CINCINNATI, Dec. 6, 2017 /PRNewswire/ — In response to strong interest from Asian pharmaceutical companies seeking access to U.S. markets, Cincinnati-based Camargo Pharmaceutical Services’ Chief Executive Officer, Ken Phelps, will be traveling to Tokyo, Seoul, Taipei, and Mumbai throughout December 2017. In each city, Phelps will hold seminars on 505(b)(2) drug development and meet with leading companies. Phelps’ trip to the region follows a prior trip to China, during which Camargo held a seminar with the U.S. Food and Drug Administration (FDA) on American regulatory issues, and builds on the global nature of Camargo’s clients.
"I am honored to be visiting Japan, South Korea, Taiwan, and India on this trip," said Phelps. "I look forward to sharing the benefits and impact of the 505(b)(2) pathway and meeting with forward-thinking companies."
Co-founded in 2003 by Phelps and Dr. Ruth Stevens, Camargo is the world’s leading strategic consultancy specializing in helping clients navigate the 505(b)(2) FDA approval pathway and global equivalents, from concept to approval. The 505(b)(2) approval pathway allows sponsors to leverage scientific data from existing studies and publications not conducted by or for the sponsor. By utilizing and bridging to existing data, a 505(b)(2) drug development program can result in a much less expensive and faster route to approval and market. The 505(b)(2) pathway brings to market new, differentiated products with tremendous commercial value.
"The US 505(b)(2) regulatory pathway has spurred innovation and helped bring quality products to market at affordable prices, impacting the lives of countless patients worldwide," said Phelps, widely regarded as one of the world’s foremost experts on 505(b)(2) development.
With its industry-leading expertise and multi-disciplined approach, Camargo helps to design development strategies to navigate the scientific, medical, regulatory, and commercial aspects of the 505(b)(2) drug development, and to position a drug for market success. The more than 35 PhDs on Camargo’s staff — experts in pharmacokinetics, toxicology, formulation development, and Chemistry, Manufacturing, and Controls — have led more than 1100 FDA meetings, and hold up to eight pre-IND meetings a month across all divisions of the FDA.
Camargo’s integrated team approach moves partner-clients’ products forward through each step of the 505(b)(2) pathway for generics, pharmaceutical, biotech, active pharmaceutical ingredient manufacturers, and medical device sector companies in 25 countries.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com