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| Clinical Research / Biometrics |
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Agnes Schiewe, PhD
Director Clinical Research, Europe
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. 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). |
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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. |
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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). |
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Jayanti Gupta, PhD
Director – Biostatistics, Programming & Medical Writing, Asia
Dr. Jayanti Gupta heads the biostatistics, programming and medical writing teams at India. She is responsible for building and leading these teams with functional and administrative expertise by developing capabilities to match global standards in study design, analysis and reporting. She has over 7 years of experience in statistical consulting and experience gained with leading pharmaceutical companies on clinical development programs for drugs and vaccines.
Prior to joining us, Dr Gupta has worked at Merck Research Laboratories, USA, and GlaxoSmithKline Biologicals in India. Dr. Jayanti Gupta obtained her PhD in Statistics from the University of Michigan, Ann Arbor, Masters in Statistics from the Indian Statistical Institute, New Delhi and Bachelors in Mathematics from Jadavpur University, Kolkata. She has coauthored several publications in reputed journals. |
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Krathish Bopanna, PhD
Senior Vice President, Asia
Dr Bopanna is responsible for managing clinical operations, data management, biostatistics, medical writing and reporting services in Asia.
Prior to joining us, he was the Functional Consultant with Tata Consultancy Services (TCS), Global Life Sciences and Healthcare (LS & H) Practice. His key accomplishments at TCS include setting up a BPO for CDM, shaping the Tata CTMS, bringing RFID in clinical lab management systems and getting a web-based pharmacovigilance program. He was one of the active leads in bringing Clinical Data Interchange Consortium (CDISC) to India.
Prior to TCS, he was with AstraZeneca in the capacity of Senior Medical Advisor for over eight years spanning activities in medical, clinical, safety & regulatory domains. He had end to end responsibility from protocol design to submission for products. He has managed multiple projects and deliveries in clinical development and medico-marketing activities.
He has a Doctorate in Psychopharmacology from NIMHANS, Bangalore. In addition to this, he has been awarded the Doctorate of Science in Biochemical Pharmacology (DSc) from the University of Washington, Washington DC, USA. The American Biographical Institute, Inc, North Carolina, USA has nominated Dr Bopanna as the ‘Man of the Year 2002’. This Institute had placed him in the board of advisors to nominate members for the year 2004. Dr Bopanna was also chosen as one of the ‘2000 Outstanding Scientists of the 21st Century’ in October 2002, by the International Biographical Centre of Cambridge. |
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