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How has the U.S. Food and Drug Administration changed and what does it take to get a new drug approved and on your pharmacy’s shelf?

Matthew Confeld, associate director of clinical research methodology at Worldwide Clinical Trials, will provide a brief history of how and why the FDA came to be and the immense work that goes into getting new therapies approved. Confeld, of Minneapolis, will give a newfound appreciation for the little pills sitting in your medicine cabinet when he talks to pharmacy students at South ��ֱ���� State University Oct. 21.

The 3 p.m. talk in Founders Recital Hall in Oscar Larson Performing Arts Center is open to the public, and he promises a pharmacy education won’t be necessary to appreciate his message.

Worldwide Clinical Trials has worked with pharmaceutical researchers for more than 30 years and has 3,500 therapeutic experts in 60 countries. Confeld is a 2021 Pharm.D./Ph.D. graduate from North ��ֱ���� State University and started working with Worldwide in May 2021. In those three years he has helped support dozens of pharmaceutical and biotechnology companies in successfully launching clinical drug development programs. 

Worldwide helps researchers on development path

Confeld leads a team of clinical scientists that supports small to mid-sized biotechnology companies in their clinical drug development journey. This support includes assisting with regulatory affairs across many global agencies including the FDA, the European Medicines Agency and Health Canada.

His team provides strategic clinical program support, including writing clinical trial protocols, determining which disease indications to pursue and commercialization initiatives to support formulary placement and reimbursement.

“My expertise is focused in cancer therapy, but my team provides strategic consultations across four main therapeutic areas: neuroscience, cardiometabolic, oncology and immune-mediated diseases,” Confeld said.

His personal pharmaceutical journey began at age 8, when he suffered an epileptic seizure while on a family vacation.

“This requires me to take daily medication, likely for the rest of my life. I thought it was fascinating how a small pill could prevent me from having seizures and help me to live a completely normal life. It got me more interested in biology and health care and led me to pursue a professional degree in pharmacy. 

“My career goals shifted toward drug development and clinical research after realizing my intellectual interests didn’t quite fit traditional pharmacy careers.”

Reconnects with former professor

Confeld’s path also intersected with Sanku Mallik, the new associate dean of research within the College of Pharmacy and Allied Health Professions at SDSU. Both were at NDSU when Confeld was pursuing his education. He worked in Mallik’s research lab during the summer after his first year of pharmacy school.

“I was then offered a position in his lab as a graduate research assistant to pursue my Ph.D. in pharmaceutical sciences. Following my graduation, Dr. Mallik selected me to be a translational research adviser to the pancreatic cancer research center that he led while at NDSU,” Confeld said.

He said his work with Mallik’s lab testing new cancer therapies on mice as well as working across a range of niche health care opportunities, including clinical pharmacogenomics, COVID case worker and medical cannabis, helped him advance rapidly at Worldwide.

“Following graduation, I was selected for a fellowship at Worldwide Clinical Trials where I was able to gain enough respect within the organization that they created a new position for me. From there I was quickly promoted up to my current position as associate director.”

‘Choose your own path’

He encourages students to look broadly at the opportunities available in their field. . 

“Whether we’re talking pharmacy or farming, one size doesn’t fit all. Be willing to divert from the traditional road and find the path meant for you,” he said.

Confeld’s message is the keynote address at the Keo Glidden Smith Fall Pharmacy Convocation. The event was named after Keo Glidden Smith in 1996. A 1937 graduate from the SDSU College of Pharmacy, she did pharmacy relief work until 1987. In 1989, she created an endowment fund to bring renowned research speakers to the campus.

This year’s lecture is being organized by Rho Chi pharmacy fraternity and associate professor Kyle LaPorte. For more information, contact LaPorte at Kyle.LaPorte@sdstate.edu.