The COVID-19 pandemic forced the pharmaceutical industry to do what once seemed impossible: compress launch cycles that traditionally stretched over a decade into mere months.
The urgency of the crisis redefined what “readiness” meant, with organizations working across functions, geographies, and regulators at a pace previously unthinkable. While the world has shifted into a post-pandemic reality, the lessons learned from this period of radical acceleration remain invaluable. The question now is not whether we can move at crisis speed; it’s how to translate that experience into sustainable models that balance agility with resilience, compliance, and patient safety.
The Compression of Time
Before 2020, launch readiness followed sequential milestones: clinical trials, regulatory submissions, and commercialization often moved linearly. COVID-19 shattered that model. Timelines were compressed through real-time data sharing, parallel workstreams, and unprecedented collaboration between industry and regulators. Time compression is possible when urgency demands it but requires rethinking governance, decision-making, and resource allocation.
From my experience leading a launch team at a large pharma company, I witnessed firsthand how traditional timelines could be collapsed without compromising safety. In early 2020, our team was tasked with accelerating the development of a drug for COVID-19. We tore up the old playbook: steps that used to happen sequentially were done in parallel.
For example, we initiated large-scale manufacturing at-risk while Phase III trials were still underway, a bold resource allocation decision that meant producing doses before final approval. We also worked closely with regulators through “rolling” data submissions, sharing emerging trial results in real time so that review processes ran concurrently with trial execution.
This overlapping of activities involved key trade-offs. We had to accept higher upfront costs and the possibility of rework if a trial failed, but these were balanced by constant regulatory oversight and built-in safety checkpoints. By the time the pivotal trial read out positive results in April 2020, the FDA was already deeply familiar with our data, enabling an EUA.
The compressed timeline demanded long hours and new levels of coordination, but it taught us that with urgency, years of work can be done in months, provided teams are empowered and coordination is tight. It was a radical departure from business-as-usual, one that proved we could maintain high standards under extreme time pressure by making smart adjustments (like concurrent manufacturing and real-time regulatory reviews).
This experience fundamentally changed my perspective on what is achievable.
I now know that seemingly ‘impossible’ timelines can be met by reimagining processes and embracing calculated risks.
The Power of Agile Collaboration
At the heart of this acceleration was agile cross-functional collaboration. Regulatory, clinical, manufacturing, commercial, and medical affairs teams had to shed traditional silos and operate as a single organism. Leaders relied less on hierarchy and more on rapid, transparent communication, enabling issues to be identified and resolved in days instead of weeks.
This was not just operational efficiency; it was cultural transformation. For many organizations, the pandemic revealed the latent capacity of their people to rise to extraordinary challenges when empowered with trust and clarity of mission.
I recall a specific story of cross-functional collaboration that I witnessed during the height of the Covid-19 crisis. In mid-2020, as we were ramping up Covid-19 drug production, we hit a potential snag: a critical raw material was in short supply globally.
Normally, the manufacturing department might struggle in isolation or escalate through a bureaucratic chain. But instead, we convened an emergency cross-functional huddle that same day, pulling in experts from supply chain, procurement, regulatory, and even our legal and partner teams.
Within days, this ad hoc task force identified an alternative supplier overseas, and our regulatory team proactively worked with the FDA to ensure the new source would not derail compliance.
Under normal circumstances, such an issue might have taken weeks of memos and inter-department negotiations. During the pandemic, it took two days and a few frank phone calls.
This experience highlighted to me that hierarchy can become secondary to mission, junior team members flagged problems without fear, and senior team members acted as leaders rather than gatekeepers.
During this time, I led regular stand-up meetings each morning with representatives from R&D, clinical operations, marketing, medical, and manufacturing all in one room. In these meetings, if, say, a clinical trial enrollment issue arose, our commercial team (with their on-ground physician contacts) and insights team (with patient outreach tools) would immediately brainstorm solutions instead of waiting for directives. Having all the right people at the table meant problems got solved almost instantly.
This period showed me a new model of leadership: one where transparency, speed, and trust triumphed over rigid structures. When people are united by a clear purpose and given the autonomy to act, they can achieve feats that top-down management alone could never accomplish.
What Needs To Stay
Now, the industry must decide which elements of “crisis mode” should endure. Among the most critical are:
● Agile governance models that empower teams to make decisions quickly while maintaining accountability.
● Embedded cross-functional collaboration, not as an emergency measure but as a standard operating principle.
● Digital-first engagement, from trial recruitment to medical education, which proved invaluable when physical access was limited.
● Flexible supply chains that can pivot quickly in response to global disruptions.
From my perspective, the most critical practice to carry forward is agile governance. In a crisis, we learned the value of streamlined decision-making structures, and I believe this is the linchpin that enables all other improvements. An agile governance model means establishing small, accountable leadership squads and ‘tiger teams’ that can rapidly evaluate data and authorize actions. In my organization, we created a COVID-19 response steering committee that met daily and had the authority to green-light trials, allocate funding, and shift resources on the fly.
For example, when early data suggested a new patient subgroup could benefit from a drug, our committee approved a protocol amendment within days, something that would usually require weeks of review.
This kind of empowerment ensured that teams didn’t sit idle waiting for approvals. They had air cover to act swiftly, with leadership clearing roadblocks in real time. It also maintained accountability. Each decision was logged and reviewed in parallel by teams to ensure we never cut ethical or safety corners.
In short, agility in governance is what converts good ideas into good results. Retaining this practice beyond the pandemic is, to me, most critical for building a resilient organization. When urgency strikes again, having empowered governance will mean the difference between scrambling reactively and responding with coordinated confidence.
Even during non-crisis times, this model can accelerate innovation by ‘trimming the fat’ of overly complex decision chains while still upholding rigorous oversight. We shouldn’t need a crisis to act with urgency. Agile governance can make urgency the norm when it matters most.
The Digital and Data Revolution
COVID-19 was a proving ground for digital tools and real-time data. Virtual trials expanded access and accelerated recruitment, cloud platforms enabled global collaboration, and real-world evidence gave regulators unprecedented insight into safety and efficacy.
The next step is integrating these capabilities into standard launch readiness frameworks. Real-time data sharing and digital platforms should be treated as essential infrastructure, enabling faster, smarter decisions beyond the pandemic.
One example from my work during the pandemic highlights how digital tools transformed a key aspect of launch readiness, and it signals where I see the greatest potential going forward.
Faced with a virus that was both novel and highly unpredictable, our team did not have the luxury of robust historical data to forecast patient surges or variant patterns. Instead, we adopted a scenario-planning approach, preparing for low, medium, and high surge situations in parallel. This meant building flexible operational playbooks where manufacturing, distribution, and medical engagement could scale up or down depending on how the pandemic unfolded.
Digital tools played a crucial role in making this possible. Real-time dashboards pulled in global case counts, hospital utilization rates, and supply chain data, allowing us to constantly stress-test our scenarios and adjust in near real time. For example, when hospitalization spikes began to appear in certain geographies, our digital monitoring systems triggered supply chain alerts so that the drug stockpiles could be redirected quickly. Similarly, our medical affairs teams
used virtual platforms to pivot educational content depending on whether a region was facing a moderate or severe surge.
In essence, digital enablement gave us preparedness, not prediction. By having structured scenarios and the tools to monitor signals dynamically, we were ready for whichever path the pandemic took. If we embed scenario-based planning supported by digital infrastructure into all launch readiness frameworks, we will not only react faster but also be prepared for multiple possible futures.
Beyond COVID-19, I see tremendous potential in using these same methods to manage uncertainty in other therapeutic areas, whether anticipating shifts in patient demand, supply chain shocks, or competitive entries. Digital collaboration tools, from shared cloud environments with regulators to AI-driven scenario simulators, will be the backbone of these efforts. Embracing them as permanent infrastructure means decisions that once took weeks can be made in near real time with confidence.
Building for the Future
The pandemic reminded us that patient safety and regulatory compliance cannot be compromised, even under extreme pressure. But it also demonstrated that speed and safety are not mutually exclusive. By rethinking launch readiness through the lens of agility, collaboration, and digital enablement, pharma leaders can position their organizations not only to withstand the next crisis but to thrive in an increasingly dynamic global landscape.
The future of launch readiness will not be measured solely in how quickly we can bring new therapies to market. It will be measured in how effectively we embed the best of crisis-driven innovation into sustainable, resilient systems that put patients first.
On a personal level, I am genuinely excited about the future of launch readiness. What excites me most is the realization that the old constraints were more malleable than we thought. We’ve seen that drug development doesn’t have to be a slow, monolithic journey. It can be adaptive and lightning-fast when guided by science and enabled by modern tools.
I’m thrilled by the prospect of applying the agile mindset permanently, where cross-functional teams continue to collaborate as closely as they did during the pandemic, not because of emergency but because it simply yields better outcomes. I’m also energized by the advances in data and digital tech. Imagine using AI to design clinical trials that optimize themselves in real-time, or predictive models that help us allocate resources even before a health threat fully emerges.
These are no longer far-fetched ideas but tangible next steps and being part of an organization that invests in these areas. Personally, I plan to champion the continuation of the rapid-response culture.
I believe many of the pandemic’s lessons can evolve into standard practice. The COVID-19 crisis was a harsh teacher, but it gifted pharma a new playbook. Now, it’s up to us to keep refining that playbook. The agility, unity, and innovation that emerged in the face of disaster should become the foundation of how we operate moving forward. I am confident that by holding onto these advances and never losing sight of our ultimate mission to put patients first we can usher in a new era of pharmaceutical launches.
I look forward to a future where life-saving therapies get to those in need faster than ever, where the industry can nimbly navigate uncertainty, and where ‘readiness’ means being prepared not only for what we expect, but also for the surprises that inevitably come. The post-pandemic world will continue to test us in unforeseen ways. However, now that we are armed with the lessons of COVID-19, we stand ready to meet the challenge at the speed of crisis, every day if needed.
About George Stephen
George Stephen is an accomplished pharmaceutical executive at Gilead Sciences with over 15 years of global experience leading cross-functional drug development programs, strategic planning initiatives, and portfolio management in the biotech and life sciences industries. He holds an MBA from the University of Chicago Booth School of Business and has been featured in Science Times for his leadership in COVID-19 treatment development.
