spacer
home > epc > winter 2003 > streamlining phase i through a successful partnership strategy
PUBLICATIONS
European Pharmaceutical Contractor

Streamlining Phase I Through a Successful Partnership Strategy

The industry is under increasing pressure to streamline all phases of new drug development and significant emphasis is being placed on the ability of Phase I to identify and 'kill' unsatisfactory candidates quickly and efficiently. At the same time, this phase must arm the winners with not just safety information, but as much efficacy data as possible to help smooth the transition into later-phase clinical trials. These trends have strategic implications not only in the design of studies and programmes, but also in the organisation of R&D and selection of outsourced development partners.

Key Strategic Role of Phase I in Drug Development

Today, it takes around 15 years to develop a new drug from synthesis to NDA approval, and with the attrition rates associated with this process, the full R&D costs are, on average, more than US$800 million, with most of this being incurred during later phases of clinical development. Subsequent sales revenues are only sufficient to recoup the R&D investment for around a third of all drugs on the market. Therefore, the majority of launched products could have been terminated in R&D with a net financial benefit to the company. These considerations place significant economic emphasis on the selection and backing of only the winning candidate drugs. At the same time, new technologies in drug discovery, such as high-throughput screening, combinatorial chemistry and the 'omics', are generating more and more potential therapeutic targets. The net result is that the industry needs to be increasingly discerning in its selection process, identifying the very best candidate drugs from an expanding reservoir of new chemical entities entering development.

The real challenge is to identify the 'losers' and to stop their development as soon as possible. Apart from time, the key metrics in this process are safety, efficacy and commercial viability. With regards to safety and efficacy, a great deal of information can be obtained from increasingly rigorous in silico, in vitro and animal models available to support discovery and preclinical development phases.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Dr David Griffiths, Head of Business Development at LCG Bioscience

Dr David Griffiths joined LCG Bioscience as Head of Business Development in 1998, where he has played a pivotal role in creating one of the foremost European CROs specialising in exploratory phase clinical development. David's career began in R&D positions with Shell and Pfizer during which time he obtained a BSc in Applied Biology and a PhD in Drug Metabolism. He then joined a biotech start-up company as a Development Scientist, moving into business development where he was responsible for several successful projects within a fast growing diagnostics and health care group. David also holds an MBA from Anglia Business School, Cambridge.

spacer
Dr David Griffiths
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

High Throughput Analytics Herald a Paradigm Shift in the Development of Biopharmaceuticals

Heilbronn/Dortmund August 2019: Biopharmaceuticals have revolutionized therapies of various diseases. In particular with regard to chronical and/or severe clinical conditions like multiple sclerosis, rheumatoid arthritis or cancer they are considered the future of treatment. Also economically biological drugs are on their way up: The global biopharmaceuticals market is anticipated to reach about 400 billion USD by 2025. Which strategic alignment will help best to fill a successful pipeline?
More info >>

White Papers

The current and future role of the medical oncologist in the professional care for cancer patients: a position paper by the European Society for Medical Oncology

European Society for Medical Oncology (ESMO)

  The number of cancer patients in Europe is rising and significant advances in basic and applied cancer research are making the provision of optimal care more challenging. The concept of cancer as a systemic, highly heterogeneous and complex disease has increased the awareness that quality cancer care should be provided by a multidisciplinary team (MDT) of highly qualified healthcare professionals. Cancer patients also have the right to benefit from medical progress by receiving optimal treatment from adequately trained and highly skilled medical professionals. Built on the highest standards of professional training and continuing medical education, medical oncology is recognised as an independent medical specialty in many European countries.
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement