| |
|
| |
 |
| |
| Clinical Research / Biometrics |
| |
 |
|
Agnes Schiewe, PhD
Director Global Clinical Operations
Dr Schiewe has been with Ecron Acunova since 1993. Having joined as a Clinical Research Associate, her exemplary performance quickly involved her with project management functions in 1995, after which she rose to being Director Clinical Research from 1999 onwards. She has been critical in expanding the Ecron Acunova partner network all over the world and has been designated as Ecron Acunova’s Director Global Clinical Operations in 2010. Dr Schiewe's managerial and team leading skills predestine her for the supervision of project performance, cost control and manpower management. Dr Schiewe has supervised about 50 multi-national clinical trials (phase II - phase IV) in Western and Eastern Europe as well as in South America. Some key areas include oncology, cardiovascular diseases, gastrointestinal diseases and hormone replacement therapy.
She had been working as an Assistant Lecturer at the chair of phytopathology of the University of Constance before she joined Ecron Acunova. Dr Schiewe is a member of the German Society for Pharmaceutical Medicine (DGPharMed). She is an MSc in Biology and was awarded a PhD by the Faculty of Biology of the University of Constance (Germany). |
| |
|
|
 |
|
Ayaaz Hussain Khan, PhD
Vice President – BA/BE Services
As the Vice President BA/BE Services, based in Manipal Dr Khan brings with him an experience of conducting over 250 BA/BE studies and has been part of various regulatory audits like USFDA, ANVISA, AFSSAPS-France and DCGI India.
He started his career with Ranbaxy Research Laboratories where he was responsible for method development and validation of drugs and / or metabolites for BA/BE studies using LCMSMS. He was sponsored by Ranbaxy Labs for a Senior Research Fellowship for Doctoral Research at Hamdard University. After his stint with Ranbaxy, he was in-charge of the pharmacokinetic unit at Orchid Healthcare, Chennai responsible for biostudies with the clinical team with the credit of conducting over 22 studies in the in-house centre.
Dr Khan moved to GVK Biosciences, Hyderabad as Principal Scientist. As a Project Director, he was responsible for the conduct of BA/BE studies and has managed the facility of 4 clinics with 144 beds and the bioanalytical facility.
Dr Khan has completed PhD in Pharmaceutical Medicine with specialization in Clinical Pharmacokinetics from Jamia Hamdard University, New Delhi. He completed M.Pharm from BIT, Ranchi and is a gold medalist in pharmacy from his graduating University from The Tamil Nadu Dr. MGR Medical University, Chennai. Dr Khan is a member of Indian Pharmacological Society. |
| |
|
|
 |
|
Ernst Bluemner, MD & MSc
Director Biometrics, Europe
Dr Bluemner has been with Ecron Acunova since 2001. With over 25 years enriched experience in Clinical Research, he is responsible for various aspects in the project progress namely planning, data management, statistics and medical writing. Dr Bluemner has provided biometrical guidance for numerous multi-national clinical trials (phase II - phase IV) in Western and Eastern Europe as well as in South America. The key areas include oncology, cardiovascular diseases, gastrointestinal diseases, skin diseases, and hormone replacement therapy.
Prior to Ecron Acunova, he had been with Max Planck Institute for Plasma Physics as Data analyst and programmer in Garching (Germany) and as Director Biometrics at Staticon International in Martinsried (Germany). Dr Bluemner is a member of the German Society for Medical Informatics, Biometrics and Epidemiology (GMDS) and the International Biometric Society. He is also a member of the Drug Information Association (DIA). In 1993 he was awarded with the E.W. Baader prize in Industrial Medicine.
Dr Bluemner is an MSc in Mathematics and was awarded an MD by the Ludwig Maximilian University in Munich (Germany). |
| |
|
|
 |
|
Prof. Sreekumaran Nair, PhD
Scientific Advisor
Dr. N. Sreekumaran Nair (Sree) provides scientific advice in the area of statistics in drug development and epidemiology. He plays an important role in mentoring Biostatisticians and Research Physicians. Dr. Nair is Professor of Biostatistics and heads the department of Statistics at Manipal University. He holds responsibility of Statistical Bureau of the university and Secretary of University Research Committee. He is on the executive committee of Indian Society for Medical Statistics and South Asian Cochrane network.
Dr. Nair is a Master in Statistics from Kerala University and Doctorate from Indian Institute of Technology New Delhi. He has trained in epidemiology; controlled clinical trials; issues in clinical trials; medical writing; systematic reviews and meta-analysis from Universities of Monash, Sydney and Queensland.
Dr. Nair started as Biostatistician at National Institute of Immunology, New Delhi and worked on fertility control vaccine trial and leprosy vaccine trial and received institute’s meritorious award. He joined Kasturba Medical College, Manipal as Assistant Professor of Biostatistics and rose to Professor in 2003. In 2006 he came to head the department of Statistics and directed doctoral programs in Biostatistics and Statistics. Dr. Nair chairs the biostatistics board of MPH program. Dr. Nair has attracted research grants from government & industry including Dept of Biotechnology, Bhabha Atomic Research Center, Dept of Science & Technology (DST) and Intel.
Dr. Nair serves as the statistical editor for the Cochrane public health review group and acute respiratory infection group. He is editor of the Bulletin of Indian Society for Medical Statistics. He has 35 publications in national and international journals and conducted more than 50 workshops. Dr. Nair is the recipient of fellowship from Council of Scientific & Industrial Research, DST, Indian Academy of Medical Sciences, Manipal Foundation and Cochrane Collaboration. |
|
|
|
