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

When does a biotech need a Chief Medical Officer? "If you're asking, you probably needed one yesterday," suggests Dr. Benit Maru in this straight-talking episode of Emerging Biotech Leader.

The SSI Strategy medical lead breaks from convention, arguing that early-stage organizations - particularly those in rare disease or novel modalities - can't afford to postpone medical leadership. His analysis cuts through traditional timing metrics to focus on strategic impact and organizational readiness.

Benit delivers three refreshing insights that challenge standard industry practices:

The myth of the complete CMO. Rather than searching for "unicorns" who excel at everything, successful organizations build complementary teams that acknowledge and address leadership gaps. "Having the wherewithal to acknowledge your gaps and own them" proves more valuable than pretending they don't exist.

The strategic necessity of early program management. While traditionally viewed as a later-stage hire, Benit positions strong program leadership as essential from day one - a shift he's seeing more frequently among successful biotechs. This infrastructure enables faster decision-making and more effective cross-functional collaboration.

The critical CEO-CMO dynamic. Through candid examples, Benit illustrates how transparent communication about capabilities and needs strengthens rather than undermines leadership credibility.

Ready to orchestrate your medical success? SSI Strategy partners with biotechs to build medical leadership structures that perform. Let’s talk! letstalk@ssistrategy.com

Have you ever wondered what makes a great biotech CMO? In this episode of the Emerging Biotech Leader, Dr. Steven Zelenkofske shares the practical, hard-earned insights he’s gained from his five CMO positions and multiple board roles, offering straightforward advice on how CMOs can step in early, build strong executive relationships, and drive clinical programs to successful outcomes. This episode is your behind-the-scenes look at the evolving role of biotech’s top medical leaders.

Steven strikingly describes the CMO role as "like an octopus with eight arms," each representing essential functions from external relations to operational oversight. This colorful analogy captures the multifaceted nature of modern medical leadership in biotech, where CMOs must constantly adapt their approach based on company stage and needs.

Beyond One Leader

Timing emerges as a critical theme: companies often delay bringing in clinical expertise until after key development decisions are made. While founders and CSOs excel at scientific innovation, Steven argues that early clinical perspective is essential to bridge the gap between groundbreaking science and effective drug development.

The discussion explores a modern solution to the growing trend of fractional CMO roles. Rather than relying on a single part-time leader, Steven advocates for a "CMO office" model - a team of specialists collectively fulfilling the role's diverse requirements. This approach ensures comprehensive coverage while maintaining cost efficiency in today's resource-conscious environment.

Steven also points out that successful clinical development often relies on preparation and anticipation of challenges. His practical advice includes building strong partnerships between CMOs and other executives, particularly CEOs and CSOs, while fostering a culture where teams feel empowered to provide critical feedback.

If you are building a biotech organization, this episode offers practical answers to your critical questions: When do you need a CMO? What should you look for? And how can you structure the role to maximize impact while maintaining efficiency?

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you!

The relationship between biotech leadership and their boards is evolving, particularly as private equity takes a larger role in the industry. In this episode of the Emerging Biotech Leader, Nick Amigone from Amulet Capital Partners offers a unique perspective on building effective board relationships from the private equity vantage point.

The conversation explores three distinct board structures that shape company governance:

• Public Company Boards: Diverse shareholders acting as fiduciary representatives
• Venture Capital Boards: Multiple meaningful shareholders but no controlling interest
• Private Equity Boards: Majority control while fostering collaborative decision-making

A key theme that emerges is the importance of maximizing board effectiveness. Nick advocates moving beyond routine quarterly updates to strategic engagement focused on critical decisions.

The role of independent board members is highlighted as vital. Nick outlines three key criteria for selecting these directors:

1. Subject matter expertise that directly aligns with the company's focus and challenges
2. A customer-centric perspective to provide valuable outside insights
3. A true commitment to dedicated board engagement, rather than spreading themselves thin

He emphasizes the importance of finding directors who will make their board service a top priority, noting that "it should be an important part of their professional life."

From avoiding the "quarterly update trap" to balancing short-term milestones with long-term vision, Nick shares how biotech leaders can transform their board interactions from routine reporting exercises into strategic partnerships that drive company success.

Would like to share your experience as a biotech leader on our podcast? Send a message to letstalk@ssistrategy.com

How can biotech CEOs and their boards foster strong, trusting relationships that drive effective decision-making and long-term success? In this episode of Emerging Biotech Leader, host Kim Kushner explores this critical question together with Don de Bethizy. Don is a seasoned life sciences executive with over 30 years of experience, having served as a founder and CEO as well as board member and advisor.

The episode highlights key strategies for building trust, setting clear objectives, and managing board relationships, making it essential listening for anyone looking to enhance their leadership approach in the biotech industry. Here you’ll find actionable advice that can significantly impact your company’s success and your own professional growth.

Key takeaways include:

The delicate balance of board relations: Don stresses the importance of transparency with the board while maintaining a strategic focus.

Building the right team: "Get the right people on the bus, but in the right seats," Don advises. He discusses the challenges of early hiring decisions and the need to make tough choices quickly when someone isn't the right fit.

Leveraging board expertise: Don highlights the value of specialized committees, like R&D, to dive deeper into critical areas without bogging down full board meetings.

Throughout the discussion, Don's humility and willingness to learn shine through. He candidly shares mistakes and lessons learned, offering a refreshing perspective on leadership growth.

Tune in to gain a deeper understanding of what it takes to successfully manage board relationships, refine your strategic focus, and build a culture of accountability and trust within your organization.

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you!

In this episode of "The Emerging Biotech Leader" podcast, host Ramin Frahood speaks with Helen Kargaryani, VP Global Head of Quality/Quality Services at SSI Strategy. With over 30 years of experience in the pharmaceutical and biotech industries, Helen shares her expertise on quality and risk management.

Risk management in these industries is a critical process that helps companies identify, prioritize, and mitigate potential issues affecting their operations, compliance, and financial stability. "Quality is the ultimate goal” Helen explains. “A Quality Management System maintains quality, while risk assessment helps us identify and mitigate risks to quality. Together, these three elements build a solid platform for compliance in the company."

The approach varies between organizations based on their specific business, stakeholders, and patients served.

Key Takeaways:

Proactive risk management is essential for biotech and pharma companies: It helps avoid regulatory issues and financial losses, working in tandem with quality management systems (QMS) to ensure effective compliance.

Risk management should be tailored and integrated: Strategies need to be customized to a company's size, resources, and specific needs. Importantly, risk management should be integrated into company-wide strategy and culture, not isolated to a single department.

Common pitfalls in risk management can have severe consequences: Many companies fail by either not including risk management in strategic planning or not implementing it effectively. This can lead to regulatory non-compliance, financial losses, and potential product shortages affecting patients.

Early implementation is crucial, especially for startups and small biotech firms: Even with limited resources, companies should start implementing risk management early on a small scale, ensuring their approach is scalable as they grow.

This episode provides valuable insights into the critical role of quality and risk management in the biotech and pharmaceutical industries, based on Helen’s extensive professional experience and perspective.

If you'd like to discuss how you might apply these learnings to your own context, contact us at letstalk@ssistrategy.com

This episode offers critical insights on leveraging risk management as a strategic advantage in medical device development. In a conversation with Ramin Farhood, Bijan Elahi, with over 30 years of experience, provides a roadmap for integrating safety considerations into innovation pipelines, potentially accelerating time-to-market and enhancing competitive positioning.

Key Strategic Takeaways:

Early integration of risk management, starting at the concept stage, can significantly reduce costs and accelerate time-to-market. This approach can level the playing field between firms of different sizes and serve as a market differentiator.

Bijan emphasizes the balance between innovation and safety, noting that firms demonstrating significant benefits, especially in underserved areas, may find more regulatory flexibility.

Risk-based approaches are increasingly expected across all business operations. Implementing this holistically can improve efficiency and reduce vulnerabilities in supply chain and manufacturing processes.

Strategic Implications:

Prioritize early investment in risk management capabilities for long-term cost savings and faster market entry. Consider risk management expertise in key hires and partnership decisions.

Use risk management insights to refine product pipeline strategy, focusing resources on projects with the highest likelihood of regulatory success and market acceptance.

Foster a company-wide culture of safety and risk awareness. This aligns with regulatory expectations and can drive responsible innovation.

Robust risk management practices can serve as a powerful narrative for investors, demonstrating foresight and responsible innovation.

By integrating these insights, companies can potentially accelerate development timelines, enhance their competitive position, and build a reputation for responsible innovation that resonates with regulators, partners, and customers alike.

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you! Please reach out to us.

The latest Emerging Biotech Leader podcast tackles the important topic of patient-focused drug development, offering valuable insights for the biotech industry. Our host Kim Kushner engages in an insightful dialogue with Dr. Laurie Smaldone-Alsup, SVP Regulatory Science at SSI Strategy, who brings years of hands-on regulatory experience to the conversation.

Laurie’s career, spanning from pioneering HIV/AIDS treatments to her current work in rare diseases, underscores a powerful message: patients are not just beneficiaries of drug development, but essential partners in the process. She explains how early collaboration with patient advocacy groups can transform the development process, providing invaluable insights that shape everything from clinical trial design to regulatory strategies.

The discussion explores the delicate balance between scientific rigor and patient needs, particularly in the context of rare diseases. Laurie offers practical advice on educating regulators, developing meaningful endpoints, and building a solid foundation of disease understanding. Her approach challenges the notion that speed always equals progress, advocating instead for a thoughtful, patient-centric strategy that may initially seem slower but ultimately leads to more successful outcomes.

Another often overlooked challenge is getting boards and investors to support a patient-focused approach. Here Laurie shares strategies for convincing stakeholders of the long-term benefits, even when they're focused on short-term results.

This episode is more than just a discussion; it's a call to action for the biotech industry to reimagine drug development with patients at its core. For leaders and innovators in the field, it provides not just food for thought, but actionable strategies to enhance their approach to drug development and, ultimately, improve patients' lives.

If you'd like to discuss how you might apply these learnings to your own context, contact us now.