Universitat Internacional de Catalunya
Product Development in the Pharmaceutical Industry
Other languages of instruction: Catalan, Spanish
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, in vitro diagnostic products and medical devices. Each of these different areas involves special characteristics that will be analyzed throughout the course, both at the level of R&D, regulation, and market access.
Pre-course requirements
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 process of development of a medical device.
• To know the process of development of digital health technologies.
• To know the basic concepts of market access.
• To know the basic concepts of product development regulations.
Competences/Learning outcomes of the degree programme
CB3: That students have the ability to gather and interpret relevant data (usually within their study area) to make judgments that include a reflection on relevant issues of a social, scientific or ethical nature.
CG7: Integrate the basic concepts related to the field of biomedicine both at a theoretical and experimental level.
CE7: Apply statistical tools to studies in Health Sciences.
Learning outcomes of the subject
At the end of the course, the student:
• Knows the stages of preclinical and clinical research in drug development, 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
1) Pharmaceutical development
a. Therapeutic areas
b. The pipeline and all its pre-clinical phases: target, hit, lead, ADME / Tox
c. Clinical phases.
d. From product development to public funding: steps to follow
e. Drug types: small molecules, biologics, reprofiling
f. Vaccines
g. Pharmacovigilance
2) Development of in vitro diagnostic products
a. Typologies
b. Development phases
c. Specific regulatory
3) Development of medical devices
a. Typologies
b. Development phases
c. Specific regulatory
4) Development of digital health technologies
a. Typologies
b. Development phases
c. Specific regulatory
5) Market access
a. Efficiency (economic evaluation) and budget impact
b. Payment and refund models
c. Evaluation of the Social impact of the development of a biomedical product
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: 30%
Pipeline Presentation: 35%
Study and oral presentation by teams of two or three people (depending on the number of students) of the pipeline of one of the large global pharmaceutical companies that each group will choose at will.
Multiple choice test: 35%
Study and oral presentation by teams of two or three people (depending on the number of students) on the development of a product. The different phases and information they need to take the value dossier to the public health provider will be detailed.
2) Students in second or subsequent sittings: the continuous assessment mark will be saved.
The presentation of the Pipeline in the second call may only aspire to a maximum mark of 6 out of 10.
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) Attendance to case methods is mandatory.
3) 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.
4) Attendance at the theoretical classes is not compulsory, but the assistants will have to be governed by the norms indicated by the professors. In case of not arriving on time, enter in silence without disturbing or interrupting the class. 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 17/01/2021 A08 16:00h