The Emerging Biotech Leader

SSI Strategy

Biotech—it's complicated. A successful product launch requires grit, determination, and clear direction. But let’s be real, the path to launch isn’t a straight one. There are curves, hard turns, and dead ends. Here’s the good news, you don’t 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.

  1. 50 Episodes in: Lessons from The Emerging Biotech Leader

    3D AGO · BONUS

    50 Episodes in: Lessons from The Emerging Biotech Leader

    Kim and Ramin celebrate the anniversary of The Emerging Biotech Leader, marking three years, 50 episodes, and listeners across 50 countries. Unlike past episodes with guests, this milestone is a reflective conversation between the two hosts, weaving together the themes and lessons that have emerged across the series.  Lesson 1: Leading Without Certainty  Biotech is defined by ambiguity, and success requires clarity of direction rather than certainty of outcomes.  Teams and stakeholders respond best to transparency, conviction, and timely decisions, even if those decisions need to be revisited. Rituals such as quick decision sprints, red team reviews, and frequent check-ins help leaders pivot effectively. The early years of the show, set against post-pandemic disruption and market volatility, underscored how conviction and adaptability became essential. This tension was captured powerfully by Ilan Ganot in Episode 11, who described the loneliness of leadership when faced with conflicting expert advice.  Lesson 2: Mission Before Metrics  Patient-first thinking consistently anchors effective organizations.  Patient-first thinking consistently anchors effective organizations.  Keeping the patient voice at the center shapes strategy, drives board and investor alignment, and builds durable conviction in uncertain environments. Advocacy communities can shift industry attention and mobilize resources, and even in less visible disease areas, engaging patients early creates clarity and conviction. Building culture around the patient is not a “soft” attribute but a core measure of organizational integrity. As Edward Kaye reflected in Episode 36, bringing patients into protocol design early can transform both the science and the experience: asking advocates whether a trial design is reasonable, too burdensome, or practical enough for participation ensures the patient perspective drives decision-making from the start.  Lesson 3: The Role of the Chief Medical Officer  The CMO role emerged as uniquely demanding and multifaceted.  CMOs act as scientific leaders, organizational builders, investor communicators, and enterprise thinkers. The “octopus” metaphor, introduced in one episode, captured how CMOs must stretch across many functions without a single playbook. Effectiveness depends on the right fit for the stage of the company, supported by scaffolding to cover the many dimensions of the role. Chrystal Lewis captured this in Episode 45, noting how her predecessor was the right fit as a Phase 1 trialist, while her own role shifted to shaping Phase 2 registrational studies with the end in mind—focusing on the medical questions and value story needed for the next stage.  Lesson 4: Flexible Talent and Agility  Organizational success is less about building the biggest team and more about building the most adaptable one.  Lean, flexible structures supported by fractional or outsourced expertise enable speed and resilience. Avoiding silos and prioritizing integration across functions accelerates decision-making, clinical progress, and fundraising. Agility wins; silos stall. As Al Beardsly noted in Episode 47, sometimes the smartest move is bringing in consultants to cover critical gaps rather than rushing to hire, ensuring capabilities evolve with each development stage without becoming a long-term liability.  Theme 5: Strategic Differentiators  Capabilities beyond science—such as safety, quality, and real-world evidence—are becoming critical levers of differentiation.  Embedding safety and risk management early transforms them from compliance activities into strategic advantages. Forward-looking approaches to RWE help organizations prepare for payer expectations, clinician adoption, and patient preference, positioning them to be “best in market,” not just first. Christian Howell explained this in Episode 34, contrasting “evidence-based selling” with the more powerful approach of real-world evidence—where data must reflect diverse patient populations and support decision-making not just before approval, but across the entire product lifecycle.  Closing Reflections  Kim and Ramin ended the conversation by looking ahead. They noted the rapid pace of technological change, particularly around AI and digital tools that are beginning to transform clinical trial design and evidence generation. Yet what stood out most to them was that tools alone are not decisive—the defining factor is mindset. Patient-centricity, enterprise thinking, and resilience in uncertainty are what ultimately set leaders apart.  They closed by thanking the many guests who have shared their stories over the past three years and expressing excitement for what lies ahead. Reaching fifty episodes felt like a moment to pause and reflect, but also a springboard—both for the show itself and for the biotech community it highlights—as they look forward to the next fifty conversations.

    36 min
  2. Biotech Leadership: The CEO–CMO Dynamic

    NOV 6

    Biotech Leadership: The CEO–CMO Dynamic

    In this conversation, Kim Kushner and Adriana Valenciano, Head of Client Delivery at SSI Strategy, take a closer look at what truly drives progress in early-stage biotechs. Picking up on themes first raised by Dr. Ed Tucker, they explore how leadership partnership, the structure of a Target Product Profile, and the intentional use of AI all shape how young organizations grow.  In biotech’s earliest stages, the relationship between the CEO and Chief Medical Officer often determines whether a company builds momentum or stalls in misalignment. When these roles evolve together, sharing a view of how science, business, and culture intersect, the organization gains the clarity to move fast without losing direction.  That clarity is reinforced by a strong Target Product Profile (TPP). More than a regulatory document, the TPP functions as a living blueprint that connects clinical strategy to company purpose. Used well, it aligns teams across functions, sets measurable targets for efficacy and value, and keeps both the scientific and organizational focus anchored to a shared definition of success.  Innovation also depends on intentional design. With new AI tools transforming how work gets done, early biotechs face a pivotal question: how to introduce technology without losing the human judgment and governance that protect sound science. Building those checks and balances too late risks chaos; building them too early can slow down the momentum. The challenge is knowing when to formalize, what to automate, and how to keep scientific integrity at the core.  This discussion is about the discipline of leadership in complex systems, how culture, decision-making, and innovation reinforce each other when guided by a clear framework and an honest partnership at the top. Listen to explore how shared intent and disciplined structure translate vision into progress.

    24 min
  3. From TPP to Teamwork: Creating Structure as a Biotech CMO

    OCT 9

    From TPP to Teamwork: Creating Structure as a Biotech CMO

    Being a Chief Medical Officer looks very different on the inside than it does from the outside. In this episode, Dr. Ed Tucker talks openly about what he’s learned after serving as CMO in companies big and small. He traces his path from large pharma training grounds to the unpredictable world of startups, and what that shift taught him about adaptability, trust, and resilience.  Along the way, Ed talks about:  Carrying the pressure of being “the voice of the science” in front of investors and regulators, and why alignment with the CEO is non-negotiable. Building trust with KOLs and investigators so that confidence outside the company translates into motivation and problem-solving inside the team. Using the Target Product Profile as the anchor of the program—a reference point that keeps assumptions in check and the whole team aligned on what they’re building toward. Seeing safety as a strategic lever, not just an operational task, and how a stronger safety profile can become the reason a drug succeeds in a crowded market. Learning that resilience matters more than endurance, and why humility and curiosity are essential traits for any CMO. Relying on the CMO community and networks for perspective and support, especially when facing the inevitable setbacks in drug development. This is not a formula or a checklist, but a set of lived lessons. What emerges is an honest look at the role from someone who’s still learning, even after a decade in the seat.

    39 min
  4. Build the Company You Say You Are: How culture shapes real-world execution

    JUL 8

    Build the Company You Say You Are: How culture shapes real-world execution

    In this episode, Kim speaks with Jill Milne, Ph.D., CEO of Astria Therapeutics, about what it really takes to build a biotech company around patient needs, not just in mission statements, but in everyday decisions. Drawing on her 25+ years in pharma and biotech, Jill shares how Astria is redefining what it means to be patient-first, why culture is more than a slogan, and how leaders can align boards and investors behind values that also deliver business results.  They talk about:  Patient-Centricity as Strategy: Jill details how Astria embeds patient insight across every phase of development; from target product profile to clinical design to commercialization. This is not just about listening sessions or checkbox advocacy, it’s about consistently translating lived experiences into decisions that accelerate development, improve retention, and drive value.  Culture being a Strategic Asset: With the motto “Patients first. People always,” Jill emphasizes how every function, from finance to CMC, is connected to patient impact. The culture extends beyond Astria’s walls to CROs and partners, creating a shared mindset that scales.  Board & Business Alignment: Jill outlines a compelling case for why patient-centered and culture-led approaches aren't just feel-good strategies but force multipliers that enhance clinical development, commercial positioning, investor confidence, and regulatory credibility.  For biotech leaders building companies with long-term impact in mind, this episode offers a grounded look at how values like culture and patient focus can be turned into consistent, daily execution.

    32 min
  5. From Vision to Viability: The Decisions That Define a Biotech

    JUN 26

    From Vision to Viability: The Decisions That Define a Biotech

    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.

    23 min

Ratings & Reviews

5
out of 5
10 Ratings

About

Biotech—it's complicated. A successful product launch requires grit, determination, and clear direction. But let’s be real, the path to launch isn’t a straight one. There are curves, hard turns, and dead ends. Here’s the good news, you don’t 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.

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