Innovative Medicines Initiative PharmaTrain Academia-Industry Collaboration in Europe

Transcription

1 9 th Forum de Etica em Pesquisa Clinica Sociedade Brasileira de Medicine Farmaceutica SBMF, São Paulo, August 23, 2011 Innovative Medicines Initiative PharmaTrain Academia-Industry Collaboration in Europe Fritz R. Bühler, MD Coordinator IMI PharmaTrain, Co-Founder ECPM, ACDRS and CCDRS, ex Head Worldwide Clinical Research and Development and CMO at Roche Professor of Pharmaceutical Medicine, Pathophysiology and Cardiology Brasilien August 23, 2011_112 / 1

2 The Industry-Academia Collaboration Academia - Education (pregraduate, graduate, postgraduate) - Research (free, innovative, personal, fundamental, (applied)) pursuit of knowledge for knowledge s sake - (Services) Industry - Academia trained scientists, marketing specialists ( training on the job ) Continuing Professional Development - product-oriented applied research - technology development Brasilien August 23, 2011_112 / 2

3 The new Industry-Academia Collaboration Academia public science independent investigator-based environment large-scale (-omics) science translational research Industry proprietary science economic large scale production style work Quality assurance FP7 e.g. Innovative Medicines Initiative Brasilien August 23, 2011_112 / 3

4 IMI Aims at: Building on Strengths and tackling Weaknesses in the EU Major pharma companies based in Europe High-quality research and medical centres Insufficient global investment in R&D Fragmented legal framework for IP rights Critical mass assembled through EU programmes Insufficient incentives for bioentrepreneurs Biomedical clusters based on PPP* Education programmes not adapted to industry needs Brasilien August 23, 2011_112 / 4

5 The Research Focus of IMI Brasilien August 23, 2011_112 / 5

6 Efficacy and Safety are often disease specific Brasilien August 23, 2011_112 / 6

7 IMI PharmaTrain Objectives To provide a Europe-wide comprehensive solution to training needs of integrated drug development (sciences) for all professionals involved, incl. physicians, pharmacists, pharmaceutical scientists, biologists, biometricians, health economists, safety & regulatory scientists from universities, regulatory agencies, all industry as well as research ethics committees & investigators To create a (new) multi-modular 3-tier programme of advanced studies in pharmaceutical medicine / drug development sciences leading to a postgraduate Master as well as Specialist qualification and accreditation, based on the Bologna credit and title system with 60+ ECTS credits Brasilien August 23, 2011_112 / 7

8 What is Pharmaceutical Medicine? What is Medicines Development Sciences? Pharmaceutical Medicine is the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of marketing of medicines for the benefit of patients and public health. Medicines Development Process Hit Discovery Research Lead Identification Optimization Combinatoral chemistry EIM POC NDA Market 00 0 I II III IIIB IV Genomics Proteomics SAR CLOP Learning Confirming Medicines Development Sciences is shaped by scientific advances, changing regulatory requirements and pharmaco-economic conditions. It is critical to the industry as an engagement tool that considers patient outcomes as the centre of everything it does. Brasilien August 23, 2011_112 / 8

9 PharmaTrain Syllabus 2010 Learning Outcomes Modules e-learning products Brasilien August 23, 2011_112 / 9

10 The PharmaTrain Module One ECTS 1 ECTS 2 ECTS 2 Pre e-product Intro F2F Post Assessed Assignments 1 ECTS = min 25 hrs Brasilien August 23, 2011_112 / 10

11 Diploma (Base) Course in Medicines Development DIMD B2 Non-clinical Testing to Proof of Concept in Humans B6 Healthcare Marketplace and Economics of Healthcare B1 Introductory Module One B5 Regulatory Affairs, Safety and Pharmacovigilance B3 Exploratory and confirmatory Clinical Development B4 Clinical Trials: Methodology and Biostatistics Brasilien August 23, 2011_112 / 11

12 Extension Master of Medicines Development MMD B2 Non-clinical Testing to Proof of Concept in Humans B1 Introductory Module One B3 Exploratory and confirmatory Clinical Development B6 Healthcare Marketplace and Economics of Healthcare B4 Clinical Trials: Methodology and Biostatistics B5 Regulatory Affairs, Safety and Pharmacovigilance E10 Special Populations: Clinical Trial Practice and Regulation E7 Healtheconomics / Markets E9 Biologicals and Advanced Therapies E8 Drug Safety, Pharmacoepidemiology Surveillance, Riskmanagement E11 E12 Master-Thesis Brasilien August 23, 2011_112 / 12

13 Ethical Principles throughout the Drug Development Process: from Molecule to Market Place Legel Framework Law Ordinance Provisions GCP Conformity Ethics Committees Inducement for Patients Marketing Authorization Hit Discovery Research Lead Identification Optimization EIM POC NDA Market 00 0 I II III IIIB IV Combinatoral chemistry Genomics Proteomics SAR CLOP Learning Confirming Special Populations Vulnarable Groups Orphan Indications Fraud, Misconduct Brasilien August 23, 2011_112 / 13

14 Creating the PharmaTrain e-library Existing e-product Background Select Drug Development Process Hit Discovery Research Lead Identification Optimization Combinatoral chemistry EIM POC NDA Market 00 0 I II III IIIB IV Genomics Proteomics SAR CLOP Adapt PharmaTrain e-library Create de novo INTRO 1 MOD 2 MOD 3 MOD 4 MOD 5 MOD 6 Safety Ethics P+P CLIC TA1 TA2 Brasilien August 23, 2011_112 / 14

15 e-library e1. An introductory module e2. Translational medicine e3. Biological/monoclonal antibody full development e4. Safety module e5. Medicines regulation e6. Health economics and market e7. Module on therapeutic area 1, Parkinson s disease e8. Module on therapeutic area 2 e9. An online Clinical Investigators Course e10. A train the trainers initiative Brasilien August 23, 2011_112 / 15

16 PharmaTrain Quality Management System ENQA based Audit (2-annual) Assessors (n = 2-3) Checklist Syllabus Manual Exams Assignments Trainers QA WP8 IFAPP nma Control-assessment Report Training Centre Self-assessment Brasilien August 23, 2011_112 / 16

17 PharmaTrain Course Quality Criteria The PharmaTrain ExBo has decided by way of correspondence to accept the following criteria proposed by the Cross Project Task Force on Course Quality and supported by the Cross Project Coordination Board (December 16-17, 2010) 1. Quality criteria are based on the following principles: a. Trainees are supported to acquire the necessary knowledge and skills b. Course structures encourage exchange and multidisciplinarity c. Facilities, infrastructure, leadership and competences adequate to deliver the approved curriculum d. Equality principles e. Teaching methods appropriate to the goals of the course f. Transparency regarding potential conflicts of interest 2. A formalised and transparent QA/QC policy that includes the following: a. University accreditation OR a suitable system for approving, monitoring and reviewing the training offered. b. A system for quality assurance of teaching staff. c. Regular review of the QA/QC process and demonstration that the training is further developed in light of this review. 3. A set of documented criteria for individual training modules, courses or course programmes that include the following: a. Defined and transparent admission criteria. b. A predefined set of teaching objectives, leading to defined learning outcomes. c. The facilities, infrastructure, leadership and competences available for the support of student learning should be adequate, appropriate and up to date for the training offered. d. Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered. e. A system for collecting, assessing and addressing feedback from learners, teachers, technical/administrative staff and programme/course/module managers. Brasilien August 23, 2011_112 / 17

18 Standards for PharmaTrain CPD Core Platform and on-course database e-library n = 9 (-30!) B6 Healthcare Marketplace and Economics of Healthcare E7 Biologicals E11 Electives n = 5/70 MMIC n = 3/12 B2 Non-clinical Testing to Proof of Concept in Humans B1 Introductory Module One n = 6 B5 Regulatory Affairs, Safety and Pharmacovigilance E8 Special Populations Trial Practice n = 3-4 DMDR n = 6/6 on course database B3 Exploratory and confirmatory Clinical Development B4 Clinical Trials: Methodology and Biostatistics E10 Pharmacoeconomics / Markets E9 Pharmacoepidemiology Drug Safety Surveillance E12 CLIC DCTP n = 6/6 Non-IMI Eu2P SafeScMET EMTRAIN Brasilien August 23, 2011_112 / 18

19 Interest in PharmaTrain Affiliation of non-european Training Centres The following 10 University Centres have voiced some interest to discuss a PharmaTrain Affiliation ICPM Israeli Centre of Pharmaceutical Medicine, Tel Aviv ACDRS DC + SF CCDRS PU ICDRS New Delhi South Africa, Stellenbosch ICPM Tokyo (?) PharmaTrain South America São Paulo + Buenos Aires + Mexico (?) South Korea, Seoul (?) Brasilien August 23, 2011_112 / 19