New Horizons Pharma Inc. has a very strong and balanced management team with over 15 years of drug development experience and over 15 years of operational and investment management experience between the two cofounders.
Ilana Katsnelson MD, RAC, Co-founder, President
Dr. Katsnelson is the inventor of enzyme therapy technology designed to treat drug and alcohol dependence, as well as acute alcohol-related diseases. She is the founder of New Horizon Pharma, which owns the intellectual property on this technology.Dr. Katsnelson has over 25 years of clinical practice experience in the U.S. and Latvia, and over 12 years of experience in the pharmaceutical industry. She is an expert in drug safety and is certified in FDA regulatory affairs (RAC). Her fundamental knowledge of all aspects of drug and device development, as well as her in-depth understanding of FDA regulations, have allowed Dr. Katsnelson to develop a unique concept that enhances the safety of disulfiram by treating DER. ALDH2 is one of the most important enzymes in the metabolism of ethanol and has been studied extensively for over 50 years. As a result, this program has a solid scientific base. Bioengineering is a relatively new scientific discipline, so the cost of development of biological drugs was very high until recently.
During her career in the pharmaceutical industry, Dr. Katsnelson has developed, established, and implemented scientific methods for clinical study protocol design, data collection, and data analysis. Dr. Katsnelson has also assisted clients in selecting the best indications for new compounds and has provided consultation regarding regulatory strategies for new drug development. In addition, she has evaluated drug safety trends during clinical trials, as well as post-marketed safety surveillance.
Dr. Katsnelson has led multiple drug development programs. She conducted a clinical gap analysis for NDAs and was involved with FDA communications, resolving issues, and responding to FDA requests. She was a medical monitor for multiple clinical trial projects in the U.S., Canada, and EU. In her role, Dr. Katsnelson was responsible for monitoring clinical studies from Phase 1 to Phase 3 in numerous clinical areas, including endocrinology, oncology, neurology, rheumatology, vaccine, and medical devices. Dr. Katsnelson is certified in Regulatory Affairs (RAC) and has in-depth knowledge of FDA regulations, particularly relating to new drug development.