Lindsay Cobbs named to head KPIC at USC see more
The Kennedy Pharmacy Innovation Center (KPIC) announced that James Lindsay Cobbs has been named chair for the center.
In his role, Cobbs will focus on creating a regulatory affairs program for students in the College of Pharmacy, including classroom, cocurricular, experiential, and post-graduate opportunities, as well as supporting Nephron Pharmaceuticals in regulatory affairs.
“My priorities will hone in on developing experiential training opportunities that will enable our students to build skills for both traditional and nontraditional pharmacy roles, developing key partnerships that can support training for our students and to identify ways that will make the College of Pharmacy stand light years apart from other colleges across the country,” says Cobbs.
Cobbs brings a wide array of career experiences to KPIC, ranging from clinical pharmacy to global policy development in the pharmaceutical industry. After graduating from the UofSC College of Pharmacy in 1992, he launched his career as a staff pharmacist at Johns Hopkins Medical Center. After four years, he entered public service as a regulatory affairs professional at the U.S. Food and Drug Administration (FDA) where he served as regulatory project manager, special assistant and lead project manager in the Office of Compliance and later as associate director for regulatory affairs (ADRA) in the Office of Translational Sciences.
Cobbs then transitioned to the corporate sector at Janssen Pharmaceuticals, a division of Johnson & Johnson as a policy lead in the Americas, Global Regulatory and Policy Intelligence Department. Cobbs later became the head of US Policy, Global Regulatory Policy and Intelligence for UCB (Union Chimique Belge translated as Union Chemical of Belgium), a multinational biopharmaceutical company headquartered in Brussels, Belgium.
Cobbs says his various roles have led him to this next challenge. “My experience as a pharmacist at a major teaching institution, working as a public health servant, co-leading drug review teams for novel drug products, and regulatory policy and intelligence in the pharmaceutical industry have prepared me for this unique role,” he says.
Patti Fabel, Pharm.D. and executive director of KPIC is looking forward to joining efforts with Cobbs. “Our faculty, staff, and students can learn a great deal from him due to his background, experience and skill set,” Fabel says. “He will broaden the scope of what KPIC can offer our students and alumni by developing a regulatory affairs program. I’m excited to see the impact he has on the center and college.”
Dean Stephen J. Cutler says Cobbs is an exceedingly accomplished expert in pharmaceutical regulatory affairs. “His addition to our faculty will bring added depth and breadth to our educational program as we launch our college’s latest initiative, the Regulatory Affairs Academic Program,” Cutler adds. “This academic program will offer regulatory education to our pharmacy students, provide postgraduate education for residents and fellows, and give another educational track to our graduate program. Our partnership with Nephron Pharmaceuticals will afford us a working laboratory for the development of future pharmacists and scientists serving in regulatory affairs. We are thrilled that Lindsay Cobbs will shepherd this initiative for the College of Pharmacy.”
Cobbs will begin his role on July 1, 2020.
Monday Moment 5-4-2020 see more
SCBIO's latest Monday Moment arrives amidst the COVID-19 storm to provide meaningful and inspiring information in 3 minutes or less. This week, enjoy an uplifting reminder from University of South Carolina College of Pharmacy Dean Stephen Cutler saluting all those on the front lines of healthcare, plus helpful webinars, news on how SC is stepping up and the ever-popular 3 Great Links. Click here.
USC, Nephron partner to improve safety through automation see more
Nephron Pharmaceuticals Corporation has joined forces with the University of South Carolina's College of Engineering and Computing and the College of Pharmacy to design and implement an automation process that significantly boosts production of pre-filled medication, reducing the physical burden on workers and increasing patient safety.
Traditionally, pre-filled syringes are filled by hand in clean-room environments. In recent years, federal regulations governing sterile compounding have become more stringent and complex as a result of accidental contaminations. The use of robots to compound prescription products exceeds those new federal guidelines and provides a more sterile environment with better accuracy and precision than traditional methods of compounding.
The research collaboration with Nephron will position UofSC to develop state-of-the-art sterile compounding methods benefiting hospitals throughout South Carolina and the nation.
“Demand for pre-filled medication has exploded in recent years, and our company is responding to the market needs for affordable and accessible life-saving medications in pre-filled syringes,” said Nephron CEO Lou Kennedy. “We are excited to partner with innovative students and leading researchers from Engineering and Pharmacy at the University of South Carolina to meet the demands of hospitals and patients, and we look forward to working together for years to come.”
To help Nephron meet the market demand, the College of Engineering and Computing and the College of Pharmacy have finalized plans to build a fully functional sterile compounding lab at the McNAIR Aerospace Center. This fully functional, first-of-its-kind compounding suite will offer students the opportunity to learn and develop the techniques of sterile, robotic manufacturing processes for human drug compounding.
Between the College of Engineering and Computing and the College of Pharmacy, well over a dozen undergraduate, graduate and doctoral students are involved in the project. Utilizing a state-of-the-art robot from UofSC corporate partner Yaskawa Motoman Robotics, as well as Process Simulate — a Siemens software package included in its $628 million gift to McNAIR Center and to the College of Engineering and Computing in 2017 — these students are learning skills that will immediately translate to increased job opportunities upon graduation.
“This team is a unique collection of talents, not just from engineering but with advisers from the College of Pharmacy and partners from Office of Economic Engagement as well,” said Ramy Harik of the McNAIR Aerospace Center, who leads the project design team. “By bringing together a cross-disciplinary team, and constantly seeking feedback from Nephron engineers and pharmacists, our students are building a real-life application that, when completed, will be implemented in production. Particularly for our undergraduate students, this type of impactful research experience is invaluable.”
The Nephron project is a continuation of an ongoing university partnership with the company. When Nephron Pharmaceuticals Corp. opened its manufacturing campus in West Columbia in 2015, proximity to the flagship research university was an important factor. Owned and operated by UofSC alumni Lou (’84) and Bill (’66) Kennedy, whose $30 million endowment created The Kennedy Pharmacy Innovation Center (KPIC) in the College of Pharmacy in 2010, Nephron has found success by meeting the increasing demand for pre-filled medications at medical facilities nationwide.
“Our engagement with industry leaders like Nephron is key to helping our students gain important knowledge and experience while solving real-world problems,” said UofSC President Bob Caslen. “By tapping into our research expertise, our corporate partners can bring innovative products to market, which grows their businesses and the state’s economy. That ensures more opportunity for all South Carolinians and furthers our university system’s mission of service.”
Nephron is a certified woman-owned business and one of the fastest-growing pharmaceutical companies in the country. In 2017, they added a $12.5 million, 36,000-square-foot expansion to its manufacturing facility so they would be strategic in meeting the U.S. drug shortages. By partnering with UofSC students and researchers, Nephron seeks to fully automate parts of the syringe-filling process.