Training of clinical trial specialists and reviewers: Current situation of Pharmaceutical Medicine Kihito Takahashi President of JAPhMed The 6th Kitasato University-Harvard School of Public Health Symposium Tuesday, October 26th, 2005 Today’s Agenda JAPhMed and IFAPP Pharmaceutical Medicine: Current Global Situation Path Forward for Training and Education in Japan 2 JAPhMed and IFAPP Japanese Association of Pharmaceutical Medicine (JAPhMed) JAPhMed is a group of physicians, mostly working in the pharmaceutical industry, with the following goals: To contribute to the advancement of the pharmaceutical industry To provide opinions on evaluation of efficacy and safety of pharmaceuticals from medical point of view To develop understanding about the role and importance of medical doctors in pharmaceutical companies To foster international exchange for the above-mentioned purposes To promote Pharmaceutical Medicine in Japan 4 IFAPP: The International Federation of Associations of Pharmaceutical Physicians The International Federation of Associations of Pharmaceutical Physicians (IFAPP) was founded in 1975 to promote international cooperation among medical doctors working in pharmaceutical companies around the world Japan, through JAMDI (the predecessor of JAPhMed), was one of original member countries in the foundation of IFAPP IFAPP also has a primary objective to establish the role of Pharmaceutical Medicine and pharmaceutical physicians on a global basis 5 Pharmaceutical Medicine: Current Global Situation What is Pharmaceutical Medicine? Definition of Pharmaceutical Medicine Pharmaceutical Medicine is a medical scientific specialty concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of marketing of medicines for the benefit of patients and the public health – Faculty of Pharmaceutical Medicine, Royal College of Physicians (RCP) Careers in pharmaceutical medicine encompass three main groups of physicians and qualified non-physicians: Those working in the pharmaceutical industry Those with appointments within medicines regulatory bodies Those working in independent research organizations dedicated to the development of new medicines (e.g. academia, CRO) 7 Pharmaceutical Medicine in Europe In Britain, the British Association of Pharmaceutical Physicians (BrAPP) introduced a 2-year program of part-time study in 1975 The Royal College of Physicians (RCP) has been supporting this initiative by providing examinations for a diploma in Pharmaceutical Medicine based on the BrAPP syllabus Similar accreditation systems have been adopted in other countries: Switzerland Belgium Germany France Italy Sweden Spain Argentina (South America) 8 European Center of Pharmaceutical Medicine - Example European Center of Pharmaceutical Medicine (ECPM) is a university institute within the Medical Faculty of the University of Basel Course: A postgraduate education program especially designed for professionals working within the pharmaceutical industry, regulatory authorities and university hospitals Established in 1991, providing specialist knowledge in the field of drug development at an advanced level. Emphasis is placed on requirements for rational and rapid development of a new drug for the world market Eligibility Criteria: Applicants must have a university degree, MD or PhD The program is aimed at scientists who are involved in the drug development process and have already at least 1 to 2 years of working experience Diploma: Participants who successfully complete the course cycle and pass the final (multiple-choice) examination will be awarded a diploma by the three EUCOR medical schools: University of Basel, Albert-Ludwigs University, and Louis Pasteur University Examinations: A multiple-choice questionnaire for self assessment of acquired knowledge 9 ECPM Sessions from 2005 to 2007 Sessions Topics Days 1 The Future of Drug Development 4 2 Toxicology and Clinical Pharmacology 4 3 Clinical Trails and Biostatistics I 4 4 Clinical Trials and Biostatistics II 4 5 Regulatory Affairs 4 6 Project and Product Management 3 Final Examination - 10 A majority of Pharmaceutical Medicine Courses accept both physicians and non-physicians Except for two universities, most of Pharmaceutical Medicine Courses in Europe accept both physicians and non-physicians: 100% Student Ratio Physicians to non-Physicians in each course in Europe 90% 80% 70% 60% Non-Physicians 50% 40% 30% Physicians 20% 10% 0% Belgium: Free University of Brussels France: Claude Bernard University, Lyon Spain: Autonomous University of Barcelona Spain: Universidad Complutense de Madrid Sweden: Karolinska Institutet Switzerland: University of Basel Source: HP of each school 11 United Kingdom: University of Surrey United Kingdom: University of Wales, Cardiff Pharmaceutical Medicine in the United States The American Academy of Pharmaceutical Physicians (AAPP) has been chartered since 1994 with the mission to contribute toward the progress and advancement of Pharmaceutical Medicine The largest single group of physicians in this specialty – Membership includes medical doctors working for the Food and Drug Administration – Government-industry collaborative efforts No accreditation system has been adopted Educational syllabus compatible with the RCP model has been adopted A certificate for “Certified Physician Investigator” through a qualifying examination is offered Academic training and education: – Tufts Center for the Study of Drug Development (CSDD) – Harvard University School of Public Health 12 Harmonization of Pharmaceutical Medicine courses: The Council for Education in Pharmaceutical Medicine (CEPM) Given the global and various professional aspects of pharmaceutical medicine, harmonization of the programs is necessary to ensure consistency of the programs at the global standard The Council for Education in Pharmaceutical Medicine (CEPM), created in 2001 under the auspices of the IFAPP, is striving to harmonize the programs of the existing postgraduate courses in Pharmaceutical Medicine The CEPM has already completed accreditation of Pharmaceutical Medicine courses in the UK (Cardiff and Surrey), Belgium, Barcelona and Stockholm 13 Pharmaceutical Medicine in Japan: Path forward Need of Education and Training for clinical trial specialists and reviewers: What are the issues in Japan? Several Biostatistics courses and Clinical Pharmacology programs are available in Japan Various opportunities and methods exist to develop the expertise needed for effective drug development Programs and courses are rather isolated – efforts are therefore segmented No clear criteria exists regarding the level of knowledge, skills and experience required for individuals to be accepted as experts in drug development and reviewers The lack of clear criteria often results in inconsistencies in the quality of clinical trials conducted and the evaluation of associated clinical trial results 15 Vision for Pharmaceutical Medicine in Japan Develop experts in drug development in industry, academia and regulatory agencies who are capable of leading high quality drug development with scientific regulatory process As part of this mission, we wish to: Promote excellence in Pharmaceutical Medicine in Japan Set standards for Pharmaceutical Medicine – Certification Develop programs and standards in collaboration with academia – Provide academic study guidance, Develop curriculum 16 Tokyo University Laboratory of Pharmaceutical Regulatory Science Programs Intensive Course (IC) – A seminar which concentrates on a specific timely topic. It will be conducted for two or three days and held twice a year • First IC was held on July 8 and 8, 2005 • Second IC is scheduled on January 25, 2006 • Seminar 1 was held on Aug.29, 2005 • First Mini Symposium was held on Sep. 22, 2005 Regular Course (RC) – A seminar to educate specialists in statistics, data management techniques and evaluation of drug efficacy that are needed for the development and approval of new drugs Lecture for the Graduate Students – Initiated at Oct 13, 2005 17 On-going Initiatives •Kitasato University School of Pharmaceutical Science Post Graduate Pharmaceutical Medicine Course is planned to start in 2006 International collaboration with Harvard University School of Public Health, FDA and other academic and regulatory bodies Master and Doctoral degree will be awarded •Oita University Faculty of Medicine Undergraduate lectures 18 Outline of Pharmaceutical Medicine Program proposed by JAPhMed Scope of the Program Accreditation system compatible with CEPM of IFAPP Curriculum with practical case studies Appraisal of the qualification by an external accredited body Structured continuing education throughout a pharmaceutical physician’s career Globally harmonized with IFAPP standard Program Content Pharmaceutical Medicine curriculum is comprised with following two parts – Basic Program • Principally covers the core curriculum of IFAPP syllabus in Pharmaceutical Medicine • Suitable for entry class investigators who will conduct clinical trials – Advanced Program • Workshop with case studies by the trainers with practical experiences 19 Potential programs for JAPhMed Session 1 2 3 4 5 6 7 8 9 10 11 12 Title Discovery of New Medicines Pharmaceutical Development Toxicity Testing Legal and Ethical Issues Development of Medicines Clinical Trials Statistics and Data Management Safety of Medicines Regulatory Affairs Information, Promotion and Education Economics of Healthcare Medical Department 20 Start from September 2005 ~ December 2005 ~ October 2005 ~ November 2005 ~ Proposed Structure for Pharmaceutical Medicine in Japan There are three ways to get qualification of Pharmaceutical Medicine professionals Qualification of Pharmaceutical Medicine Professional will greatly improve employability Graduate Students + Company Employees + Physicians Internet / Independent Courses 12 Sessions Certificate Academia OJT, Conference, Symposium etc. Tokyo Kitasato Others ▪ JAPhMed Course ▪ Tokyo Univ. ▪ Kitasato-Harvard Diploma Examination for Qualification executed by Independent Legal Entity (ILE) ILE Univ. Qualified Pharmaceutical Medicine Professional (TBD) 21 14th International Conference on Pharmaceutical Medicine ICPM2006 3-6 September, 2006, Seoul, Korea Beyond the Horizon Beyond the Geographical Horizon Beyond the Technical Horizon Beyond the Functional Horizon http://www.icpm2006.org 22 Conclusion It is absolutely necessary to make all the efforts to consolidate training and education from isolated and segmented forms to a highly organized, continuous, and comprehensive activity in order to establish the highly qualified specialists of global standard for clinical trial and regulatory review 23 Acknowledgement Prof. Masashi Takeuchi (Kitasato University, Dept. Pharmacy, Biostatistics) Prof. Yuichi Sugiyama (Tokyo University, Dept. Pharmacy, Regulatory Science) Dr. Kyoko Imamura (Janssen Pharmaceutical KK, Secretariat for Education task team, JAPhMed) Dr. Akiyoshi Uchiyama (CEO of Artage, Chair for Education task team, JAPhMed) Mr. Chris Albani (PRTM) Mr. Yorozu Tabata (PRTM) Ms. Mieko Hasegawa (Banyu/Merck) 24
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