Every pharma executive faces the same core challenge: developing safe, efficacious therapies that reach patients while delivering sustainable returns.
The industry exists for one fundamental purpose: to discover, develop, and deliver innovative treatments that are both clinically proven and commercially viable. Yet despite record R&D investments, most companies are trapped in cycles that work against this mission:
- Lengthy development timelines that erode patent value and delay patient access
- High capital investment with uncertain outcomes, where failed programs may cost hundreds of millions
- Growing operational complexity that pulls resources away from core innovation
The challenge is no longer just scientific, it’s operational.
While leadership focuses on the right strategic goals, fragmented execution models often make them harder to achieve.
The Real Executive Imperatives
Based on extensive research with pharma leadership, three priorities consistently emerge:
- Maximize the probability of regulatory success – Get therapies through approval with robust evidence packages
- Optimize portfolio economics – Ensure sustainable returns that fund future innovation
- Accelerate time-to-patient – Minimize the window between discovery and therapeutic availability
These aren’t isolated objectives; they’re interconnected challenges that require coordinated solutions. Optimizing each in isolation can unintentionally create friction elsewhere.
Why Traditional Approaches Fall Short
Most organizations respond to these challenges with point solutions:
- For regulatory success: “We need better data management.”
- For portfolio economics: “We need to reduce trial costs.”
- For time-to-patient: “We need faster recruitment.”
This fragmented approach creates three recurring operational obstacles that undermine core pharma objectives:
Late-Stage Data Integrity Risks
Phase III submissions now include over 3.6 million data points; triple the volume from a decade ago. When data issues arise late in development, they can delay approvals and reduce the effective patent window. For many therapies, this results in a material loss in potential revenue during peak exclusivity.
Expert Resource Inefficiency
Clinical statisticians and medical directors spend 50–70% of their time on manual data preparation instead of strategic analysis. This limits the speed and depth of critical program decisions.
Lack of Scalable Execution
Many programs tackle the same data challenges repeatedly without reuse. High-performing teams build scalable frameworks that accelerate timelines and compound value across programs.
What Separates High Performers
The small percentage of companies that consistently outperform industry benchmarks invest in three distinct capabilities:
Submission-Ready Data Architecture: Rather than scrambling to assemble regulatory packages at the end of a trial, these companies maintain audit-ready data throughout the lifecycle. When regulators request additional analyses, they respond with full traceability and documentation, eliminating the 6–18 month delays that often occur between study completion and submission.
Self-Service Analytics for Decision-Makers: Clinical teams can generate complex statistical analyses without waiting for data science support. A medical director can ask, “Show me safety signals by dosing cohort,” and get rigorous, documented results immediately. This accelerates go/no-go decisions and keeps expert time focused on strategy, not data wrangling.
Connected Evidence Generation: These companies link preclinical safety data, biomarker results, and clinical outcomes in real time. This enables earlier detection of dose-limiting toxicities, more targeted patient selection, and stronger regulatory submissions grounded in connected data.
The Compounding Advantage
Companies with integrated operational platforms demonstrate measurable gains:
- 20–30% shorter development timelines
- Higher Phase III success rates due to better dose optimization and patient selection
- Submission acceptance rates above 85%, compared to industry averages of 60–70%
More importantly, their capabilities improve with each program.
Every trial generates reusable analytical frameworks, validated data models, and institutional knowledge that strengthen the next one.
The Strategic Imperative
The shift toward integrated operations is accelerating. Regulatory bodies are converging on real-time data expectations from the FDA’s digital submission initiatives to EMA’s real-world evidence frameworks and ICH M11 protocol standards.
Companies that invest in these capabilities today will be best positioned to lead as these expectations become the norm.
The Choice Facing Leadership
For pharma executives, the strategic decision is becoming urgent:
- Continue optimizing fragmented processes—and remain stuck in cycles of preventable delays, cost overruns, and missed opportunities.
- Or build integrated operational capabilities—systems that improve regulatory success rates, optimize portfolio economics, and accelerate therapeutic availability.
The companies making this shift aren’t just achieving faster approvals—they’re building institutional capabilities that compound with every program. This leads to greater patient impact and long-term competitive advantage.
Integrated platforms are fast becoming the new industry standard. The real question is whether your company will lead this transformation or be forced to catch up.
About the Author: Aruna Adhikari Thapa is the Chief Product and Commercial Officer at PointCross Life Sciences, and a 2024 PharmaVoice 100 honoree recognized for her leadership in advancing the use of technology and AI across clinical development and regulatory operations. She is a product and commercial expert with over 20 years of experience scaling AI-powered SaaS businesses, transforming healthcare through data innovation, and driving enterprise growth across regulated industries.
References
- Biotechnology Innovation Organization (BIO), Clinical Development Success Rates and Contributing Factors 2011-2020 → link
- GlobalNewsWire: Tufts Center for the Study of Drug Development (CSDD), Protocol Complexity and Data Growth Studies 2021-2024 → link
- Fierce Biotech, Drug development cost pharma $2.2B per asset in 2024 as GLP-1s drive financial return → link