Universitat Internacional de Catalunya
Product Development in the Pharmaceutical Industry
Other languages of instruction: Catalan, English
Teaching staff
Questions will be resolved before or after class. To resolve non-face-to-face questions, they will be done by videoconference.
Introduction
The subject shows the student the process of developing biomedical products, including the development of drugs and in vitro diagnostic products. Each of these different areas involves special characteristics that will be analysed throughout the course, both at the level of R&D, regulation, and market access.
Pre-course requirements
It is recommended to remember the concepts studied in: Introduction to Bioenterprise
Objectives
• To know the process of developing pharmaceutical products.
• To know the process of developing in vitro diagnostic products.
• To know the basic concepts of market access.
• To know the basic concepts of product development regulations.
Competences/Learning outcomes of the degree programme
- CB01 - Students must demonstrate that they have and understand knowledge in an area of study that is based on general secondary education, and it tends to be found at a level that, although it is based on advanced textbooks, also includes some aspects that involve knowledge from the cutting-edge of their field of study.
- CB03 - Students must have the ability to bring together and interpret significant data (normally within their area of study) to issue judgements that include a reflection on significant issues of a social, scientific and ethical nature.
- CB04 - That students can transmit information, ideas, problems and solutions to specialist and non-specialist audiences.
- CB05 - That students have developed the necessary learning skills to undertake subsequent studies with a high degree of autonomy.
- CE19 - To be aware of the principles of biomedical science related to health and learn how to work in any field of Biomedical Sciences (biomedical companies, bioinformatics laboratories, research laboratories, clinical analysis companies, etc.).
- CG07 - To incorporate basic concepts related to the field of biomedicine both at a theoretical and an experimental level.
- CG10 - To design, write up and execute projects connected to the field of Biomedical Sciences.
- CG11 - To be aware of basic concepts from different fields connected to biomedical sciences.
- CT01 - To develop the organisational and planning skills that are suitable in each moment.
- CT02 - To develop the ability to resolve problems.
- CT03 - To develop analytical and summarising skills.
- CT04 - To interpret experimental results and identify consistent and inconsistent elements.
- CT05 - To use the internet as a means of communication and a source of information.
- CT06 - To know how to communicate, give presentations and write up scientific reports.
- CT07 - To be capable of working in a team.
- CT08 - To reason and evaluate situations and results from a critical and constructive point of view.
- CT09 - To have the ability to develop interpersonal skills.
- CT10 - To be capable of autonomous learning.
- CT11 - To apply theoretical knowledge to practice.
- CT12 - To apply scientific method.
- CT13 - To be aware of the general and specific aspects related to the field of nutrition and ageing.
- CT14 - To respect the fundamental rights of equality between men and women, and the promotion of human rights and the values that are specific to a culture of peace and democratic values.
Learning outcomes of the subject
At the end of the course, the student:
• Knows the stages of preclinical and clinical research in drug development, in vitro medical devices, as well as the structure of pharmaceutical companies.
• Understands the fundamental elements of the structure of the National Health System and health legislation
• Develops a professional attitude appropriate to the work environment.
Syllabus
- Pharmaceutical development
- Therapeutic areas
- The pipeline
- Drug types: small molecules and biologics
- Intellectual Property
- Pre-clinical and clinical phases
- Generics and biosimilars
- Requirements and regulatory pathways
- From product development to public founding: steps to follow
- Pharmacovigilance
- Vaccines
- Development of in vitro diagnostic products
- Typologies
- Development phases
- Specific regulations
- Market access
- Efficiency (economic evaluation) and budget impact
- Payment and refund models
- Expansion to other international markets
- Expansion strategies
- Business models
Teaching and learning activities
In person
Lectures: 50-minute presentation of a theoretical topic by the teacher.
Clinical cases or case methods (CM): Approach to a real or imaginary situation. Students work on the questions formulated in small groups or in active interaction with the teacher and the answers are discussed. The teacher intervenes actively and, if necessary, contributes new knowledge.
Virtual education (VE): Online material that the student can consult from any computer, at any time and that will contribute to the self-learning of concepts related to the subject.
Evaluation systems and criteria
In person
1. Students in first sitting:
Class participation and attitude: 10%
Pipeline and Product Development presentation: 40%
Study and oral presentation by teams of two or three people (depending on the number of students) of (a) the pipeline of one of the large global pharmaceutical companies that each group will choose at will together with (b) the development of a drug product detailing the different phases and information needed to bring the value dossier to the public healthcare provider.
Multiple choice test: 50%
2. Students in second or subsequent sittings:
The mark of (a) class participation and attitude as well as (b) the pipeline and product development presentation will be saved from the first sitting: 50%
Multiple choice test: 50%
NOTE: in second or subsequent sittings, the student may only aspire to a maximum mark of 6 out of 10.
3. General points to keep in mind about the evaluation system:
1) To be able to average, in the Pipeline presentation a minimum grade of 5 must be obtained.
2) To be able to average, in the multiple choice test a minimum grade of 4 must be obtained.
3) Attendance to Lectures as well as the presentations of "Pipeline and Development of product development" is mandatory.
4) Class participation is understood to be the contribution of interesting ideas or the raising of pertinent questions that help to improve the quality of the session, whether it is a lecture or case methods.
5) Assistants will have to be governed by the norms indicated by the professors.
6) In case of not attending a minimum of 65%, participation in class will be scored in a very reduced way.
Bibliography and resources
The Enterpreneur's Guide to a Biotech Startup. Peter Kolchinsky. www.evelexa.com. Free download: https://www.ctsi.ucla.edu/researcher-resources/files/view/docs/EGBS4_Kolchinsky.pdf
Evaluation period
- E1 15/01/2024 A08 14:00h
- R1 22/01/2024 A10 18:00h
- E2 17/06/2024 A04 18:00h