VOL. 123 | NO. 228 | Thursday, November 20, 2008
Bioworks Business Group Forms to Kick Start Collaboration
By Tom Wilemon
The topic at the inaugural luncheon of the Memphis Bioworks Business Association was how to get new drugs tested, manufactured and approved, but the purpose was networking.
More than 50 people traded business cards and exchanged information Tuesday at the Fogelman Executive Center on the University of Memphis campus.
“The association’s primary focus is really to provide a forum that facilities collaboration on business issues that are pertinent to the advancement and growth of companies and organizations in the Memphis bioscience community,” said Darryl Jackson, vice president of sales and development for the Memphis Bioworks Foundation.
The association is a “core initiative” of the Foundation and will kick off its membership drive in February, he said. Annual membership fees range from $500 for an innovator with 10 or fewer employees to $7,500 for a partner with 200 or more employees.
“We structure our membership fees to attract large, medium and startup companies,” Jackson said. “We want to really make sure we capture the voice of everyone who is in the bioscience industry here in Memphis.”
Events planned next year include a CEO roundtable, a guest speaker series and a career fair. The association will share best practices and be an advocacy organization at the local, state and federal levels for bioscience development.
The goal is to help the foundation position Memphis as an “internationally recognized center for research and commercialization,” Jackson said.
The featured speaker at the luncheon, Kamaal Anas, represents one of the bioscience companies with operations in Memphis that does business internationally. Anas, senior director of regulatory affairs and quality assurance for Meridian Life Science Inc., explained how a contract manufacturing organization, such as Meridian, assists in early stage drug development.
He displayed a chart showing success rates and test periods for potential drugs.
“You move from 5,000 candidates in preclinical, only five of them will make it into any kind of clinical trial,” Anas said. “And out of that five you’ll only get one that might actually get developed. That’s a lot of investment when you talk about pharmaceutical R&D. That’s where your money is going.”
Meridian manufactures materials for phase one and phase two clinical trials. Anas outlined keys to success for navigating this process.
“Imagine that you have a great drug,” he said. “It’s safe. It’s effective. You’ve done all your background, but you didn’t work with the right contract manufacturing organization. You didn’t prepare appropriately, and now you have a drug that’s just great. You’ve got your venture capital money, and you didn’t execute. Who’s going to invest in you after that?”
The means of production
Selecting the right contract manufacturing organization is the first key to success in developing a drug, he said, pointing out that it’s the stack of papers a company sends to the U.S. Food and Drug Administration that determines whether a new pharmaceutical makes it to market.
“There are a lot of great scientists out there that don’t understand anything about documentation,” Anas said. “That’s where you run into trouble.”
The other keys to success he outlined included setting specifications for a potential drug while avoiding assumptions, considering the human element in partnerships, communicating throughout the process and establishing a multidisciplinary approach.
“The more people you have included at the early stages, the better it is going to be,” he said.
Location is not a primary concern in selecting a contract manufacturing organization, he said. Meridian Life Science does work for clients as far away as Australia, he said, and sometimes ships materials that have to be kept at subfreezing temperatures.
“Having FedEx in our backyard is just great,” he said.
Meridian Life Science is a wholly owned subsidiary of Meridian Bioscience Inc. Besides Memphis, the company also has manufacturing facilities in Saco, Maine, and Boca Raton, Fla.