Lucerna Via provides senior-level strategic guidance to help companies developing neurotherapeutics and neurotechnology generate the evidence needed for regulatory approval, reimbursement, commercialization, and long-term growth—without the cost and commitment of a full-time executive.
Illuminating the Path from Neurotherapeutic Innovation to Commercial Success
From Science to Strategy
Personalized, High-Impact Partnership
Lucerna Via partners with neuroscience innovators at every stage of development, helping early-stage teams translate strong science into actionable clinical strategies and supporting established companies expanding into neurotherapeutics with focused, evidence-based insight. Every engagement is tailored to your company’s specific challenges and objectives, delivering guidance that is scientifically rigorous, commercially informed, and aligned with regulatory requirements. The result is practical, actionable strategies that move programs efficiently toward approval and market success.
Why Neuroscience Is Different
Clinical development in neuroscience presents unique challenges, from the subjectivity of endpoints and high placebo responses to slow disease progression and patient recruitment hurdles. Lucerna Via brings specialized experience across these complexities, helping teams design studies that are scientifically rigorous, operationally feasible, and positioned to generate meaningful clinical and commercial value. We understand where biology, behavior, and regulatory science intersect, and apply practical strategies that balance scientific ambition with operational reality.
Science-Driven, Strategy Focused
Lucerna Via bridges deep neuroscience expertise with strategic foresight. We help clients anticipate development challenges, align clinical development with regulatory and commercial goals, and identify evidence strategies that strengthen clinical and business outcomes. From early concept through pivotal planning, we help leadership teams evaluate critical clinical development decisions through the lens of scientific rigor, strategic clarity, and downstream regulatory, reimbursement, and commercial objectives.
Collaborative Partnership
We see ourselves as an extension of your team. Whether serving as a strategic thought partner to executive leadership or collaborating closely with clinical and cross-functional teams, we adapt to your organization's needs while providing experienced guidance exactly where it creates the greatest value. Whether collaborating on protocol design, strengthening communication plans, or shaping broader clinical strategy, we integrate seamlessly with your workflow to provide the expertise and additional capacity your program needs to keep moving forward.
The Cost of Time in Neurotherapeutic Development
Developing a new neurotherapeutic is a long and complex journey, often taking 12 to 15 years from discovery to commercialization. For early-stage companies, every delay matters. Each added month increases costs, consumes limited runway, and shortens the period of potential market exclusivity. Every study represents an investment of time, capital, and market opportunity. The decisions made today influence not only the next clinical milestone, but also future regulatory success, reimbursement potential, strategic partnerships, financing opportunities, and ultimately the commercial value of the program. Lucerna Via helps companies identify the critical decisions most likely to influence timelines, development costs, and long-term value creation. By aligning clinical development strategy with regulatory expectations, operational feasibility, and future commercial objectives, we help clients make informed decisions that preserve both time and enterprise value. Our goal is to position programs for steady, efficient progress while generating evidence that supports success throughout the product lifecycle—from regulatory review and reimbursement to partnership discussions and commercialization.
Focused on Outcomes
Every project begins with a core question: How will this create meaningful impact?
For us, impact means accelerating innovation, strengthening trial outcomes, and positioning programs for regulatory, investor, and payer confidence. By uniting science with market strategy, we help you maximize resources, mitigate risk, and build a clear path to commercialization—so promising therapies can reach the patients who need them most.
Services
Clinical Development Strategy
Clinical development that ultimately leads to commercial success requires more than well-designed studies—it requires a clear strategy that generates the right evidence at the right time. Our engagements often begin with a comprehensive assessment of your existing evidence package, planned studies, and overall development strategy. We identify critical evidence gaps, evaluate how your program compares within the competitive landscape, and determine what additional data will be needed to support future regulatory, reimbursement, clinical adoption, partnership, and financing objectives. Using these insights, we develop integrated clinical development strategies that are scientifically rigorous, strategically differentiated, and aligned with your long-term business goals. Rather than viewing each study as an isolated milestone, we help ensure every clinical investment contributes to a cohesive evidence package that creates value throughout the product lifecycle. From first-in-human studies through post-market evidence generation, we help leadership teams make informed decisions that reduce development risk, maximize the value of each study, and position programs for regulatory approval, reimbursement, commercial adoption, strategic partnerships, and long-term growth.
Statistical Planning & Interpretation
A well-designed statistical analysis plan is essential to generating evidence that supports meaningful scientific, regulatory, and commercial decisions. We partner with experienced biostatisticians—whether from your internal team or through Lucerna Via's trusted network—to develop statistical analysis plans that align with your overall clinical development strategy, ensuring statistical methods, endpoints, and planned analyses generate evidence that supports regulatory approval, reimbursement, clinical adoption, and long-term commercial objectives. Beyond statistical planning, we provide guidance on data interpretation, analysis strategies, and presentation of results, helping teams translate complex findings into clear, evidence-based insights that strengthen decision-making, inform future development, and build confidence among regulators, investors, strategic partners, and other key stakeholders.
Protocol Development & Optimization
We work collaboratively with sponsors, key opinion leaders, regulatory experts, and other stakeholders to develop protocols that are scientifically rigorous, operationally feasible, and strategically aligned with long-term development objectives. Beyond optimizing study design, we provide detailed guidance on protocol structure, endpoint selection, inclusion and exclusion criteria, assessment schedules, and operational considerations to help ensure each study generates meaningful evidence while remaining feasible to execute. Where appropriate, we incorporate regulatory, reimbursement, market access, and clinical adoption considerations early enough to meaningfully influence study design—helping ensure the evidence generated addresses the needs of regulators, payers, clinicians, strategic partners, and investors, not just the immediate objectives of the study. By considering how individual protocol decisions contribute to the broader evidence strategy, we help clients build studies that strengthen the overall development program and support long-term commercial success.
Scientific Communications
We develop clear, compelling scientific communications—from peer-reviewed publications and conference presentations to materials for regulators, investors, and strategic partners—that communicate your data, clinical evidence, and development strategy with scientific rigor and strategic clarity. Whether translating complex results into impactful publications or supporting regulatory and investor communications, we help ensure your message is accurate, credible, and aligned with your broader business objectives.
Early-Stage Development Support
We partner with early-stage and resource-constrained companies to provide the strategic expertise and execution support needed to advance development programs without the cost of building a full clinical organization. Whether you are generating preclinical or early-stage clinical data, refining protocols, preparing investor or regulatory materials, or engaging key opinion leaders, we provide experienced guidance tailored to your stage of development. Leveraging both Lucerna Via's expertise and our trusted network of collaborators, we can provide support across critical activities—including data analysis, visualization, pitch deck development, scientific communications, and KOL engagement—ensuring each deliverable is scientifically rigorous, strategically aligned, and positioned to support future development milestones. By providing flexible access to senior-level expertise, we help companies achieve critical milestones, strengthen investor confidence, and build a solid foundation for future clinical and commercial success.
About Us
Founder & Principal Consultant
Kristen Ade, PhD
Lucerna Via Consulting is led by Dr. Kristen Ade, a neuroscientist with more than 20 years of experience in neuroscience and neurology clinical research. She partners with companies developing neurotherapeutics and neurotechnology to make strategic clinical development decisions that generate the evidence needed for regulatory approval, reimbursement, clinical adoption, and long-term commercial success. Drawing on experience across the clinical development lifecycle, she helps leadership teams align clinical strategy with scientific, regulatory, reimbursement, and commercial objectives.
As Vice President and Chief Scientific Officer at Scion NeuroStim, Kristen led clinical development programs for neuromodulation therapies targeting Parkinson's disease and migraine. She played a key leadership role in the successful FDA De Novo authorization of a migraine neuromodulation device. While leading the Parkinson's disease development program, she worked closely with regulators, key opinion leaders, patient advocacy groups, and cross-functional teams to develop a clinical strategy that balanced scientific rigor with regulatory requirements while anticipating future reimbursement and commercial needs. She also secured non-dilutive funding from leading foundations to advance innovative research.
Personal Note
My work has always been guided by a commitment to improving patients' lives, but innovation only reaches patients if it successfully navigates the clinical, regulatory, reimbursement, and commercial journey. That journey requires more than scientific excellence—it requires thoughtful clinical development decisions made early enough to shape the evidence that will ultimately determine a therapy's success. Helping companies make those decisions is what I enjoy most. By aligning clinical strategy with long-term regulatory, reimbursement, and commercial objectives, I strive to help innovative neurotechnologies reach patients more efficiently and improve the lives of those they are designed to serve.
Expertise on demand. Efficiency by design.
A Focused Flexible Approach
Lucerna Via is designed to provide the expertise your program needs—without the cost and complexity of building a full clinical organization. Every engagement is led by Dr. Kristen Ade, who serves as your primary strategic advisor and single point of accountability.
To complement that leadership, Lucerna Via maintains a trusted network of experienced independent consultants spanning clinical trial operations, biostatistics, regulatory affairs, clinical medicine, intellectual property, market access, commercialization, data management, and other specialized disciplines. These collaborators are engaged selectively based on the specific needs of each project, allowing clients to access senior-level expertise only when it adds value. This flexible model enables companies to scale resources as programs evolve while remaining lean, efficient, and focused on their core objectives.
The result is a highly experienced, integrated team that delivers strategic guidance and specialized execution—without the overhead of full-time executive hires or large consulting firms.
"What sets Kristen apart is her ability to see the big picture while still driving the details that move programs forward. She bridges science and strategy seamlessly, keeping stakeholders aligned and keeping development efforts centered on delivering treatments to patients."
— ROBERT BLACK, PHD, FORMER CTO &COO OF SCION NEUROSTIM, PRESIDENT OF VEINCARE TECHNOLOGIES
Endorsements
"True medical device breakthroughs are rare, and the difference between success and failure often lies in the design and execution of pivotal clinical studies. Kristen Ade is the most skilled professional I have worked with in designing and conducting such studies. She anticipates challenges, weighs every detail—from inclusion criteria to statistical powering—and ensures studies are both scientifically rigorous and commercially relevant. If there is a role for a new medical technology in clinical practice, Kristen will design and conduct the study to define it, minimizing risk and maximizing the chance of success."
— NAT BOWDITCH, FORMER CEO OF AVANTEC VASCULAR, APNEON, HANCOCK MEDICAL AND ORTHOHUB
"Dr. Ade is exceptional. I had the pleasure of working closely with her for more than five years, and she consistently demonstrated not only intelligence and rigor, but also a deep commitment to collaboration and execution. She brings passion for advancing treatments in neurological disorders and translates that into clear strategies that move programs forward efficiently and with patients always in focus."
— LANTY SMITH, FORMER CEO OF SCION NEUROSTIM, CEO OF TIPPET CAPITAL
Contact us
We offer a complimentary 20-30 minute consultation to learn about your program and discuss your goals.
There’s no obligation- just a chance to explore whether Lucerna Via is the right partner to help move your project forward. Complete the form below, and we will reach out to schedule a consultation at a time that works for you.
This consultation is for informational purposes only and does not establish a client relationship.