In this episode of The Emerging Biotech Leader, host Kim Kushner sits down with Matt Trudeau, President of ITF Therapeutics, to discuss what it means to operate within a family-run pharmaceutical company and how that model shapes decision-making differently than a public or venture-backed organization.  

With more than 25 years of experience spanning Genzyme, Biogen, Bluebird Bio, and now ITF, Matt shares how his career has been defined by following the science, building commercial strategies, and putting rare disease patients at the center of every decision. He reflects on ITF’s journey in rare disease, exploring the unique challenges of commercializing therapies in underserved communities, from gaining regulatory approval to ensuring meaningful patient access and payer alignment.  

Matt also offers insights into:  

• The evolving role of the patient voice post-approval and why commercialization is only the starting line.  
• The balance of working across U.S. and European markets to deliver consistent value to small, global patient communities.  
• Why the real challenge in rare diseases isn’t competing products, but overcoming complacency - ensuring patients gain access, education, and true choice among therapies.  

Approval may mark a milestone, but in rare disease the real work begins afterward: breaking through barriers of access, evidence, and complacency.  

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. 

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. 

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. 

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. 

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. 

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. 

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. 

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. 

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.