Agile Launch for Life Sciences Companies is no Longer Agile Enough – Here’s How to Move Forward in 2021

Before the COVID-19 pandemic devastated the world and rapidly changed how life science companies do business, many pharmaceutical and biotech companies were still playing catch up. While some progressive companies adopted advanced analytics-infused agile launch, many others did not. Instead, they adhered to traditional approaches of relying on past launch templates, making significant investments in the peri-launch period, and relying heavily on field force activity for product success.

Unfortunately, for both the progressives and the laggards, the once-novel form of agile launch is no longer nimble enough. The pandemic ushered in a next-generation approach for launch agility, pushing companies to go beyond leveraging real-time data analysis and market trends in order to uncover and overcome adoption barriers as they are presented. Now companies must also harness advanced analytics to accurately forecast and successfully manage unexpected outcomes and market fluctuations.

Where the Market Stands

By now, it is well documented how the public health crisis disrupted lives and created market volatility around the world. For reference, the first quarter of 2020 saw increases in both total and new prescriptions as people stockpiled due to pandemic-based fears of medication supply shortages. The second quarter witnessed a decline in prescriptions, as people sheltered in place and healthcare practitioners limited in-person visits. Affordability also became an issue, among other factors, as unemployment levels rose. In the third quarter, however, prescriptions stabilized as the world adjusted to the new challenges of the pandemic. And, despite the unprecedented turmoil, the market finished 2020 strong.

Several critical success factors are attributed to launch success and should be thoroughly addressed by companies commercializing products. Past launch overperformers illustrate that being ready to launch is more critical than launching early, as it allows: 1) companies to ensure the market is properly prepared for the launch, 2) the product is available across relevant channels, 3) field teams are properly trained and deployed, and 4) marketing efforts are well underway. While this remains critical, recent analyses of launches in the COVID-19 environment reveal a next-gen approach for launch agility to achieve proactive organizational and market readiness in the post-pandemic world.

As the market navigated these unchartered territories, pharmaceutical and biotech manufacturers continued to introduce new products to the market in 2020. Many forward-thinking business leaders were forced to rapidly adjust to the changing market dynamics in order to socialize their products safely and conduct business prudently. An analysis of products launched during the pandemic revealed that companies rapidly adopted innovative solutions in a matter of months to mitigate the impacts of the pandemic. These solutions focused on:

1. Investing in digital programs to enable multi-channel market shaping and stakeholder engagement
2. Utilizing digital outreach tools and scaling up e-detailing efforts to maintain sales force activity as the majority of physician offices limited in-person visits
3. Designing websites and online campaigns to virtually connect patients to healthcare providers in order to understand disease and product background
4. Establishing partnerships with telehealth companies to ensure patient access to diagnosis and treatment
5. Modifying patient support and financial assistance programs to ensure uninterrupted access to treatment and alleviate the burden due to loss of coverage and financial hardships

These manufacturers reacted quickly, shifting to digital-centric solutions to accommodate the pandemic-induced new market realities. Well-deserved praise to them for succeeding in making it to market amidst one of the most challenging times in modern history.

Even as the vaccine breakthroughs bring hope for an end to the public health crisis, the reality is the business world is no longer the same. The fluctuating economy continues to put pressure on affordability and increases the need for enhanced patient support services. For supply chain and distribution, the dynamic shift in demand and accessibility must be continuously monitored and proactively addressed. Meanwhile, start-and-stop shelter-in-place guidelines along with lingering and latent fears of disease spread continue to hinder patient motivation to seek treatment for non-emergency needs. Given these pandemic-induced complexities, the path forward for product launch will require exceptional agility in the face of near-term uncertainty.

Operationalizing the Next-Gen Approach for Launch Agility

For companies launching a new product, the most critical lesson to learn from 2020 is to be forward looking. Put agile plans into place to expect the unexpected, while taking advantage of advanced technologies and best practices to anticipate, prepare for, and be ready to shift as new information comes in and disruptions occur.

At an organizational level, companies need to establish a master data management protocol and mechanism for real-time data collection and analysis to inform pre-launch decisions and post-launch course corrections. This means: 1) deploying an oversight committee for checks and balances to ensure an efficient launch and allow for rapid course correction, 2) creating a fit-for-purpose standard operating procedure and protocol to enable efficient, timely launch, and 3) establishing oversight committees for pricing, compensation, and promotional regulatory review, amongst others, to prioritize operational efforts and minimize inefficiencies.

The pandemic has accelerated the adoption of digital solutions that will continue to be heavily utilized in the future. This approach will generate even larger amounts of market data that organizations must be well-equipped to translate into actionable commercial strategies. This, in combination with advanced data analytics and machine learning algorithms, further bolsters the ability of functional teams to implement the next-gen approach for launch agility. Advanced analytics and machine learning play a key role across various functional areas in an integrated next-gen agile launch, specifically but not limited to:

• Sales: Machine learning-driven segmentation and targeting enable a more accurate and scalable targeting approach, leading to an enhanced understanding and dynamic design of stakeholder solutions
• Marketing: Provider network analysis allows a customer-centric approach that enables content and channels optimization and focused engagement, while taking into account the changing market dynamics
• Medical affairs: Cluster analysis, a reduction method of complex multivariable data, allows for more accurate customer segmentation and tailored value proposition, and ensures delivering on patient outcomes is a key driver in decision-making processes
• Clinical development and regulatory affairs: Machine-learning algorithms and real-world evidence support improved clinical trial design from study preparation to execution and forecasting of clinical trial outcomes, leading to potential acceleration of the approval process
• Market access: Predictive analytics inform pricing strategies and allow for the modelling of optimal discounts and rebates, while improving understanding of the product’s clinical value and cost effectiveness

It’s a given that no one can predict the future. Companies should take advantage of data-driven resources and tools to be in a position to know what can be known and control what can be controlled, while hard-wiring organizational mobility to be able to rapidly shift and account for changing market dynamics.

Moving Forward

As companies prepare for 2021 launches and beyond, it will be critical that advanced technologies and analytics remain fully utilized. Organizations must take a forward-looking approach by harnessing robust analytics and machine learning to design and implement successful commercial strategies. Those companies will have a head start on the next-gen agile launch approach moving forward and will be in a better position to launch successfully.

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Co-authored by Ryan Ariss, Consultant, Blake Beber, Consultant, and Maya K. Desai, Ph.D., Director