Calmare Therapeutics Inc.02.18.16
Fairfield, Conn.-based Calmare Therapeutics Inc. (CTI), a chronic pain and wound care company, has appointed Christine Chansky, M.D., JD, FCLM, chief regulatory officer (CRO) of the company.
As part of Chansky’s duties and responsibilities as the company’s chief regulatory officer and corporate executive, she will spearhead all of CTI-sponsored clinical studies, and oversee all global regulatory issues related to the company’s medical device practice.
On being offered the opportunity to be CTI’s first regulatory officer, Chansky said, “Working with the CTI team is an exciting opportunity for me to apply by regulatory and clinical knowledge to the continued development of CTI’s novel devices in order to improve patient care. My clinical interests and expertise fit perfectly with the CTI portfolio.”
Chansky will discontinue her private medical practice and devote all of her time to CTI.
“This is a significant step forward for the company,” said Calmare Therapeutics President and CEO Conrad Mir. “She will be instrumental in establishing CTI as a medical device powerhouse in the chronic neuropathic pain and wound ailment space.”
Chansky has been a licensed, practicing physician and attorney for over 20 years. She has a comprehensive background in global regulatory affairs and regulatory law with a proven track of applying expertise in research and development, pharmacovigilance, regulatory, compliance, clinical development and global medical affairs. Her multiple therapeutic expertise in immunotherapy, oncology, infectious disease and hematology, has allowed her to leverage her extensive relationships with the U.S. Food and Drug Administration and resulted in the successful submissions of over 15 investigational new drug applications, new drug applications, and biologics license applications.
Prior to her new position with CTI, she served as chief regulatory counsel and chief clinical officer for BioTest Pharmaceuticals where she was responsible for the development and review of all regulatory strategies, submissions and compliance, clinical development plans, trial design, launch campaigns and educational materials. Contemporaneously, she was the medical director of her private medical practice, Emergency Medical Care N.Y. and STAT Medical Associates in New York City. And before that, she had held senior executive regulatory positions in such notable companies as Aventis, Johnson & Johnson, Glaxo Wellcome and Roche Holdings A.G.
Chansky is a licensed Medical Doctor in New York and a licensed attorney in New Jersey. She was an adjunct assistant professor of global regulatory affairs at Temple University, and is board certified as a Fellow of the American College of Legal Medicine. She received her bachelor’s degree, magma cum laude, from Georgetown University in Washington, D.C.n, and her medical degree from Georgetown University. Chansky received her law degree from Seton Hall University in South Orange, N.J.
As part of Chansky’s duties and responsibilities as the company’s chief regulatory officer and corporate executive, she will spearhead all of CTI-sponsored clinical studies, and oversee all global regulatory issues related to the company’s medical device practice.
On being offered the opportunity to be CTI’s first regulatory officer, Chansky said, “Working with the CTI team is an exciting opportunity for me to apply by regulatory and clinical knowledge to the continued development of CTI’s novel devices in order to improve patient care. My clinical interests and expertise fit perfectly with the CTI portfolio.”
Chansky will discontinue her private medical practice and devote all of her time to CTI.
“This is a significant step forward for the company,” said Calmare Therapeutics President and CEO Conrad Mir. “She will be instrumental in establishing CTI as a medical device powerhouse in the chronic neuropathic pain and wound ailment space.”
Chansky has been a licensed, practicing physician and attorney for over 20 years. She has a comprehensive background in global regulatory affairs and regulatory law with a proven track of applying expertise in research and development, pharmacovigilance, regulatory, compliance, clinical development and global medical affairs. Her multiple therapeutic expertise in immunotherapy, oncology, infectious disease and hematology, has allowed her to leverage her extensive relationships with the U.S. Food and Drug Administration and resulted in the successful submissions of over 15 investigational new drug applications, new drug applications, and biologics license applications.
Prior to her new position with CTI, she served as chief regulatory counsel and chief clinical officer for BioTest Pharmaceuticals where she was responsible for the development and review of all regulatory strategies, submissions and compliance, clinical development plans, trial design, launch campaigns and educational materials. Contemporaneously, she was the medical director of her private medical practice, Emergency Medical Care N.Y. and STAT Medical Associates in New York City. And before that, she had held senior executive regulatory positions in such notable companies as Aventis, Johnson & Johnson, Glaxo Wellcome and Roche Holdings A.G.
Chansky is a licensed Medical Doctor in New York and a licensed attorney in New Jersey. She was an adjunct assistant professor of global regulatory affairs at Temple University, and is board certified as a Fellow of the American College of Legal Medicine. She received her bachelor’s degree, magma cum laude, from Georgetown University in Washington, D.C.n, and her medical degree from Georgetown University. Chansky received her law degree from Seton Hall University in South Orange, N.J.