Secondary_-_Drug_Dev111elopment_PPT.pptx

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1. Drug Development   'Presenter 1' 'Presenter 2' This activity has been supported by a grant from Roche Products Ltd  

2.   Drug discovery Phase 0 Phase I Phase II Licensing Phase III Phase IV CLINICAL TRIALS From lab to shelf How long does drug development take?

3. Drug discovery

4. Receptor Ligand Receptor always ON Ligand that blocks activation How will you target the receptor? Designing drugs DISEASE

5. 5000-10000 potential compound candidates are considered Fungi Genetic engineering and synthetic compounds Bacteria Plants Animals Where do these compounds come from?

6. Pre-clinical or phase 0 From the 5000-10000 initial candidates, 10-20 show promising results In vitro Computer modelling Animal testing Microdosing

7. Clinical trials From initial 10-20 candidates, only 5-10 pass. 2-5 drugs continue Only 1-2 drugs pass Phase I Phase II Phase III 20-100 healthy volunteers Confirm safety in humans. 100-300 patients 1000-5000 patients (multiple locations) Effectivity, dose and delivery method Reconfirm findings, identify the best dosage regimen

8. Clinical trial experiment Group 1 Normal cream Group 2 Pain-relief cream

9. Informed consent INFORMED CONSENT (THIS FORM MUST BE COMPLETED PRIOR THE TEST) I confirm that my participation is voluntary I understand the possible risks attained to the experiment (as an example, skin conditions) I agree that my data may be shared with others for their analysis

10. The Placebo effect

11. Drug passed clinical trials, what next? The pharmaceutical company must apply to the appropriate authorities to produce and market the drug    Assess long term effects To test use in combination with other drugs or patients with different conditions Phase IV Licensing

12. Patenting Patents help pharmaceutical companies to: Recoup investments Invest in new medicine Make profit Pharmaceutical industry invests hundreds of billions of pounds Long process: 10-15 years Many fail

13. Drug discovery Phase 0 Phase I Phase II Licensing Phase III Phase IV CLINICAL TRIALS Summary

14. Any questions?