LENA
LENA
LENA

Ethicare GmbH

 

Jörg Breitkreutz

  

 

Ethicare GmbH

Prof. Dr. Jörg Breitkreutz, PhD

Founder and Shareholder of Ethicare GmbH

Director of the Institute of Pharmaceutics and Biopharmaceutics (UDUS)

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Ethicare GmbH

Am Fliederbusch 2
45721 Haltern am See
Germany

 

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Wolfgang Wiedey

Dr. Wolfgang Wiedey

Managing Director of Ethicare and Shareholder

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Gertraude Breitkreutz

CEO of Ethicare

Pharmacist

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Silke Breitkreutz

CEO of Ethicare

Biologist

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Ethicare, founded by Dr. Jörg Breitkreutz, is a company that develops drugs for pharmaceutical niche markets such as paediatrics and orphan diseases. It has developed a 10 mg 6-mercaptopurine tablet for acute lymphoblastic leukaemia (ALL) for use in paediatric patients which is currently marketed by the German company Medice. Furthermore, Ethicare currently holds the EU orphan drug designation for the use of sodium benzoate in nonketotic hyperglycinemia (NKH), an inborn error of metabolism, and is currently working on completing the development programs associated with this drug.

 

The founders of Ethicare are highly experienced in drug development. Dr. Jörg Breitkreutz is well known as one of world’s leading experts in paediatric formulations, assessment of paediatric medicines, and regulatory processes for paediatric medicines. In his additional role as the Director of the Institute of Pharmaceutical Technology and Biopharmaceutics of the Heinrich-Heine-Universität Düsseldorf, he has full access to the well-equipped facilities at the institute. As a leading developer of drugs for pharmaceutical niche markets, Ethicare has extensive experience in planning, coordinating and assessing GMP manufacturing of medicinal products as well as in the preparation and submission of the required regulatory documents.

The LENA Team of Experts at Ethicare

 

Robert Hermann

 

 

 

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Dr. med. Robert Hermann, FCP

 

Work package 13 Major Contributor

 

Dr Hermann is a board-certified Anaesthesiologist and Clinical Pharmacologist, and a fellow (FCP) of the American College of Clinical Pharmacology (ACCP). He joined the pharmaceutical industry in 1990 and assumed over the years various expert and managing functions of increasing responsibility in Clinical Pharmacology, Translational- and Exploratory-Medicine, including VP and CMO roles. Robert and his teams contributed significantly to the clinical development and international regulatory approval of several products, including three “first-in-class” NCEs. In 2008, Dr Hermann has established his own consulting company (cr.appliance) and serves as an independent consultant to the pharmaceutical and biotech industry in the field of early clinical development.
In the LENA project Dr Hermann provides input and support in his capacity as Clinical Pharmacologist and as lead author of the Investigator’s Brochure.


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Jenny Walsh

 

 

 

Jenny Walsh Consulting Ltd

Dr. Jenny Walsh

 

Work Package 2 Major Contributor

Work Package 13 Major Contributor

 

Dr Walsh is a PhD pharmacist with over 20 years experience in the Pharmaceutical and Consumer Healthcare Industry.  Her areas of expertise include the formulation of oral dose forms and the development of paediatric medicines.  She has extensive experience of reviewing and writing technical and regulatory documents including Paediatric Investigation Plans (PIPs). 

For the LENA project, Dr Walsh is responsible for leading the preparation of the PIP, in conjunction with LENA project partners.  She is also the lead for regulatory discussions and interactions regarding the PIP and responsible for the compilation of summary data generated for the future submission of a PUMA.  In addition, Dr Walsh provides input and support as required to the LENA project pharmaceutical development activities.

 

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Elizabeth Horsely

 

 

 

 

 

Elizabeth Horsely, MsC, PhD

 

Work Package 3 Major Contributor

 

Dr. Horsley earned her PhD in 2002.  She has worked as a toxicologist in contract research and for small and large pharmaceutical companies in Europe and the USA from 2003 to 2011. Her areas of specialization include reproductive toxicology and cardiovascular disease.

For the LENA project, Dr Horsley is responsible for overseeing the non-clinical aspects of the project including regulatory documentation contribution.

 

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