INTRODUCTORY MODULE:
PRODUCT
RESEARCH &
DEVELOPMENT PROCESS
Aveiro
October 3 - 5, 2013
UCM 01
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A PHARMATRAIN CENTRE OF EXCELLENCE
PRODUCT RESEARCH &
DEVELOPMENT PROCESS
Face-to-face course: 3 – 5 october 2013
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
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.
ORGANISATION:
TRAINING PROGRAMME IN PHARMACEUTICAL MEDICINE A PharmaTrain CENTRE OF EXCELLENCE
Director: Luis Almeida, MD, PhD ([email protected])
Deputy Director: Bruno Gago, PharmD, PhD ([email protected] Associate Director: Miguel Forte, MD, PhD ([email protected])
Health Sciences Department
University of Aveiro | 3810-193 Aveiro | Portugal Tel. +351 234 370 213 | Fax +351 234 401 597 E-mail: [email protected]
COLLABORATION
www.pharmaceutical-medicine.pt
03 october 2013 DAY 01
09:00-09:30
WELCOME NOTE
Helena Beaumont, BSc (University of Aveiro & INFARMED)
PART
#01 INTRODUCTION TO THE PROGRAMME
CHAIRPERSON: Helena Beaumont, BSc (University of Aveiro & INFARMED)
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 (University of Aveiro & INFARMED)
12:30-13:00 x. Discussion
PART
#01
(CONT.)INTRODUCTION TO THE PROGRAMME (CONTINUED)
CHAIRPERSON: Helena Beaumont, BSc (University of Aveiro & INFARMED)
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
PART
#01
(CONT.)INTRODUCTION TO THE PROGRAMME (CONTINUED)
CHAIRPERSON: Helena Beaumont, BSc (University of Aveiro & INFARMED)
09:00-09:50 9. Principles of drug regulation and approval
Graça Freire, PharmD (University of Aveiro & GlaxoSmithKline) 09:50-10:40 10. Drug safety, pharmacovigilance and pharmacoepidemiology
Teresa Herdeiro, PharmD, PhD (University of Aveiro & CESPU) 11:00-11:50 11. The payors, market support activities and health economics
Nuno Cobrado, PharmD (Novartis) 11:50-12:30 x. Discussion
PART
#02 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
05 october 2013 DAY 03
PART
#02
(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 Jean-Louis Roux Dit Buisson, MBA (Grenoble Business School & Foro Ventures) 11:50-12:30 x. Discussion
PART
#02
(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 Jean-Louis Roux Dit Buisson, MBA (Grenoble Business School & Foro Ventures) 14:50-15:40 9. R&D portfolio planning; in-licensing and out-licensing of medicines
Jean-Louis Roux Dit Buisson, MBA (Grenoble Business School & Foro Ventures) 16:00-16:50 10. Resource planning, budgeting and cost control, insourcing and outsourcing
Jean-Louis Roux Dit Buisson, MBA (Grenoble Business School & Foro Ventures) 16:50-17:10 x. Discussion
17:10-17:30
CLOSING NOTE
Luis Almeida, MD, PhD
(University of Aveiro & Blueclinical & Luzitin)
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
e-workshop
#01
Major therapeutic areas and areas of unmet medical need, including rare diseases
Teresa Nunes, MD, MSc, MBA (PRA)
e-workshop
#02
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)
e-workshop
#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)
e-workshop
#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)
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
