Clinical Development

2.21.2014 Clinical Development

Roche’s Bad News Emphasizes Clinical Data Transparency and Patient-Reported Outcomes

By Nicole May, Research Analyst Roche’s recent announcement about the failure of its schizophrenia drug, Bitopertin, highlights two hot topics within pharma: clinical trial transparency and patient-reported outcomes (PROs). The drug failed to...
 

2.4.2014 Clinical Development

Planning Ahead to Meet Clinical Data Stakeholders’ Expectations

By Sarah Ray, Research Analyst Clinical data transparency has become one of the hottest issues for pharmaceutical and biotechnology clinical development and regulatory teams. From new disclosure policies at PhRMA and the EFPIA to working with the...
 

1.30.2014 Biomarkers

Can a Video Game Diagnose and Treat Mental Health? Clinical Trials are Underway

By Natalie DeMasi, Research Analyst In today’s age, many people play video games to relieve stress, solve riddles, overcome challenges, conquer opponents and plain-old have fun.  But what if people could play video games as a form of medicine? ...
 

1.8.2014 Clinical Development

Drug Safety Data and HEOR Driving Clinical Trial Costs and Time

By Ryan McGuire, Research Team Leader The healthcare marketplace has seen seismic shifts over the past five years.  Austerity measures have strained the reimbursement climate in many EU countries and driven government payers to scrutinize every...
 

1.6.2014 Biomarkers

Pharma Gets Personal: The Cost of Personalized Medicine

By Victoria Cavicchi, Research Analyst The end of big pharma’s blockbuster era is often in the forefront of the industry’s strategic planning.  Healthcare’s focus has long reflected pharma’s focus on products with far-reaching effects. ...
 

1.2.2014 Clinical Development

Get Safety Data Right the First Time in Critical Phase 3 Trials

By Ryan McGuire, Research Team Leader Getting safety data correct the first time is essential to keeping drug development on schedule and avoiding potentially costly overruns.  Several recent cases in which regulators requested additional drug...
 

12.23.2013 Clinical Development

Targeting the Alpha 7 Nicotinic Receptor May Be More Difficult Than Companies Originally Anticipated

By Sarah Ray, Research Analyst One of the characteristic symptoms of schizophrenia is patients’ inability to differentiate among important and unimportant stimuli in their environments.  Researchers attribute this symptom to a “P50 Auditory...
 

12.2.2013 Clinical Development

Clinical Teams Should Re-Think Risk-Based Monitoring to Improve Their Bottom Line

By Jennifer Harrell, Research Analyst Often, news surrounding the clinical development process seems pretty grim.  R&D budgets are being slashed, promising new compounds fall short in late-stage trials, patients struggle to find and enroll...
 

11.26.2013 Clinical Development

Let’s Give Thanks for Specialized Clinical Trial Third-Party Vendors

By Nicole May, Research Analyst This Thanksgiving, let's all put down our forks and thank third-party vendors performing critical clinical trial tasks. Third-party clinical trial vendors provide Continue reading “Let’s Give Thanks for...
 

11.5.2013 Clinical Development

Expanding Schizophrenic Patients’ Treatment Options: A Look into Companies’ Clinical Pipelines

By Sarah Ray, Research Analyst Back in July, Biopharm Insight noted that a number of companies have drugs with new mechanisms of action (MoAs) that target patients’ negative and cognitive symptoms.  These compounds exist across various stages...