PRODUCT RESEARCH & DEVELOPMENT PROCESS

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1 0 :: 2 v01 x y p.345 B xxx.:: B A x y pval«««[xy] -løøøø xxx.:: øøøø A PHARMATRAIN CENTRE OF EXCELLENCE INTRODUCTORY MODULE: PRODUCT RESEARCH & DEVELOPMENT PROCESS Aveiro October 3-5, 2013 UCM 01

2 INTRODUCTORY MODULE: PRODUCT RESEARCH & DEVELOPMENT PROCESS Face-to-face course: 3 5 october 2013 COLLABORATION MODULE LEADERS: Helena Beaumont, BSc Invited Auxiliary Professor, Health Sciences Department, University of Aveiro; Director of the Clinical Trials Unit, INFARMED. Luis Almeida, MD, PhD Invited Associate Professor and Director of the Training Programme in Pharmaceutical Medicine, Health Sciences Department, University of Aveiro; Managing Partner, Blueclinical Ltd; C.E.O., Luzitin SA. LECTURERS: Bruno Gago, PharmD, PhD Graça Freire, PharmD Helena Beaumont, BSc Ingrid Klingmann, MD, PhD Jean-Louis Roux Dit Buisson, MBA João Paulo Guimarães, MD Luis Almeida, MD, PhD Luis Arnaut, PhD Mónica Galo, PharmD Nuno Cobrado, PharmD Paulo Fontoura, MD, PhD Samuel Silvestre, PharmD, PhD Roberto Pinto, MD Teresa Herdeiro, PharmD, MSc, PhD Teresa Nunes, MD, MSc, MBA ORGANISATION: TRAINING PROGRAMME IN PHARMACEUTICAL MEDICINE A PharmaTrain CENTRE OF EXCELLENCE Director: Luis Almeida, MD, PhD Deputy Director: Bruno Gago, PharmD, PhD Associate Director: Miguel Forte, MD, PhD Health Sciences Department University of Aveiro Aveiro Portugal Tel Fax

3 03 october 2013 DAY 01 09:00-09:30 WELCOME NOTE Helena Beaumont, BSc #01 INTRODUCTION TO THE PROGRAMME CHAIRPERSON: Helena Beaumont, BSc 09:30-10:20 1. Medicines market overview and the industry we are in João Paulo Guimarães, MD (Angelini) 10:50-11:40 2. Meeting the challenges of developing new, more effective, safer medicines Luis Almeida, MD, PhD (University of Aveiro & Blueclinical) 11:40-12:30 3. The highly regulated and ethical environment of medicines development Helena Beaumont, BSc 12:30-13:00 x. Discussion #01(CONT.) INTRODUCTION TO THE PROGRAMME (CONTINUED) CHAIRPERSON: Helena Beaumont, BSc 14:30-15:20 4. The discovery process and non-clinical development Bruno Gago, PharmD, PhD (University of Aveiro) 15:20-16:10 5. Target product profile (TPP) to satisfy patients, providers, regulators and payors Luis Almeida, MD, PhD (University of Aveiro & Blueclinical & Luzitin) 16:10-17:00 6. Helicopter view of integrated drug development Luis Almeida, MD, PhD (University of Aveiro & Blueclinical & Luzitin) 17:20-18:10 7. Exploratory development: translational medicine; predictive science and personalized healthcare Luis Almeida, MD, PhD (University of Aveiro & Blueclinical & Luzitin) 18:10-19:00 8. Confirmatory development Teresa Nunes, MD, MSc, MBA (PRA) 19:00-19:30 x. Discussion

4 04 october 2013 DAY 02 #01(CONT.) INTRODUCTION TO THE PROGRAMME (CONTINUED) CHAIRPERSON: Helena Beaumont, BSc 09:00-09:50 9. Principles of drug regulation and approval Graça Freire, PharmD (University of Aveiro & GlaxoSmithKline) 09:50-10: Drug safety, pharmacovigilance and pharmacoepidemiology Teresa Herdeiro, PharmD, PhD (University of Aveiro & CESPU) 11:00-11: The payors, market support activities and health economics Nuno Cobrado, PharmD (Novartis) 11:50-12:30 x. Discussion PRINCIPLES OF DISCOVERY OF MEDICINES AND DEVELOPMENT PLANNING CHAIRPERSON: Luis Almeida, MD, PhD (University of Aveiro & Blueclinical & Luzitin) 14:00-14:50 1. Disease models; target identification, validation and selection Samuel Silvestre, PharmD, PhD (University Beira Interior, UBI) 14:50-15:40 2. Molecular based approaches: agonists, antagonists, enzyme inhibitors; genomics, proteomics, epigenetics Samuel Silvestre, PharmD, PhD (University Beira Interior, UBI) 16:00-16:50 3. Chemical and biological medical agents, natural medicines, medicine-coupled devices and advanced therapies Samuel Silvestre, PharmD, PhD (University Beira Interior, UBI) 16:50-17:40 4. Quality management in the global integrated development of new medicines Mónica Galo, PharmD (University of Aveiro & Novartis) 17:40-18:00 x. Discussion

5 05 october 2013 DAY 03 (CONT.) PRINCIPLES OF DISCOVERY OF MEDICINES AND DEVELOPMENT PLANNING (CONTINUED) CHAIRPERSON: Luis Almeida, MD, PhD (University of Aveiro & Blueclinical & Lusitin) 09:00-09:50 5. The principal steps in discovering, modifying, assessing and patenting new drugs Luis Arnaut, PhD (University of Coimbra & Luzitin SA) 09:50-10:40 6. Lead optimisation and candidate selection; testing for biological activity Luis Arnaut, PhD (University of Coimbra & Luzitin SA) 11:00-11:50 7. Strategy and organisation of research, including collaborative approaches 11:50-12:30 x. Discussion (CONT.) PRINCIPLES OF DISCOVERY OF MEDICINES AND DEVELOPMENT PLANNING (CONTINUED) CHAIRPERSON: Luis Almeida, MD, PhD (University of Aveiro & Blueclinical & Luzitin) 14:00-14:50 8. Strategy and organisation of research, including collaborative approaches 14:50-15:40 9. R&D portfolio planning; in-licensing and out-licensing of medicines 16:00-16: Resource planning, budgeting and cost control, insourcing and outsourcing 16:50-17:10 x. Discussion 17:10-17:30 CLOSING NOTE Luis Almeida, MD, PhD (University of Aveiro & Blueclinical & Luzitin)

6 01 october 2013, 14:30-18:00 pre-course workshop Good Clinical (Trial) Practice Ingrid Klingmann, MD, PhD (Coordinator, PharmaTrain; Chairman of the Board, European Forum for Good Clinical Practice, EFGCP) Post-course e-learning workshops #01 Major therapeutic areas and areas of unmet medical need, including rare diseases Teresa Nunes, MD, MSc, MBA (PRA) Major drug classes, including small molecules, biological, advanced therapies: mode of action, use, safety, and benefit-risk balance Roberto Pinto, MD (Faculty of Medicine, University of Porto) #03 Project management techniques Central role of development plan, project teams, tools and decision making from target product profile and target product claims to registration dossier submission Teresa Nunes, MD, MSc, MBA (PRA) #04 Principles of translational medicine Relationship between animal and human pharmacology, molecular, biological and physiological approach (e.g. biomarkers, functional imaging, modelling and simulation) Paulo Fontoura, MD, PhD (University of Aveiro & Hoffman-LaRoche)

7 INTRODUCTORY MODULE: PRODUCT RESEARCH & DEVELOPMENT PROCESS This introductory module is a mandatory part of the curricular unit Product Research and Development Process. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments. Curricular unit learning outcomes: On successful completion of this Module the participant should be able to: 1. Outline the process of drug development and identity of critical factors and decision points. 2. Explain the importance of the patient in drug development. 3. Describe the background to the development of the regulation of medicines and the role of the competent authorities. 4. Outline the monitoring of drug safety. 5. Describe the principles & practice of medical marketing. 6. Outline the role of pathophysiology and molecular biology-based pharmacology in drug development. 7. Describe the principal steps in discovering, modifying, assessing and patenting new chemical and biological compounds (including advanced therapies) according to their therapeutic indication. 8. Discuss the resource planning (in terms of project management, budgeting and cost- control) involved in the management of a drug development programme. 9. Describe the principles of translational research and its role in drug development. 10. Outline the functions and elements (including business aspects) involved in the integrated development of a new drug. Course Project Manager: Ana Isabel Correia, BSc (Master Student) ENDORSEMENT EXTERNAL ACCREDITATION

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