Training of clinical trial specialists and reviewers: Current situation of Pharmaceutical Medicine Kihito Takahashi President of JAPhMed The 6th Kitasato.

Training of clinical trial specialists and reviewers:

Current situation of Pharmaceutical Medicine

Kihito TakahashiPresident of JAPhMed

The 6th Kitasato University-Harvard School of Public Health Symposium

Tuesday, October 26th, 2005

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Today’s Agenda

JAPhMed and IFAPP

Pharmaceutical Medicine: Current Global Situation

Path Forward for Training and Education in Japan

JAPhMed and IFAPP

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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

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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

Pharmaceutical Medicine: Current Global Situation

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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)

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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)

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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, reg

ulatory 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 awarde

d 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

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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 -

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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:

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Belgium: FreeUniversity of

Brussels

France: ClaudeBernard

University, Lyon

Spain:AutonomousUniversity ofBarcelona

Spain: UniversidadComplutense de

Madrid

Sweden:KarolinskaInstitutet

Switzerland:University of

Basel

United Kingdom:University of

Surrey

United Kingdom:University ofWales, Cardiff

Student Ratio Physicians to non-Physicians in each course in Europe

Physicians

Non-Physicians

Source: HP of each school

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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  

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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

Pharmaceutical Medicine in Japan:Path forward

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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

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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

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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

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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

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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

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Potential programs for JAPhMed

Session Title Start from

1 Discovery of New Medicines

2 Pharmaceutical Development

3 Toxicity Testing

4 Legal and Ethical Issues

5 Development of Medicines

6 Clinical Trials

7 Statistics and Data Management September 2005 ~

8 Safety of Medicines December 2005 ~

9 Regulatory Affairs October 2005 ~

10 Information, Promotion and Education November 2005 ~

11 Economics of Healthcare

12 Medical Department

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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

Qualified Pharmaceutical Medicine Professional (TBD)

Graduate Students + Company Employees + Physicians

Internet / Independent Courses

Certificate

12 Sessions

Academia

Tokyo Kitasato Others

Diploma

Examination for Qualificationexecuted by Independent Legal Entity (ILE)

OJT, Conference, Symposium etc.

▪ JAPhMed Course▪ Tokyo Univ.▪ Kitasato-Harvard

ILE Univ.

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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

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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

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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)