Anika-Anina Dr. Philipp

- Responsible for medical-scientific projects and studies in the area of cardicovascular, metabolism & renal and radioligand therapy/oncology - Lead the clinical studies conducted in Germany (both global and local, across Phase I to IV) for multiple compounds, in close collaboration with all departments involved in clinical research - Close collaboration with Study Site Operations and Regulatory Authorities

Carrying out all control activities of the AMG Information Officer in close cooperation with Daiichi-Sankyo European Regulatory Affairs & PV Departments. Final release of labelling, PIL, SmPC, advertising and field service documents in accordance with the requirements of the AMG § 74a. Final review and approval of print templates for printed packaging materials, compulsory advertising texts, entries in compendia of medicinal products as well as other medical information and training materials.

Responsible for medical-scientific projects and studies in the cardiovascular field, especially in the area of hypercholesterolemia and anticoagulation. Conception, organisation and support of medical and scientific projects, such as studies, registers and external research projects. Establishing and maintaining cooperation with opinion leaders. Cross-functional cooperation, especially with the Marketing and Market Access Departments.

Set up of clinical pharmacology passages of project, regulatory and submission documents. Set up of clinical pharmacology assessments for potential license candidates. Responsible for the preparation, clinical conduct, evaluation and reporting of Phase I clinical trials in the therapeutic area of pain and local anesthesia. Active contribution in meetings with regulatory authorities. Advisory support for other project teams in area of expertise. Mentorship for new colleagues within Clinical Pharmacology.

Reponsible for the preparation, clinical conduct, evaluation and reporting of Phase I clinical trials in the therapeutic area of pain and local anesthesia. Assessment of preclinical pharmacological, toxicological and pharmacokinetics data of new drugs and license candidates. Medical monitoring and supervision of clinical trials performed at CROs. Scientific evaluation of trial methodologies, e.g. safety measures, PD. Clinical pharmacology input to project, regulatory and submission documents.

Laboratory supervisor for clinical toxicology routine and stand-by for emergency duties. Graduate teaching assistant for teaching and practical lessons in pharmacology and toxicology for students of pharmacy.

Holiday Replacement

"Studies on the phase I and II metabolism and the toxicological analysis of the alkaloids of the herbal drug of abuse Mitragyna speciosa Korth. (Kratom) using GC-MS and LC coupled to low- and high-resolution linear ion trap mass spectrometry"

"Development of an oral drug delivery system for lauric acid - a potent appetite suppressant"