Subject

Introduction to Biomedical Companies

  • code 13487
  • course 2
  • term Semester 1
  • type OB
  • credits 6

Main language of instruction: Spanish

Other languages of instruction: Catalan, English

Teaching staff

Head instructor

Dr. Luis Antonio RUIZ - lruiz@uic.es

Office hours

Questions that students may have will be resolved before or after class in person, or via email through direct contact throughout the course.

Introduction

In the event that the health authorities announce a new period of confinement due to the evolution of the health crisis caused by COVID-19, the teaching staff will promptly communicate how this may effect the teaching methodologies and activities as well as the assessment.

The course is aimed at giving students a complementary view of science that allows them to be informed and, where appropriate, make decisions in relation to the development of a career in the field of creation and management of biomedical oriented companies and R&D. It is presented at an introductory level, as within the curriculum there will be core and optional subjects that will develop in depth some of the issues raised.

Pre-course requirements

None.

Objectives

  1. Provide students with the basics to understand the complexities involved in developing and marketing a drug (including determining its price), beyond the scientific aspects associated with its mechanism of action in relation to the disease. 
  2. To present the biomedical company as a necessary instrument for the transformation of scientific knowledge into socio-economic value, in the form of services or products that improve the quality of life of patients.
  3. To offer students an overview of the different types of biomedical company and the professional profiles that can be integrated into them, with special emphasis on recent cases of local companies created and stemming from university research.

Competencies

  • Recognize the different areas and dynamics of the biomedical company in which a graduate in Biomedical Sciences can practice.
  • Identify the stages of the process of basic knowledge transfer in a product, technology or service as well as the methods for entrepreneurship and innovation that facilitate the stages of knowledge transfer.
  • Develop the ability to organize and plan appropriately at the time.
  • Develop the ability to solve problems.
  • Develop the capacity for analysis and synthesis.
  • Be able to carry out autonomous learning.
  • Be able to work in a team

Learning outcomes

At the end of the course, the student will:

  • Learn about the value chain from the generation of new ideas in the biomedical research laboratory and the development of clinical trials to the creation of a new drug, technology or service to assist patients.
  • Become familiarised with the different types of biomedical company, their business models, partnership profile, etc., and be able to match existing companies with their type.
  • Meet the main players in the Spanish and Catalan biomedical sector.
  • Understand the importance of non-scientific elements in the development of new drugs or biomedical services: industrial and intellectual property, legal and regulatory aspects, financing strategies, non-scientific communication, industrial development (scaling and quality control).
  • Know the main elements that condition the price of a biomedical service or product (introductory notions of "market access").
  • Become familiarised with the current trends in biomedicine: precision or personalised therapy, gene therapy, cell therapy, immune-oncology.
  • Become familiarised with the different professional options (“job descriptions”) offered by the biomedical company to graduates and doctors in biomedicine

Syllabus

  • Basic definitions, what a company is, governance structures, basic management. Basic concepts in business biomedicine. The aim is for the student to become familiar with everyday concepts and to use them in subsequent classes. There will also be a "glossary" of basic terms to help throughout the course.
  • Drug / device development. The aim is for students to know the timelines, risks and costs of developing biomedical products and services, including regulatory, industrial and legal aspects, in addition to demonstrating the effectiveness and safety of a new treatment.
  • Transmission of the concepts that define companies that use biomedicine as a central part of their existence: what is meant by biotech, MedTech, pharma, generic, biologists, etc.
  • Case method discussion using the web pages of different companies defined in the previous section.
  • Case method: the example of the discovery and development of penicillin will be used to introduce the four key factors that affect the success of a biomedical development, technical, industrial, regulatory and commercial, with a focus on the importance of the existence of incentives associated with an unsatisfied need, the most obvious symptom of which is the financial incentive.
  • Monographic workshop to introduce the concept of patents (the importance of which will have been pointed out in the case of penicillin), in an open case format in which the different options that exist for the protection of the industrial property are covered, including basic definitions of what a patent is.
  • Evolution of the biomedical industry, from a single model (2000) to a diversified model (2019).
  • Case method: based on comments in class on recent news that confirms the evolution of the sector described in the previous point.
  • Description of the current technologies that are creating the highest expectations for the health of the future (gene editing, CART, ehealth, oncoimmunology, precision medicine, cell therapy and healing ...). The class will be used to work for the first time on the controversial issue of the price of health and medicines, as an introduction to pharmacoeconomics.
  • Case study of a disruptive company: cell therapy company and project and CART (Tygenix and CART project Carreras Foundation)
  • Case Study of an Orphan Disease Business Model: Mynorix
  •  Case study of disruptive spin-off, with curative potential through gene therapy of a minority disease (Friedrich's Ataxia): Biointax
  • Case study of the world's leading company in the processing of human plasma and the marketing of blood products: Grifols
  • Case study: discussion with the CEO of an oncology company with a product in clinical stages.
  • Value of an R&D project: cost / benefit / profitability. Temporary value of money and expected value.
  • Practical project assessment exercise (in groups)
  • Basic principles of financing emerging biomedical companies. This will fundamentally focus on the concept of the generation and sale of future expectations, its analogy with the market of financial futures and capital, and the difference between a purely speculative market and the system of risk financing of the biomedical industry.
  • Case study financing vehicles: Asabys, a venture capital fund that operates in Barcelona financing biomedical companies with therapeutic orientation and a biotech, MedTech or ehealth profile.
  • Practical case of a Contract Research Organisation, or CRO, service company, in this case a regulator (Asphalion).
  • Economic assessment of health interventions (drug economics).
  • Practical exercise in economic assessment of health.
  • Technology transfer models based on biomedical research of academic origin.
  • Cases associated with the previous class: Bosch Gimpera Foundation, UPF Ventures, OTRI IGTP, Spherium case, depending on availability.
  • Case study startup in ehealth.
  • Stakeholder concept, which is fundamental to understanding the economic levers of the biomedical industry.
  • Practical class and open discussion using the web pages of different companies to work on the concept of the stakeholder introduced in the previous class.
  • General review of the main concepts of the subject and review of possible career opportunities in the industry.

Teaching and learning activities

In person

Master classes: presentation during 2 sessions of 50 minutes of a theoretical topic by the teacher.


Practical classes and case methods (CM): Approach to a real or imaginary situation. Students interact directly with those involved in the creation of biomedical companies in Spain and Catalonia, and work on the questions in small groups or in interaction with the teacher and discuss the answers. The teacher and the speakers take an active part and, if necessary, contribute new knowledge.

Virtual Education (VE): Online material that the student can consult from any computer, at any time, that will contribute to the self-learning of concepts related to the subject

Evaluation systems and criteria

In person

Assessment parameters in the first sitting:

20% Class attendance

20% Attitude and participation

20% Partial exam

40% Final exam (first sitting)

 

Assessment parameters in the second sitting:

In the second sitting, the part of the mark related to attendance, attitude and participation in class will be saved, so the mark will be composed of the following parameters:

20% Class attendance (saved from the first sitting)

20% Attitude and participation (saved from the first sitting)

60% Final exam (second sitting)

Class attendance (both in Master classes and in the case method):

Attendance ≥ 80% of sessions: Mark = 10

Attendance <80% of sessions: Mark proportional to the level of attendance

Attitude and participation in class and case studies:

Subjective assessment by teachers and speakers, based on:

Predisposition to learning, positive and constructive attitude

Proactivity in discussion dynamics

Active participation in the questions posed by the teacher / speaker

Asking questions throughout the sessions

Response to the ideas expressed by classmates

Exams:

You must get a mark of 5 or higher on the exam in order to average the final mark.

Partial examination

60% of the mark:

Test with 20 multiple choice questions, 4 answer options. Rating +1 in case of correct answer. The incorrect answer does NOT count towards the overall mark

40% of the mark:

Two development questions (15 lines): Critical explanation of a news item (chosen from 3 options) and explanation of the activity profile of a company (to choose between 3 companies seen in class)

 

Final exam (first and second sitting)

60% of the mark:

Test with 30 multiple choice questions; 4 answer options. Rating +1 in case of correct answer. The incorrect answer does NOT count towards the overall mark

40% of the mark:

2 development questions (15 lines): Explanation of the activity profile of a company (chosen from 3 companies seen in class) and explanation of a theoretical concept described in the Master classes

Bibliography and resources

Ciencia y Negocio, una visita a Businesslandia. Luis Ruiz Avila, Editorial EUNSA, 2020.

Evaluation period

E: exam date | R: revision date | 1: first session | 2: second session:

  • E1 11/01/2021 14:00h I1
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