Episodios

  • Adapting Biotech Leadership Across Development and Therapies
    Sep 11 2025

    Biotech leaders are asked to do a lot; move fast, manage limited resources, and guide teams through very different stages of development. In this episode of The Emerging Biotech Leader, host Kim Kushner talks with Dr. Benit Maru, Senior Vice President at SSI Strategy, about what it really looks like to lead in that environment.

    They cover:

    • The contrasts between early and late development leadership, and why those transitions can feel like two different roles
    • How scenario planning and structured conversations help teams prepare for uncertainty
    • Why documents like the clinical development plan or target product profile should be seen as living tools, not paper exercises
    • The similarities and differences in leading across modalities—devices, biologics, and advanced therapies like cell and gene
    • The importance of team dynamics, culture, and knowing when to bring in outside expertise

    This episode is full of practical takeaways for biotech leaders who want to keep their strategies sound, their teams aligned, and their programs moving forward under pressure.

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    25 m
  • The CMO’s Role in Building a Scalable Biotech Strategy
    Aug 28 2025

    In this episode of The Emerging Biotech Leader, Kim Kushner speaks with Dr. Michael Goldstein, ophthalmologist and multi-time Chief Medical Officer, about the realities of biotech leadership across modalities and development stages.

    Dr. Goldstein reflects on lessons learned from leading clinical programs in small molecules, biologics, gene therapies, cell therapies, and drug-device combinations. The discussion highlights what remains consistent across modalities such as the need for regulatory clarity and cross-functional alignment, and what differs significantly, particularly in manufacturing complexity, immune responses, and development timelines.

    Other key themes include:

    • Why time is an underappreciated constraint in biotech
    • The strategic role of the CMO in manufacturing oversight and decision-making
    • How to balance regulatory and commercial thinking in early development
    • Building teams that function as integrated units, not parallel functions
    • Advice for early-career CMOs seeking to grow beyond clinical roles

    This episode offers practical insight into how biotech leaders can operate more effectively across the full development arc, from IND to commercialization, without losing sight of the clinical and patient perspective.

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    46 m
  • Designing Patient-Centric Trials That Work
    Jul 24 2025

    What does it take to bring patient-focused values into the real decisions that shape drug development, especially when you're moving fast, working lean, and under pressure to deliver?

    In this episode, host Kim Kushner speaks with Victoria Oswald, Vice President at SSI Strategy, about how biotech teams can start small but think deliberately when embedding patient input and cultural intent into early-stage development.

    Together they explore:

    • Why even basic decisions in Phase I, like assessment burden or endpoint design, should reflect patient relevance, not just regulatory safety
    • How teams can integrate patient perspectives without large budgets or formal infrastructure
    • The tension between doing what’s feasible now vs. setting up for long-term alignment
    • The role of internal culture in shaping how development teams prioritize, communicate, and make trade-offs

    Drawing on her work across gene therapy, rare disease, and oncology, Victoria highlights how early engagement, shared mindset, and cross-functional awareness can help even lean teams avoid rework and stay focused on what truly matters.

    This episode offers insight for biotech leaders and clinical teams working to connect patient priorities with real-world development choices from the start.

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    17 m
  • Build the Company You Say You Are: How culture shapes real-world execution
    Jul 8 2025

    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.

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    32 m
  • From Vision to Viability: The Decisions That Define a Biotech
    Jun 26 2025

    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.

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    23 m
  • Five Fundamentals for Building a Biotech That Lasts
    Jun 13 2025

    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.

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    36 m
  • The Many Shapes of a CMO
    May 30 2025

    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.

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    16 m
  • Expanding the CMO Role: The Value of Difference
    May 15 2025

    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.

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    35 m