samedan logo

 
 
spacer
home > ict > winter 2009 > stemming the tide
PUBLICATIONS
International Clinical Trials

Stemming the Tide

 

One of the most interesting developments of 2008 has been the news that the US Food and Drug Administration (FDA) is considering the intention of three US biotechnology companies, Geron Corporation, Advanced Cell Technology, and Novocell, to commence clinical development of human embryonic stem cellbased therapies (1). It can only be a matter of time before European regulators will have to face similar issues. Given that means of isolating human embryonic stem cell hESC lines were only discovered in 1998, the regulatory framework has had a comparatively short period of time to respond to the challenges presented by these innovative therapeutic agents. This article examines the UK’s response to such challenges.

WHAT REGULATORY ISSUES WILL BE FACED IN THE UK?

Anyone seeking to develop a therapy that has been derived from human embryonic stem cells is faced with three, to some extent overlapping, sets of regulatory issues affecting the following matters, each of which is overseen by a separate regulatory authority (2).

  • Work on human embryos – regulated by the Human Fertilisation and Embryology Authority (HFEA)
  • Processing and storing tissues and cells for use in human subjects – regulated by the Human Tissue Authority (HTA)
  • Conducting clinical trials in human subject – regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) (3)

Each raises its own legal and regulatory issues, which are examined in turn below.

WORK ON HUMAN EMBRYOS

Using human embryos as a source of material for therapeutic agents has been an ethically controversial topic for some time, and this has resulted in widely differing approaches in different European countries to the permissibility of such activity. The UK has, through the HFEA, regulated the creation, storage and use of human gametes and embryos since 1990 in a comparatively permissive manner (4).


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

John Wilkinson is a partner in the Life Sciences Health Industry Group at international law firm Reed Smith. John’s practice focuses primarily on the life sciences sector, advising pharmaceutical, biotechnology and medical technology companies, as well as financial institutions, on a wide range of IP, regulatory and transactional matters. John’s practice has involved advising companies in the US, UK, Denmark, Hungary, Switzerland, Portugal, Germany and Belgium. John trained and qualified at law firm Lovells in 1993 and moved to Cancer Research Technology Limited in 1998. In 2000, John joined the law firm Bird & Bird, before moving to Reed Smith in 2005.

 

spacer
John Wilkinson
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Merck Introduces New Integrated Plug & Play Upstream Development Service

• Adaptive approach to cell line development, analytics and clone selection for emerging biotechs and start-up • Tailored upstream development from a single source reduces time to clinic by 20 percent • Fast-track process reduces timeline by 10 weeks for first pharmacodynamic experiment
More info >>

White Papers

Accelerate Your Database Lock Using Clean Patient Optics

Bioclinica

Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data are clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data. However, this can be challenging when manually reviewing study data, particularly with larger studies.
More info >>

 
Industry Events

SCOPE Summit for Clinical Ops Executives

18-21 February 2020, Hyatt Regency, Orlando, Florida, US

Celebrating its 11th successful year, SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 20 different conferences, 3 plenary keynote sessions, the annual Participant Engagement Awards, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement