Future-proofing drug R&D to ensure a successful commercial launch

For the approximately 10% of biopharma candidates that actually manage to make it to clinical trials, many fail to achieve enough revenue once they reach the market to justify the R&D effort. In fact, one-third of drugs launched over a recent 10-year period fell short of sales expectations. Although some companies have the financial wherewithal and portfolio diversity to weather slower-than-expected sales trajectories or outright product failures, others are forced to sell off assets, seek acquisition or even close up shop.

For some products, the point of failure is a single oversight or miscalculation. Others stumble across multiple hurdles before finally calling it quits. However, not all product missteps end in outright failure –some companies are able to learn from their mistakes in real time, salvage their development efforts and emerge triumphant.

From each of these scenarios, valuable lessons can be learned and folded into the next development cycle. A review of multiple product setbacks and failures by Clarivate analysts revealed that they stemmed from a few common reasons:

  • Lack of early communication and collaboration across departments: Scientific discovery alone is often not sufficient to guarantee market success, yet R&D and early-phase trials continue to operate independent of clinical development, regulatory, commercial and market access teams. Without insight from across the company about what will drive success when the product emerges from the lab, issues occur when it can be too late or cost-prohibitive to implement countermeasures. Early due diligence informs a program design that addresses concerns across the entire development lifecycle.
  • Misinterpreting or not anticipating stakeholder expectations. It is not sufficient to assume that what worked during the last product market launch will meet the ever-evolving priorities of patients, physicians, governments, regulators and payers at the next product launch. Furthermore, what is considered appropriate for one country or region might not apply to others. Keeping a finger on the pulse of stakeholder demands helps identify products (molecules, platforms and devices) that answer unmet needs; establish clinical trial designs to collect the data needed to demonstrate efficacy, safety and benefit beyond merely clinical outcomes; and communication strategies to effectively differentiate the product.Even for biotech companies looking to be acquired after promising early-phase results, investors and potential partners are seeking confirmation that the product will be viable once it reaches the market—will it be acceptable to use, considered reimbursable, and does the value outweigh its risks? These stakeholders want to avoid inheriting poor choices that have already become part of the fabric of the product development process.
  • Not addressing red flags as they occur. Early regulatory feedback about additional data needed, competing developments in the same drug class/therapeutic area and criticisms of pricing are all examples of pending roadblocks that companies have ignored along the way to submission and market launch. The cost of continuing, in both resources and company reputation, was often higher than if the companies had paused to re-evaluate and adjust their strategies or to make crucial go/no-go decisions earlier.

Reviewing and analyzing past failures and recoveries highlight the types of data that can inform future product and clinical trial design as well as commercial launch, helping future-proof product candidates from early R&D through commercialization. These include real-world data about:

  • Patient unmet need
  • Biomarkers and disease/patient segmentation
  • Clinical trial sites in patient and physician-dense areas
  • Safety and efficacy signals of possible concern
  • Geographic differences in regulatory requirements
  • Evolving government policies and initiatives
  • The clinical and competitive landscape surrounding a developmental product
  • How to accurately value product candidates to secure funding and inform pricing and market access strategy

Hear from Clarivate analysts about specific examples of products that were overlooked, failed to gain market approval or struggled at launch in our Learning the Lessons of Failure: How to improve the economics of life sciences R&D webinar and how these roadblocks could potentially have been overcome with earlier, better-informed planning and monitoring.