How Early-Stage Planning Strategies Are Optimizing Drug Development

Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact. Strategic decisions made at a program’s outset shape its adaptability to emerging data, competitive shifts, and technological advances. As novel modalities and insights into disease biology proliferate, sponsors must prioritize opportunities through a structured framework that balances feasibility, reimbursement potential, and therapeutic value.

Citeline and IQVIA's global survey of 100 drug-development professionals—spanning discovery through Phase II—reveals that 83% of biopharma companies now employ a formal TPP, yet only two-thirds develop multiple scenario-based profiles. Best practice entails defining a minimally viable profile, a base-case target, and an aspirational benchmark, then continuously refining the living document as trials progress. Smaller biotech firms emphasize commercial viability and technical feasibility to attract investment, while large pharma focuses on cost management and risk mitigation. External expertise in regulatory strategy, clinical design, and indication prioritization is sought by nearly two-thirds of respondents, underscoring the value of diverse perspectives. Looking ahead, artificial intelligence emerges as the foremost accelerator of early-stage programs. Embracing dynamic TPPs, external input, and advanced technologies will empower sponsors to optimize timelines, manage uncertainties, and deliver transformative therapies to patients.