Launching an innovative medicine that can positively transform people’s lives is one of the most fulfilling and challenging things we do in the world of healthcare. With the FDA approving 48 new treatments in 2019, and many new approvals on the horizon for 2020, there’s abundant opportunity to experience what these launches are all about. In recent years, the origin of these launches has shifted considerably from big pharma to smaller, innovation-driven startups. In fact, startups have accounted for 63% of all new prescription drug approvals over the past five years, according to HBM Partners.

From an agency perspective, partnering with innovative small companies that are engaging in trailblazing science can be quite rewarding. But working with companies new to commercialization requires a different approach, requiring greater flexibility and creativity in your thinking. Here are five important guidelines to keep top of mind:

1. You’re establishing both the brand and the company.

To a significant degree, that first brand launch is also a corporate launch, so a wider range of marketing factors need to be taken into consideration. A lack of corporate awareness can potentially hinder acceptance of the brand. Creating positive company perception and branding is therefore critical in establishing credibility for—and driving adoption of—the treatment itself.

2. Budgets are often limited.

New pharma and biotech startups are heavily dependent on outside funding. The Tufts Center for the Study of Drug Development estimated the average cost of bringing a new drug to market with post-approval research and development costs was $2.8 billion. Pockets are not as deep as those of big pharma. The startup may not make a profit for a number of years. Commercial teams therefore need to stretch their marketing dollars and will require the most innovative and targeted thinking to support their launch efforts. Agency partners must come specifically equipped for this kind of challenge and be ready to shake up their traditional thinking.

3. Agility drives ability.

Working with limited resources is a common hallmark of the startup launch experience. This requires a higher degree of agility, creativity, and, yes, boldness on the part of internal and external teams. It’s vital to maximize the impact of the resources that are available. As agency partners, we often become extensions of the internal commercial team, providing a wider range of critical services than is typical for an agency. Stepping into uncharted launch territory means there will be things that will be overlooked or don’t go as planned. Therefore, every day we must be on our best game, bringing our best insights and thinking, and constantly critiquing the launch plan to ensure nothing has been missed—while managing to get the huge volume of work completed on time and on budget.

4. Process shouldn’t impede progress.

Maximizing startup agility means minimizing bureaucracy. Startups often don’t have standard processes in place or best practices to draw from. This includes everything from medical, legal, and regulatory review committees to standardized financial documents or best practices for launch, to name a few. This lack of structure doesn’t signify a lack of organization, nor is it a pass for freewheeling decision-making. It does mean there is fertile ground to develop an SOP that takes into consideration the specific needs of the brand and launch team and also benefits the future of the company. While a “roll up your sleeves” attitude is essential, careful attention needs to be paid to implementing company policies, particularly with respect to pharma compliance. Fortunately, agency partners offer the skills necessary to help make process a positive rather than a hindering force.

5. Infrastructure may need to be constructed.

It takes time to establish marketing operations infrastructure, yet it is a vital component of day-to-day marketing and sales operations. Drawing upon prior best practices and outlining pros and cons can help determine contingency planning. As agency partners, this can translate into actually building a central analytics HUB, integrated CRM to CLM, and sales platforms—demonstrating once again that in startup launch environments, agencies must come prepared to deliver value far beyond what is expected in a traditional launch.

In Conclusion

All things considered, the shifting healthcare environment poses challenges to any company launching a medicine. With the right partners and preparation, you can proactively adapt your planning and execution to the changing needs of the market. At the end of the day, each product launch remains about the patient and the potential it has to impact their lives for the better.

  • Kim Barcenilla

    Kim Barcenilla is EVP, Director of Account Service at Calcium. Kim has 20 years of experience in Client Services and has launched biopharmaceutical brands across various therapeutic areas. Her forward-thinking approach and passion to advance healthcare for patients inspires her to provide innovative and engaging solutions to today’s healthcare challenges.


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