Kasra Shakeri Nejad

Kasra Shakeri Nejad

Professional Associations

  • German Medical Association (Bundesärztekammer)
  • Medical Association of Berlin (ÄK Berlin)
  • Association for Applied Human Pharmacology (AGAH)
  • German Society for Pharmaceutical Medicine (DGPharMed)
  • German Society for Aerospace Medicine (DGLRM)
  • Association of Iranian Physicians Berlin (VIÄ)
  • Pharma Network Basel (PNB) - Moderator
  • Iranian Pharma network (IPN) - Moderator

Languages

  • German (native speaker)
  • English fluent
  • Persian fluent
  • French school knowledge

Conferences & Workshops

2009             European Association for Clinical Pharmacology and Therapeutics (EACPT), Edinburgh, UK

2009            3rd Joint Annual Meeting (AGAH/Club Phase I), Lyon, France

2008             WinNonLin & Autopilot, PK Analysis and PK/PD Modeling (Pharsight)

2007             Clinical Drug Development - Design, Planning and Performance (AGAH)

2007             Investigator Guideline for Clinical Studies, ICH-GCP (PAREXEL Academy)

2006             Transatlantic Strategies in Early Drug Development (AGAH)

Pharma Network Basel

Selected Publications

Joachim Stangier, Hildegard Stähle, Karin Rathgen, Willy Roth, and Kasra Shakeri-Nejad. Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate, an Oral Direct Thrombin Inhibitor, Are Not Affected by Moderate Hepatic Impairment. Journal of Clinical Pharmacology 2008 Dec; 48(12):1411-9.

K. Shakeri-Nejad and R. Stahlmann. Drug interactions during therapy with three major groups of antimicrobial agents. Expert Opinion on Pharmacotherapy 2006; 7(6):639-651.

C. Schreiber, K. Shakeri-Nejad, O. Fialkowski, I. Baumann-Wilschke, T. Platzek and R. Stahlmann. Investigation of the sensitizing potential of amoxicillin in a modified local lymph node assay in mice. Poster presentation, 46th Conference of the DGPT (German Society of experimental and clinical Pharmacology and Toxicology), Mainz, Germany, 15-17 March 2005. 

K. Shakeri-Nejad, M. Shakibaei, R. Stahlmann. Chinolone-induced Tendopathies. Arzneimitteltherapie 2005; 23:122-129.

Summary

KEY EXPERTISE

Pharmaceutical Industry

  • Clinical Trial Leader and responsible Medical Officer for different projects (insomnia, immunology, and cardiovascular indications) in the Department of Clinical Pharmacology (CP) from planning to publishing
  • In-depth knowledge of the clinical drug development process together with hands-on experience in the conduct of international clinical trials
  • Main CP interface for other departments such as preclinical DMPK, Pharmacology, Toxicology, Clinical Science, Drug safety, DRA, Biometry, and for scientific/medical related issues with regulatory authorities
  • Writing of Study Protocols, Final Study Reports, Statistical Analysis Plans, IBs, and NDAs according to regulatory requirements and contribution to IMPDs, Pediatric Investigation Plans, Data Management Plans, and Bioanalytical Study Plans and Reports

Clinical and Preclinical Research

  • Management of Phase I-IV projects in the Department of CP at PAREXEL International GmbH, Berlin, Germany in roles of increasing responsibility (6years)
  • Line Management experience as Head of Physicians (2years)
  • Principal Investigator or sub-investigator in more than 200 single- or multi-center phase I - IV studies in various therapeutic indications with main focus on phase I/II
  • Main therapeutic areas: Central Nervous System, Infectious diseases (HIV, Hepatitis C), Immunology (Rheumatoid Arthritis, Vaccine studies, Immunomodulation), Cardiovascular indications, Comparative PK studies in patients with renal or hepatic impairment
  • Experimental Pharmacology and Toxicology (1year)

Medical & Clinical Experience

  • Medical Specialist in Clinical Pharmacology (Board Certification, German Medical Association)
  • Clinical experience in Neurosurgery, Neurology and Anaesthesiology (2 years)
  • Management of patients with severe head trauma and cerebral hemorrhage in an interdisciplinary ICU (Neurosurgery & Anesthesiology)
  • Management of patients with various neurological disorders
  • Planning and involvement in various neurosurgical interventions

Work History

Work History

Residency

CHARITÉ, DEPARTMENT OF NEUROSURGERY AT THE CHARITÉ FACULTY OF MEDICINE
  • Management of patients with severe head trauma and cerebral haemorrhage on an interdisciplinary ICU (Neurosurgery & Anesthesiology)
  • Management of patients with various neurological disorders and daily involvement in neurosurgical interventions
Mar 2008 - Present

Clinical Pharmacologist/Clinical Trial Leader

Actelion Pharmaceuticals Ltd
  • Clinical Trial Leader and responsible Medical Officer for projects in the Department of CP from planning to publishing
  • Responsibility for the pharmacokinetic, pharmacodynamic and PK/PD components of CDPs
  • Provision of clinical expertise and assumption of medical responsibility for CP studies in insomnia, immunology, and angina pectoris/hypertension
  • Expertise in CP studies in patients with renal and hepatic impairment and in entry‑into-man studies with adaptive dose escalation designs.
  • Writing of Study Protocols, Final Study Reports, Statistical Analysis Plans, IBs and NDAs according to regulatory requirements
  • Contribution to IMPDs, Pediatric Investigation Plans, Data Management Plans, Bioanalytical Study Plans and Reports.
  • Ensure the timely development of the CP component of the CDP
  • Ensure accurate data interpretation and presentation of study data in Development Team and Life Cycle Team Meetings and in meetings with external partners
  • Representation of CP in life cycle management teams and in meetings with investigators, and clinical experts
  • Represent the main interface for other departments such as preclinical DMPK, Pharmacology, Toxicology, Clinical Science, Drug safety, DRA, and Biometry, and for scientific/medical related issues with regulatory authorities
  • Clinical and bioanalytical site selection and coordination of CTA and submission to HA and EC/IRB
Jun 2005 - Feb 2008

Head of Physicians - Phase II, Clinical Pharmacology

PAREXEL International GmbH

  • Principal Investigator and sub‑investigator in more than 200 single- and multi-center phase I - IV studies covering a broad spectrum of indications with main focus on phase I/II
  • Project presentation and discussion in ethics committee meetings
  • Design, preparation, conduct, evaluation and publishing of clinical trials
  • Writing of study protocols and medical reports
  • Line Management of a study physicians team and leader of matrix teams (CNS work group, study setup teams)
  • Medical consulting in special indications (CNS, infectious diseases, immunology, renal and hepatic impairment)
Jun 2004 - May 2005

Scientist in Toxicology

CHARITÉ BERLIN - INSTITUTE OF CLINICAL PHARMACOLOGY AND TOXICOLOGY
  • Cell culture (murine fibroblasts, human and marmoset tendocytes)
  • Investigation of in-vitro effects of flurochinolones on murine fibroblasts
  • Western Blot
  • Investigation of in-vitro effects of parathyroid hormone on human tendocytes
  • Investigation of the sensitizing potential of amoxicillin in a modified murine local lymph node assay
  • Limb bud culture and immunhistochemical methods
  • Regular semester lectures and active training of medical students in Pharmacology and Clinical Pharmacology
Jan 2004 - May 2004

Medical Advisor - Phase II-IV

PAREXEL International GmbH
  • Medical support to Phase II-IV trial concepts and management of multi-center clinical trials
  • 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)
Mar 2002 - Dec 2003

Study Director

PAREXEL International GmbH

  • Principal Investigator and Sub‑investigator in phase I/II clinical trials
  • Project presentation and discussion in 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)
Sep 2000 - Feb 2002

Associate Study Director

PAREXEL International GmbH
  • Participation in preparation, organization, conduct, and evaluation of clinical studies
Aug 1999 - Aug 2000

Medical Writer

Max-Bürger-Zentrum
  • Medical documentation and Statistics
  • Design and preparation of scientific publications
Jun 1997 - Nov 1998

Internship - Department of Neurology & Neurosurgery

Median Clinic Grünheide, Germany
  • Management of patients with various neurological disorders
  • Main focus on brain tumors and cerebral haemorrhage

Education

Education
Oct 1989 - Oct 1990

Student

Christian-Albrechts University
Oct 1989 - Oct 1990

Student

Christian-Albrechts University

Skills

Skills

Drug Development

§ In-depth knowledge of the clinical drug development process together with hands-on experience in the conduct of international clinical trials

Line Management

 Line Management experience as Head of Physicians (2 years)    

Medical and Clinical Experience

Clinical experience in Neurosurgery, Neurology and Anaesthesiology (2 years) Management of patients with severe head trauma and cerebral hemorrhage in an interdisciplinary ICU (Neurosurgery & Anesthesiology) Management of patients with various neurological disorders Planning and involvement in various neurosurgical interventions  

Medical Writing

Writing of Study Protocols Final Study Reports Statistical Analysis Plans Investigator's Brochures NDAs according to regulatory requirements and contribution to IMPDs Pediatric Investigation Plans Data Management Plans, and Bioanalytical Study Plans and Reports.  

Management of Clinical Studies

Clinical Trial Leader and responsible Medical Officer for different projects (insomnia, immunology, and cardiovascular indications) in the Department of Clinical Pharmacology (CP) from planning to publishing Main CP interface for other departments such as preclinical DMPK, Pharmacology, Toxicology, Clinical Science, Drug safety, DRA, Biometry, and for scientific/medical related issues with regulatory authorities Management of Phase I-IV projects in the Department of CP at PAREXEL International GmbH, Berlin, Germany in roles of increasing responsibility (6years) Principal Investigator or sub-investigator in more than 200 single- or multi-center phase I - IV studies in various therapeutic indications with main focus on phase I/II