Frontage Labs, Inc.
Offered Nov. 1-3, 2011, in conjunction with a major healthcare industry forum, the workshop introduced and interpreted Food and Drug Administration (FDA) regulation of new and generic drug development. FDA officials and Frontage executives covered the many regulatory challenges within the Chinese and U.S pharmaceutical industries, and guided participants through the processes of compliant product development.
The workshop was hosted by Zeke Li, MD, PhD, Senior Vice President and Nick Zhang, PhD, General Manager, Frontage China. Speaking at the seminar were Frontage executives Ron Connolly, PhD, Derek Zhang, PhD, and Abdul Mutlib, PhD. Their presentations offered extensive detail on meeting FDA requirements for Good Laboratory Practices, Good Manufacturing Practices and Good Clinical Practices. Seminar attendees also learned about conducting successful pre-clinical studies in support of Investigational New Drug and New Drug Application filings, and preparing documentation for FDA audits.
Workshop Held Concurrently with Healthcare Conference
Now in its 3rd year, the Frontage workshop ran concurrently with the 15th Beijing International Healthcare Industry Forum, which drew 700 business, regulatory, and academic professionals. The theme of this year’s forum was “Open Communication, Resource Integration, Win-Win cooperation, and Leap Forward Development.”
The most popular sessions were pharmaceutical development using antibody therapies and the potential for products based on traditional Chinese medicine. Other key topics included medical reform policy, technology transfer, and project financing.
The forum was hosted by the Beijing Municipal Science and Technology Commission and the Administrative Office of the National Key Program for New Drug Research and Development.
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform. Frontage runs three Phase 1 Clinical units, a 72-bed Phase 1 Unit in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China. Frontage has an AALAC certified preclinical animal facility in Pennsylvania, where it also maintains bioanalytical and CMC facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. As a rapidly expanding CRO with ten years of success providing high-quality GXP services, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems.