What does it really take to launch a biotech company that lasts? In this episode, host Kim Kushner sits down with Dr. Marcia de Souza Lima, a physician-executive whose journey spans clinical care, global pharma, investment, and startup leadership. Together, they explore the earliest days of company formation—where every decision, from team design to product development, can shape the long-term path of the organization.

The conversation begins with a familiar framework—the “Five P’s” of early biotech building: Product, People, Patents, Pennies, and Place. But Marcia challenges the idea that these alone are enough. She offers a fresh perspective on what leaders often overlook in the rush to build: the patient voice, the real-world context, and the flexibility to adapt as markets, teams, and therapies evolve.

This Conversation Highlights:

• Why scientific novelty isn’t enough—your product must be positioned to matter.
• How to think about the patient perspective even before your first clinical milestone.
• Ways to balance scientific rigor with entrepreneurial speed in a resource-constrained environment.
• The talent trade-offs of hybrid vs. in-person teams—and how agility may be your biggest asset.
• The role of mentorship, curiosity, and asking the right questions—especially when you're doing this for the first time.

Rather than presenting a checklist, this episode invites biotech leaders to think more holistically: How do you build something both scientifically sound and human-centered? How do you grow fast—without missing the fundamentals?

If you're leading (or planning to lead) in biotech, this is a conversation that helps you zoom out, refocus, and reconsider what should come first.

In this episode of The Emerging Biotech Leader, host Kim Kushner speaks with Al Beardsley, CEO of Cirius Therapeutics, about the foundational principles that guide sustainable biotech company building. A seasoned operator with experience across early discovery and late-stage development, Al introduces his “Five P’s” framework—a practical, clear-eyed guide for leaders responsible for turning science into durable enterprise value.

The discussion covers:

• Product – How to ensure scientific innovation aligns with clinical relevance, provider expectations, and payer value frameworks—starting from day one.
• People – Why successful teams prioritize adaptability, strategic clarity, and trust over pedigree alone—and how CEOs can foster cohesion across lean or hybrid structures.
• Patents – The critical timing decisions that shape long-term market viability, particularly in light of small molecule vs. biologic exclusivity windows.
• Pennies – Why overcapitalization is rarely the problem, and how disciplined resource allocation—not just headcount—defines a company’s survival window.
• Place – Rethinking organizational design in a post-geography world, and how cultural alignment can outperform location-based hiring.

Al also shares reflections on leadership at different stages of company maturity, the evolving role of the CEO as “Chief Everything Officer,” and how early-stage biotech leaders can structure their organizations to move deliberately, avoid unforced errors, and keep teams focused in uncertain conditions.

This episode offers grounded, experience-based insight for biotech executives who are building with limited resources, high stakes, and longtime horizons.

In this episode, Chief Business Officer Kim Kushner talks with Dr. Carrie Brownstein, SVP Medical at SSI Strategy, about how to think through the fit between a biotech leader and their company’s stage of development.

Carrie shares lessons from her own path from large pharma to biotech and how different kinds of experience shape what a CMO can offer at different points in a company’s growth. They talk about building the right kind of support team, knowing your own limits, and making space for others when it’s time.

Topics include:

• How to assess your readiness for a CMO role
• Why no single background covers everything a biotech will need
• The value of building a team that fills in the gaps
• Learning to ask the questions that matter

It’s a thoughtful discussion for anyone thinking about leadership fit—not just titles.

Listen to hear Carrie’s perspective on what makes a CMO effective, and how to stay aligned with what your company really needs.

In this episode of The Emerging Biotech Leader, Chief Business Officer Kim Kushner and Dr. Carrie Brownstein, SVP Medical at SSI Strategy are joined by Dr. Chrystal Louis, Chief Medical Officer at TScan Therapeutics, to discuss how different professional experiences shape leadership approaches in the biotechnology sector. Dr. Louis brings extensive experience across clinical development and medical affairs, with a career spanning pediatric oncology, industry leadership roles, and the buildout of medical strategy teams at both early-stage and commercial-stage biotech companies.

Drawing on their respective backgrounds in clinical development and medical affairs, Dr. Brownstein and Dr. Louis explore how different career experiences shape decision-making, stakeholder engagement, and development strategies within the CMO role.

Being a CMO with medical affairs expertise often brings a broader focus on patient access, payer engagement, and real-world adoption, while those from clinical development backgrounds typically lead with regulatory strategy and trial execution. Dr. Brownstein and Dr. Louis explore how both profiles shape the CMO role, and why aligning clinical programs with real-world use is becoming increasingly important. The medical affairs perspective remains less common in biotech leadership today but offers growing strategic value across early and late-stage development.

They also discuss how some biotech companies are shifting focus from oncology to immunology and metabolic diseases, partly in response to changing investment trends. This shift brings new challenges for leadership teams, including recalibrating risk-benefit expectations, regulatory standards, and long-term access planning.

The episode closes with a discussion on the importance of deliberate career development and mentorship, particularly in supporting diverse leadership pipelines. Dr. Louis shares practical advice on planning career moves over a five-year horizon, gaining cross-functional experience, and driving leadership advancement with strategic intent.

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