Clinical Development in Biotech: The 3 Biggest Challenges and How to Tackle Them

Emerging biotechs are driving scientific innovation—but when it comes to clinical development, the road is anything but smooth.

After two decades in clinical operations and drug development, I’ve seen how early-stage biotechs often face the same recurring hurdles. These issues are now magnified by rising expectations, tighter timelines, and increasing complexity. A recent McKinsey report confirms this: despite more innovative pipelines, R&D productivity remains flat. The main challenges? Rising trial costs, complex protocols, and mounting recruitment difficulties.

1. Rising Cost of Clinical Trials

   Biotechs are under pressure to move faster and collect more data, often without the resources of big pharma.

   
   

   As McKinsey notes, development cycles are growing longer, with trial costs now accounting for up to 70% of total drug development budgets. Without the right planning and vendor oversight, expenses can spiral quickly.

   
   

   ✔ How I help: I work closely with clients to design leaner, scalable clinical programs—prioritising what’s essential for decision-making, while maintaining GCP and regulatory compliance.

   
   

2. Patient Recruitment Challenges Finding and enrolling the right patients, especially for advanced therapies or rare indications, is more difficult than ever. McKinsey’s data shows enrolment productivity is dropping, with fewer patients enrolled per site per month. For early-stage biotechs, this means delays, higher costs, and frustrated teams.

   
   

   ✔  How I help: From site strategy to inclusion/exclusion criteria, I bring a pragmatic lens to protocol feasibility, flagging challenges early and ensuring cross-functional alignment to avoid bottlenecks.

   
   

3. Protocol Complexity New science often comes with complex study designs, more endpoints, and demanding data requirements.

   McKinsey reports that the average number of endpoints in Phase 2–3 studies has increased significantly. This creates operational strain, not just for sponsors, but also for sites and patients.

   
   

   ✔ How I help: I guide biotech teams to balance innovation with operational reality, mentoring teams and vendors to anticipate complexity, streamline assessments, and adapt study design where needed.

   
   

   In a resource-constrained environment, biotechs need more than good science, they need hands-on, experienced leadership to navigate trial complexity with confidence.

   That’s where I come in.

   🧬 Let’s talk about how I can help your team de-risk and accelerate your clinical development.