Services and expertise in Drug Development: from drug candidate to proof of concept

Services and expertise

 

Fraunhofer vs. Corona

As an institute with decades of experience in infection and airway research, drug development, biomedical engineering, and in chemical risk assessment, Fraunhofer ITEM can make an important contribution to scientific progress in the fight against SARS-CoV-2.

 

Clinical trials

We are a highly specialized, academia-affiliated research center for early-phase and proof-of-concept clinical trials

 

Preclinical research

We offer preclinical studies with a focus on respiratory diseases such as asthma, COPD, infection, and pulmonary fibrosis. 

 

Regulatory research and risk assessment

Quality assurance

Already in the early phase of drug development, we provide assistance as independent consultants and negotiators in the dialog between applicant and regulatory authority. We work in compliance with regulatory and legal requirements for drug development – quality platforms according to GLP, GMP, and GCP standards are available for this.

Selected projects

Innovative research

We are committed to translating innovative drug research into therapeutic applications – safely, reliably and efficiently. Based on our scientific expertise, we offer appropriate methods and approaches for this purpose. With a development strategy tailored to your product, we support you in process development and manufacturing of your active biopharmaceutical ingredient and sterile investigational medicinal product, in preclinical testing – both pharmacology and toxicology – and in early-phase clinical trials from first-in-human to the clinical proof of concept. Our state-of-the-art equipment and innovative research approaches allow us to develop new methods and techniques – also in cooperation with you and beyond the scope of our own services.

Read more about our focuses of research in Drug Development.

Contact

Holger Ziehr

Contact Press / Media

Prof. Dr. Holger Ziehr

Coordinator of the business area Drug Development

Phone +49 531 6181-6000

Henning Weigt

Contact Press / Media

Dr. Henning Weigt

Coordinator of the business area Drug Development

Phone +49 511 5350-329