The Emerging Biotech Leader

SSI Strategy
  • 5.0 (10)
  • Business
  • Updated Biweekly

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.

  1. 2d ago

    From Academia to Biotech: Making the Transition into Biotech Leadership

    Moving from academia to biotech requires scientists to apply their expertise in a different environment. In this episode of The Emerging Biotech Leader podcast, Kim Kushner and Mattia Calissano, VP Medical at SSI Strategy, discuss moving from academic research into drug development, collaborating effectively, communicating scientific evidence to investors and adapting to the commercial realities of biotech.  In Brief How can scientists successfully transition from academia to biotech?  Scientific expertise provides a strong foundation, but succeeding in biotech requires more than technical knowledge. Curiosity, critical thinking and collaboration are important, as is the ability to adapt and communicate scientific ideas clearly.  Mattia brings first-hand experience to the conversation, with over 10 years in academia. He spent nearly five years at the MHRA as a Medical Assessor working in pharmacovigilance and benefit-risk assessment, and then moved to Orchard Therapeutics where he progressed through drug safety/PV roles to Head of Pharmacovigilance.  Drawing on that journey, Mattia reflects on how academia and industry differ and how scientists can apply their existing skills in a new environment.  For biotech leaders, this raises another question: what should they look for when hiring someone directly from academia? Mattia points to strong scientific understanding, an openness to learning and a willingness to step outside their comfort zone.  What you’ll learn: How scientists can make the transition from academia to biotech Which academic skills can provide a strong foundation for working in biotech Why curiosity, adaptability and collaboration matter in biotech leadership How the scientific and commercial contexts of academia and biotech differ What biotech leaders can look for when hiring scientists directly from academia Listen to the full episode to hear Mattia’s perspective on moving from academia into biotech, developing as a scientific leader and recognising the qualities that help scientists succeed in the biotech industry.

    From Academia to Biotech: Making the Transition into Biotech Leadership

  2. Aug 20

    When the Science Becomes a Company

    For scientific founders, moving from academia into a biotech startup means turning personal expertise into organizational capability.  In this episode of The Emerging Biotech Leader, Kim Kushner is joined by Samir Ounzain, co-founder and CEO of HAYA Therapeutics, to look at how the founder's role changes as the science becomes a company and the team grows around it.  One of the biggest changes for Samir was moving from the more open-ended nature of academic research to a much more deliverable-oriented way of working. In a biotech, the science ultimately has to become a product. That quickly takes you beyond any one person's expertise. The founder who is used to being an executor has to become a facilitator and enabler, bringing together the expertise needed to move the work forward.  Taking a scientific idea from research into a company requires conviction. You have to believe enough in the idea to build a company around it, without becoming so attached to it that you stop listening to what the evidence is telling you. HAYA itself grew from questioning established assumptions about biology, including the idea that much of the non-protein-coding genome was simply “junk.” The lesson carries beyond the science. Conviction still needs to respond to what the evidence tells you.  As the company grows, the CEO can't be involved in every decision. People need enough context to understand what they're working toward and enough autonomy to make decisions where the information actually sits. The idea is “context over control” and building a team that is “highly aligned but loosely coupled.”  In biotech, perfection is unrealistic. What you can build is an organization that learns quickly and keeps moving.   Listen to the full episode for the full conversation.

    When the Science Becomes a Company

  3. Jul 9

    Flexible Leadership in Biotech: Building Teams Around Program Needs

    In this episode of The Emerging Biotech Leader, Kim Kushner sits down with Chris Kennedy, CEO of Pacific Genetech, to examine a different approach to building leadership teams in early-stage biotech: building organizations around program needs rather than fixed leadership structures.  Biotech companies are often built around a familiar assumption: identify the key leadership roles, hire the right people, and grow from there. Increasingly, that model is being challenged by the realities of early-stage development.  The question is not simply whether a role should be full-time or fractional. It is whether the company has access to the capabilities it needs at a given stage of development.  Early-stage companies rarely have the resources to build every capability in-house from the outset. Whether working with academic institutions, investors, scientific advisors, or operational leaders, progress often depends on bringing the right perspectives into critical decisions at the right time. Expertise becomes something companies can access as needs evolve, rather than something that must always exist as a permanent role.  That changes how leadership itself is viewed. Rather than filling an organizational chart as quickly as possible, companies can build access to expertise that evolves alongside the needs of the program. The question becomes less about which roles exist and more about what capabilities are needed next.  The challenge is often less about having every role in place and more about knowing when specific expertise needs to be brought in.  Listen to the full episode.

    Flexible Leadership in Biotech: Building Teams Around Program Needs

  4. May 22

    Designing Studies that Work in Complex Settings

    Rare disease programs force teams to confront operational realities much earlier in development, particularly when advanced modalities, limited patient populations, and complex site requirements intersect.  In this episode of The Emerging Biotech Leader, hosts Kim Kushner and Ramin Farhood are joined by Brendan Slagle, Senior Director, Medical at SSI Strategy to discuss why operational feasibility needs to be built into study design from the beginning rather than addressed later during execution.  Site readiness, patient burden, follow-up care, delivery logistics, and cross-functional alignment all become critical much earlier in development, especially in studies where there is little room for operational inefficiency.  Breaking down silos across clinical operations, medical affairs, regulatory, investigators, and patient communities becomes critical in these settings. Waiting too long to involve these perspectives can create studies that are scientifically sound but difficult to execute in practice.  Designing studies that patients and caregivers can realistically participate in becomes critical for generating meaningful data and sustaining enrollment over time. Generating meaningful data depends on designing studies that patients and caregivers can realistically participate in, while balancing scientific ambition with operational feasibility. Many of these lessons increasingly apply beyond rare disease as clinical development grows more complex across therapeutic areas.  Successful programs depend not only on scientific innovation, but on early alignment, operational realism, and a clear understanding of what patients and sites can actually sustain.  What can rare disease development teach the rest of the industry about trial execution? Listen to the full episode.

    Designing Studies that Work in Complex Settings

  5. May 8

    Rethinking Trial Design for Rare Diseases

    Rare disease drug development has a design problem. In this episode of The Emerging Biotech Leader, hosts Kim Kushner and Ramin Farhood speak with Marshall Summar, CEO and founder of Uncommon Cures, who has run more than 200 rare disease trials across academic medicine and industry. His core argument: sponsors are still defaulting to trial models built for large, homogeneous populations, in diseases where the entire patient pool may number fewer than 150 people.  "You need to pick a design that's appropriate for the size of the population you have and the outcomes you're looking at."  - Marshall Summar  The double-blind placebo-controlled trial has its place. That place is not a disease with 80 patients in the world.  Better-fit designs exist: patient-as-own-control models, adaptive phases that allow course corrections before they become costly, natural history studies funded through patient organizations before a trial opens. Reducing patient burden, home drug delivery, remote consent, home nursing visits, is a data integrity decision as much as a patient experience one. Pediatric inclusion from the start produces stronger evidence and a cleaner access story than studying adults and moving to off-label pediatric use later.  Study design, patient engagement, access, and reimbursement are not a relay race. Know your patient population before you design the study, and the rest tends to follow.  If rare disease trial design is a live issue in your programme, we work with teams to make these calls early, with fewer trade-offs. Let’s talk. letstalk@ssistrategy.com

    Rethinking Trial Design for Rare Diseases

  6. Feb 4

    Driving Global Patient Access: Managed Access as a Strategic Lever

    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.

    Driving Global Patient Access: Managed Access as a Strategic Lever

  7. Jan 14

    Rare Disease Commercialization: Beyond Approval

    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.

    Rare Disease Commercialization: Beyond Approval

  8. 12/02/2025

    Clinical Operations as a Strategic Function

    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 as a Strategic Function
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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.

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