Presentation (CTI)

OBJECTIVES: Collating right evidence during innovative drug development process is important to get faster approvals and hence access for patients. Right evidence is generated when manufacturers are thoroughly able to understand various aspects of drug candidate, disease, perspectives of physicians, regulators, payers & patients and develop Clinical Development Plan of the drug candidate accordingly.
METHODS: Key steps or approaches to collate right evidence during innovative drug development process for faster approval & access are: (a) Thorough understanding of Target Product Profile (TPP) and know more about product, dose, dosage regimen, target disease population, efficacy & safety profile of drug candidate. (b) Detailed understanding of disease; covering scientifically endorsed definition, risk factors, epidemiology, various stages of disease, clinical features, clinical trial end-points, treatment paradigm, burden of illness, cost of illness, PROs including HRQOL, unmet needs in disease area. (c) Competitor and differentiation of drug candidate vis-a-vis competitor including economic evaluation of drug candidate relative to competitors (d) All requirements of evidence to be built in Clinical Development Plan of product should be in active consultations with both internal & external stakeholders. Internal stakeholders being cross-functional product team, viz. Development, Medical, Commercial teams and individual main country markets.External stakeholders being physicians, regulators, payers and patients so that all relevant inputs / requirements are captured.
RESULTS:
CONCLUSIONS: Conclusion: It is important to understand evidence requirements for a product being developed and incorporate relevant perspectives of internal & external stakeholders in Clinical Development Plan. Right evidence ensures prompt and fast due approvals for product.