N.C. Biomedical Innovation Network Launches With February 26 Symposium

Three-Way Partnership Hosts Symposium on Discovery And Development Of New Drugs And Medical Devices

[ClickPress, Fri Feb 05 2010] The North Carolina Biomedical Innovation Network will officially launch with a symposium on February 26, 2010. The symposium will focus on available local facilities that offer high-quality preclinical services and on cutting-edge approaches to accelerate the development of innovative drugs and devices. Speakers for the symposium include:

•Richard Stack, M.D., SyneCor, LLC
•Tim Bertram, D.V.M., Ph.D., Tengion
•Alison Harrill, Ph.D., The Hamner-UNC Institute for Drug Safety Sciences
•Howard McLeod, PharmD, UNC Eshelman School of Pharmacy
•Bill Zamboni, PharmD, Ph.D., UNC Eshelman School of Pharmacy
•Brian Booth, Ph.D., Food and Drug Administration

The North Carolina Biomedical Innovation Network was founded by The Hamner Institutes for Health Sciences, SynecorLABS, and The University of North Carolina Good Laboratory Practice (GLP) Bioanalytical Facility. The Network will expand to include additional leading preclinical research and development organizations within the state. The full-service contract research network is dedicated to providing a “one-stop shop” for the development and commercialization of pharmaceutical, biotechnology and medical device products. Overall, the goal is to utilize the capabilities and expertise within North Carolina to accelerate the discovery and development of innovative biomedical technologies and products in the U.S. The Network’s rigorous preclinical research standards will also be available to partners in other countries, such as China and India, that want to enter the U.S. market.

“North Carolina has a broad array of preclinical research capabilities that together can move a new drug or device from the laboratory bench into the clinic,” said Shayne Gad, Principal of GAD Consulting Services. “Additionally, experienced consultants in the state are readily available to provide guidance and services to ensure a time and cost effective development program. And the array of laboratory/clinical service providers offer both the required general case product development activities and cutting edge science and technology to solve the expected problems that always arise in development. As a drug development consultant in North Carolina, it is not only more convenient, but more efficient for me and my clients to use local facilities that can conduct all the research necessary for regulatory approval rather than coordinating and monitoring programs across the country.”

“The North Carolina Biomedical Innovation Network showcases the robust capabilities and expertise available within the state,” said John P. Richert, vice president of the business and technology development program at the N.C. Biotechnology Center. “By utilizing these services, pharmaceutical, biotechnology and medical device companies will be able to more efficiently and effectively take their products into the clinic and eventually the marketplace, where they can benefit patients.”

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- The N.C. Biomedical Innovation Network was founded by The Hamner, SynecorLABS, and the UNC GLP Bioanalytical Facility, which have the necessary infrastructure and expertise required to move innovative technologies through the regulatory process and into the clinic. With the creation of the Network, pharmaceutical, biotechnology, and medical device companies can now access these critical resources in order to advance their novel therapeutics and devices.

- Clients of the N.C. Biomedical Innovation Network use its services for the full spectrum of research & development studies including those to support to file an Investigational New Drug Application (IND), 510(k) Clearance, or Premarket Approval Application (PMA).

- The N.C. Biomedical Innovation Network provides access to a vast network of experienced drug and device development consultants, including local and national members of the Roundtable of Toxicology (RTC).

The Hamner Institutes for Health Sciences is a nonprofit research organization located in the heart of Research Triangle Park (RTP), NC. For 35 years, scientists at The Hamner have conducted preeminent research in environmental health sciences and chemical risk assessment. The Hamner is now leveraging its heritage to perform traditional GLP and R&D small animal studies to evaluate the safety and efficacy of drugs. The two flagship institutes at The Hamner, the Institute for Drug Safety Sciences and the Institute for Chemical Safety Sciences, build upon this expertise by developing and validating cutting-edge tools for safety assessment. Novel technologies include in silico models for predictive toxicology, in vitro models that utilize human cells or cell lines to evaluate perturbations of cellular responses, and in vivo models to elucidate genes that play a role in susceptibility to drug-induced toxicities. The Hamner continues to grow its campus through partnerships with academia, industry, and government and remains dedicated to positively impacting public health. For more information, please visit www.thehamner.org.

SynecorLABS is a premier AAALAC-accredited large animal preclinical contract research organization located in Research Triangle Park. The SynecorLABS team holds decades of world-class clinical and preclinical experience across the spectrum of advanced medical technologies including pharmaceuticals, biotechnology, nanotechnology, medical device and combination products. Through its pioneering approach to preclinical research, SynecorLABS enhances the predictive nature, and consequently seamless transition, from preclinical animal model testing to human outcomes. For more information, please visit www.synecorlabs.com.

Dr. William Zamboni is the director of the UNC GLP Bioanalytical Facility and the Translational Oncology and Nanoparticle Drug Development Initiative (TOND2l) Lab in the UNC Eshelman School of Pharmacy and the UNC Lineberger Comprehensive Cancer Center. The expertise of the Zamboni laboratories strengthens the N.C. Biomedical Innovation Network with its superior capabilities in drug discovery and development, pharmacology methods (formulation and assay development, and biomarkers), and analytical chemistry methods. A research focus of these labs is the translational development of nanoparticle agents.

Ryal Curtis
MMI Public Relations
(919) 233-6600


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