Interaction between academia, the pharmaceutical industry and regulatory authorities is of paramount importance for ensuring the quality, efficacy and safety of drugs in clinical use.
Although collaboration between biopharma and academia is increasing, life science trainees in academia often do not get significant exposure to how biopharma industries approach drug discovery and development, and how clinical research should be performed (Lauren C. Wu, Trends in Immunology - May 2015, 36:290-292).
The foundation for a successful career in clinical pharmacology and biopharma research encompasses strong scientific training and broad technical skills. While a rigorous, critical, and thorough approach to science is always important, it nonetheless should be emphasized that a strong scientific background enables one to think broadly and creatively about scientific problems, which is essential to the successful development of new therapeutics. Since the activities of members of a clinical pharmacology project team are interconnected, it is important to be able to understand not only one's own area of clinical research but also those of the other members.
As such, multi-disciplinary training is required to provide the ability to think about all aspects of a drug discovery program and clinical development of drugs. An understanding of the clinical development process for new therapeutics is necessary to conduct the most robust and effective drug discovery research possible, and to maximize understanding of clinical data and the chances of clinical development success.
This will help to prepare postgraduate trainees for a career in clinical pharmacology research both in academia and the biopharma industry, with the objective of balancing public needs with commercial aims, and ensuring effective drug evaluation by regulatory authorities.
The course is promoted by the University of Milan, a public teaching and research university, which - with 8 faculties, 2 schools, and a teaching staff of more than 2000 professors - is distinguished by its wide variety of disciplinary fields.
A leading institute in Italy and Europe for scientific productivity, the University of Milan is the largest university in the region, with approximately 64,000 students; it is also an important resource for the socio-economic context it is a part of.
For further information, please visit http://www.unimi.it
To equip participants for careers developing and expanding current knowledge of drugs and their uses in clinics, the course will provide a multi-disciplinary approach to clinical trials, data management and regulatory affairs.
The main objectives of the course are to:
To integrate the skills acquired, training and practical experience in the pharmacological workplace, in both academic and industry environments, are essential.
The course is based on close interaction between the academic study and practical experience in clinical research.
Participants will acquire core skills, giving them an understanding of how to apply clinical pharmacological, regulatory and ethical principles to the optimization of therapeutic practice and clinical research.
The course focuses on the application of pharmacological principles in clinical research, closing the gap between laboratory science and clinical practice.
Successful participants will be able to:
The Master's degree program in Pharmaceutical Medicine prepares individuals to perform valid, credible patient-based research in academia, industry, research institutes, and health and regulatory agencies.
Linking the academic and professional scientific communities, the program is most beneficial for:
Careers in pharmaceutical medicine are very varied and can be challenging, exciting, fulfilling and rewarding. Pharmaceutical medicine offers a challenging multidisciplinary environment and one of great complexity.
The proposed Master's degree program in Pharmaceutical Medicine may offer several career opportunities, including positions in:
The course comprises seven modules spread over a period of one year.
The program is based on the general concept of "on-the-job training", meaning that there will be mainly practical activities related to all aspects of clinical research trials, helping the candidates to gain the skills needed in this field.
Thus, the bulk of the training involves practical work with different teams involved in a multi-disciplinary approach to clinical research. The research activity takes place daily under the guidance of a tutor who will supervise the participants during their training. In fact, participants are assigned to a research group in which they will collaborate, with the objective of learning about the group's working approach and methodology.
Participants are also expected to attend lessons, seminars, courses and congresses organized by the partner institutions. These are all important educational opportunities and attendance is compulsory for all participants.
The course is divided into seven macro-modules:
The main topics covered by the specific macro-modules will be:
Macro-module 1: Theory, research practice and innovation in pharmacology
1.1 Introduction to Clinical Research
Aim: To provide an in-depth and comprehensive understanding of the principles and practice of clinical research.
This module provides a thorough understanding of the history and evolution of clinical research, including the principles and organization of global clinical research, the future direction of health economics, innovation in Research and Development (R&D) as a response to existing and emerging medical needs, and examples of landmark studies and controversies. The participants will examine the context in which research is undertaken (from molecular screening to Proof of Concept (PoC) and from PoC to Full Development) and consider types of studies, objectives and outcomes, definitions and phases of protocols, and the roles and responsibilities of the clinical research team and study sponsors.
Macro-module 2: Ethical and legal requirements for clinical research programs
2.1 Ethical, Legal, Regulatory and Financial Considerations in Clinical Investigations
Aim: To provide an in-depth understanding of the ethical, legal, regulatory and financial dimensions of clinical research.
This module offers an in-depth examination of ethical, legal and regulatory requirements and their interplay in clinical research. Topics include the recruitment and protection of subjects, diversity and vulnerability of populations, informed consent, privacy/confidentiality, and the role of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). Participants will also explore international research, relationships with the industry, conflicts of interest, intellectual property rights, and publications and authorship. Budgets: how to estimate study costs; how to keep budgets under control. Grants: how to write a grant application.
Macro-module 3: Clinical studies in practices: project management and coordination
3.1 Designing a Clinical Protocol and Conducting a Clinical Trial
Aim: To provide a systematic understanding and critical awareness of clinical trial protocol requirements.
This module will cover all aspects of research design, including methods, objectives and hypothesis, specification of the study population, outcome measures, reliability and validity, randomization, documentation requirements, outsourcing and multi-centre trials. According to their postgraduate status, trainees will also actively participate in carrying out specific ongoing clinical trials at the Clinical Research Centre of the Mario Negri Institute in Ranica (Bergamo).Specific issues regarding the design and conduct of studies with "cells and gene" therapies will also be discussed extensively, including new ethical challenges (e.g. the lack of preclinical data; long-term safety in patients, "donor and patient journeys", etc).
3.2 Good Clinical Practice (GCP) in Managing and Monitoring Clinical Trials
Aim: To critically examine requirements of good clinical practice and to understand correct strategies and plans for developing risk-based monitoring for investigational studies.
Participants will acquire a firm grounding in the tenets, history and regulatory context that inform GCP as defined by the International Conference on Harmonization (ICH), from study initiation to final reports. Topics include Standard Operating Procedures (SOPs), recruitment, quality assurance, data safety monitoring boards (DSMBs), multi-centre/large-scale trials, protocol management and amendments, audits, and reporting. Particular attention will be paid to monitoring, which is a necessary aspect of the processes and procedures for ensuring clinical trial quality and subject safety.
3.3 Information and Data Management
Aim: To provide a critical understanding of the issues surrounding efficiency and security in the context of data management in clinical research.
In this module participants will examine the importance of information systems and information technology in increasing efficiency in the management of clinical research data. Participants will consider the application of legal and ethical principles to the development of a data collection and management plan. The module also addresses issues of confidentiality, security of information systems and electronic remote data capture (e-RDC). The value of in-stream data review and of "data analytics" models to detect safety signals or suboptimal data quality will also be addressed.
3.4 Pharmacovigilance and Investigational Medicinal Product (IMP) Management
Aim: To provide an understanding of the relevance and importance of the proper monitoring of study drug safety.
This module will cover all aspects of pharmacovigilance in clinical research. Participants will consider the phases of identification, recording, reporting and analysis of safety information to ensure that any safety signals that arise during a trial are quickly identified and acted upon. Moreover, they will consider the steps of production, distribution and disposal of the investigational medicinal product according to international good manufacturing practices.
Macro-module 4: Statistical methods in pharmacological research
Aim: To provide an understanding of the relevance and importance of statistics in clinical research.
This module addresses the role of biostatistics in clinical research, including descriptive methodologies, statistical tests, and confidence intervals. Participants will examine basic concepts of data collection and analysis. The module also covers the development of the Statistical Analysis Plan (SAP), preparation of the statistical report, and integration in the Clinical Study Report (CSR).
Macro-module 5: Scientific communication
5.1 Writing Reports and Scientific Manuscripts
Aim: To provide an understanding of how to read the results of clinical research and how to write a scientific paper.
Through a guided process of critical analysis, handling everyday practical problems and real research experience scenarios, participants will address and complete all phases of drafting a research paper for publication. The participant will acquire the skills necessary to succeed in publishing scientific papers in top international journals and gain an in-depth understanding of scientific peer-review publishing and how to best present their work.
5.2 Patient Advocacy and Relations
Aim: To understand the role of the patient in clinical research from the passive patient (the patient is a data point) to the active patient (the patient is a researcher)
This module will explore the activities of patients' associations to support the problems faced daily by patients with chronic diseases and by their relatives, and the role of the associations in representing and informing patients. Participants will also examine increasing collaboration between patients, patient advocacy groups and academia and the pharmaceutical industry in facilitating clinical trial design and patient recruitment, as well as in funding new therapies, and how these relationships are having an impact on drug development and approval.
Macro-module 6: Legal regulations of the drugs
Aim: To deepen knowledge of the health system and the drug cycle, the two most crucial sectors to measure sustainable strategies of the entire national health system:
6.1 Public, national and supranational law
6.2 Competition law
6.3 Intellectual property law
6.5 Responsibility in the health sector
This module will allow the achievement of high skills in legal and regulatory matters, by examining the issues that are more binding in the developing and dynamic perspectives of reorganization of the pharmaceutical, health and related services.
Macro-module 7: The drug discovery and development process, regulatory and commercial aspects of management in the pharmaceutical industry
7.1 Drug Registration and Approval Process
Aim: To understand the general principles of medicine regulation (both pre- and post-approval).
This module will provide an overview of mechanisms and regulatory processes for medicine registration across Europe, the US and Asia. In addition, it will explore documentations and collaborations between developers and regulators.
7.2 Integrated Product Development, Healthcare Marketplace and Marketing
Aim: To understand the principles and the practice of the quality system of drug lifecycle activities.
This module will focus on principles of project and portfolio management and decision-making in clinical research. Ethical and legal principles of introducing a drug to the market; Good Promotional Practices. Overview of health economics and health technology assessment (HTA). Management of cross-functional teams, team-work and performance assessment.
7.3 Roles and Responsibilities in Enterprise
Aim: To acquire an understanding of how enterprises are organized, who the main internal stakeholders are, how to manage a matrix organization, principles of leading oneself and leading a team.
This module will offer an overview of organizational structures, the main roles and responsibilities, principles of matrix management and influencing, principles of leadership development in the two aspects of leading oneself and leading a team (direct report team or project management/functional team), and principles of time management, facilitation skills, negotiation skills, and how to build a highly performing team.
Professor of Nephrology, University of Milan – Italy
Piergiorgio Messa is Professor of Nephrology at the Università degli Studi di Milano Statale and Director of Nephrology, Dialysis, and Kidney Transplants at the Hospital Maggiore Policlinico in Milan.
Since 2009 Prof. Messa is Vice-Scientific Director of the Ca´ Granda Foundation-IRCCS and Co-director of the Department of Medicine and Transplantation.
He produced significant scientific contributions in the field of: mineral and electrolyte metabolism; hepatic infectious diseases in kidney patients; immune-mediated renal diseases; dialysis and renal transplantation.
Professor Messa has authored and co-authored more than 450 scientific articles, 323 of which present in PubMed.
TO BE DEFINED
Each student will undertake a major individual research project over the remainder of the course in one of the primary research areas in academia or the industry. The research will be supervised by senior staff.
Based on the research project assigned to each student, an internship lasting approximately 4 months will be done at one of the following sites:
The registration fee is 4500€.
The first three candidates on the ranking list will receive a scholarship equal to the tuition fee.
Students will have the opportunity to stay at the guesthouse of the Clinical Research Centre (Ranica, Bergamo) where the main activities of the master's will take place.
Each candidate must pass a written examination (multiple choice test), which counts for 60%, as well as an interview, which counts for 20%, at the Aldo e Cele Daccò Clinical Research Centre for Rare Diseases - IRCCS - Mario Negri Institute for Pharmacological Research in Ranica (Bergamo) Italy. The number of places is limited in order to guarantee that instructors will be able to provide adequate support to participants, and to ensure the proper use of scientific equipment.
The Curriculum Vitae et Studiorum will be assessed and will account for 20% of the evaluation (10% for publications and for the scientific value of the degree thesis, 10% for professional experience in scientific research). Applicants whose first language is not English are usually required to provide evidence of proficiency.
For information related to administrative procedures regarding selection, registration, payment and certification of students, please refer to the Office of Doctoral and Master university:
Tel. 02 50312302
Fax 02 50312300
The Aldo e Cele Daccò Clinical Research Center for Rare Diseases is located in Ranica (Bergamo) in Villa Camozzi, and has been working on promoting awareness of and treating rare diseases since 1992. The villa is dedicated to Mr and Mrs Daccò in recognition of their generous donation, which allowed the Mario Negri Institute for Pharmacological Research to completely restore Villa Camozzi.
The Daccò Center is a unique example of an institution capable of establishing all the necessary steps in a clinical research project. To this end, scientists and professionals, such as physicians, biologists, bioengineers, nurses, biostatisticians and computer technicians, work together closely to evaluate the health status of patients, to monitor and collect data derived from clinical studies, and to process and analyze this information to ultimately determine the efficacy of possible new therapeutic strategies.
Aldo e Cele Daccò Clinical Research Center for Rare Diseases"
Mario Negri Institute for Pharmacological Research
Villa Camozzi, via G.B. Camozzi, 3 - 24020 Ranica, Bergamo (Italy)
Phone +39 035 42131
The Aldo e Cele Daccò Clinical Research Center for Rare Diseases is located in Villa Camozzi in Ranica, 5 km from Bergamo.
From Orio al Serio Airport (10 km from Bergamo), there is a bus service to Bergamo city center.
From Milano Linate Airport (50 km from Bergamo) and Milano Malpensa Airport (120 km from Bergamo) it is possible to use public transportation to the Central Station and Milano Cadorna station.
Bergamo is one hour from Milan (Centrale or Lambrate railway stations).
Check the timetable on the Italian railways website at: http://www.trenitalia.it
The A4 highway (Milano-Venezia) connects Bergamo directly to the major Italian highway network.
Take the Bergamo exit, at the roundabout take the second exit, in the direction of Alzano Lombardo.
Exit at Ranica and proceed to the center.
Follow the directions for Villa Camozzi.
Take the local ATB Bus, line 5A (from the centre of Bergamo, Porta Nuova) to Ranica. Villa Camozzi is 300 meters from the bus stop.
Moreover, near the railway station, the Tram delle Valli (TEB) leaves every 15 minutes and stops in Ranica. The stop is a 15-minute walk from Villa Camozzi.
Mario Negri Institute for Pharmacological Research
Via Mario Negri, 2 - 20156 Milan (Italy)
Phone +39 02 390141
Milan is easily reachable from three international airports: Milano Linate (about 12 km from Mario Negri Institute), Milano Malpensa (40 km) and Milano Orio al Serio (50 km, close to Bergamo).
From Milano Linate: you can take a taxi or a bus to Piazza San Babila, in the centre of Milan, where you can take the underground Linea 1 to the railway station Cadorna Ferrovie Nord. All trains leaving Cadorna station stop at the Milano Bovisa-Politecnico station. Exiting the Bovisa Politecnico stop you should take the stairs on the right and reach the main road. Take the left and follow the road, then take the first road on the right. After 100 m. take the first road on the left and the Istituto Mario Negri will be right in front of you (5 minutes walk).
From Milano Malpensa: you can take the train called Malpensa Express and get off at the Milano Bovisa Politecnico station (see above). If you already are in Milan, the easiest way to get Mario Negri Institute is by taking a train from Cadorna Station (see above).
From Milano Orio al Serio: there is a shuttle bus to the railway station Milano Centrale, from where you can use the subway Linea 2 to get the station Cadorna Ferrovie Nord and then, by train, the Mario Negri Institute (see above).
Coming from the centre of Milan take via Mac Mahon until you reach Piazza Pompeo Castelli. Take the first road on the right (via degli Ailanti), then the first on the left, under the railroad tunnel. After the tunnel turn to the left in via Giampietrino. Go straight in via La Masa and take the first road on the right (via Mario Negri)