Challenges and opportunities for the innovation of novel drugs

Inhaltsverzeichnis (Table of Contents)

• 1. Introduction
  • 1.1. Background
  • 1.2. Objective, research gaps and research question
  • 1.3. Definitions and concepts
  • 1.4. Delimitation
  • 1.5. Outline of the thesis
• 2. Methodology
  • 2.1. Analytical framework
  • 2.2. Methodological approach
    • 2.2.1. Research philosophy
    • 2.2.2. Research perspective
    • 2.2.3. Research strategy
  • 2.3. Data collection
    • 2.3.1. Surveys
    • 2.3.2. Secondary data
    • 2.3.3. Design of the field phase
    • 2.3.4. Reliability
    • 2.3.5. Validity
  • 2.4. Summary
• 3. Theoretical framework
  • 3.1. The sectoral innovation system
  • 3.2. The innovation value chain and open innovation
  • 3.3. Learning and idea generation through R&D collaborations
  • 3.4. Summary
• 4. Research context
  • 4.1. Self-reliance policy: Amendment of the patent law and introduction of the New Drug Policy (1947-1991)
  • 4.2. The phase of liberalization, de-control and product patent (1991- today)
  • 4.3. Summary
• 5. Key components of the SIS of the API sector in India
  • 5.1. Descriptive Analysis
  • 5.2. The Government of India
    • 5.2.1. Overall policy framework
    • 5.2.2. The patent regime
    • 5.2.3. Product and quality regulations
  • 5.3. The academia
  • 5.4. The industry
    • 5.4.1. Balance of Trade
    • 5.4.2. Production of APIs
    • 5.4.3. R&D intensity
    • 5.4.4. R&D stages and skills to develop NCES
  • 5.5. Summary
• 6. R&D collaboration strategies
  • 6.1. Sources of innovation information
  • 6.2. Prime motives for R&D collaborative projects
  • 6.3. Collaborative R&D projects aimed at early stage drug development
    • 6.3.1. Invention stage of early stage R&D collaboration projects
    • 6.3.2. Most important objectives of early stage R&D collaboration projects
    • 6.3.3. The contribution to success of early stage R&D collaboration projects
    • 6.3.4. Problems related to early stage R&D collaboration projects
  • 6.4. R&D collaboration cases
    • 6.4.1. In-licensing
    • 6.4.2. Out-licensing
    • 6.4.3. Contract research and manufacturing services
    • 6.4.4. Collaborative research projects
    • 6.4.5. Public private R&D partnerships
  • 6.5. Summary

Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)

This work provides an in-depth analysis of R&D collaborations within the sectoral innovation system (SIS) of the Indian pharmaceutical industry. The research aims to identify the challenges and opportunities that this system faces in developing novel drugs.

• The role of R&D collaborations in the innovation process
• The impact of the Indian patent regime on R&D collaborations
• The key components of the SIS, including government, academia, and industry
• The challenges and opportunities for developing novel drugs in India
• The strategies for successful R&D collaboration in the Indian pharmaceutical sector

Zusammenfassung der Kapitel (Chapter Summaries)

• Chapter 1: Introduction This chapter provides an overview of the research topic, outlining the background, objectives, research gaps, and research question. It also defines key concepts and delineates the scope of the study.
• Chapter 2: Methodology This chapter details the research methodology employed in the study, including the analytical framework, research philosophy, perspective, and strategy. It also describes the data collection methods, reliability and validity considerations, and summarizes the methodological approach.
• Chapter 3: Theoretical framework This chapter presents the theoretical foundation for the study, exploring the concepts of the sectoral innovation system, the innovation value chain, open innovation, and the role of R&D collaborations in learning and idea generation.
• Chapter 4: Research context This chapter examines the historical context of the Indian pharmaceutical industry, focusing on the evolution of the patent regime and the impact of liberalization policies on the SIS.
• Chapter 5: Key components of the SIS of the API sector in India This chapter analyzes the key components of the SIS, including government policies, the role of academia, and the structure of the industry. It also explores the industry's Balance of Trade, production of APIs, R&D intensity, and the skills required for developing novel chemical entities.
• Chapter 6: R&D collaboration strategies This chapter examines various R&D collaboration strategies employed by pharmaceutical companies in India. It analyzes the sources of innovation information, prime motives for collaborations, and the challenges and opportunities associated with different types of collaborative projects.

Schlüsselwörter (Keywords)

The primary focus of this work lies in the analysis of R&D collaborations within the Indian pharmaceutical industry. Key terms and concepts include sectoral innovation system, open innovation, R&D intensity, patent regime, API production, novel drug development, and collaborative research strategies. The research delves into the impact of these factors on the development of novel drugs and the challenges and opportunities for innovation within the Indian pharmaceutical sector.