How Project Managers Can Help Accelerate Regulatory Submissions

Pharmaceutical and biotech companies want to speed up regulatory submissions for a number of strategic reasons. Competitors are close behind. Investors are eager to see progress. And most importantly, new therapies will enhance or even save patient lives.

The most effective cross-functional submissions teams work together, and with their executive leaders, to set and achieve reasonable but accelerated milestones. Here’s how project managers can do their part to speed up investigational new drug applications (IND), new drug applications (NDA), biologic license applications (BLA), and other submissions.

• Enable and lead cross-functional teams in working together. Document the process and define roles and responsibilities. Identify all interdependencies and handoffs between functions, and provide open communication channels.
• Work with management to understand and enforce budgets, priorities, and risk tolerance.
• Calculate the resources needed and the type of expertise required to accomplish a faster submission. Identify where you can get additional resources, internally and externally, and build a case for management.
• Work with the regulatory strategy, data management, clinical, pre-clinical, CMC, and medical writing teams to identify all potential acceleration methods, identify and mitigate risks, and document assumptions.
• Keep the team focused on the task at hand; for example, prevent them from collecting or analyzing nice-to-have data. Document ideas and potential opportunities that the company might consider tackling later, but don’t allow them to distract the team.
• Build scenarios that streamline submission activities and weigh the pros and cons. For example, Integrated Project Management Company worked with a biotech startup that used scenario planning that helped it to decide to file a clinical trial application (CTA) in Australia rather than an IND in the United States. Australia has fewer requirements, so the company hopes to gain approval there and continue testing to support its U.S. submission later.

For ways that other regulatory roles can work faster, as well as real-world examples of how they did so, download Working Together to Accelerate Regulatory Submissions.