Month: May 2021

The executive who strides into her expansive office may have come a long way from the Fulton County government building where she once stood in line to get her water service turned back on, but Lou Kennedy remains the same Lexington County product, rooted in hard work and family, that other S.C. businesses leaders say they have known for decades.

The national spotlight has recently shone on Kennedy, owner and CEO of West Columbia-based Nephron Pharmaceuticals Corp., as a program she created to help teachers earn extra cash was featured on NBC News while her on-premise lab has churned out respiratory drugs during the COVID-19 pandemic and processed tests for the community. But those who have known her the longest say that, along a career path that wound through Georgia and Florida before circling back to her hometown, Kennedy has never changed who she is.

“Lou has always been a dynamo,” said Sam Konduros, the former CEO of SCBIO who recently became president and CEO of a new health innovation division at Charleston-based Vikor Scientific. “Her mother taught me first grade. We actually met when we were six years old at Seven Oaks Elementary School in Columbia and have known each other ever since.”

To read the entire story, visit the Columbia Regional Business Report.

Pharmacy students at the University of South Carolina (USC) have partnered with researchers and engineers to develop an innovative, automated syringe-filling system. According to USC, the product can complete this task with small-batch products, which is known to be challenging for workers to do by hand.¹

The technology demonstrates the important role students can play in pushing the pharmaceutical industry forward. The system was designed by pharmacy and engineering students, who partnered with researchers and were led by mechanical engineering professor Ramy Harik, PhD.¹

Traditionally, prefilled syringes are filled by hand in clean-room environments. Strict federal regulations have made this process increasingly difficult because workers must stand for hours performing repetitive motions. The new system could not only free up health professionals’ time but also help ensure safety and efficacy.¹

The collaboration began when officials at Nephron Pharmaceuticals sought out the engineering and pharmacy colleges at USC 2 years ago.² They pursued the partnership because of issues that arose when machinery operators at their facilities called in sick or were unable to work, which led to a halt in the production process. The new automated system developed in the collaboration will solve this problem.²

In order to develop the filling system, students and researchers worked with industry partners.¹ The new system uses flexible, high-speed robots developed by Yaskawa Motoman and technology from the automation company Siemens.¹ Several classes at USC worked to create the technology, resulting in the development of a robot named Smithers, which a press release noted was chosen based on the character from The Simpsons.²

At USC, Harik led 3 teams of senior engineering students to create the robot, and pharmacy students ensured that the medical and sterilization aspects were safe for future human injection. Students tested about 10 designs before finding one that worked.²

The robot was installed at Nephron Pharmaceuticals’ facility in late January 2021 and is currently undergoing commercial validation. Once it receives regulatory approval, USC and Nephron Pharmaceuticals will license the technology to health care and bioscience users.¹

“Partnerships like this one are a win for patients, employees, and students, not to mention for companies like ours, that continue to grow and expand our capacity to help others,” said Nephron Pharmaceuticals’ owner and CEO, Lou Kennedy, in a prepared statement. “We are excited to build on the momentum created by our work with the university, especially with Dr Ramy Harik, and I can’t wait to see what we can do in the years ahead.”¹

The system consists of 4 pieces of equipment that work in tandem to mimic a human filling the syringes. Separate pieces work together to hold, fill, and seal the syringes. In an article in The State, Kennedy said she would love to see future partnerships between Nephron Pharmaceuticals and USC.²

“My dream for the university is that we could commercially market these robots for hospitals around the world,” Kennedy said in the article. “If we had the ultimate dream, it would be to sell these, and a portion of the proceeds go back to the pharmacy and engineering school and allow us to endow a scholarship for future research.”

Read the entire story at Pharmacy Times.

A three-year legal battle centered around allegations of trade secrets theft from Nephron Pharmaceuticals Corp. has been resolved in a $7.9 million settlement that the case’s lead attorney said sends a strong message.

Arkansas-based U.S. Compounding Inc. and parent company Adamis Pharmaceuticals Corp. agreed to pay the West Columbia-headquartered company that sum and are also permanently enjoined from using any of the confidential customer and pricing information two former Nephron employees were found to have provided its competitor.

“I think the rulings we obtained and then the fact that the settlement was so big is going to benefit not only Nephron and the protection of the sanctity of its trade secrets going forward but also any company who is trying to protect its trade secrets,” said Nikole Setzler Mergo, Nexsen Pruet’s Columbia office managing partner and lead trail lawyer in the Nephron litigation.

The settlement, reached last month as the case was about to go to trial, involves final judgments and permanent injunctions in Florida, New Jersey and South Carolina.

According to court documents, the first former employee downloaded data including customer contacts, purchasing history and pricing details before leaving Nephron to work for U.S. Compounding.

“Her first week on that job was her last week on my job,” Nephron owner and CEO Lou Kennedy said. “She was double-dipping, and the whole time, they were able to prove, she had four different devices plugged in downloading all my contractual terms, all manner of quality ideas. It was like giving the playbook to a competitor.”

A second former Nephron employee was alleged to have used confidential information in her new sales territory in New Jersey. An individual breach of contract suit against that employee was transferred to South Carolina in December 2020.

Nephron relocated its operations to West Columbia from Orlando in April 2017.

“It was three separate federal court lawsuits all going on at the same time,” Mergo said. “It was three years of very hard-fought litigation with a lot of very complicated issues. It was a trade secrets case, which is a complicated area of the law because you have to demonstrate that the information that was appropriated was a trade secret, first of all, which is a very high standard, and you have to demonstrate the company, Nephron, used reasonable methods to protect those trade secrets.”

The settlement was reached April 9, 10 days before a trial was to begin.

Kennedy was prepared to see the cases through, having recently purchased a new accessory in the event the litigation dragged on.

“I had bought an Apple watch because you can’t take phones into the court room, and if I was going to be subjected to potentially a 10-day trial, there’s no way. I can’t be that far away from technology,” she said. “I wasn’t concerned about not winning. I was concerned about how can I spare that much time away from Nephron?”

Mergo said several factors led to the settlement. On March 29, U.S. Compounding and California-headquartered Adamis were found in civil contempt for violating a Florida injunction against using Nephron’s information while the case was being litigated.

“Once we found out about the second employee, we made a motion for a finding of contempt,” Mergo said. A ruling in Nephron’s favor reimbursed the company $123,000 in legal fees and imposed daily fines, the amount of which was still pending at the time of the settlement.

In addition, Mergo said evidence related to the second employee in New Jersey was going to be allowed into the Florida case.  

In an April 15 filing with the U.S. Securities and Exchange Commission, Adamis said Nephron’s allegations of misappropriation of trade secrets were without merit, but cited factors including the outcome of pre-trial motions and ongoing legal expenses as well as “the uncertainties of litigation and jury trials, and the possibility of punitive damages and other adverse awards or sanctions” in agreeing to the settlement.

Mergo said that Kennedy’s determination also sent a strong signal.

“She was ready to go to a jury,” Mergo said. “It was that resolve that put a lot of pressure and I think ultimately resulted in the settlement.”

Reach Melinda Waldrop at 803-726-7542.