In this episode of The Emerging Biotech Leader, Kim Kushner sits down with Nicky Wisener, Vice President, Managed Access Practice at Clinigen Group, to explore how emerging biotechs can think more strategically about patient access well before commercialization.

The discussion shifts the focus from market access to patient access, viewed globally, and across the product lifecycle. Nicky brings nearly two decades of experience working at the intersection of clinical development, medical affairs, and commercialization, helping companies navigate managed access pathways in complex regulatory environments.

The conversation challenges a common assumption in early-stage biotech: that managed access is either too complicated, too costly, or only relevant for large pharma. Instead, this episode reframes managed access as a continuum that can support patients, inform strategy, and strengthen long-term launch readiness when designed with intent.

Key Takeaways for Emerging Biotech Leaders

• Managed access should be considered a strategic option for emerging biotechs, not an exception reserved for large organizations.
• Access programs can be designed to complement clinical development without compromising trial enrollment.
• Decisions around funding, reimbursement, and charging for product depend heavily on where an asset sits in the development and launch lifecycle.
• Early cross-functional alignment (clinical, medical, and commercial teams) improves both patient access and future commercialization outcomes.
• Proactive engagement with regulators, physicians, and patient communities can support smoother transitions toward launch.

The discussion offers practical perspectives for biotech leaders evaluating how patient access considerations can be integrated earlier into development and launch planning.

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.

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.