Drug Development: IND Process 

BionorthTX RA/QA Committee hosts Betty Holland, President of BCH Regs, Inc. presenting "Drug Development: IND Process".

Betty Holland has over 35 years of experience in drug development, including chemical research, scientific writing, project management and more than 20 years in regulatory affairs.  She has experience working in both large pharma and startup biotech companies, and more recently has served as a consultant to startup biotech companies, both to define and implement regulatory strategy.  She has served as the contact with FDA, submitted INDs and NDAs, lead meetings with FDA, worked on risk management plans and negotiated labeling with FDA.  She held positions at Hoffmann-La Roche, Inc., Tanox, Inc. (now part of Genentech) and Reata Pharmaceuticals, Inc.  She has a Master of Science degree in Organic Chemistry from Purdue University and currently serves as President of BCH Regs, Inc., a regulatory consulting company

Betty will overview the IND portion of the new drug development process in the United States, outline the FDA Organization, describe various phases of drug development and information to be submitted, clinical trials, FDA Meetings, and discuss programs for expedited development for serious conditions. 

Join us starting at 5:30PM for lite bites and networking, presentation at 6:00PM, followed by additional networking time.