BioCorRx Retains Regulatory Drug Expert Priya Jambhekar and CMC Expert Bruce Firestone, Ph.D
ANAHEIM, CA, Jan. 05, 2018 (GLOBE NEWSWIRE) -- BioCorRx Inc. (OTCQB: BICX) (the "Company"), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions, today announced that it has retained regulatory drug experts Priya Jambhekar and Bruce Firestone, PhD, to assist with the drug development and regulatory process for BioCorRx’s product pipeline. Ms. Jambhekar and Dr. Firestone are additions to the Company’s current team, which is preparing for its pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) scheduled on January 24, 2018. As previously announced, the Company is seeking FDA approval for BICX102, a naltrexone implant for the treatment of opioid and alcohol use disorders.
Ms. Jambhekar is a drug development entrepreneur with over 25 years of executive experience in worldwide regulatory, quality, clinical and pharmacovigilance operations, as well as early and late stage development product registration and commercial support. She has held positions including Global Senior Vice President of Regulatory & Quality Operations at Paramount BioSciences, Global Vice President at Ethicon, a Johnson & Johnson company, and Worldwide Vice President of Regulatory and Government Relations at Alkermes. Other senior positions include Baxter ACC, as Regulatory Head of Compliance, and Bristol-Myers Squibb, as Manager of Regulatory, Safety, Compliance. She is also certified by the Regulatory Affairs Professional Society and the New Jersey Pharmaceutical Quality Control and Assurance Society.
Dr. Firestone has over three decades of pharmaceutical research & development experience with on-time delivery of over 15 product approvals as new chemical entities and line extensions. Dr. Firestone is an accomplished author with over 40 publications, abstracts and patents. He also has extensive chemistry, manufacturing and controls (CMC) expertise with: small molecules, drug and drug-device combinations, sustained-release products, semisolids, topical and intravitreal routes of administration. He has held senior positions at Allergan and is an expert in pharmaceutical product development, manufacturing process development and scale-up, technology transfer, process validation, risk management, technology assessment, due diligence, CMC documentation, and CMC strategy.
Brady Granier, President, CEO and Director, stated, “Priya and Bruce are valuable additions to the BioCorRx team and we are honored to have them on board. They both bring extensive regulatory and manufacturing experience in drug development and have proven track records bringing drugs to market. We look forward to their contributions as we accelerate our efforts to obtain FDA approval for our naltrexone product that we feel will help many families suffering from the current opioid epidemic and massive alcohol dependence problem.”
BioCorRx Inc. (OTCQB: BICX) is an addiction treatment company offering a unique approach to the treatment of substance abuse addiction. The BioCorRx® Recovery Program, a non-addictive, medication-assisted treatment (MAT) program, consists of two main components. The first component of the program consists of an outpatient implant procedure performed by a licensed physician. The implant delivers the non-addictive medicine, naltrexone, an opioid antagonist that can significantly reduce physical cravings for alcohol and opioids. The second component of the program developed by BioCorRx Inc. is a one-on-one counseling program specifically tailored for the treatment of alcoholism and other substance abuse addictions for those receiving long-term naltrexone treatment. The Company also has an R&D subsidiary, BioCorRx Pharmaceuticals, which is currently developing injectable and implantable naltrexone products for potential future regulatory approval. For more information on BICX, visit www.BioCorRx.com.
Safe Harbor Statement
The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.
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Released January 5, 2018