2013 TMP Teams Get the Job Done
Whether it's DNA profiling or cold chain 'supplying' KGI TMPs exceed expectations
Jennifer Lee, MBS '13, probably never imagined that she'd spend so many hours in her second year at KGI tracking down law enforcement officers. But, then again, KGI students are known to go above and beyond the call of duty when working on their Team Master's Projects, which are capstone projects in which teams of three to six students get the opportunity to work with sponsoring companies to solve real problems. And, this year's 24 teams were no different.
Lee was on one of the two teams sponsored by Life Technologies Corporation, a Carlsbad, California-based global biotechnology tools company. Life Technologies tasked Lee and fellow students Ifeanyi Amadi, Jinghua Jia, Aimee Lake, Duojiao Ni and Amanda Walker with evaluating the forensic rapid and decentralized DNA profiling market. The company is one of the leading suppliers of DNA testing systems to forensic laboratories and is interested in expanding its product line to include rapid integrative DNA processing systems. This new technology allows personnel with limited or minimal training, such as a police officer or border patrol agent, to generate DNA profiles outside of a centralized laboratory.
"We wanted an independent assessment of the situation. We felt we needed to take a step back and ask ourselves how big is the need for this technology in the market at this time," explained Ravi Gupta, who acted as the Life Technologies corporate liaison on the project. "We looked at getting a professional consulting firm, but we had a history here and the past projects we had done with KGI students have been highly successful."
Initially, the project may have appeared like a "simple" or "straightforward" market assessment, but once the team got going they found out that DNA testing for profiling is an incredibly complex issue often involving multiple legal and logistical challenges. "There's a perception that there's this bottleneck in DNA testing at a centralized facility, and if a machine could automate or speed up the process, it would solve a lot of the problems, but that's really not the case," Lee said. "As we familiarized ourselves with the technology and the market, we realized we were going to have to talk to a lot more people than we had initially planned, starting with local law enforcement agencies."
After developing a series of market assessment questions and conducting interviews with L.A. county law enforcement, the team reached out to other law enforcement agencies around the country and in February attended an American Academy of Forensic Sciences conference in Washington, D.C. There, they were able to speak to a wide sampling of professionals who would be potential end-users of the technology. They also spoke to a judge who expressed concerns about chain of custody issues that may occur from having people who were not as highly trained (as technicians in a centralized lab) processing samples.
"The bottom line is that there are multiple agencies involved with DNA testing, and in order for the product to be successfully adopted, you'd have to create an entire infrastructure to support it," Lee said. "For example, you need the software that creates and explains statistical matches. It's not just a question of 'yes' and 'no' with this type of profiling, you have to be able to understand the difference between an 82 percent match and a 94 percent match. The concept of having this type of automated system operated by minimally trained personnel is definitely something to think about especially when, as one person we interviewed mentioned, police officers are usually required to have 40 hours of training to operate a breathalyzer."
Faculty advisor Dr. Susan Bain says the group provided Life Technologies with valuable insight into potential hurdles and opportunities they may face when commercializing the rapid-profiling technology. "They were able to clarify where and why bottlenecks in DNA processing occur, and they did a superb job of identifying potential secondary markets for the technology, primarily U.S. Customs and Border Patrol and the military's criminal investigative services, such as USACIL."
While the Life Technologies Forensics team was busy cold-calling police departments, the BioMarin TMP team was focused on cold storage, or more specifically, cold chain. The Novato, California-based pharmaceutical company develops, manufactures and commercializes drugs for the treatment of rare disease. Team members Ian Brown, Kencey Busick, Sean Delfosse, Stephen Kim and Hadi Mirmalek-Sani were tasked with helping the company develop a temperature-controlled supply chain that meets the needs of its expanding product pipeline.
"Ensuring the safe and stable transportation of extremely valuable biotechnology products is commonly referred to as 'cold chain supply,' explained the team's faculty advisor Vince Anicetti. "Biotechnology medicines are very sensitive to temperature and container interactions, so the control of temperature and container conditions during transportation is essential to reducing the risk of damaged product."
In fact, during their presentation, the team noted that because BioMarin works in the rare disease arena, a single shipment of product could contain up to 10 percent of the world's supply - making the need for failsafe transport even more vital.
"In BioMarin's case in particular, but really when it comes to all biotechnology companies, supply chain is an unsung hero," Mirmalek-Sani said. "Everything has to move from one place to another and a breakdown can really affect a company's operations."
The team took a two-stage approach to determine the best overall configuration of containers and shippers to ensure the safe transport of BioMarin's one-of-a-kind products. First, they interviewed various experts on pharmaceutical cold chain; then they compiled a list of BioMarin's requirements for their particular cold chain. They used these requirements to create a decision matrix of vendor solutions to find the most appropriate primary and tertiary containers for shipping BioMarin's bulk clinical products.
Next, comes the "fun" part. In Phase II, the team conducted qualification tests at KGI, which involved dropping the containers from various heights, stretching them, and testing their ability to maintain various temperatures. They also researched and analyzed international cargo carriers. The result was a comprehensive, commercial-ready list of solutions to meet BioMarin's cold chain needs for their pipeline products.
"We are extremely pleased with the outcome of the project as well as the quality of the results and the final presentation," said corporate liaison Kim Fellows-Peake. "The team has provided valuable information that we will be able to use to make decisions to help advance our supply chain in a manner consistent with our company's growth."
Dropping things, cold-calling the NYPD-KGI President Sheldon Schuster isn't surprised at what TMP teams will do to meet a sponsoring company's expectations. "Over the years, I've spoken to many senior-level executives whose companies have participated in TMPs, and almost universally their reaction is one of surprise that students are performing at comparable levels to highly paid consultants."