Shots
- Cross-industry lessons from technology, design thinking, and startups can reshape drug development by encouraging faster iteration, disciplined decision-making, and a stronger focus on real patient needs, unlocking innovations that traditional biotech models may overlook.
- Clinical experience and thoughtful engagement with the U.S. Food and Drug Administration highlight the importance of patient insights, transparent communication, and strong data preparation to build trust with patients, partners, and investors while maintaining scientific rigor.
- PharmaShots welcomes Shalabh Gupta, Founder, President, and Chief Executive Officer of Unicycive Therapeutics, for an insightful conversation on cross-disciplinary innovation, patient-centric drug development, and advancing new possibilities in kidney disease care.
Saurabh: How can lessons from outside pharma; like tech, design thinking, or startups, unlock new ways to approach drug development and spark breakthroughs that traditional models might miss?
Shalabh: Many of the most valuable lessons come from industries that emphasize user experience, speed of iteration, and systems thinking. In tech and design, teams are trained to define the real problem before proposing a solution, to prototype early, and to learn quickly from failure. In drug development, those instincts can translate into asking better questions at the outset about patient burden, adherence, and tradeoffs rather than assuming the molecule alone defines value. Startup culture also reinforces capital discipline and decision clarity–knowing when to double down and when to pivot. This is essential in biotech and biopharma, where resources are finite. Bringing these perspectives into pharma does not replace scientific rigor. It complements it by sharpening the focus on what truly matters and where innovation can meaningfully change outcomes.
Additionally, we can expand this way of thinking to include other industries beyond start-ups and the medical sector. The technology behind Unicycive’s lead-active, Oxylanthanum carbonate (OLC), has its origins in the automotive industry, specifically in battery shrinking. By identifying promising research on molecular shrinkage and applying it to medicine, we addressed an unmet need identified by our team: patient adherence to a therapeutic regimen. Innovation can come from anywhere; we just have to be ready to identify it.
Saurabh: How does direct experience in the clinic shine a light on patient problems that might otherwise be overlooked before any technology comes into play?
Shalabh: Clinical experience grounds innovation in reality. When you spend time with patients, you see firsthand the gap between how therapies perform in trials and how they are experienced in daily life. You understand symptom burden, treatment fatigue, and the practical challenges that only surface in conversations after the exam ends and never make it into a dataset. Insights like these shape everything from dosing strategies to trial endpoints to how success is defined. Technology can enable solutions, but it is the clinician’s perspective that helps identify the problems worth solving in the first place.
Saurabh: What practices lay the foundation for long-term trust with patients, partners, and investors even before a company brings a therapy to market?
Shalabh: Trust starts with how founders behave when there is no product on the market and no certainty of success. That means making disciplined choices early, being clear about what therapy can and cannot realistically achieve, and resisting the temptation to oversell progress to any audience. Strong founders build credibility by showing how decisions are made, how trade-offs are evaluated, and how capital is allocated intentionally.
For patients, this manifests as respect for their time, privacy, and lived experience rather than as a means of positioning them as promotional assets. With partners and investors, this entails clear governance, consistent communication, and documentation that link insights to execution. Trust is not created at approval. It is earned over time through consistency, transparency, and follow-through, even when the stakes remain uncertain.
Saurabh: Where do unconventional or cross-disciplinary approaches uncover opportunities that conventional biotech frameworks might miss entirely?
Shalabh: Opportunities often emerge at the intersection of disciplines rather than within the boundaries of any single industry. When organizations look beyond established frameworks, they can uncover gaps in execution, adoption, and scalability that technical innovation alone cannot resolve. Insights from fields such as logistics, industrial design, behavioral science, and operations influence how products are built, deployed, and sustained in real-world environments. This cross-disciplinary lens helps leaders challenge assumptions early, anticipate friction points, and design solutions that function reliably at scale.
It is this unconventional framework that established the foundation for our lead drug candidate at Unicycive, and continues to challenge our team’s conventional way of thinking daily. Breakthroughs don’t happen in isolation. Rather than applying innovations from other industries to your own, we, as a scientific community, can ensure best practices and continued success.
Saurabh: How can a company push the boundaries of innovation while keeping scientific rigor and regulatory compliance firmly in sight?
Shalabh: Innovation and rigor are not opposing forces. In my experience, they often reinforce each other. The key is structure. Clear hypotheses, defined objectives, and disciplined documentation allow teams to explore new ideas without compromising standards. Early and thoughtful engagement with regulators helps align innovation with expectations rather than forcing course corrections later. Creativity thrives when guardrails are clear, and the right regulatory strategy enables progress rather than restricting it.
Saurabh: What are the key lessons from FDA interactions and submissions that can make the difference between a smooth pathway and repeated hurdles?
Shalabh: Preparation and transparency matter most. Successful FDA interactions are grounded in strong data packages, clear rationale for decisions, and proactive disclosure of potential issues. Listening carefully to feedback and incorporating it early can prevent costly delays. It is also critical to maintain consistency across clinical, regulatory, and advisory efforts so that submissions reflect a coherent and credible development strategy.
Saurabh: How can complex scientific progress be translated into a story that resonates equally with investors, collaborators, and patients?
Shalabh: The most effective stories connect science to impact. What the data shows matters, but why it matters is what creates a connection. Investors seek to understand risk and value creation, collaborators seek strategic clarity, and patients care about how innovation improves daily life. A shared narrative emerges when scientific progress is framed around solving real problems, supported by evidence, and communicated in plain language without dilution of rigor.
Saurabh: How do real-world patient experiences shape therapy design and clinical trial planning, ensuring that outcomes go beyond efficacy to truly improve lives?
Shalabh: Spending time with patients changes how you think about therapy design. Their experiences inform decisions that directly affect trial feasibility and relevance. Input on symptoms, treatment burden, and daily routines can influence endpoint selection, visit schedules, and inclusion criteria. This leads to trials that are more representative, and you start to see outcomes that reflect meaningful benefit rather than abstract measures. When patient insight is integrated thoughtfully, therapies are better positioned to succeed beyond regulatory approval.
Saurabh: What principles turn scientific expertise into a thriving biotech venture that can navigate regulatory, commercial, and patient landscapes?
Shalabh: Successful biotech ventures combine scientific excellence with disciplined entrepreneurship. That requires clear prioritization, an honest assessment of product-market fit, and early engagement with diverse perspectives. Leaders must balance long-term vision with operational pragmatism and ensure that every decision aligns scientific goals with patient and business realities. Over time, trust, transparency, and adaptability become as critical as innovation itself.
Saurabh: Which unmet needs in kidney disease or related areas hold the greatest potential for breakthroughs that could redefine patient care?
Shalabh: Kidney disease remains an area with profound unmet needs, particularly when it comes to slowing progression without adding burden to patients’ daily lives. Many existing options struggle with tolerability, complexity, or limited applicability across disease stages. There is a meaningful opportunity to design therapies that are more adaptable and better aligned with how care is delivered in practice. The next wave of progress will be driven not only by scientific advances, but by combining clinical experience with real-world insight to create solutions that work for patients beyond the clinic
About the Author:
Shalabh Gupta, MD
Founder, President, and Chief Executive Officer of Unicycive Therapeutics
Shalabh Gupta, MD, is the Founder, President, and Chief Executive Officer of Unicycive Therapeutics, a publicly traded biotechnology company he launched in 2016, where he has advanced a therapy for kidney disease now under FDA review. A physician trained in India who completed his residency and fellowship at NYU, he also holds a Master of Public Administration in Health Care Finance and Management, and previously worked on Wall Street covering pharmaceutical and biotechnology companies. Dr. Gupta is focused on advancing practical, patient-centered innovation in biotechnology.
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