Call for more patient-centered drug development in oncology — NEJM

In an article in the New England Journal of Medicine (NEJM), published online on 3 July 2013, Dr Ethan Basch highlights the lack of information on how a drug will make patients feel in the US label of most new cancer drugs.  … Continue reading

ECLIPSE study provides insights into biomarkers predictive of COPD mortality

Results of the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study were published on-line on 16 March 2012.  The trial, which enrolled 1’843 COPD patients and followed them for 3 years, was a prospective, observational study.  COPD is characterized by low-grade … Continue reading

CRO gearing up to deliver health outcomes

Dublin-based CRO, ICON, announced on 28 February that they have acquired PriceSpective, an established pricing and market access consultancy to expand their capabilities following their purchanse of Oxford Outcomes, a specialist  health economics and patient reported outcomes (PROs) consultancy, a little more than … Continue reading

Cancer Research UK calls for improvement of the EU clinical trials directive

In an article published in The Telegraph on 14 February 2012 Professor Peter Johnson, chief clinician at Cancer Research UK, said that while the principles of the EU clinical trials directive were “sensible” the increased bureaucracy which has arisen from its … Continue reading

The value of choosing the “right” indication for phase 2a

Even if your company is not planning to develop a pipeline asset through phase 3, you’re significantly more likely to secure a favorable deal with a pharma partner if you deliver relevant phase 2a data in a commercially viable indication. … Continue reading

The value of developing a good TPP for your product in early development

There have recently been a number of articles in biopharma publications and social media suggesting that the target product profile (or TPP) is an enemy of innovation and and reduces productivity in the industry.  The authors of these articles suggest … Continue reading