Improving new drug development for paediatric cancer: the EMA and PDCO vision
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1 Dr. Dirk Mentzer, MD, PhD Consultant General Paediatrics Head of Pharmacovigilance unit Chair of PDCO at EMA Paul-Ehrlich-Institut Federal Institute for Vaccines and Biomedicines, Germany
2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to the Paul-Ehrlich-Institut or to the European Medicines Agency (EMA). My employee is the Paul-Ehrlich-Institut, a national regulatory agency, and I have nothing to disclose. By education, I am a paediatrician with limited experience in paediatric oncology 1
3 The target should have an effect to all children in need for treatment! 2
4 PDCO has to serve all children needs PDCO/ EMA role and influence Paediatric needs and trial feasibility International cooperation New methodologies 3
5 Theory Improving new drug development for paediatric cancer: the EMA and PDCO vision Initial PIP application: PIP Opinion after 60 day or Clock stop to respond to request for supplementary Information Assessment of responses (60d) Final PIP opinion at D120 Request for Modification of an agreed PIP opinion Assessment of changes proposed to PIP PDCO opinion on changes after 60 days Final Compliance check Validation of submitted study reports of studies agreed in the PIP PDCO opinion on compliance after 60 days Paediatric Indication Medicinal product development MAA Adult clinical trial program PIP opinion and paediatric clinical trial program Post-marketing Non-clinical studies PK/PD Safety & efficacy 4
6 Problem: Timely availability of marketed medicines for children Deferrals 5
7 Problem: PIP submission Deferred studies in PIPs 6
8 Reality Improving new drug development for paediatric cancer: the EMA and PDCO vision Initial PIP application: PIP Opinion after 60 day or Clock stop to respond to request for supplementary Information Assessment of responses (60d) Final PIP opinion at D120 Request for Modification of an agreed PIP opinion Assessment of changes proposed to PIP PDCO opinion on changes after 60 days Final Compliance check Validation of submitted study reports of studies agreed in the PIP PDCO opinion on compliance after 60 days Paediatric Indication Medicinal product development Initial MAA Variation Variation Adult clinical trial program PIP opinion and paediatric clinical trial program Post-marketing Non-clinical studies Studies deferred PK/PD Safety & efficacy Not deferred Deferred 7
9 Theory Improving new drug development for paediatric cancer: the EMA and PDCO vision Initial PIP application: PIP Opinion after 60 day or Clock stop to respond to request for supplementary Information Assessment of responses (60d) Final PIP opinion at D120 Request for Modification of an agreed PIP opinion Assessment of changes proposed to PIP PDCO opinion on changes after 60 days Final Compliance check Validation of submitted study reports of studies agreed in the PIP PDCO opinion on compliance after 60 days Paediatric Indication Medicinal product development MAA Adult clinical trial program PIP opinion and paediatric clinical trial program Post-marketing Non-clinical studies PK/PD Safety & efficacy 8
10 Reality Improving new drug development for paediatric cancer: the EMA and PDCO vision Initial PIP application: PIP Opinion after 60 day or Clock stop to respond to request for supplementary Information Assessment of responses (60d) Final PIP opinion at D120 Request for Modification of an agreed PIP opinion Assessment of changes proposed to PIP PDCO opinion on changes after 60 days Final Compliance check Validation of submitted study reports of studies agreed in the PIP PDCO opinion on compliance after 60 days Paediatric Indication Medicinal product development Initial MAA Variation Variation Adult clinical trial program PIP opinion and paediatric clinical trial program Post-marketing Non-clinical studies Studies deferred PK/PD Safety & efficacy Not deferred Deferred 9
11 Timing of first submission of PIP (e.g. early versus late) End P1 Condition/ indication (therapeutic area) (e.g. PAH, MS, Diabetes, Asthma) Unmet therapeutic needs in paediatrics (by population like neonates/ oncology) (by needs like epilepsy, psychiatry) (by mechanism of action) Initial MAA 10
12 Timing of first submission of PIP (e.g. early versus late) End P1 Condition/ indication (therapeutic area) (e.g. PAH, MS, Diabetes, Asthma) Unmet therapeutic needs in paediatrics (by population like neonates/ oncology) (by needs like epilepsy, psychiatry) (by mechanism of action) Initial MAA Stakeholder Meeting at EMA 11
13 Strategy by timing of submission End P1 12
14 Strategy by timing of submission Initial MAA Paediatric Indication End P1 Experience from PRIME Science based plan, Cy to come back with more robust information in due course, MODs to come, no deferrals Define Population, need for formulation, trials (non clinical and clinical, dose finding, extrapolation) Deferal for completion 13
15 Strategy by timing of submission Initial MAA Paediatric Indication End P1 Experience from PRIME Science based plan, Cy to come back with more robust information in due course, MODs to come, no deferrals Define Population, need for formulation, trials (non clinical and clinical, dose finding, extrapolation) Deferal for completion During P2 More detailed opinion, no deferrals on initiation CT non clinical, dose finding, before initial MAA Deferal for completion 14
16 Strategy by timing of submission Initial MAA Paediatric Indication End P1 Experience from PRIME Science based plan, Cy to come back with more robust information in due course, MODs to come, no deferrals Define Population, need for formulation, trials (non clinical and clinical, dose finding, extrapolation) Deferal for completion During P2 More detailed opinion, no deferrals on initiation CT non clinical, dose finding, before initial MAA Deferal for completion Close to MAA Deferal for initiation completion 15
17 Strategy by timing of submission Initial MAA Paediatric Indication End P1 Experience from PRIME Science based plan, Cy to come back with more robust information in due course, MODs to come, no deferrals Define Population, need for formulation, trials (non clinical and clinical, dose finding, extrapolation) Deferal for completion During P2 More detailed opinion, no deferrals on initiation CT non clinical, dose finding, before initial MAA Deferal for completion Interaction with CHMP/ PRAC is needed to define the need for treatment in adults versus likelihood for off-labeluse in paediatrics risking the completion of the PIP. Close to MAA Risk for delay of initial MAA Deferal for initiation completion 16
18 Significant therapeutic benefit for the Paediatric population Defining the need for treatment per subpopulation Standard or care approved alternatives Paediatric clinical Trial methodology Preterm newborn Term newborn (0 to 28 days) Infants and toddlers (29 days to 23 months) Children (2 to 11 years) Adolescents (12 to 18 years) 17
19 Modelling & Simulation followed by Extrapolation Adult=> Adolescence => Children=>Neonate/ Pre-term PD (Extrapolation, Biomarker) PK (Bridging, Pop-PK, Extrapolation, modelling) Efficacy and Safety Dose finding Endpoints, Monitoring of risks 18 18
20 PD (Extrapolation, Biomarker) PK (Bridging, Pop-PK, Extrapolation, modelling) Efficacy and Safety Dose finding Endpoints, Monitoring of risks 19 19
21 To bedside Research Patient health Paediatric needs From bench Science Research development Market forces Regulators PIPs Waiver Deferrals guidelines 20 20
22 Decision on minimal information available on paediatric medicinal product development at time initial MAA (e.g. Non-clinical, PK, dose-finding, sub-population) PIP related to medicinal products, where adult needs are covered (authorised and available for adults in the EU), deferrals should strictly be related to technical (formulation) or safety issues Justifications for requesting deferral for initiation and completion (after initial MAA) in late submissions needs to be reflected against the unmet paediatric medical need. (MAA for adults potentially delayed)? Inclusion of adolescence in initial MAA (extrapolation)? 21
23 Let us move to the next gear! 22 Thank you for your attention
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