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1. Overview of Pharmaceutical Product Development

1. Overview of Pharmaceutical Product Development. Anthony Taylor. Overview of Pharmaceutical Product Development. Objective; To achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality.

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1. Overview of Pharmaceutical Product Development

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  1. 1. Overview of Pharmaceutical Product Development Anthony Taylor

  2. Overview of Pharmaceutical Product Development Objective; • To achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality.

  3. Overview of Pharmaceutical Product Development • Development of the Drug Product • Development of a Manufacturing Process • Development of Product Controls • Specifications • Test methodology • Stability testing • Support to the Development process • Preclinical/clinical pharmacology • Manufacture and Supply of CTM

  4. Overview of Pharmaceutical Product Development Lead Optimisation Preclinical Evaluation Phase IIb/ Phase III studies Post-marketing studies Safety/ tolerability/ PoC in humans Lead Series Identified Candidate Selected Concept Proven Approval for FTIH Product Launched

  5. Overview of Pharmaceutical Product Development Lead Optimisation Preclinical Evaluation Safety/ tolerability/ PoC in humans Phase IIb/ Phase III studies Post-marketing studies Lead Series Identified Candidate Selected Approval for FTIH Concept Proven Product Launched Preformulation & developability assessment

  6. Preformulation and Developability Assessment • Purpose • Determination of fundamental physical and chemical properties of the drug molecule • Identifies potential dosage forms • Identifies potential issues in the development of dosage forms • Assessment of likelihood of being able to turn drug into a Medicinal Product

  7. Overview of Pharmaceutical Product Development Lead Optimisation Preclinical Evaluation Safety/ tolerability/ PoC in humans Phase IIb/ Phase III studies Post-marketing studies Product Candidate Approval Concept Lead Series Launched Identified Selected for FTIM Proven Preformulation & developability assessment Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies

  8. Formulation Development and Testing for Safety Assessment • Purpose • Facilitate dosing in safety assessment studies • Ensure quality of test material • Issues • High exposures • Limited drug supply • Consistency with clinical products

  9. Formulation Development for Clinical Pharmacology & Clinical Studies • Purpose • Facilitate unequivocal testing in humans • Ensure quality of test material • Issues • Simple, flexible dosage form required early on • Limited drug supply • Consistency with final product

  10. Overview of Pharmaceutical Product Development Lead Optimisation Preclinical Evaluation Safety/ tolerability/ PoC in humans Phase IIb/ Phase III studies Post-marketing studies Product Candidate Approval Lead Series Concept Launched Identified Selected for FTIM Proven Preformulation & developability assessment Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies Formulation development for market

  11. Formulation Development for Market • Purpose • Design of optimal dosage form • Assurance of safety & quality • Demonstration of consistency of performance • Issues • Dose may be unknown • Feedback from Clin Pharm studies required • Drug substance may change • Timing of introduction (Phase IIb, Phase III, Launch?)

  12. Overview of Pharmaceutical Product Development Lead Optimisation Preclinical Evaluation Safety/ tolerability/ PoC in humans Phase IIb/ Phase III studies Post-marketing studies Product Candidate Approval Lead Series Concept Launched Identified Selected for FTIM Proven Preformulation & developability assessment Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies Formulation development for market Manufacturing Process Development

  13. Manufacturing Process Development • Purpose • Develop and validate commercial manufacturing process • Issues • Product must be equivalent to Phase III product • Manufacturing site • Product volumes • Drug substance may change

  14. Overview of Pharmaceutical Product Development Lead Optimisation Preclinical Evaluation Safety/ tolerability/ PoC in humans Phase IIb/ Phase III studies Post-marketing studies Product Candidate Approval Lead Series Concept Launched Identified Selected for FTIM Proven Preformulation & developability assessment Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies Formulation development for market Manufacturing Process Development Product Line extensions

  15. Product Line Extension Development • Purpose • Improve therapy (efficacy and/or safety) • Provide patent protection • Support additional indications

  16. Overview of Pharmaceutical Product Development Lead Optimisation Preclinical Evaluation Safety/ tolerability/ PoC in humans Phase IIb/ Phase III studies Post-marketing studies Product Candidate Approval Lead Series Concept Launched Identified Selected for FTIM Proven Preformulation & developability assessment Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies Formulation development for market Manufacturing Process Development Product Line extensions Product Control - Specifications, Method development, Testing

  17. Overview of Pharmaceutical Product Development • Product Control - Specifications, Method Development and Testing • Purpose • Define standards for safety, efficacy and quality of product • Assurance of product quality for preclinical, clinical and marketed product, i.e. at all stages of development

  18. Overview of Pharmaceutical Product Development • Summary; • To turn a drugsubstance into a viable medicinal product which delivers the drug to the right place at the right time in the right quantity to exert the desired effect by….

  19. Overview of Pharmaceutical Product Development • Ensuring that the drug product is sufficiently stable that it reproducibly and reliably affects the desired pharmacological response • no loss of activity • no loss of performance • no increase in side effects

  20. Overview of Pharmaceutical Product Development • Ensuring that the manufacturing process is robust, reliable and able to meet the predicted sales volumes for the product

  21. Overview of Pharmaceutical Product Development • Developing analytical test methods to provide assurance of the quality of the medicinal product

  22. Overview of Pharmaceutical Product Development • Commercial pressures; • How can we turn this drug into a medicine? Vs • Can we turn this compound into the medicine we want? • Primarily a question of drug substance control • Pharmacist has many approaches for formulating “difficult” compounds • How difficult is development likely to be?

  23. Where is the Industry Today? • Need 2 or 3 NCE’s each year to be launched--not happening! • Applications for NCE’s in the US were down from 34 in 1995 to 12 in 2003 • Cost of development increased from $1.1bn to $1.7 bn over same period

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