Dr. Kasra Shakeri Nejad

Major contributor to the clinical program strategy, design of Clinical Development Plans and clinical execution and interpretation of FiH/Clinical Pharmacology, PoC and Phase IIb dose-range finding components for different drug candidates in multiple sclerosis and neuropathic pain. Providing high-quality, innovative, Translational Medicine/Clinical Pharmacology expertise for different Neuroscience development programs.

Global Trial Leader for multinational studies leading cross-functional Clinical Trial Teams with comprehensive responsibility for the scientific, medical, logistical, and financial trial components, Clinical Trial Leader and responsible Medical Officer for projects in the Department of Clinical Pharmacology (CP) from planning to publishing, Responsibility for the Early Development components of Clinical Development Plans (CDP) ensuring timely development of the CP components of the CDP

Management of projects in the Department of CP from planning to publishing (main focus on insomnia, immunology and cardio‐vascular indications) Responsibility for the pharmacokinetic, pharmacodynamic and PK/PD components of CDPs Provide clinical expertise and assume medical responsibility for CP studies in insomnia, immunology, and angina pectoris/hypertension Planning and running CP studies for the pediatric, geriatric, renally and hepatically impaired patient goups

Clinical Pharmacology & Pharmacokinetics, associated bioanalytical anthropometric methods Drug development and approval of medicinal products, Drug safety and risk benefit assessments Good Clinical and Laboratory Practice (GCP, GLP) guidelines and their implementation in clinical trials Pharmaceutical legislation and clinical pharmacology reporting system of adverse drug reactions - Pharmacovigilance Ethical and legal requirements for clinical trials in humans

Principal Investigator and/or investigator for more than 200 single- or multi-center Phase I-IV studies in various therapeutic areas with main focus on Phase I/IIa Management of Phase I-IV clinical studies in the Department of Clinical Pharmacology in roles of increasing responsibility. Leadership and management of clinical trial teams optimizing their performance as Head of Study Physicians (5 direct reports).

Tasks & Responsibilities Experimental lab work on tendocyte cell cultures investigating the effects of fluoroquinolones and parathyroid hormone on tendocyte function Experimental lab work on limb bud cultures of Wistar rats investigating effects of fluoroquinolones on embryonic bone and cartilage development Investigation of sensitizing potential of different drugs using a modified experimental lymph node assay in mice Lectures in Clinical Pharmacology & Toxicology

Medical support to Phase II‐IV trial concepts and management of multi‐center clinical trails Medical link between physicians and medical departments of sponsors Medical support in the development of study protocols and clinical study reports Main therapeutic areas: CNS, Cardiovascular (Hypertension, Angina pectoris), Endocrinology (Diabetes, Hyperlipidemia), Respiratory Diseases (COPD, Asthma)

Principal Investigator and Sub‐investigator in phase I/II clinical trials Project presentation at the ethics committee meetings Design, preparation, conduct and evaluation of clinical trials Finalization of study protocols Participation in writing of study protocols and medical reports Main therapeutic areas: CNS, Endocrinology (Diabetes, Hyperlipidemia), Respiratory Diseases (COPD, Asthma)

Participation in preparation, organization, performance and reporting of clinical studies

Tasks & Responsibilities Preparation of toxicological expert opinions for judicial proceedings (requirement for advanced training in Clinical Pharmacology) Design and preparation of scientific publications Medical documentation and statistics Achievements & Recognitions Preparation of 10 pharmacological/toxicological expert opinions, which were used for judicial proceedings/health insurance purposes Enhanced medical writing skills used in multiple scientific publications and medical communications

Tasks & Responsibilities Clinical management of patients with various neurological disorders Main focus on various brain tumors and ischemic and hemorrhagic stroke on the stroke unit Achievements & Recognitions Successful state-of-the-art management of stroke patients on a stroke unit

Tasks & Responsibilities Clinical management of patients with severe head trauma and cerebral hemorrhage on an interdisciplinary ICU (neurosurgery & anesthesiology) Clinical management of patients with various neurological disorders and daily involvement in neurosurgical interventions Completion of the neurosurgical interventions and imaging follow up for the doctoral thesis

Board Certification, Medical Specialist in Clinical Pharmacology

Clinical Experience with the Hydrostatic Dual-Switch-Valve in the Treatment of Hydrocephalus – A Prospective Randomized Study in 60 Patients