25 % RR in premature mortality due to CV diseases Cancer Diabetes COPD Better educated, higher income population which requires modern health care,

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1 Education and training of medicines development, regulation and clinical research in Low and Middle Income Countries (LMICs) S. Kerpel-Fronius & B. Rosenkranz Sándor Kerpel-Fronius, M.D., D.Sc. Semmelweis University Department of Pharmacology and Pharmacotherapy Budapest, Hungary KERPEL-FRONIUS S. 1

2 25 % RR in premature mortality due to CV diseases Cancer Diabetes COPD Better educated, higher income population which requires modern health care, well equipped medical facilities, and highly effective medicines Medical personnel who can apply up-to-date treatment, is able to participate in international clinical studies and can organize local clinical trials Regulatory Agency which can adequately handle modern sophisticated medicines and increased work load caused by many follow-on chemical and biological medicines KERPEL-FRONIUS S. 2

3 Continuous Professional Development (CPD) Meeting the challenge How to develop further my competencies & professional career? University Workplaces Post-graduate courses Whom to teach? What to teach? How to train competent clinical investigators, regulators, industry professionals The cooperation in CPD of academic centers and various work places is an educational necessity and the requirement of modern society KERPEL-FRONIUS S. 3

4 Modern concept of drug development Marketing Authorization Indication Side effect profile Companion biomarkers, diagnostics Predictive non-clinical research PK/PD parameters Pathway analysis Dose selection Biomarker identification Analogue development Clinical research Confirmation Use of biomarkers for patient selection, stratification Efficacy/Safety Benefit/Risk Proof of concept in humans Mechanism of action Confidence in safety Biomarker validation Multiple effects in humans? Kerpel-Fronius S. 4

5 Overlapping competencies in drug development and application Health care providers Molecule to patient car Clinical pharmacologists Clinical investigators Discovery research Drug development Drug application Pharmaceutical industry Molecule to market place Drug development scientists Pharmaceutical physicians KERPEL-FRONIUS S. 5

6 African regional economic integration g Kimenyi MS: Trade and Development Board, sixtieth session Geneva, September 2013 KERPEL-FRONIUS S. 6

7 Training of Specialists in Medicine Development KERPEL-FRONIUS S. 7

8 Core competencies for Specialist of Medicine Development H. Silva et al. Frontiers in Pharmacology doi: /fphar Ethics & subject protection Discovery of medicines & early development Health care market place Domains of core competencies Clinical development & clinical trials Communication & management Drug safety surveillance Medicines regulation KERPEL-FRONIUS S. 8

9 Training of Clinical Investigators KERPEL-FRONIUS S. 9

10 Harmonized Core Competencies for the Clinical Research Professional Joint Task Force for Clinical Competency 2013 Several competencies overlap with those of the Specialists in Medicine Development Clinical Pharmacologists Related to drug development Domains of Core Competencies KERPEL-FRONIUS S. 10

11 PharmaTrain educational harmonization Topics from molecule to marketplace 180 Syllabus topics 60 Learning outcomes 6 Base modules Elective modules (CPD) Shared standards Joint examination Learning outcomes are the main tools for harmonization Joint examination & MCQ pool provide information on the uniformity of educational success KERPEL-FRONIUS S. 11

12 Training of Clinical Investigators European Clinical Research Infrastructures Network + + Goal: Training of planning, performing and organizing clinical trials at the investigators site Clinical Investigators Course (CLIC) Three levels of training related to distinct responsibilities in the performance of clinical trials: Level 1: site staff (CRA, CTA, study coordinator, study nurse) Level 2: (principal) investigator (responsibility for a clinical trial at a site) Level 3: sponsor-investigator (overall responsibility for a clinical trial) KERPEL-FRONIUS S. 12

13 Translational genomics Kerpel-Fronius S.: 1 3

14 The harmonization of contradictory scientific aims, social needs and ethical principles Freedom of research Safety and the protection of personal rights and dignity The value of the scientific results for the society New medicines, techniques and processes will lead to new ethical challenges KERPEL-FRONIUS S: 14

15 Early Clinical Medicines Development and Clinical Research for the Clinical Team DRAFT proposal for a combined course Early Clinical Medicines Development and Clinical Research for the Clinical Team to be presented in Zimbabwe, prepared by Prof Bernd Rosenkranz (05 June 2015) COURSE PLANNING 5 days, 8:00 17:00, including 2 x 0.5 hr tea breaks and 1 hr lunch break Approximately hr for each topic (average) KERPEL-FRONIUS S. 15

16 Early Clinical Medicines Development and Clinical Research for the Clinical Team PRINCIPLES OF CLINICAL MEDICINES DEVELOPMENT Overview of the medicine development process, phases of clinical development, clinical development plans Introduction to clinical studies in special and vulnerable populations Introduction to clinical safety EARLY CLINICAL MEDICINES DEVELOPMENT Objectives, design and analysis of early (phase I and IIa) clinical studies, considerations for first-in-man studies Trial designs; endpoint selection and validation; biomarkers; patient reported outcomes Basic statistical concepts for designing and evaluating clinical trials KERPEL-FRONIUS S. 16

17 Early Clinical Medicines Development and Clinical Research for the Clinical Team Overview of in- trial procedures Management of the investigational medicinal product Biological samples management Document management Subject recruitment, enrolment and retention ETHICAL AND LEGAL ASPECTS Introduction to the ethics of clinical research, the informed consent process and Good Clinical Practice Legislative framework and guidance for clinical research Financial and contractual issues, insurance Quality assurance, monitoring, audits and inspections Clinical trial data transparency: From regulatory obligations to patient communication KERPEL-FRONIUS S. 17

18 Early Clinical Medicines Development and Clinical Research for the Clinical Team PRACTICAL CONSIDERATIONS Clinical project management Planning and preparation of a trial at the site Site organization and management Overview of in- trial procedures Management of the investigational medicinal product Biological samples management Document management Subject recruitment, enrolment and retention KERPEL-FRONIUS S. 18

19 Conclusions The management of advanced life-long education for various professionals is a formidable challenge for both the universities and the society The expectations can be met only by broad cooperation between various universities, educational organizations and workplaces The education in developing economies should be coordinated by local experts and organizations but international cooperation is recommended The internationally accredited educational material should be tailored both in content and complexity for local needs KERPEL-FRONIUS S. 19