Clinical biopharma: Trials in the clinic, and in the business

As your therapeutic candidate enters the clinic for human trials, the stakes rise for your biopharma company. There are more complexities and a greater need for visibility and cash flow management. You are entering perhaps the most critical and complex part of your business’s evolution.

Even as you focus on patient recruitment, clinical trial results and data analysis, you need to ensure that you have a firm foundation and a strong digital backbone on which to build your business. Whether based on promising results or actual approval, your business could be poised to grow rapidly.

Key considerations for clinical success

Within your biopharma business, the lab is still important, but administrative investment becomes more critical. Now you must manage outside contractors, prepare for approval, build for expansion, fill a multitude of new roles and develop new capabilities. Considerations include:

Office planning and back office

• Evaluate your information technology infrastructure, including enterprise resource planning, to ensure that it will meet the company's growing needs.
• Make sure your data analysis capabilities go beyond crunching clinical trial results. Analyze market data and your own business data for insights and action items that can drive success.
• For key functions, continually evaluate whether these are best fulfilled under an outsourced, co-sourced or in-sourced model.
• Consider what kind of office location and setup you need and how to best accommodate in-office versus remote work needs.
• Analyze and update compensation programs to ensure they are sufficiently competitive and scalable to attract and retain talent.

Funding, financing and spending

• Develop and enhance financial planning and analysis processes to gain better visibility and optimize cash flow and expense management, inclusive of clinical trial costs.
• Identify the right contract research organization(s) for your company, product and disease indications, bearing in mind the importance of a successful partnership.
• Create processes to evaluate potential vendors and manage existing vendors.
• Consider acquiring or improving upon existing lab procurement and expense management tools.
• Adjust your audit, tax, and accounting processes and relationships to accommodate additional rounds of funding.
• Consider the risks and benefits of centralized versus decentralized trials; keep close tabs on trial recruitment.
• Think about how to monetize your intellectual property portfolio to raise additional capital.
• Have a robust long-range plan and an underlying planning process that is dynamic enough to respond to changing variables.

Commercialization and globalization

• Start thinking now about preliminary commercialization plans; phase 3 is too late to initiate this process.
• Identify your competition and potential partners.
• Strategically plan for globalization, considering distribution networks, tax structure and supply chains.
• Think about your future distribution strategies.
• Figure out how you want to set up your end-to-end supply chain.
• Begin vetting and selecting potential contract manufacturing organizations.
• Do you need to build out your company physically? Will that need to include manufacturing facilities?
• Fully develop your systems, processes, controls and product traceability to ensure regulatory compliance.

Collaboration

• Consider collaboration agreements and co-development agreements to spread risk.
• Explore these types of agreements as a way to raise additional capital or gain access to another therapy you need in your trial.

Data security

• Understand the applicability of privacy and data protection requirements and the potential ramifications of a data breach, which can be severe under both U.S. law and Europe’s General Data Protection Regulation.
• Prioritize cybersecurity, with the funding and resources to sustain it, so that you can decrease the likelihood and/or impact of regulatory noncompliance and data compromise.
• Consider further enhancement of controls protecting your intellectual property. As clinical trials progress and you approach approval, the risk of theft grows.
• This is a critical stage for the potential future of companies; investing now can help support long-term company viability.

Be ready for transformative events

Biopharma companies need to raise considerable capital to prepare for and conduct clinical trials—which often involves an initial public offering, but could be achieved through acquisition by strategic partners as well. Your company needs to be organizationally ready to undertake a transaction along these lines and then function effectively after completion.

• Try to have systems, processes, controls and reporting set up sufficiently to gear up if your company goes public; by later trial stages you may want to consider an IPO.
• Owners/operators should start exit planning to either protect ownership/control or position themselves advantageously if the company is acquired or if they want to cash out after an IPO.