Genegobio Inc.

In the process of developing drugs and medical devices, companies often face multidimensional challenges including technology, regulations, funding, and operations. Below is our services of key issues and corresponding strategies:

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I. Common Issues and Solutions in Drug Development

1. High Costs and Long Timelines

   • Issue: On average, new drug development takes 10-15 years and costs over $2 billion (DiMasi, 2021), with a high failure rate (about 90% of drugs in clinical stages fail to reach the market).

   • Solutions:

     • Modular Developmen

     • CRO Collaboration

     • Adaptive Clinical Trial Design:

2. Complexity of Clinical Trials

   • Issue: Difficulties in patient recruitment (e.g., rare diseases) and unclear endpoint metrics.

   • Solutions:

     • Real-World Evidence (RWE)

     • Decentralized Clinical Trials (DCT)

     • Biomarker Stratification

3. Regulatory Compliance Challenges

   • Issue: Increasingly stringent FDA/EMA requirements 

   • Solutions:

     • Early Communication (Pre-IND Meetings)

     • Quality by Design (QbD)

4. Intellectual Property Protection

   • Issue: Patent cliffs and risks of compulsory licensing in emerging markets

   • Solutions:

     • Patent Thicket Strategy

     • Data Exclusivity

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II. Shared Challenges and Cross-Sector Strategies

1. Funding Shortages

   • Strategies:

     • Risk-Sharing Models

     • Government Funding

     • Genegobio's Co-Investment

2. Barriers to Interdisciplinary Collaboration

   • Strategies:

     • Digital Collaboration Platforms

     • Our partnership database

3. Market Access Uncertainty

   • Strategies:

     • Parallel Submissions

     • Early HTA Involvement

     • Our market entry strategy