Thought Leadership
At SSI Strategy, we believe that knowledge is a key driver in building better biotechs. Our Insights provide valuable information and expert perspectives to empower biotech leaders like you.
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30-07-2024
Driving Therapeutic Impact: A Novel Model for Strategic Medical Affairs Integration
Implement a cross-functional team structure that includes Medical Affairs from the outset and develop a comprehensive evidence generation plan that goes beyond regulatory requirements.
30-07-2024
EU HTA Regulation: What’s changing & why it matters!
Get insights into the new EU Health Technology Assessment (HTA) Regulation and its significant implications for the biotech and drug development sectors.
12-01-2024
Joint Scientific Consultations – Advice for EU Health Technology Assessment
Get expert advice on your drug or device development through the EU's Joint Scientific Consultation. This voluntary program lets developers receive feedback from EU health technology assessment bodies on their clinical study designs and evidence needs.
14-12-2023
Understanding why the Patient Holds the Key to Successful Drug Development
Enhance drug approval success through Patient-Focused Drug Development. This white paper explores how systematically incorporating the patient voice throughout the development can help address unmet medical needs and strengthen regulatory applications.
14-11-2023
Ensuring Quality and Compliance: Foundational Principles for Drug Development
Maintaining quality and compliance is crucial for drug developers bringing new treatments to market. Read about understanding FDA and EMA requirements, having a robust QMS, and partnering with experienced consultants to navigate the complex landscape.
23-10-2023
Optimizing Preclinical Programs and Streamlining Clinical Translation
Translating scientific discoveries into approved treatments requires strategically navigating complex technical, regulatory, and business challenges at each development stage to maximize chances of delivering medical breakthroughs.
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Building Better Biotechs
