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Educator’s guide on Drug development

(Tools’ information)

Drug development - 2 – Tools’ information

Table of contents

I. Introduction 3

II. The tools 3

1. Virtual experiment - Produce a drug target 4

2. Virtual experiment – Develop a drug! 5

3. Game – How are drugs developed? 6

4. Video - The long and incredible story of a tablet 7

5. Video – New drugs against new threats 8

6. Video – Drug development and ethics 9

7. Discussion Continuum games 10

8. Decide game 11

Drug development - 3 – Tools’ information

I. Introduction

This document provides information on the tools that are available on the Xplore Health portal for the first module. For each tool, we provide an ID table and explanation on how to use the tool in class and interact with the curriculum.

II. Lesson plans The tools that have been created for the use of teachers and students in order to help them in their familiarization process of drug development are listed and explained below.

In the table that describes each tool, information on the link is given, as well as suggestions on how the tool can be implemented in class: pre-, during, and post-exercises

The tools are the following:

1. Game- How are drugs developed? 2. Virtual experiment 1 - Produce a drug target 3. Virtual experiment 2 – Develop a drug! 4. Video 1- The long and incredible story of a tablet 5. Video 2 - New drugs against new threats 6. Video 3 – Under development 7. Video 4 – Drug development & Ethics 8. Discussion continuum: Game 1 (Access to treatment) and 2 (Who pays for drug

development) 9. Decision game: Orphan drugs

Drug development - 4 – Tools’ information

1. Virtual experiment - Produce a drug target

Tool name Virtual experiment - Produce a drug target

Link to the tool http://www.xplorehealth.eu/en/media/produce-drug-target

Description Activities in which this tool can be used

• Most of the drugs work fitting with a target.

Key messages:

• To investigate a new drug scientists usually first produce its target to investigate latter the drug that will better fit with it.

• Most of the targets are proteins, the chemicals that build cells and control the jobs cells do, which in the lab are produced using bacterial DNA.

• Drug fitting with a target Concepts that appear:

• What is an enzyme and specifically a restriction enzyme

• Introduce DNA inside a plasmid • Introduce a plasmid inside bacteria to

produce protein • Resistance of bacteria to antibiotics

Manipulation of bacteria

Pedagogical objectives

• How drugs work

: Students will learn about :

The research involoved in the inital stages of the devlopment of a new drug

Time needed: 50 minutes

Process

• Teacher leads discussion during the introduction of the Virtual Experiment (10 minutes)

:

• Short demonstration showing students how to use the Virtual Experiment software, eg drag’n’drop (5 minutes)

• Student activity – Virtual Experiment 1 (25 minutes)

Teacher leads class discussion to summarise lesson (10 minutes)

Outcomes:

• How a drug works

Students will now have knowledge of:

• The different processes involved in the inital stages of the development of a new drug

• The laboratory equipment required • The laboratory techniques used • How bacteria are used in the development

of a new drug

Bacterial resistance to antibiotics

Drug development - 5 – Tools’ information

2. Virtual experiment – Develop a drug!

Tool name Virtual experiment – Develop a drug!

Link to the tool http://www.xplorehealth.eu/en/media/develop-drug

Description Activities in which this tool can be used

• Scientists have to investigate the 3-D structure of a protein before they can identify and design molecules which will interact with it.

Key messages:

• Scientists use a wide range of techniques such as centrifugation, liquid chromatography and NMR to separate, isolate and investigate the structure of proteins.

• Candidate drugs have to pass many tests before they become commercially available.

• Centrifugation (separate bacteria from growth medium)

Concepts that appear:

• Osmosis (salt added to bacteria in order to burst them and get the POP protein they’ve synthesized)

• Liquid chromatography (another separation technique, to isolate POP protein from the rest of bacterial proteins)

• NMR – nuclear magnetic resonance – technique used to determine 3D structure of proteins

• interaction between inhibitor and target (POP protein )

• Synthesis of peptide (inhibitor) Biological assay – to test the POP inhibitor (chemical reaction & fluorescence)

Pedagogical objectives

Students will learn about :

:

• Investigating the 3-D structure of a protein • Identifying a drug which will react with the

protein • The synthesis of a new drug • Testing if the new drug reacts with the

protein as it is should

Time needed: 50 minutes

• Teacher leads introduction to the lesson, including a recap of the last lesson where the students learned about the different processes involved in the initial stages of the development of a new drug (10 minutes)

Process:

• Explanation of how to use the software for the Virtual Experiment (5 minutes)

• Student activity – Virtual Experiment 2 (25 minutes)

Teacher leads class discussion to summarise lesson (10 minutes)

Outcomes:

• The laboratory techniques used to investigate the 3-D structure of a proteín

Students will now have knowledge of :

• How to identify a drug which will react with the proteín

• The laboratory techniques used to synthesise a new drug

• How to test if the new drug does the job it was designed to do

The laboratory equipment used for the above processes

Drug development - 6 – Tools’ information

3. Game – How are dugs developed?

Tool name Develop a drug in this race against time!

Link to the tool http://www.xplorehealth.eu/en/media/develop-drug-race-against-time

Description Activities in which this tool can be used

• Discovering and developing new drugs is a long, expensive and risky process.

Key messages:

• It can take on average 10-15 years and 800–1000 million dollars to convert an idea into a drug that is commercially available.

• Antiviral drugs are being developed to help combat infections caused by viruses.

Concepts that appear: • Virus – antiviral-virus outbreak • How drugs work in the body • Sequencing (virus genome) • X-ray crystallography (to determine 3D

structure of proteins) • Animal testing • Clinical trials: phase 1 (healthy

humans), phase 2 (few patients, with the double blind) and phase 3 (increased amount of patients)

Registration/approval of the drug by regulatory body

Pedagogical objectives

Describe in a step by step way all the stages needed for developing a drug from fundamental research to drug production at a larger scale (final commercialisation)

:

Time needed: 2 hours (more depending on material being made available for this activity)

• Material needed: videoprojector and interative board

Process:

Activity should be carried out when the whole subject has been covered.

• Understand what it takes for a drug to be developed before it is made available over the counter (pharmacy shelf) or for prescription by a Doctor.

Outcomes:

• Understand all the technical aspects to view drug at a molecular level and all the concepts underlying these techniques

• Get a glance at some of the basic molecular biology routines (genetic engineering, DNA sequencing method, purification of protein of interest…)

Raising awareness on some bioethical issues associated with manipulating viruses, drug testing on animal and human

Drug development - 7 – Tools’ information

4.Video – The long and incredible story of a tablet

Tool name The long and incredible story of a tablet

Link to the tool http://www.xplorehealth.eu/en/media/long-and-incredible-story-tablet

Description Activities in which this tool can be used

• Drug development process Concepts that appear:

• Research to find candidate molecules • Animal testing • Clinical trials – phase 1, phase 2, phase

3 Approval by regulatory body

Pedagogical objectives

Describe in a step by step way all the stages needed for developing a drug, from fundamental research to drug production at a larger scale (final commercialisation)

:

Time needed: 1 hour (more if students produce a PPT

- Material needed : video projector and interactive board & woofers for the material to be heard by the entire classroom

Process:

- Activity good to be carried out at the beginning of the module to introduce the main concept, stage, phase behind the story of the tablet

A slide can be produced by the students in order to exhaustively sum up all the chronological stages associated with a screen capture of the video next to each stage. ICT use is recommended.

Get further acquainted with the process of developing a drug from scratch or from a natural occurring living organism.

Outcomes

Understand that drug development requires the involvement of many disciplinary fields (chemistry, pharmaceutical industry, biology, doctors…)

Understand all the requirement needed for a drug to comply with the drug agency guidelines

Drug development - 8 – Tools’ information

5. Video – New drugs against new threats

Tool name New drugs against new threats

Link to the tool http://www.xplorehealth.eu/en/media/new-drugs-against-new-threats

Description Activities in which this tool can be used

● Examples of research taking place in Europe

Concepts that appear:

● Emerging viruses – research to find candidate drugs against them

● Research process: isolate gene, integrate it in bacteria, protein produced, purified, 3D structure studied.

Career options in a biomedical research project

Pedagogical objectives

• How drugs work

: Students will learn about :

The research involoved in the inital stages of the devlopment of a new drug

Time needed: 5 sessions (50-60 min. each)

Process

● (All) Display video

: (it could be created in web quest format)

● (Teacher) Propose some target questions to define the scope of the activity.

● (Pupils) Search information on the Internet.

● (Pupils) Produce some kind of multimedia output (video, presentation, animation, podcast,...) to explain in a new way.

● (All) Show session.

Outcomes:

● Learn about another research taking place in Europe

Students will now have knowledge of:

● Understanding in-vitro production of human proteins.

Understanding the ways for one investigation to be used in humans

Drug development - 9 – Tools’ information

6. Video – Drug development and ethics

Tool name Drug development and ethics

Link to the tool http://www.xplorehealth.eu/en/media/listen-some-experts-opinions-and-let-us-know-what-you-think

Description Activities in which this tool can be used

● ELSA aspects of drug development

Concepts that appear:

● People in the world do not have equal access to treatment

● Are we making a rational use of drugs in Western Countries?

Pedagogical objectives

● Web search skills

:

● Information processing skills

● Critical skills

Time needed: 4-5 sessions (50-60 min. each)

Process

● (All) Brain storming

:

● (All) Display video

● (All) First debate. Contrast between results of brain storming and video information

● (4 persons teams maximum, 1 spokesman) Contrast with Internet Information

● Spokesmen workshop. (Rest hearing, final debate)

● Importance of healthy habits

Outcomes:

● Reasonable drug comsumption

● Awareness of social differences

Equitable distribution of wealth

Drug development - 10 – Tools’ information

7. Discussion Continuum games

Tool name Discussion continuum Game 1 (Access to treatment) and 2 (Who pays for drug development)

Link to the tool

http://www.xplorehealth.eu/sites/default/files/Xplore_Health_Discussion_Continuum_game_1_Who_pays_for_drug_development.pdf

http://www.xplorehealth.eu/sites/default/files/Xplore_Health_Discussion_Continuum_game_2_Access_to_treatment.pdf

Description Activities in which this tool can be used

• Access to treatment: overmedicalisation, vaccination and complementary and alternative medicine

Concepts that appear:

• Who pays to develop drugs: drug testing,

marketing and the effects of globalisation

Pedagogical objectives

● Describe what is overmedicalisation, vaccination and complementary and alternative medicine

:

● Cover the social and ethical issues surrounding access to medical treatment.

● Investigate ethical, legal and socioeconomic issues around the drug discovery and development process, such as drugtesting, marketing investment, and the effects of globalisation

● Present number of statements and situations surrounding the costs of drug development, and the investment on rare diseases.

● Present own opinions

● Execute tasks according to instruction

● Analyse game in the field of the problem

Know rules of team work

Time needed: 2 x 45 minutes

● Work with text

Process:

● Work in team

Panel discussion

● Knowledge about farmaceutical market and problems with overmedicalisation

Outcomes

Kowledge about social and ethical issues of drugs development

Drug development - 11 – Tools’ information

8. Decide game

Tool name Decision game: Orphan drugs

Link to the tool http://www.xplorehealth.eu/sites/default/files/PlayDecide%20Orphan%20Drugs%20-%20english.pdf

Description Activities in which this tool can be used

• Access to treatment: overmedicalisation, vaccination and complementary and alternative medicine

Concepts that appear:

• Who pays to develop drugs: drug testing, marketing and the effects of globalisation

Pedagogical objectives

:

Pupil can:

● Describe what is orphan drugs

● Describe UE Policy for orphan drugs

● Present own opinions

● Describe multiaspect situation according to refunding of such type of drugs

● Execute tasks according to instructions

● Analyse game in the field of the problem

Know rules of team work

Time needed: 90 minutes

● Work with text

Process:

● Work in team

Panel discussion

● Social sensitivity

Outcomes

Term of orphan drugs and UE rules according to orphan drugs

Drug development - 12 – Tools’ information

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