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The Emerging Biotech LeaderBiotechit's complicated. Author: SSI Strategy
Biotechit's complicated. A successful product launch requires grit, determination, and clear direction. But lets be real, the path to launch isnt a straight one. There are curves, hard turns, and dead ends. Heres the good news, you dont have to navigate the complexities alone. Welcome to The Emerging Biotech Leader, where we help biotech leaders maximize the value of their therapeutics from clinical development to product launch. Language: en Genres: Business, Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it Trailer: |
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The Road Ahead: Biotech in 2025
Episode 44
Wednesday, 18 December, 2024
As biotech innovation accelerates across therapeutic areas organizations face complex strategic decisions about their future. In this episode of The Emerging Biotech Leader, former EMA Director Dr. Thomas Lönngren offers insights into the market dynamics and organizational requirements that will define success in 2025. Several key themes emerged from our discussion that will shape the industry's trajectory in the coming year. A Fight for Funding The funding environment remains challenging, with over 300 US biotech companies competing for limited capital. Thomas notes: "Many CEOs are spending more than 60% of their time talking with investors to get more money", highlighting a critical leadership challenge. While non-traditional investors, particularly from the tech sector, are entering the space, they're primarily interested in AI and digital health applications. The Regulatory Shift 2025 marks a pivotal year for regulatory changes, particularly in Europe. The new Health Technology Assessment (HTA) regulation introduces parallel clinical assessments, initially affecting oncology products and advanced therapies. This shift requires companies to think about market access evidence during early development stages – a significant departure from traditional approaches. US companies, in particular, need to prepare for these changes as they affect global development strategies. Organizational Design The complexity of modern biotech development demands a fundamental rethink of organizational structure. As Thomas emphasizes, "Biotech companies need to think about how they populate their organization with the right resources." Success requires strong medical leadership, regulatory expertise, and operational efficiency – all while maintaining focus on core drug development activities. The AI Advantage Artificial intelligence isn't just a trend; it's becoming a necessity for competitive advantage. Companies must strategically decide whether to develop internal AI capabilities or partner with specialized providers. This decision impacts everything from drug discovery to clinical trial efficiency and requires careful consideration of resources and core competencies. Looking Ahead As we move into 2025, success will depend on building organizations that can balance scientific innovation with operational excellence. Companies need partners who understand both the complexity of drug development and the organizational requirements for success. The coming year will require organizations to build effective regulatory and HTA capabilities to meet the demands of the new legislation. Your science deserves the strongest possible organization behind it. Let's talk about building yours. letstalk@ssistrategy.com
