10.09.14
BioRestorative Therapies, Inc. has partnered with Access BIO to provide strategic preclinical and regulatory consulting services related to its brtxDISC program. Initially Access BIO will help BioRestorative prepare for pre-IND and IND meetings with the FDA to advance its brtxDISC procedure into the clinic.
Access BIO’s founder, Joy A. Cavagnaro, Ph.D., was a long-time senior regulator and policymaker at the FDA’s Center for Biologics Evaluation and Research (CBER).
“The engagement of Access BIO marks an important step in advancing our brtxDISC procedure as a treatment for patients with protruding and bulging discs who face the prospect of surgery,” said Mark Weinreb, BioRestorative Therapies’ chief executive officer. “Dr. Cavagnaro and her team have extensive experience in formulating strategies in communicating with the FDA and a deep understanding of the activities BioRestorative will need to receive trial commencement approval from the FDA. Working in concert with Access BIO, we look forward to holding constructive meetings with the FDA and to commencing our clinical trials as soon as possible thereafter, potentially in the second half of 2015.”
Access BIO’s founder, Joy A. Cavagnaro, Ph.D., was a long-time senior regulator and policymaker at the FDA’s Center for Biologics Evaluation and Research (CBER).
“The engagement of Access BIO marks an important step in advancing our brtxDISC procedure as a treatment for patients with protruding and bulging discs who face the prospect of surgery,” said Mark Weinreb, BioRestorative Therapies’ chief executive officer. “Dr. Cavagnaro and her team have extensive experience in formulating strategies in communicating with the FDA and a deep understanding of the activities BioRestorative will need to receive trial commencement approval from the FDA. Working in concert with Access BIO, we look forward to holding constructive meetings with the FDA and to commencing our clinical trials as soon as possible thereafter, potentially in the second half of 2015.”