Abstract of the Talk (30 min plus Q&A):
Over 80% of new chemical entities (NCEs) today have poor solubility (BCS Class II or IV). Preclinical animal safety study formulations are often different from first-in-human formulations, as preclinical scientists often use strong solvents and/or surfactants to solubilize otherwise insoluble drug candidates to achieve maximum exposure levels in animals. Many of these formulations are not suitable for human clinical trials due to the toxicity associated with the high levels of strong solvents and/or excipients. Many companies use fit-for-purpose simple formats, such as liquid formulations, powder-in-bottle or powder-in-capsules with little solubility enhancement of the investigational drug. This formulation switch between preclinical and FIH clinical trials can result in the bioavailability of the drugs being limited by solubility.
Nano PharmaSolutions developed the nanoformulation platform – NanoTransformerTM which generates stable drug nanoparticles using no additives. This highly soluble easy-flow nano-granules can be used for animal safety study as oral gavage, and FIH clinical sample as powder in capsule; without having to change formulation. This clean formulation has high loading of drug (up to 30%) and is fast to develop for any small molecule with less than 10 grams of API.
Bio of Kay Olmstead, Ph.D., MBA (CEO/Co-founder of Nano PharmaSolutions)
Dr. Olmstead has over 30 years of experience in the pharmaceutical industry in both API (drug substance) and finished dosage form development. Prior to founding Nano PharmaSolutions, Dr. Olmstead served numerous small to medium pharmaceutical companies 0worldwide as a CMC subject matter expert, especially in poorly soluble drug development. During the past 20 years, Dr. Olmstead played a lead role in the development and the FDA approval of five commercial drugs for San Diego based companies, including Santarus, Inc. (NASDAQ: SNTR | acquired by Salix in 2013) and Intercept Pharmaceutical (NASDAQ: ICPT).
Dr. Olmstead has published more than 12 manuscripts and has 12 issued patents and 4 pending patent applications. Dr. Olmstead received a Ph.D. degree in Organic Chemistry at Johns Hopkins University followed by a NIH post-doctoral fellowship at Stanford University under Professor Harry Mosher.