'Project launch': from research finding to therapeutic product.

Area of Science:

• Drug Development
• Medical Devices
• Therapeutic Product Innovation

Background:

• High attrition rates for new therapy candidates (0.1-0.5% approval).
• Low return on investment for approved therapies (~10-20% recoup R&D costs).
• Significant risks, suboptimal decisions, and lack of experience contribute to development failures.

Purpose of the Study:

• To provide a comprehensive review of the therapeutic product development lifecycle.
• To bridge the experience gap for researchers and developers in the pharmaceutical and medical device industries.
• To facilitate better communication and co-operation between researchers, developers, and partners.

Main Methods:

• Review of public information and personal experience.
• Succinct overview of key stages: opportunity identification, patent protection, commercial assessment, preclinical and clinical testing, registration, and reimbursement.
• Inclusion of risk management strategies throughout the process.

Main Results:

• Clarification of key terms and identification of common pitfalls in product development.
• Highlighting essential requirements and goals for each development stage.
• Providing recommendations for improving decision-making and project progression.

Conclusions:

• Effective navigation of the development pathway can mitigate risks and improve success rates.
• Enhanced understanding of the process facilitates smoother collaboration with consultants and partners.
• This review supports the initiation and advancement of new therapeutic products from concept to market.