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NCBIO Chairman Robert Schotzinger has been named by state Health and Human Services Secretary Lanier Cansler to serve on the Department’s new Medicaid Preferred Drug List Review Panel. The group, which was mandated by the General Assembly’s 2010 state budget legislation, provides an independent review of recommendations from the Department’s Division of Medical Assistance regarding drugs to be automatically covered by North Carolina’s Medicaid program. Schotzinger was appointed to fill a seat on the Panel reserved to represent the research-based pharmaceutical industry.

The Preferred Drug List program is new to North Carolina’s Medicaid program, which has historically offered an open formulary to enrollees. The state Department of Health and Human Services implemented the PDL program in early 2010 as a back-up cost containment measure, after other cost cutting measures failed to achieve legislatively programmed savings targets.

“The Review Panel offers our state life science industry an avenue to provide thoughtful, science-based input into the Department’s PDL process,” said NCBIO President Sam Taylor. “NCBIO is grateful for this important opportunity, and we can think of no one better qualified to represent the industry than Dr. Schotzinger.”

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Medicago will develop a 90,000-square-foot cGMP facility in Research Triangle Park (RTP), North Carolina. The facility will be used by Medicago to produce 10 million doses/month of influenza vaccines with the potential for further expansion in the future.

"We are thrilled to be awarded such significant funding from DARPA for the development of a state-of-the-art plant-based VLP vaccine capability, as it further validates the growing and strategic interest in our rapid and cost-effective vaccine technology," said Andy Sheldon, President and CEO of Medicago.  

 

 

Seeking to reduce state vaccine costs, legislators included a provision in the 2010 State budget designed to transfer responsibility for funding vaccinations to private insurers and federal programs. Historically, the State has purchased vaccines for children and provided them at no cost to health care providers across North Carolina. The provision does not impose any new costs or restrictions on vaccine manufacturers.

Under the new arrangement providers, including local health departments, will bill insurers or obtain reimbursement from other programs – such as the federal Vaccines for Children program. The legislature’s 2010-11 state budget provides $3 million in one-time funding for providers to stock interim vaccine supplies necessary to support transition to the new reimbursement system. For more information on the change, contact Sam Taylor at (919) 281-8960 or staylor@ncbioscience.org.

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NCBIO President Sam Taylor joined leaders from other state life science trade associations in Washington, DC, July 13-14 for AdvaMed’s annual Congressional Fly-In. Taylor met with members and staff from North Carolina’s delegation to Congress, including Representatives Howard Coble, Virginia Fox, and David Price, and Senators Richard Burr and Kay Hagan. The meetings focused on new guidelines under development at the Food and Drug Administration for approval of medical devices.

“Our goal was to sensitize members of Congress to the potentially very significant changes to the Food and Drug Administration’s 510(k) guidelines for clearance of new medical devices,” said Taylor. “The changes under consideration could make it substantially more difficult to bring new, incremental product innovations to market.”

The AdvaMed Fly-In was NCBIO’s second congressional expedition this year. Taylor participated in a similar set of meetings organized by the Biotechnology Industry Organization in April.

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“The hands-on experience at BTEC (North Carolina State University’s Golden LEAF Biomanufacturing Training and Education Center) allowed me to jump right in with my work at Yonkers Industries and then later at Merck,” Megan Crum told the NCBioImpact Coordinating Council at a meeting in July. Crum, a graduate of North Carolina State, was the first recipient of the university’s new academic minor in Biomanufacturing.

Hadassah Watson, a former student of North Carolina Central University’s BRITE program -- now employed with Merck -- talked about the real-life applications taught by her professors on state-of-the-art equipment. She noted that she used the same equipment on her job. Beverly Jones, a former North Carolina Community College BioNetwork student currently employed at Talecris Biotherapeutics discussed how courses at the Capstone Center had allowed her to redirect her career after years in the semiconductor industry. She noted the importance of the Capstone program’s hands-on laboratory experience and thanked her instructors for their encouragement.

The three students were part of the presentations updating the NCBioImpact Coordinating Council on the progress consortium’s training program, which is offered in the university and community college systems. The Council provides oversight for the training initiative, and the July session was an orientation session for new members. Leaders from BRITE, BTEC and BioNetwork provided progress reports on programs at their facilities.

From industry’s perspective, Lou Arp of Eisai, Adam Monroe of Novozymes North America, and Craig Farquharson of Talecris Biotherapeutics outlined some of the ways the training programs have benefited their companies, and outlined the future training needs required to keep companies and students competitive. For more information about the meeting, contact NCBIO Biotech Manufacturers Forum Program Manager Bruce Kaylos.

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As part of their Boot Camp training, the students produced a recombinant DNA protein in a simulated SMP environment using pilot-scale bioreactors.  The students also worked in the Capstone Center’s aseptic suite, one of only three certified “clean room” sterile-filing training facilities in the country. A total of 23 students were trained.  David Yarley of the Capstone Center was the lead instructor and director of the project.  Other Capstone instructors, Capstone staff, as well as faculty and staff from North Carolina State University, assisted with the course.
 
The Program Manager of NCBIO Biotech Manufacturers Forum, Bruce Kaylos, spoke to one of the classes.  “I was impressed with the students and the work they did,” said Kaylos. “I think industry leaders will recognize the training at this level as actual work experience, and it will help students in securing a position in the biomanufacturing field.”

 

 

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Leveraging Distribution to Commercialize New Products, is a two-day seminar designed to help pharmaceutical manufacturers leverage the services and expertise of healthcare distributors to better understand the high impact tactics that can be used to successfully commercialize new products. Hosted by the Healthcare Distribution Management Association (HDMA) and NCBIO, the seminar will be held at the Marriott Crabtree Valley in Raleigh, October 4th and October 5th.

NCBIO Members can register for this seminar at the discounted HDMA member rate. Click here for a special registration form.

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Five NCBIO member companies are among those to be honored by CED and the Edward Lowe Foundation next month. The groups’ new awards program, Companies to Watch (CTW), honors second-stage companies that demonstrate high performance in the marketplace, exhibit innovative products or processes, or otherwise make those companies “worth watching.” The award ceremony will be September 23rd at the Raleigh Marriott City Center.

Life science companies to be honored include Affinergy, Liquidia Technologies, Piedmont Pharmaceuticals, TransEnterix, and Tranzyme Pharma.

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If the advanced biofuels industry is to grow to meet national goals for reducing reliance on imported oil, then enduring federal commitment is vital to maintaining progress in research, development and investment in building infrastructure. The Biotechnology Industry Organization (BIO) called on Congress to help the industry secure investment by strengthening and extending federal tax incentives for next-generation biofuels in any tax and energy legislation considered this year.

Brent Erickson, executive vice president for BIO’s Industrial and Environmental Section, stated, “The economic downturn in the United States has dealt a blow to advanced biofuels development. Advanced biofuels can reduce reliance on imported petroleum and contribute to renewed economic growth by creating truly green jobs, but only with sustained federal commitment to the goal of rapidly increasing their production in the United States. This support, including new tax credit options for advanced biofuels, loan guarantees and continued support for R&D is vital for producers seeking the private investment needed to build biorefineries and infrastructure. In the current economic environment, biofuels companies are finding it extremely difficult to raise private financing to scale up first-of-a-kind commercial facilities, undercutting the industry’s ability to meet national targets.”

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