Commercial biopharma: Building on the organization’s post-approval success

With a product on the market, the main focus is ensuring it effectively reaches the targeted patient population while managing imperative operational and financial components. In addition, the clock is now ticking on your patent protection, which means there must also be a focus on a strong R&D pipeline and a potential appetite for an acquisition.

Key considerations for commercial success

FDA approval was the critical moment for entering the market with your product. Being successful in the market, though, requires keeping track of a multitude of “critical moments” going forward as your business evolves and your processes mature—and as investors and regulators eye you more intensely.

Internal processes, systems and staffing

• Reexamine your headcount. After your approval-stage hiring, are you overstaffed in some areas and understaffed in others? Is there more you could outsource?
• Leverage automation to offset some of your talent gaps.
• Prepare for increased legal concerns around intellectual protection and liability lawsuits.

Product life cycles, productivity, profit and growth

• Plan how to hedge against future generic competition.
• Can you find new distribution channels for your product?
• How do I focus on ensuring we have a strong pipeline to follow?

Information technology

• You’ve likely spent a lot of money investing in IT in advance of launch. It’s time to assess, rightsize and rationalize your IT investments and headcount. Can I consolidate some of my systems? How much should I outsource or can I leverage and build on my internal resources?
• You have more information than ever that is worth stealing; is your security up to the task of protecting it?
• How can you glean unanticipated insights from the massive amounts of data that you have collected and continue to collect?

Financial, accounting and compliance concerns

• Ongoing maintenance of revenue and gross-to-net modeling is a top priority for manufacturers.
• Tax considerations become even more important and complex as you go more global.
• Make sure you are handling SOX compliance and considering the need for an internal audit function.
• Maintain your compliance and reporting for government contracts and pricing.

Working on international expansion

• What is your ex-U.S. strategy and what potential foreign markets will you enter?
• Develop your sales and distribution strategy abroad.

Environmental, social and governance (ESG)

• Consider pricing and distribution of drugs vis-à-vis public relations. Who you market to, how you market to them and how much you charge can affect your image and reputation.
• Are you providing equitable access across the marketplace?
• Consider how your environmental reporting, carbon footprint, etc. can affect your profit margin (whether improving it via credits and tax benefits or harming it via fines and penalties).
• As you grow and expand, make sure to consider differing ESG issues and regulations in other jurisdictions.
• Have you thought about opportunities and issues related to diversity, equity and inclusion (DEI)?

Be ready for transformative events

As a fully realized company, more options than ever are in front of you—which, if any, will you pursue?

• Is now the time to consider entering ex-U.S. markets?
• Should you in-license or acquire intellectual property to progress research?
• If you haven’t entered the capital markets, is now the right time?
• Should you focus on existing clinical pipeline or consider an acquisition?
• Should you consider selling off any assets?