A Conversation with MMS Founder and CEO Dr. Uma Sharma: Building MMS: 20 Years of People-First, Data-Led Drug Development 

Part One of a Two-part Interview Series 

As MMS marks its 20-year anniversary, founder and CEO Uma Sharma, PhD, reflects on how the company began and the purpose and principles that shaped its early direction. In Part 1 of this two-part conversation, she discusses the role of scientific judgement, problem-solving, and genuine partnership in building MMS, and why those values continue to make a difference in complex drug development today. 

Q: For those who may not know the full story, what led you to found MMS? Was there a specific problem you wanted to solve? 

MMS was founded for people, very deliberately. 

I had just stepped away from a senior role at a leading pharmaceutical company to raise my twins when I received a call from a former colleague. My previous employer was shutting down its Ann Arbor site. Michigan was already in the middle of the automotive recession, so it barely made headlines. But for the people impacted, it was life changing. 

I had worked with that team for eight years. I knew their talent, their integrity, and their commitment. And we were great at what we did. Before I left, we just got approval in 53 countries for a new drug we had worked on together. I couldn’t just watch them get displaced. At the same time, during my time there, I saw a second issue that was just as urgent, and far more systemic. Drug development was becoming increasingly data-rich, but not always data-led. Data is the most valuable asset for sponsors, yet too often it was being handled as a deliverable, not a strategic advantage. Sponsors needed partners who could understand data and treat it with the same seriousness as the science itself, and they needed support to strategically translate it into regulatory confidence. 

That’s where MMS began. Serving a purpose with a talented team! 

Q: How did your experience in drug development shape that data-first philosophy? 

Early in my career, I worked on a compound where the data allowed us to consider the program for yet another indication. The more closely we examined the clinical results, the clearer it became that the therapy also belonged somewhere different than we initially believed. The signals ultimately pointed us toward a new indication, an evolving one, that at the time wasn’t well defined or widely accepted. I can still feel the excitement when we discussed that. We prevailed and established both the indication (with regulators included) and obtained approval allowing patients a new treatment option.  

That experience stayed with me because it reinforced something I believe deeply: effective drug development starts with listening. Listening to patients. Listening to the data. And being willing to let evidence guide decisions, rather than forcing a program to fit a predetermined narrative. 

Too often, compounds are labeled “failures” without asking the harder questions. Was the study designed appropriately? Was the data collected correctly? Was it interpreted with the right rigor and context? 

When those questions aren’t asked, the cost isn’t just financial. Patients may lose access to therapies that could have made a real difference. 

MMS was founded to close that gap by treating data strategy and regulatory strategy as inseparable, and by bringing scientific discipline to the decisions that determine whether a program moves forward or ends prematurely. 

Q: How does that philosophy translate into the way MMS works with sponsors today? 

We don’t operate as a traditional transactional CRO. We operate as scientific and strategic partners, with accountability for the quality of the evidence, not just the production of deliverables. 

In many cases, we have advised sponsors not to initiate an additional clinical study. Instead, we focus on maximizing what the existing dataset can support through targeted, hypothesis-driven analyses and a more rigorous interrogation of the clinical and statistical assumptions underlying the program. Sometimes, that involves additional safety exercises including analyses and white papers. That may not be the commercial default for many CROs, but it is often the most scientifically defensible approach, and it matters to patients waiting for therapies that may already have a viable path forward. 

A $20–40 million trial is not simply “the next step.” Every new study introduces operational variability, interpretability risk, and additional exposure without guaranteeing a clearer regulatory outcome. We start by assessing whether the remaining uncertainty reflects a genuine lack of evidence or a credible safety risk, and whether it can be reduced through clearer definitions and better alignment of the evidence already generated. That may include reviewing the estimand framework, intercurrent events, endpoint selection and hierarchy, and the integrity of data collection, missingness mechanisms, and protocol deviations. 

From a statistical perspective, we look for issues that can distort conclusions or undermine credibility: multiplicity and alpha allocation, sensitivity analyses for missing data, robustness to model assumptions, subgroup interpretability, and the consistency of treatment effect across relevant populations and endpoints. We evaluate whether the signal is diluted by design limitations rather than absence of efficacy, and whether alternative analytic approaches, including Bayesian methods or adaptive strategies, can provide clearer inference without compromising scientific integrity. 

Just as importantly, we position the program for the regulatory questions that matter most: Is the endpoint clinically meaningful? Is the magnitude of effect credible and reproducible? Are the results robust across sensitivity analyses? Is the benefit-risk profile coherent in the context of unmet need? And does the totality of evidence support a clear and defensible conclusion? 

This approach has helped sponsors, including those coming off trials labeled as “failed,” achieve successful approval pathways. A p-value is not a verdict. What matters is whether the evidence is internally consistent, clinically interpretable, statistically robust, and framed in a way that withstands regulatory scrutiny. 

Q: Can you share an example of how this approach has made a tangible difference for clients? 

There are many such moments over the years that I am particularly proud of, especially when the stakes are high and resources are limited. 

One example was when we worked with a smaller biotech developing a therapy in a rare indication where patient recruitment was inherently constrained, and every observation carried meaningful weight. The sponsor was under pressure from both investors and internal stakeholders to “generate more data,” but the real issue wasn’t the amount of data. It was how the existing evidence was being interpreted and positioned. They couldn’t afford the full scope of analyses requested and larger CROs walked away because they didn’t think out of the box and the budget wasn’t big enough to justify the effort. 

We stepped in and said, “You don’t need 80 tables. You need six.” 

Rather than producing an exhaustive set of tables, we focused on a small number of analyses that were most decision-relevant and scientifically defensible. That included: 

• a primary endpoint analysis aligned to the estimand and the clinical question being asked
• sensitivity analyses to evaluate robustness to missing data and intercurrent events
• an assessment of treatment effect consistency using clinically meaningful subgroup definitions, without over-interpreting noise in small N settings 

In parallel, we engaged regulators with a clear and transparent rationale for the analysis strategy, including why certain “conservative” choices would have reduced interpretability without meaningfully improving credibility. In rare diseases, unnecessary exclusion of patients or overly rigid population definitions can unintentionally eliminate the very evidence needed to understand benefit-risk. 

By focusing on inferential integrity, clinical relevance, and a coherent totality-of-evidence narrative, we helped the sponsor present results that were credible to both investors and regulators. That work supported continued funding and a viable regulatory path forward, without defaulting to an expensive and time-consuming additional trial. 

That is what it means to be a strategic partner, not a transactional vendor. 

These founding principles remain core to how MMS operates today. In Part 2, Dr. Sharma discusses how a ‘can-do’ mindset and commitment to cultural excellence have translated to regulatory and technological innovations and real-world impact for patients, clients and the wider industry.  

For more information, visit www.mmsholdings.com 

Learn more about MMS’ CEO Dr Uma Sharma: Click here