The Emerging Biotech Leader Podcast Por SSI Strategy arte de portada

The Emerging Biotech Leader

The Emerging Biotech Leader

De: SSI Strategy
Escúchala gratis

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.© 2025 SSI Strategy Ciencia Ciencias Biológicas Economía
Episodios
  • Clinical Operations as a Strategic Function

    Clinical Operations as a Strategic Function
    Dec 2 2025

    In this episode of Emerging Biotech Leaders, host Ramin Farhood speaks with Meaghan Powers, Senior Director of Clinical Operations at SSI Strategy. With deep experience across biotech, pharma, and consulting, she offers a clear view of where clinical operations drives strategic value and how early engagement can set emerging biotechs up for success.

    Key Themes and Insights

    1. Clinical Operations Is a Strategic Function
    Clinical operations is often misunderstood as a task-driven, execution-only role. In reality, it requires strategic planning early in development, including anticipation of regulatory expectations, operational risks, and study feasibility well before a protocol is finalized.

    2. Early Cross-Functional Input Prevents Downstream Problems
    Strong clinical programs benefit when core scientific, operational, and quality perspectives are brought together early. Aligning these functions at the concept stage helps shape feasible early-phase designs and creates more stability as the program moves into later development.

    3. Sponsors Cannot Outsource Accountability
    Certain operational tasks can be outsourced, but responsibility for the trial remains with the sponsor. Decisions relating to strategy, vendor performance, and data stewardship require sponsor ownership, supported by clear expectations for partners and defined routes for escalation. These elements establish the framework within which a CRO or other vendor operates.

    4. Effective Oversight Systems Reduce Regulatory and Operational Risk
    Even with the right division of responsibilities, oversight must function in practice. Programs need structured processes for reviewing site conduct, monitoring outputs, and data quality to ensure issues surface early. When these checks are weak or inconsistent, avoidable problems can accumulate and lead to inspection findings or broader trial disruptions.

    5. Emerging Leaders Benefit from Staying Curious and Involved
    Leaders are not expected to master clinical operations, but early engagement with clinical operations strengthens decision-making. It gives programs better visibility into resourcing, risk points, and the operational systems required to advance development.

    For a closer look at how these ideas play out in real development settings, listen to the full episode.

    Más Menos
    21 m
  • How Clinical Operations Shapes Biotech Strategy

    How Clinical Operations Shapes Biotech Strategy
    Nov 20 2025

    Clinical operations translates scientific research into the studies and data needed to bring new therapies to patients. In this episode of The Emerging Biotech Leader podcast, host Ramin Farhood speaks with Sharon Arnold, a seasoned clinical operations executive with more than two decades of experience in both large pharma and emerging biotechs, about how operational leadership determines whether innovation reaches the clinic successfully.

    Effective clinical operations extend well beyond trial execution. When the function helps shape the protocol early, by focusing on clarity, feasibility, and patient experience, teams stay aligned and data remain reliable. Building quality into each step reduces late-stage corrections and inspection risk.

    For growing biotechs, the challenge is to scale without losing control. Success depends on choosing carefully what to build internally and what to outsource, while keeping direct oversight of data management, statistics, and the trial master file. These functions anchor the credibility of the program and protect the integrity of the evidence that supports it.

    AI and data-driven tools are reshaping how feasibility and enrollment are planned. They can highlight new patterns in site performance and patient availability, but their value depends on interpretation. Data still needs to be tested against real-world conditions and reviewed by people who understand the therapeutic area, the protocol, and the practical limits of execution.

    Patient inclusion should be built into operations from the start. Early collaboration with investigators and academic partners supports stronger site performance, while engagement with advocacy groups helps patients stay informed and invested in the study. Diversity and understanding are part of what makes a trial executable and its data meaningful.

    Clinical operations sits at the intersection of science, strategy, and delivery. This conversation sheds light on what strong operational leadership really looks like: the decisions that prevent costly detours, the structures that sustain quality, and the mindset that turns a promising molecule into a viable medicine.

    Catch the full conversation to hear how thoughtful operational leadership keeps programs on course and trials moving forward.

    Más Menos
    46 m
  • 50 Episodes in: Lessons from The Emerging Biotech Leader

    50 Episodes in: Lessons from The Emerging Biotech Leader
    Nov 10 2025
    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.
    Más Menos
    36 m
Todavía no hay opiniones