Clinical Development

GUIDANCE FOR CLINICAL TRIAL DESIGN

It’s Life Science, not just business.  Your technology will directly impact people's health and well-being.   

It could extend life ... sustain quality or lifestyle ... reduce the cost of care for patients or providers ... increase diagnostic accuracy ... reduce the workload of caregivers ...  in short, improve the delivery and state of human health. 

We advise developers, funders and acquirers of Life Science technologies, on next steps in scientific and clinical development that will directly or indirectly impact commercial viability. 

Our principals have many decades' experience advising individuals and companies in:

  • Preclinical concept testing for prospective commercial interest
  • Pipeline acquisition: platform strategy and target optimization
  • Differentiation strategies based on mechanism, indication, population, dosing, endpoints
  • Phase II and III trial design: populations, comparators, endpoints, outcomes
  • Clinical and patient-reported outcomes measures to include in trials
  • Commercial stop rules (go/no-go decisions) during clinical development
  • Cannibalization & impact on existing franchise
  • Efficacy, adverse events and administration criteria
  • Dosing and delivery system refinement for orals, injectables, other

Clinical directions are informed by commercial realities.  Strategies that consider both are central to our client partnerships. 

We’ve developed research-informed commercial and clinical strategies for everyone from start-ups to mid-size firms to the largest healthcare companies in the world.  We're entrepreneurs ourselves, and we understand the convergence of science and business.