Dr. Michael Schawan founded Schawan Consulting Group, LLC in 2002 as a clinical research and development consulting company, to assist pharmaceutical, biotechnology, and medical device companies design and implement successful strategies from initiating and designing clinical trials to market. The company clients are the leading pharmaceutical, biotechnology, diagnostic, and medical device companies such as Burzynski Clinic and Burzynski Research Institute, Millennium Parmaceuticals, Genentech, Amgen, Pfizer, Johnson&johnson, Synarc, Theranos, Stanford University, Oklahoma University Health Sciences Center (HSC), and many more.
Dr. Schawan is internationally recognized and serial Entrepreneur in pharmaceutical drug development and regulatory processes, he co-founded 3 companies such as AMG Bio-Pharma Corporation, a biopharmaceutical company focused on unmet needs in oncology. My MedFax, an Electronic Medical Record (EMR) company, and the founder and CEO for Schawan Consulting Group. Dr. Schawan has over 20 years of pharmaceutical management experience in clinical development of medicines for pharmaceutical and biotechnology industries, as well as in academic setting, he has conducted 72 clinical trials and Eight of which are FDA approved such as Avastin, Vectibix, Velcade, Retinoids, Clomid, ... and several more. He has been responsible for numerous clinical trial programs that served to support successful New Drug Application (NDA) strategies and competitive maket positions for new therapeutic products.
Dr. Schawan held several key positions wihtin the biotech, pharmaceutical, and academic industries, before he founded Schawan Consulting Group. He held key positions in clinical research and development in several departments at the University of Oklahoma (HSC) and Stanford University Medical Center, where he was responsible for multiple clinical trials from phase I-IV. He was also responsible for overseeing all aspects of the clinical development strategies for new products, as well as responsible for the following:
- Designing, writing, and developing clinical protocols.
- Writing the final study reports to the FDA.
- Writing annual reports to IND for each study.
- Assisting with data analysis and interpretation.
- Medical and regulatory compliance reviews of medical records and case reports on patients for every trial.
- Clinical record quality assurance.
- Training and supervising clinical research associates and assistants.
- Investigating professional clinical work by tightly following and applying Good Clinical Practice (GCP) guidelines and the Food and Drug Administration (FDA) regulations.
- Maintenance of clinical trials database for trial.
- Frequent visits to 25 study sites, in accordance with the FDA regulations.
- Planning and executing clinical trials in accordance with GCP and ICH guidelines and regulations.
- Writing to the National Institute of Health (NIH) and other companies for study grants.
- Taking appropriate measures to ensure data bio-availability and confidentiality.
- Monitoring and supervising multiple study sites (25 sites).
Before joining Oklahoma University and Stanford University, Dr. Schawan was the global director of medical affairs and marketing at Bio-Med Pharmaceutical, a Johnson & Johnson company, where he was responsible for overseeing multiple clinical trial projects by investigating and monitoring vaccine production to stimulate the human immune system to detect cancer (ovarian and breast cancers) during the early stages (I-II). The main focus was to control and target the cancer through medications vs. using more common methods such as chemotherapy and/or surgery.
Dr. Schawan's numerous duties included: designing, writing, and frequent visits to study sites and check on patients, writing updates to IND for every study, training and supervising clinical research associates, monitoring product lines and meeting FDA and GCP's guidelines and regulations. His exercience in meeting tight deadlines was utilized daily by working with and managing a multidisciplinary team and knowledgeable scientists. He has experienced how to apply and follow the company's regulations when working with other companies and health facilities nationwide and internationally. Throughout his experience working with global corporations, he learned the importance of being culturally diversified when working in todays multi-cultural society and benefits that this has brought to his medical profession.
Dr. Schawan has numerous publications and articles published in many internantional scientific publications and magazines such as the New England Journal of Medicine, Science and Technology Magazine, The Lancet, and several more.
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