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.