cr.appliance team members have carried out successful project work in the pharmaceutical industry as well as work in contract research organisations (CROs), hospitals and academia. Besides employer organisations (e.g. Johann-Wolfgang-Goethe University Clinic, Asta Medica AG, ALTANA Pharma AG and AiCuris GmbH & Co.KG) they have been part of international clinical development teams in co-operations with large international pharmaceutical companies, including Wyeth, Pfizer, Aventis, Sanofi-Aventis and Johnson & Johnson.
cr.appliance team members have many years of experience in early clinical development, including
- clinical pharmacology
- translational medicine
- exploratory / experimental medicine
- anaesthesiology and intensive care medicine
More specifically, the core expertise of cr.appliance includes early clinical studies, including “first-in-man” trials, drug-drug and food-drug interaction studies, studies with orally inhaled products (DPIs, MDIs, nebulizers, etc.), early clinical studies with biologics (e.g. peptides, fusion proteins, and monoclonal antibody products), and the clinical development of novel formulations.
cr.appliance team has substantially contributed to US, EU and ROW marketing authorisations.
- First in class LHRH-antagonist (Cetrorelix; Cetrotide®)
- Ciclesonide MDI (Alvesco®)
- First in class PDE4 inhibitor for the treatment of COPD (Roflumilast; Daxas®)
- Budesonide and Formoterol multiple dose dry powder inhaler (Novolizer®)
- Azelastine nasal spray and eye drops (Allergodil®)
- Azelastine / Fluticasone Propionate nasal spray (Dymista®)
- Cladribine for treatment of relapsing, remitting multiple sclerosis (Mavenclad®)
- Approvals of various novel galenical formulations, including buccal films, transdermal therapeutic systems, etc.
Karen Grave-Hermann holds a Master of Science (MSc) in “Clinical Development” (University of Tübingen / Danube University Krems). She has professional clinical experiences as well as experiences in the pharmaceutical industry and CRO business.
- Qualified nurse at Hanau Clinics
- Specialist nurse for anaesthesia and intensive care (Anaesthesiology and Resuscitation Centre, Johann Wolfgang Goethe University Hospital, Frankfurt)
- Degree as a certified study nurse (Association for Applied Human Pharmacology e.V., AGAH)
- Professional clinical experience in general surgery, anaesthesia, intensive care and endoscopy
- Clinical drug development (Clinical Pharmacology of ASTA Medica AG / Viatris GmbH & Co. KG, Frankfurt)
- Clinical pharmacology services (CRO clinphase)
- Client relations and project management at cr.appliance, Gelnhausen
Workshop secretary of the Marbach DDI Workshop Series
(see Marbach DDI Workshops)
Dr. Robert Hermann is a board-certified medical specialist in anaesthesiology and clinical pharmacology, a fellow (FCP) of the American College of Clinical Pharmacology (ACCP) and a founder member of the Association for Applied Human Pharmacology (AGAH).
He has over 35 years of professional experience as a clinician, scientist, medical expert, and clinical developer and manager in the pharmaceutical industry.
- Clinical practice as a research associate and instructor in anaesthesiology, intensive care, emergency medicine and pain therapy (Anaesthesiology and Resuscitation Centre, Johann Wolfgang Goethe University Hospital, Frankfurt)
- Clinical developer and manager in the pharmaceutical industry
– Head of Clinical Pharmacology at ASTA Medica AG, Frankfurt
– Head of Clinical Allergy & Respiratory Research at ASTA Medica AG, Frankfurt
– Vice President Clinical Development for Viatris GmbH & Co. KG, Frankfurt
– Head of Clinical Pharmacology at ALTANA Pharma AG, Constance
– Corporate Director Exploratory Medicine at ALTANA Pharma AG, Constance
– Chief Medical Officer of AiCuris GmbH & Co.KG, Wuppertal
- Author, co-author, reviewer of many original publications and articles in international peer review journals
- Member, co-chair and chair of the Board of Trustees of the Fraunhofer ITEM Institute for Toxicology and Experimental Medicine, Hanover
- Member of the Research Award Selection Committee of the Fraunhofer Gesellschaft, Munich
- Managing Director and owner of cr.appliance, Gelnhausen
- Co-founder and faculty member of the Marbach DDI Workshop Series
(see Marbach DDI Workshops)