Southwest Research Institute (SwRI) is hosting a one-day workshop on Oct. 8 to teach life science professionals strategies and tools needed for a more successful investigational new drug (IND) submission. This workshop, to be held at SwRI, is designed for beginner- to intermediate-level bioscience professionals involved in new drug development.
The workshop will help showcase SwRI’s specialized capabilities such as its new clean room, high-potency laboratory space, and complimentary storage facility to the bioscience community. The institute’s 2017 annual report details recent infrastructure investments and educational outreach efforts such as this inaugural workshop that can help attract more drug development to SwRI as well as benefit local startups bringing drugs to market.
The Small Molecule Drug Development: From Concept to IND one-day course will cover the many non-clinical and chemistry, manufacturing, and control (CMC) decisions needed for a successful new drug submission to the Food and Drug Administration (FDA). The course also will cover technical transfer, drug formulation, analytical development, and manufacturing, safety, and costs involved in developing new drugs.
Early registration cost is $375, available only until September 16. The full registration fee is $650. The workshop will include course instruction, training material, lunch, a SwRI facility tour, and networking at SwRI headquarters in San Antonio. For more information, register at pharmdev.swri.org. Email questions to workshop organizer Varsin Archer or call 210-522-5197. Space is limited to 30 participants; deadline for workshop registration is October 1.
A physician might submit a research IND to propose studying an unapproved drug or an approved product for a new indication or application. The research IND could also be for a drug to be approved for a new patient population. IND submission includes CMC and non-clinical decisions that impact the outcome for a new drug submission. IND approval is a critical step in new drug development. Without IND approval from the FDA, a new drug cannot start clinical trials and ultimately cannot enter the market.
“The process of bringing a small-molecule drug to market is complex,” said Varsin Archer, a research scientist in the SwRI Chemistry and Chemical Engineering Division and workshop organizer. “Drugs can fail IND submission if the CMC quality and process do not meet standards and regulations.”
Pratap Khanwilker is vice president for product development at InCube Labs, and president of The Health Cell, a nonprofit organization promoting professional development and collaboration across San Antonio’s bioscience and healthcare professionals. He agrees this course will be invaluable to him and others interested in learning about what it takes to develop and bring new drugs successfully to market.
“I am very pleased to see SwRI implement this course, which is complementary to what we at the Health Cell have piloted for medical device and digital health sectors,” Khanwilker said. “The Health Cell anticipates collaborating with SwRI and other like-minded institutions to develop and offer such programs on an ongoing basis to the community in the future.”
Presenters from SwRI’s pharmaceutical and drug development department will teach the workshop. Senior research scientists Bill Cantrell, Hong Dixon, and Norma Cantu, research and development director Joe McDonough, and SwRI manager Sandra Drabik will share insights from past IND submission experiences. Workshop attendees will tour SwRI’s manufacturing facility which is certified for Current Good Manufacturing Practices or cGMP. The FDA requires cGMP for manufacturing processes and facilities to assure proper design, monitoring, and control of drug production.
SwRI works with drug development companies such as San Antonio-based Rapamycin Holdings. Clinical supplies of their drug, e-Rapa, are manufactured in SwRI’s cGMP-certified facility.
Read more: Profile on Rapamycin Holdings, Inc.
“Taking a drug from inception to IND approval is a complicated, multistep process,” said Cynthia Phelps, president at Health eDesigns. “Having this type of knowledge here in San Antonio will be critical to not only help our institutions to develop drugs, but to also spin off drug development biotech companies, a huge boon to San Antonio industry.”
Featured image is of scientists at SwRI testing compounds in their new Pharma Labs facilities. Photo courtesy SwRI.