From Clinical To Market: Managing Pharma's Most Challenging Transition

By Richard Lowenthal, M.S., MSEL

Achieving regulatory approval for a new drug is an extraordinary achievement. The bar for success is high. Many companies with breakthrough scientific discoveries and promising clinical data still fall short of this significant milestone.

For companies that successfully navigate the rigors of the drug development race, market approval, understandably, is often viewed as the finish line. I believe it is the starting point for what is arguably one of the most difficult transitions of a pharma company’s growth: the evolution from development to commercialization.

Our team at ARS Pharm experienced the challenges of this transition firsthand. Following the approval of Neffy (epinephrine nasal spray) for emergency treatment of allergic reactions including anaphylaxis in adults and children who weigh 33 lbs. or greater, we evolved from our core focus on research and development to a fully integrated, commercial-stage company. That shift necessitated much more than new capabilities; it meant rethinking how we made decisions around launch timing, access assumptions, healthcare provider (HCP) prescribing, and other commercial competencies where there is often no playbook.

For growing pharma companies approaching this milestone, the challenges ahead appear to be concrete: standing up a commercial organization, solidifying payor relationships, and implementing market access programs, among other initiatives. But the most difficult work is often less obvious. It requires strategic, operational, and cultural change in company DNA. Looking back at ARS Pharma’s evolution, there are several lessons I learned.

Regulatory Approval Does Not Prepare You For Commercial Reality

As a development-stage company, success is driven by scientific rigor. Disciplined teams align around clinical execution, analytical decision-making, and the path to approval. Progress is incremental, and decisions are grounded in data.

Commercialization changes the rules.

Outcomes depend not just on data, but on prescribing behavior, market access, patient affordability, and the realities of the healthcare system. The urgency of decision-making intensifies because market dynamics demand it. You become accountable not only to regulators, but to payers, providers, patients, investors, and partners simultaneously.

These are not variables you can fully pressure test in advance. Moreover, they crystallize much quicker in commercialization compared to the R&D stage of operations.

Launch Preparedness Creates Value

One of the hardest leadership lessons for first-time commercial CEOs is accepting that launch preparation is not just an operational necessity; it is strategic leverage and value driver.

If you reach approval without a credible path to market, value stagnates. Regulators don’t reward inactivity, and neither do investors or potential acquirers. The willingness and capability to launch signals confidence in the asset and the organization behind it.

Like many companies, ARS Pharma evaluated multiple paths as we approached approval, including a potential transaction. We were built as a development organization, and there is always some inclination in that model to recycle capital and move on to the next program. That naturally shapes how leadership teams think about the end game in pharma.

At the same time, we took a pragmatic approach. We continued to prepare for commercialization because we understood that it had to be a viable path, regardless of whether a transaction materialized. You don’t really decide to sell a company; someone decides to buy it.

Further, we understood that our commercial readiness would provide potential partners with an important lens to see how Neffy would perform in the market; a value generator that cannot be minimized. Ultimately, we moved forward with commercialization ourselves.

The takeaway is straightforward: commercialization must be the default plan. That preparation creates optionality, whether you ultimately partner, transact, or launch independently.

Culture Is The Most Underestimated Commercial Risk

Perhaps the most underestimated challenge in the development-to-commercial transition is cultural.

Development teams are trained to question assumptions, demand statistical significance, and move cautiously. Commercial teams operate differently. They are driven by speed, narrative and responsiveness to market feedback.

The difference in mindset can show up quickly.

 We experienced this as we moved from approval into launch execution. Marketing decisions that “felt right” did not always align with learnings from R&D execution. Commercial urgency sometimes conflicted with analytical caution that was engrained in our company during the development stage. As CEO, my role became less about choosing sides and more about forcing clarity: What did we learn? What data supports this decision? And if it doesn’t work, how quickly will we know? And do we need to pivot?

Managing the development/commercial culture dynamic is a central leadership challenge. It requires creating clarity around what matters in each decision and ensuring the company can move forward without becoming paralyzed.

Learning Must Be Intentional

Commercialization also exposes something that is easy to overlook: experience, by itself, doesn’t improve execution.

Entering the shifting realities of the complex ecosystem that underlies our nation’s healthcare system, there were issues ARS Pharma encountered that we did not fully predict. Like many commercial-stage companies, we are navigating regulator expectations, payer negotiations, pricing dynamics, patient affordability, operational scale, investor scrutiny, and real-time market performance, all at once.

What matters is whether those experiences translate into different behaviors the next time.

It’s easy for companies to go through a full cycle, identify what happened, and still approach the next cycle in a very similar way. Without a deliberate effort to apply what was learned, the same mistakes can be repeated.

That requires discipline. You must keep revisiting what you observed, what drove the outcomes, and how decisions are being made differently as a result.

Complexity Scales Faster Than Expected

The transition to commercialization also introduces a level of complexity that is difficult to fully appreciate in advance.

In development, the stakeholder environment is relatively narrow. After launch, it expands immediately. You are working across payers, pharmacy benefit managers, physicians, patients, distributors, and investors, all operating with different incentives.

At the same time, performance becomes visible in real time. You’re no longer working toward a single event. You are running a business where results are constantly measured and influenced by factors outside your direct control.

For a CEO, the role changes immediately. It becomes less about driving toward a milestone and more about managing a dynamic system.

The Real Milestone Is Company Maturity

Above all, the development-to-commercial evolution is a company maturity test.

It changes and intensifies the needs for strategic planning, culture, and governance. It forces leaders to confront whether the company can evolve without losing its core strengths.

For ARS Pharma, commercialization has been a continuous learning process. The biggest lesson is this: success at approval does not guarantee success in the market.

The companies that navigate this transition best are not those with the flashiest launches, but those willing to adapt organizationally, culturally, and strategically to the new realities that come with commercialization.

Indeed, regulatory approval is an amazing achievement. Commercialization is its own unique test of resolve and leadership in drug development.

About The Author:

Richard Lowenthal, M.S., MSEL, is Cofounder and CEO at ARS Pharmaceuticals and has served as President and a member of the Board of Directors since 2015. He also served as Chairman from 2015 through 2018 and as Chief Executive Officer since 2018. He was previously President of Pacific-Link Regulatory Consulting and Research, Inc., a medicinal product development consultancy founded by Mr. Lowenthal. Prior to Pacific- Link Regulatory Consulting and Research, Inc., Mr. Lowenthal held leadership roles at MTG Biotherapeutics Inc.; Cadence Pharmaceuticals, Inc.; Maxim Pharmaceuticals, Inc.; AnGes, MG, Inc.; Janssen Research Foundation; and Somerset Pharmaceuticals Inc.; and was a New Drug Review Chemist at the FDA in the Division of Neuropharmacologic Drug Products, and the Division of Oncology and Pulmonary Drug Products. He has served as past chair of the American Association of Pharmaceutical Scientists (San Diego region), as well as member of the USP Biotechnology Expert Committee, Virology Working group, member of the National Organization of Rare Disease Corporate Council and has worked with various PhRMA and ICH Working Groups.