August 8, 2018 — Southwest Research Institute® (SwRI®) is hosting a one-day workshop on October 8, 2018, to address the concepts, strategies and tools needed for a more successful investigational new drug (IND) submission.
SwRI’s “Small Molecule Drug Development: From Concept to IND” one-day course will delve into the chemistry, manufacturing and control (CMC) and non-clinical decisions needed to support IND submission. CMC and non-clinical decisions can critically affect the IND approval from the FDA. IND approval is needed for new drugs to start clinical trials and ultimately enter the market. This workshop is designed for beginner to intermediate professionals.
“The process of bringing a small-molecule drug to market is complex. In addition to presentations based on actual IND experiences and a tour of SwRI’s CGMP (Current Good Manufacturing Practices) manufacturing facility, the course offers a real-world group exercise to help participants practice tackling drug development issues,” said Varsin Archer, a research scientist in the SwRI Chemistry and Chemical Engineering Division. “Drugs can fail IND submission if the CMC quality and process do not meet standards and regulations.”
Working with experienced staff in the pharmaceutical and drug development area, participants will learn more about the challenges, decision processes, and tools used to ensure smoother IND submissions. The course also will cover technical transfer, formulation and analytical development, CGMP manufacturing, safety and costs.
Registration is $650 and includes course instruction, training material, a facility tour, lunch and networking held onsite at SwRI headquarters in San Antonio. For more information, register at pharmdev.swri.org or contact Varsin Archer, 210-522-2256. Space is limited to 30 participants.