour and Welfare)
"From the Viewpoint of Japanese Pharma Companies", Iwai A, (Corporate Executive, Drug Discovery Research, Astellas Pharma Inc.)
"Global Trend of AD Clinical Development to Increase Probability of Positive Outcome", Sugino H, (Director, Innovative Indication, Regulatory Global Pharmaceutical Business, Otsuka Pharmaceutical, Copenhagen)
"The Changing Landscape for Bioinnovation: Economic Challenges in CNS Drug Development", Kaitin K, (Director and Professor, Tufts Center for the Study of Drug Development, Tufts University, USA)