Risk and uncertainty are the only guarantees in the business of drug development. This makes it even more important for biopharma companies to control what they can – particularly in the early stages in the absence of any clinical data or even proof of concept. There are ways for young, preclinical companies to proactively control risk to minimize the impact on time and resources.
- Understand the precedents. At the outset, the preclinical plan should take into account any precedent research on the clinical indication or pathway, as well as regulatory precedent.
- Don’t wait to engage regulatory authorities. Conducting these discussions sooner can yield important early guidance on development plans.
- Keep current. It’s imperative to be aware of any updated guidance and regulations that pertain to your asset.
- Prior to staging costly experiments, such as IND-enabling, ensure that earlier data is intact and supports the future plan. Use unbiased resources to review data and make sound decisions.
- Ensure that FDA requirements are followed. A timely example relates to the use of animal models that fall outside of the required range for size/weight/age. In at least one instance this caused the FDA to put a complete hold on the development program, leading to significant delays and costs for the company.
- Validate testing protocols to ensure that appropriate data is being collected and that studies will not have to be repeated for lack of critical data elements.
- Confirm GXP compliance at all testing sites.
Apart from development risk, there are additional steps that preclinical companies should take to manage enterprise risk.
- Vendors must have information security controls and cyber security insurance in place. They will be handling very sensitive private data that could cause great damage if breached.
- Vendor qualifications should be thoroughly vetted and documented. Review any existing FDA issues or citations, and seek recommendations from reliable sources to assure proper vendor selection.
- Consider the development timeline with respect to the competitive landscape. Is there a chance that a competitor will enter the marketplace with a product that will render yours less valuable?
Managing all of the above requirements on top of designing and executing the studies can put a major strain on the resources of smaller companies. Leaning on external experts to supplement internal R&D teams or to review, validate, or oversee their work can yield valuable returns. Flexible, experienced advisors can provide or review study designs and provide step-wise oversight of analysis to minimize risk.