samedan logo
 
 
spacer
home > ict > autumn 2018 > clinical complexities
PUBLICATIONS
International Clinical Trials

Clinical Complexities

ICT: What are the main challenges faced by pharmaceutical companies when moving a candidate compound from the discovery lab through to first-inhuman (FIH) studies?

Torkel Gren and Anders Millerhovf: Moving a promising compound from the laboratory to the clinic is a complex, multistage challenge. You need to coordinate API production with formulation development and trial planning. The only way to do this effectively is for the teams involved in each of these processes to communicate properly.

Specific challenges include the limited quantities of API that are available, the need to develop formulations appropriate for FIH studies and for later-stage trials in parallel, and the ability to adapt to clinical protocol revisions. Effective communication between supply, formulation, and trial teams is vital, and achieving this can be a challenge, particularly if several different contractors are involved.

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
Torkel Gren is Senior Director, and Science and Technology Officer at Recipharm. He holds degrees in pharmacy and business administration, as well a PhD in pharmaceutics from Uppsala University, Sweden. Torkel has worked in the pharma industry since 1988 and has held a number of scientist and manager positions in Europe and the US. He was lead formulator and co-inventor of Detrol OD/Detrusitol SR. Torkel is Vice Chairman of the board of the Swedish Pharmaceutical Society.

Anders Millerhovf is Chief Executive Officer at Clinical Trial Consultants. He holds a degree in medical biology from Linkoping University, Sweden. Anders has worked in the life sciences industry since 2002 and has focussed on Phase 0 to Phase 2a projects in various project management and director positions. He has been a partner at Clinical Trial Consultants since 2012.
spacer
Torkel Gren
spacer
spacer
spacer
Anders Millerhovf
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

CHDI Foundation extends collaboration with IRBM to accelerate development of Huntingtonís disease therapeutics

IRBM, a global contract research organization (CRO), has strengthened its position in neurodegenerative disease research following an extension of its long-standing collaboration with CHDI Foundation, a nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that substantially improve the lives of those affected by Huntingtonís disease (HD).
More info >>

White Papers

Biosimilars In Emerging Markets: Is It A Level Playing Field?

PRA Health Sciences (PRA)

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
More info >>

 
Industry Events

Multimodal 2019

18-20 June 2019, NEC, Birmingham, UK

Now in its twelfth year, Multimodal is the UK and Irelandís premier freight transport, logistics and supply chain management event.  Shippers and cargo owners attend to improve their businesses; by finding ways of moving their products more efficiently and by meeting new suppliers. 
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement