|
 NCBIO and other members of the Biomanufacturing and Pharmaceutical Training Consortium will be hosting their second annual life sciences internship fair Friday, January 25th, 2008, from 1:30 to 4:30 p.m. at the Golden LEAF BTEC facility at North Carolina State University. More than 200 students and 16 companies participated in the last fair, which was held in February 2007. The 2008 fair is expected to feature 25-30 life science companies interested in interns from North Carolina State University, North Carolina Central University and North Carolina Community Colleges. In addition to an opportunity to talk with company representatives, students attending the fair will have a chance to see mock interviews, get an overview of North Carolina's life science industry, have resumes reviewed and take a tour of the BTEC facility.
If your company is interested in participating, please contact Brenda Summers.
 North Carolina State University's Golden LEAF Biomanufacturing Training and Education Center (BTEC) has entered into an agreement with the Food and Drug Administration to provide training to FDA inspectors. The program will benefit FDA trainees and North Carolina's biotech industry by streamlining the field inspections process.
BTEC will design, develop and deliver pharmaceutical and biomanufacturing training for the Office of Regulatory Affairs (ORA) field and operational personnel. BTEC will receive $161,000 for the services under the first year of the agreement, which is eligible for four, one-year extensions. The first class of inspectors will begin training in the spring of 2008.
Rick Lawless, BTEC's associate director of strategic support and project manager for the FDA contract says, "Local industry could end up being the biggest winner, since BTEC students and industry employees will be able to learn pharmaceutical and biomanufacturing principles from the same faculty and trainers that deliver training to the FDA investigators. Field inspections should be more effective because company officials and FDA investigators will speak a common language and have similar technical backgrounds."
The training will consist of distance-education learning modules and hands-on training at the new Golden LEAF BTEC facility on NC State's Centennial Campus. In addition to BTEC's high-tech facility and expert faculty, the FDA valued the Center's focus on training versus contract manufacturing and North Carolina State University's ability to provide low-cost housing for on-site trainees.
BTEC will work closely with the FDA to produce courses that give participants exposure to pharmaceutical and biomanufacturing facility and equipment design issues, product development, manufacturing, and analytical testing methods. Trainees will gain experience in the same pharmaceutical and bioprocessing technologies that they inspect on a regular basis.
 North Carolina Biotechnology Center President and CEO, Norris Tolson, will be the featured guest on "North Carolina People" hosted by Bill Friday, on UNC-TV on Friday, November 16, 2007, at 9:00 p.m. The interview will cover a wide range of biotechnology topics, including the formation of the Biotechnology Center, the definition of biotechnology, various applications of the technology, regional development, the North Carolina Research Campus, education, research, Oliver Smithies' Nobel Prize, partnership, job creation and the future role of biotech in the state's economy. The program will also air on Sunday, November 18, at 5:30 p.m.
NCBIO and QuickSTAT will host their annual seminar on life science transportation regulatory issues on Tuesday, February 5, 2008. The event will be at the Hamner Conference Center at the North Carolina Biotechnology Center.
Transportation of dangerous goods and infectious materials has become increasingly regulated. Just in 2006, FAA investigated 2,345 hazardous material enforcement cases collecting $4.94 million. The February seminar will help participants understand risks and liabilities involved in the worldwide transport of time- and temperature-sensitive life sciences shipments.
The seminar will also feature industry experts with reviews of HAZMAT incidents that have resulted in FAA penalties and show participants how to avoid costly incidents by understanding current regulations and requirements for shipping dangerous goods, infectious/biological substances, and dry ice by air.
NCBIO members do receive a discount. Click here for more information.
Ralph Steinman, M.D., a scientific founder of Argos Therapeutics, has received the 2007, Albert Lasker Award for Basic Medical Research for his discovery of dendritic cells. Dendritic cells are a key element of the immune system, responsible for initiating and stimulating the body's immune response to foreign antigens, and are also the basis for Argos' personalized immunotherapy technology, called Arcelis, for infectious disease and cancer. John Bonfiglio, Ph.D., President and Chief Executive Officer, commented, "This prestigious award is a testament to Dr. Steinman's revolutionary research and provides strong validation for Argos' dendritic cell-based approach to autologous immunotherapy and its broad applicability to infectious disease and cancer. Our work so far has provided promising results, and we look forward to reporting data from our current trials in HIV, renal cell carcinoma and chronic lymphocytic leukemia in 2008."
Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), has announced plans to advance TC-5214, one of two enantiomers of mecamylamine hydrochloride, into clinical development as an augmentation therapy for patients who are inadequate responders to first-line antidepressant treatments. Targacept expects to initiate a Phase 1 trial of TC-5214 in the first quarter of 2008 and to initiate Phase 2 development soon thereafter. The company has no current plans to conduct further clinical development of mecamylamine.
To have your company news included in this section, please have your media relations contact add Brenda Summers, bsummers@ncbioscience.org to the distribution list.
 Federal Court Ruling Enjoining
Federal Patent Rules
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood has praised a Virginia federal district court for its preliminary injunction barring the U.S. Patent and Trademark Office (PTO) from implementing new patent prosecution rules. BIO believes the rules will inhibit the ability of innovators to obtain adequate coverage on their inventions, significantly decreasing their ability to attract the financing necessary to bring a product to market. Greenwood said, "This is a sound decision that reflects the concerns expressed in BIO's recent submission in the case. We hope this delay signals recognition of the unintended consequences of these rules and will ultimately result in a permanent stay. As we have long said, the rules will adversely impact biotechnology innovation."
Greenwood continued, "We recognize that the PTO has a workload challenge. But these rules are not the answer to that challenge. We look forward to working with the PTO to develop a viable and workable solution that fairly allocates responsibility for patent quality between patent applicants and patent examiners, and that enhances the strength and integrity of the American patent system."
SBIR Funding
In a letter to Congressional leaders, fifty-two patient advocacy and medical specialty groups have urged that small, venture backed biotechnology companies be allowed to once again compete for Small Business Innovation Research (SBIR) grants, a federal program that provides a vital source of funding for new biomedical innovation.
The letter stated, "The current eligibility guidelines are prohibiting many of the most innovative companies from competing for crucial early state research and development funding, which impacts the future of the research being pursued by universities and the patients that ultimately benefit from new treatments and cures. We respectfully urge you to restore SBIR eligibility for majority venture-backed companies in the upcoming reauthorization of the program."
In 2003, the Small Business Administration (SBA) reversed a 20-year-old policy by ruling that companies that are 51% owned by a group of private investors no longer qualify for SBIR grants. As a result of the 2003 interpretation, the SBIR applicant pool is shrinking at the National Institutes of Health (NIH), and work on life-saving and life-enhancing technology is being postponed, sometimes indefinitely.
NIH Director Elias Zerhouni, MD, stated in a letter to the SBA that the limit on eligibility for SBIR grants "undermines NIH's ability to award SBIR funds to those applicants whom we believe are most likely to improve human health, which is the mission of NIH."
The letter continued, stating, "Small biotechnology companies require significant venture capital investment, and unfortunately the SBA reinterpretation of the eligibility rules has hampered the continued research and development into biotechnology products, thereby delaying the delivery of future treatments to patients."
The letter was signed by a group reflecting a diverse cross section of diseases, including cancer, diabetes, Parkinson's, multiple sclerosis, Alzheimer's and a host of rare diseases. According to the groups, this decrease in SBIR grant applicants will have a severe impact on patients of all disease categories.
BIO Urges Congress to Support Emerging Biofuels Technology
The Biotechnology Industry Organization has asked Congressional leaders to ensure that energy legislation currently under consideration include strong support for emerging biofuels technologies, particularly cellulosic ethanol and other next-generation biofuels. BIO President and CEO Jim Greenwood stated, "This is a critical time. We must invest now in commercialization and ongoing research and development of new liquid transportation fuel alternatives."
In the letter BIO advocates five policies to develop renewable fuels markets, accelerate the construction of new biorefineries, ensure adequate feedstock supplies, and continue to improve the technology and reduce the cost of biofuels production. The letter calls for the federal government to:
• Accelerate commercial production of cellulosic biofuels via a cellulosic biofuels production tax credit;
• Ensure a market for an emerging cellulosic biofuels industry via an advanced biofuels Renewable Fuels Standard;
• Continue to invest in research, development and demonstration of cellulosic and other advanced biofuels technologies in parallel with commercialization activities;
• Ensure that loan guarantees will be available for first-generation cellulosic ethanol facilities; and
• Ensure that a broad spectrum of feedstocks will be available for conversion to second-generation biofuels.
Greenwood concluded, "The urgent challenges of energy security and global climate change demand that we reduce our dependence on imported petroleum and move rapidly toward greater use of clean, domestically produced renewable fuels and products. With ongoing advances in both industrial and agricultural biotechnology, biofuels can help America meet nearly half its transportation-fuel needs by the middle of this century."
BIO Investor Conference
The Biotechnology Industry Organization hosted its fourth annual BIO Investor Forum October 9-11, 2007. The conference was held against the backdrop of a fairly positive financing environment with most analysts anticipating positive growth in investment activity for the fourth quarter of 2007. Roundtables on financial issues such as biotech turnaround investments, cross-over investors and IPOs and exit strategies provided attendees with advice from industry experts on how to navigate the current environment. There were also 204 public and venture-stage company presentations.
Alan Eisenberg, BIO's Executive Vice President of emerging Companies and Business Development said, "Investors are looking for good science, a compelling story, and an understanding of where a company is in the development process. The annual Investor Forum offers them a unique opportunity to learn about and explore opportunities with emerging companies that have promising science to share."
BIOCOM Establishes Fire Relief Fund
BIO's regional affiliate, BIOCOM, has joined forces with BIO-member Invitrogen to establish two relief funds. One is for immediate needs (the Fire Relief Biotech Immediate Response Fund). The other is for long-term help with rebuilding (the Fire Relief Biotech Recovery Fund). Both funds are intended to aid the wider San Diego community. Each will provide grants to non-profit relief organizations recommended by the San Diego Regional Disaster Fund Board. Click here do donate online by credit card. To donate by check, mail to:
The San Diego Foundation
2508 Historic Decatur Rd.
Suite 200
San Diego, CA 92106
To make a donation of stock, call The San Diego Foundation
at (619) 235-2300.
December 19, 2007. MedTech Forum: Emerging Trends in Med-Tech - The Acquirers' Perspective. More information will be posted when available.
January 23, 2008. MedTech Forum: Emerging Trends in Med-Tech - The Entrepreneurs' and Venture Capitalists'' Perspective. More information will be posted when available.
January 25, 2008. BPTC Internship Fair at BTEC, 1:30-4:30. Contact bsummers@ncbioscience.org for more information.
May 19, 2008 . Biotech 2008: Fusing Science, Technology and Industry Leadership. Benton Convention Center , Winston-Salem . Hold the date. More information will be posted when available.
|
NCBIO This Month
