Regulatory use of innovative tools in drug development · Regulatory use of innovative tools in...
12
PRS Workshop, Boston, May 23 th 2013 Pharmaceuticals & Medical Devices Agency Regulatory use of innovative tools in drug development 1 Yoshiaki Uyama, Ph.D. Pharmaceuticals & Medical Devices Agency (PMDA) Visiting Professor, Graduate School of Advanced Clinical Science, Chiba University Visiting Professor, Graduate School of Medicine, Nagoya University
Transcript of Regulatory use of innovative tools in drug development · Regulatory use of innovative tools in...
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Regulatory use of innovative tools in drug development
1
Yoshiaki Uyama, Ph.D. Pharmaceuticals & Medical Devices Agency (PMDA)
Visiting Professor, Graduate School of Advanced Clinical Science, Chiba University Visiting Professor, Graduate School of Medicine, Nagoya University
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Innovation & Regulatory Experiences
2
Immature
Applicable for regulatory use
More scientific data
Reg
ulat
ory
expe
rienc
e
Many
Less Mature
More regulatory experience
Science
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
PMDA’s approaches to promote scientific
innovation in drug development
3
• Encouraging an exploratory use in drug development Formal/informal scientific
discussion Scientific consultation Scientific
conference/workshop
• More cooperation with academia Science Board Human resource exchange
program Collaborative graduate school
program
12th Kitasato-Harvard Symposium, Tokyo May 14th 2013
Pharmaceuticals & Medical Devices Agency
Recent PMDA’s initiatives to advance “Regulatory Science”
4
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Pre P-I
Clinical
End of P-II Pre NDA
ND
A
Non-Clinical Review
Pre P-II
Post-Market
Pre-post marketing
End of Re-evaluation period
PhaseⅠ
PhaseⅡ
PhaseⅢ PhaseⅣ
Prior-Assessment Consultation
IND
Special Consultation on PGx/Biomarker Qualification
Modified from Figure by Ichimaru K et al, Clin Pharmacol Therapeut, 88: 454-457, 2010
Pharmaceutical Affairs Consultation
Scientific Consultations & Drug Development Stage
5
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
PMDA
Pharmaceutical Affair Consultation
PMDA Science Board
6
Basic Research
Seeds of medical
products discovered
in Japan
Non-Clinical Clinical Quality
Practical Use
Offices of Review; Drugs, Biologics, Medical Devices Offices of Safety
Scientific Consultation Review
NDA
Office of Review Innovation
Approval Post Market
Safety Measure
Science Board
Academia
Board Member
Innovative Medical
Products
e.g.; HAL
iPS iPS-derived products
Discovery in Basic research e.g;
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Collaborative Graduate School Program
7
PMDA Staff Visiting Professor (Lecture in regulatory science) Graduate student (Ph.D. program); Research in University
University student
Graduate student (Ph.D. program); Research in PMDA
ＰＭＤＡ Graduate School
Collaboration
Joint Graduate School agreement
The agreement with 17 Universities (as of March 2013)
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Academia (University, Institute, Hospital)
○Proactive establishment of the guideline and standards
○Promoting development using innovative techniques
Outcome of research
Learning a state-of- the-art technology
↓ Improving a quality of review and other services in PMDA
Pharmaceuticals and Medical Devices Agency Reviewer
Researcher
Regulatory Science Research & Human Resource Exchange Program
(for developing innovative drug, device, cell & tissue products for practical use)
8
Training in regulatory science
↓ Effective research & development for regulatory approval
Human Resource Exchange & Development
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Research funds for developing innovative drug, device, cell & tissue products for practical use
Faculty of Pharmaceutical Sciences
Graduate School of Pharmaceutical Science
Hospital Nagoya City University, Graduate
School of Pharmaceutical Sciences
Graduate School of Pharmaceutical Sciences
Research Institute
Graduate School of Medicine
University of Tsukuba, Faculty of Medicine
Graduate School of Engineering
National Cerebral and Cardiovascular Center
National Cancer Center East Hospital
Kyusyu University, Graduate School of Medicine
Graduate School of Biomedical Engineering
Waseda University, Center for Advanced Biomedical Sciences
Graduate School of Medicine
Center for iPS Cell Research and Application (CiRA)
Foundation for Biomedical Research and Innovation
Medical Center (Hospital)
Chiba University, Graduate School of Medicine
Graduate school of Medicine
Drug
Device
Cell & Tissue
9
Hokkaido University
Tohoku University
National Cancer Center Hospital
The University of Tokyo
National Center for Child Health and Development
Osaka University
Kyoto University
Alzheimer's disease model
Safety biomarker
iPS cell-derived product
Imaging biomarker
Gene-therapy
Nanomedicine
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Regulatory Science Bridge
10
Tominaga T et al, Clin Pharmacol Ther, 90: 29-31, 2011
Patients/ Society
Products of science
(Substance, Knowledge, Information)
Data assessment
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Regulatory Science Bridge
11
Tominaga T et al, Clin Pharmacol Ther, 90: 29-31, 2011
Patients/ Society
Products of science
(Substance, Knowledge, Information)
Data assessment
Stronger & More Complete Regulatory Science Bridge will help us in the future drug developments
Drug A
PRS Workshop, Boston, May 23th 2013 Pharmaceuticals & Medical Devices Agency
Information
12
HOMEPAGE (English) http://www.pmda.go.jp/english/index.html
Regulatory Science Page http://www.pmda.go.jp/regulatory/index.html
E-mail: [email protected]
Thank you for your attention
