How We Do It

Paediatric Study Design

Therakind is a paediatric healthcare company with:

• strong drug formulation, clinical development and regulatory capabilities
• the expertise to develop a product from idea through to regulatory approval
• the ability to identify niche areas of unmet medical needs and work with other drug development companies on a collaborative basis
• design studies and write protocols entirely consistent with the new paediatric legislation which came into force in 2007

Because of the above, we have a distinct advantage over other companies who do not specialise in the paediatric field.

Expertise – from idea to regulatory approval

Therakind’s team brings a wealth of experience in:

• paediatric drug evaluation, formulation, and drug delivery;
• clinical and regulatory strategy, ensuring an optimal clinical programme avoiding unnecessary paediatric trials;
• clinical study design, management, analysis and reporting;
• interacting with Regulatory Authorities and obtaining scientific advice;
• securing agreements for Paediatric Investigation Plans (PIPs), and approvals for clinical trial and marketing authorisations.

In addition, Therakind can draw on the expertise of its network of highly competent and professional paediatric specialists in the UK and Europe.

History

• Therakind was created in 2006 in collaboration between International Property (IP) commercialiser IPSO Ventures and the School of Pharmacy, London University to address the significant unmet need for paediatric drugs.  
• Both the School of Pharmacy’s Centre for Paediatric Pharmacy Research and its director, Professor Ian Wong, have an excellent reputation in the UK and elsewhere for their research in this area.