WEST CALDWELL, NJ and TORONTO, ON / ACCESSWIRE / December 17, 2018 / Eastgate Biotech Corp. (OTC PINK: ETBI), a pharmaceutical company that focuses on innovative technological developments specifically in insulin drug delivery for the treatment of type 2 diabetes, appointed key consultants Saul A. Mashaal, PhmB, MBA and Munaf Ali, PhD to assist in regulatory matters and manufacturing of the company's liquid insulin mouth rinse solution for Type 2 diabetes and pre-diabetes patients.
Saul Mashaal has over 40 years of biotech experience. He has a degree in pharmacy and an MBA. His subject matter expertise is in the area of biotech manufacturing, pharmaceutical distribution, clinical trial development, and insulin manufacturing which are of great interest to Eastgate. Saul was instrumental in the building of major biotechnology insulin manufacturing facilities in Israel, China, India, and the UAE, the size and scope of the projects exceeded $500 million. Saul was the founder and Chairman of Acertus Pharma LLC and the founder and Chairman of the SciTech Group. Acertus is a privately held company that focuses on the distribution of biopharmaceuticals and consumer products. SciTech Group morphed into a showcase company in Singapore to implement research and development and manufacturing in Singapore. During his tenure, the company developed a breakthrough vaccine for immunization against Hepatitis B and spun off the Bioton division which was one of the first 4 companies in the world to produce recombinant human insulin. He is no stranger to the public markets. Bioton was a Polish company listed on the Warsaw Stock Exchange and his predecessor company, Scitech was listed on the Australian Stock Exchange. Early in his career at 3M he was head of business development and the clinical research group and managed 27 clinical trials in the United States and Europe. Saul’s depth of experience in key areas that Eastgate is starting to address, make him an ideal consultant.
“Eastgate has a paradigm changing drug for type 2 diabetes,” said Saul Mashaal. “Injections are not the way to address the compliance problem worldwide. An inexpensive easy to use a drug that has demonstrated efficacy is a great first step. Having worked at big pharma, I have seen the strategies they have employed to introduce new diabetes drugs, and after the price-fixing scandal, there was a huge loss of confidence. Therein lies the opportunity for Eastgate. Given my background in manufacturing, I anticipate the Eastgate team will utilize my contacts in Singapore to negotiate long-term supply contracts of insulin. Having reviewed Eastgate's clinical trial plan, I believe they are on the right trajectory and will eventually need my assistance in developing distribution following drug approval.”
Dr. Munaf Ali has over 25 years of experience in regulatory affairs and CNS (specifically in Parkinson disease, Alzheimer’s disease, depression, schizophrenia, and neuropathic pain). He is very familiar with the role insulin plays in these diseases. He is also no stranger to providing scientific and regulatory strategic advice for the conduct of clinical trials across many therapeutic areas. He has been involved on a strategic level with 46 different countries providing guidance with various global regulatory agencies, most notably the FDA and EMA on behalf of sponsors involved in developing the clinical trials necessary for registration. He worked as the head of regulatory strategies for expediting the development of CNS drugs at Ingenix which was eventually acquired by the United Healthcare Group. He now works as an independent consultant providing Pharmaceutical and Biotech companies, CROs, Universities and Financial Institution's guidance on the regulatory pathway for clinical trial development. To his credit, he has been involved in over 10 INDs, 8 NDAs and MAAs, and 5 Orphan Drug Applications. He has presented at FDA Advisory Committee Meetings, CPMP hearings, and at regulatory meetings in Europe, Asia, Central, and South America.
“Eastgate has a monumental task ahead of it when we look at the size and scope of the global epidemic in diabetes,” said Dr. Ali. “Each country has a different regulatory body and different approval requirements. This is a virtual minefield, and the only way to navigate it is through experience. I couldn’t be more pleased to be part of the Eastgate team single-handedly tackling this global epidemic. I hope to quickly and efficiently establish a global regulatory strategy that charts a course toward the quickest approvals so that we can bring a much-needed drug into the fight against this epidemic.”
“Our team at Eastgate is growing,” said Anna Gluskin CEO of Eastgate Biotech. “We have been able to attract the world’s best and brightest to this team because each of them realizes that something needs to be done to solve this global epidemic or the burden on our healthcare systems is going to collapse under its own weight. It also helps that we have such a simple and elegant solution. An oral insulin mouth rinse designed to supplement the pancreas and stave off the side effects of diabetes that burden the healthcare system. I am confident that this team will help us realize the goal of our first approval in 2019.”
About Eastgate Biotech
Eastgate Biotech focuses on innovative technological developments and produces and distributes innovative drug compounds and healthy nutraceuticals that are based on natural therapies absorbed by the body. We utilize advanced nanotechnologies and alternative delivery systems that take difficult to deliver compounds and deliver them using our nanotechnology platform which ultimately increases the bioavailability to the body. Using our methods of delivery provides healthy alternatives to conventional pharmaceuticals that all-too-often create dangerous side-effects and unexpected consequences for those trying to attain and maintain a healthy lifestyle. Eastgate's wholly owned subsidiary Omni Surgery and Anti-Aging Centre are the first of many surgery centers to come under the Omni umbrella as we plan to roll up existing business under the Omni brand and expand our footprint globally.
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SOURCE: Eastgate Biotech Corp.