The pharmaceutical industry faces a general challenge of productivity of innovation, which is evident, as the number of approvals appears to be steady, as the R&D expenditures in the industry in general are increasing (EFPIA). Almost 50 % of R&D investments in the pharmaceutical industry are allocated to the three main clinical phases, and 67.5 % if the fourth marketing and approval phase are included (PhRMA).

The clinical trial phases are defined by intensive human testing of new products, which have duration of 8 years in average (DiMasi 2001; DiMasi, Hansen and Grabowski 2003; Struck 1994). Only one of five products is eventually approved for the market and therefore survives all phases of clinical trials, with an estimated cost between $ 600 – 900 Million (Grabowski, 2003; DiMasi and Grabowski 2007).  

With such a significant ratio of R&D expenses spend on the clinical trial phases, a better understanding of this process is needed. Identifying critical factors with relevance to the performance of this late stage of the new product development offers the potential to improve effectiveness and efficiency of the overall innovation process.

This study will therefore focus on the process of clinical trials from an innovative management perspective in order to optimize these processes. The aim of the PhD project is therefore to increase our knowledge with respect to critical factors and conditions explaining the survival rate of new pharmaceutical products in clinical trials.
 
For further information regarding the project on innovation management of clinical trials in the pharmaceutical industry please contact the research team.

 
Research team

Marie Smed, PhD fellow

Cand. Merc. (International Marketing and Management) from Copenhagen Business School and M.Sc (Global Politics) from Southampton University, UK. Started her Ph.D. at DTU Business in 2009 in the subject of innovation management within the Pharmaceutical Industry. Her research interests include product innovativeness, coopetition, networks and alliances as well as political and societal influence on new product development.

Dr. Søren Salomo
Main supervisor

Dr. Carsten Schultz (TU Berlin, DE)
Co-supervisor

Advisory board

Karin Verland, MD

• Phoenixpharma — Pharmaceutical and health Care consultancy 2009 - present
• Pfizer Denmark A/S — CEO 2001-2009
• Danish Association of the Pharmaceutical Industry — Chairman of the board 2003-2009
• JANSSEN-CILAG A/S — CEO 2000-2001
• Baxter A/S — Country Managing Director for Baxter HealthCare Denmark 1997-2000
  — Business Unit Director, Dialysis Division Nordic 1996-2000
• MSD A/S — Sales and Marketing Director for the Cardiovascular Unit
• ASTRA DENMARK A/S — Product Manager/specialist 1987-1990

Ulf Hoppmann

• Boehringer Ingelheim — Manager Mergers and Acquisitions, 2007 - present
  — Involved in several international acquisition and divestiture projects of Boehringer Ingelheim with focus on Biotech, Consumer Healthcare and Animal Health.
  
• Ernst & Young, Corporate Finance — Advisor on Mergers & Acquisitions as a member of the European Health Science team, 2006 - 2007

Awards and Scholarships

The PhD project is financed through a full scholarship from Danish Technical University (DTU)

Idellafondet have granted this research project a 20.000 kr. (2650 €) scholarship for an external research stay

Marie has received an award as a high potential young researcher, and a research scholarship of 150.000 kr. (20.000 €) from Tuborgfondet.