Supporting<br />Irish patients<br />and the<br />Irish economy<br />Development of a New Medicine<br />Provided by the IPH...
Research Activities<br />These include:<br />Combinatorial libraries – vast collections of novel compounds<br />Mass scree...
Milestones in the Development<br />Compound discovered and patent application made<br />Submission of registration dossier...
Clinical Studies<br />Preparation of initial clinical plan. Selection of clinical study locations<br />PHASE II<br />Trial...
Toxicology<br />Determine the effect on impregnation and implantation in animals and whether the active substance can affe...
Pharmacokinetics / Metabolism<br />Determination of how the medicine is absorbed, distributed, metabolised and excreted in...
Dosage Form<br />Process development for large scale production of the dosage form. Testing of stability of the dosage and...
Active IngredientThe therapeutically active component in a medicine's final formulation that is responsible for its physio...
Marketing<br />Early stage commercial assessment of the medicine taking into account medical need and existing therapies o...
Pharmacoeconomics<br />Assessment of the potential impact of the new medicine on healthcare costs<br />Compilation and pub...
Regulatory Affairs<br />Compilation of registration dossier<br />Application for trial authorisation to begin trials in pa...
Quick facts about Medicines Development<br /><ul><li>It takes an average of 10 to 12 years for a medicine to travel from t...
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The Development of a New Medicine

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The Development of a New Medicine

  1. 1. Supporting<br />Irish patients<br />and the<br />Irish economy<br />Development of a New Medicine<br />Provided by the IPHA Communications Department<br />May 2010<br />
  2. 2. Research Activities<br />These include:<br />Combinatorial libraries – vast collections of novel compounds<br />Mass screening of compounds in assay systems<br />Molecular biology and modern genetics – role of genes in disease states<br />Recombinant DNA technology<br />Computer aided molecular modelling<br />
  3. 3. Milestones in the Development<br />Compound discovered and patent application made<br />Submission of registration dossier to regulatory authorities<br />Beginning of Human Trials<br />Publication in Scientific Journal<br />Trials in Patients<br />Registration<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  4. 4. Clinical Studies<br />Preparation of initial clinical plan. Selection of clinical study locations<br />PHASE II<br />Trials to determine dose ranging, safety and efficacy<br />PHASE III<br />Large scale trials to determine definitive safety and efficacy in patients<br />PHASE I<br />Human trials with healthy volunteers to test tolerability<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  5. 5. Toxicology<br />Determine the effect on impregnation and implantation in animals and whether the active substance can affect the fetus<br />Determine the reproductive effect upon future generations in animals<br />Determine effects of medicine in animals when administered over 2 to 13 weeks(depending upon length of planned use in humans)<br />Longer term animal studies. Does the active substance have long-term side effects?<br />Test to determine mutagenic potential<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  6. 6. Pharmacokinetics / Metabolism<br />Determination of how the medicine is absorbed, distributed, metabolised and excreted in animals<br />Determination of the effects of the medicine on specific populations such as the elderly, different races and sexes.<br />Determination of how the medicine is distributed, metabolised, and excreted by humans<br />Determination of how and to what extent the medicine is absorbed by humans<br />Final construction of the pharmacokinetic profile of the medicine<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  7. 7. Dosage Form<br />Process development for large scale production of the dosage form. Testing of stability of the dosage and determination of shelf-life<br />Pre-formulation activities – consultations with pharmacists / determination of physical and chemical properties of compound, e.g. particle size<br />Development of clinical trial formulation<br />Develop Market formulation based on known characteristics of medicine and patient group involved, e.g. age and condition. For example tablets, capsules, injectables or transdermal patches<br />First dosage form for volunteer trials<br />Process validation and production of the dosage form for launch<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  8. 8. Active IngredientThe therapeutically active component in a medicine's final formulation that is responsible for its physiological or pharmacological action.<br />Batch 0 synthesis (1st non-GMP batch)<br />Batch 4 using final method of synthesis <br />Batch 2 of GMP <br />Batch 5 compound produced in full scale production equipment and validation<br />Batch 1 synthesis (1st GMP standard)<br />Final production concept<br />Routine production<br />Batch 3 of GMP <br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  9. 9. Marketing<br />Early stage commercial assessment of the medicine taking into account medical need and existing therapies on the market<br />Full development commercial assessment<br />Trade Name ™ chosen for the medicine<br />Selection of a trade name begins<br />Marketing input to the design of clinical trials especially in the choice of comparator medicines<br />Medicine information formulated into brochures and videos. Displays at congresses and symposia<br />Profiling – development of comparative studies on, for example, specific patient groups and other similar medicines. Study possible applications of the medicine to other diseases<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  10. 10. Pharmacoeconomics<br />Assessment of the potential impact of the new medicine on healthcare costs<br />Compilation and publication of the pharmacoeconomic results<br />Economic evaluation parallel to clinical trials to determine the economic value of a new medicine, e.g. cost saving and cost-effectiveness<br />Research for the appropriate pharmacoecon-omic and quality of life parameters (linked to clinical trials Phase II)<br />Definition of the healthcare costs caused by the disease<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  11. 11. Regulatory Affairs<br />Compilation of registration dossier<br />Application for trial authorisation to begin trials in patients (early development)<br />Application for trial authorisation to begin trials in patients (full development)<br />Application for trial authorisation to begin trials on healthy volunteers<br />Formulation of medicine labelling and doctor/patient medicine information<br />Review of registration documentation by regulatory authorities<br />Interaction with health authorities<br />Interaction with health authorities<br />Interaction with health authorities<br />Interaction with health authorities<br />Research and Discovery<br />Early Development<br />Full Development<br />Pre-Market Activity<br />0<br />5<br />8<br />12<br />15<br />Years<br />* GMP = Good Manufacturing PracticeThe above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.<br />
  12. 12. Quick facts about Medicines Development<br /><ul><li>It takes an average of 10 to 12 years for a medicine to travel from the laboratory to the pharmacy shelf;
  13. 13. On average, only 1 out of 5,000 to 10,000 promising substances will survive extensive testing in the R&D phase to become approved as a quality, safe and efficient marketable product;
  14. 14. Several studies put the cost of researching and developing a new chemical entity €1,059 million;
  15. 15. Moreover around 70% of medicines that eventually reach the market do not provide sufficient return to recoup their R&D expenditure. As a consequence, the return on investment is highly dependent on a limited number of successful products.</li>

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