Camargo Pharmaceutical Services

2017/12/5 14:46


AsiaNet 71383 (1966)

【シンシナティ2017年12月5日PR Newswire=共同通信JBN】米国市場参入を目指すアジア医薬品企業の強い関心に応えて、シンシナティを本拠とするCamargo Pharmaceutical Servicesのケン・フェルプス最高経営責任者(CEO)は2017年12月中に東京、ソウル、台北、ムンバイを訪れる。フェルプス氏は各地で505(b)(2)医薬品開発についてセミナーを開催し、主要企業と会合を持つ。先の中国訪問でCamargoと米食品医薬品局(FDA)が米国の規制問題に関してセミナーを開いたのに続き、Camargoの顧客の国際性を拡大する。







▽Camargo Pharmaceutical Servicesについて

Camargo Pharmaceutical Servicesは、505(b)(2)承認経路とこれに匹敵する国際規制手続きを専門とする総合的な医薬品開発サービスを提供する最も経験豊富な専門家チームである。製品開発機会の科学、医学、規制、商業上の実現可能性を評価することによって、Camargoは事業戦略に合わせ、あらゆる段階で当局の承認を確実にする強固な開発計画を組織的に構築し、実行する。臨床試験実施申請前(pre-IND)協議の計画・準備を通じた調整により、Camargoは医薬品開発計画全体にわたる一貫性を維持、確実にし、新薬申請(NDA)と将来の市場での成功の見込みを拡大する。Camargoは通常、月間3件から6件のpre-IND協議をし、25カ国以上で製品開発者と協力している。Camargo Pharmaceutical Servicesの詳細は を参照。

ソース:Camargo Pharmaceutical Services


Jennifer King


Camargo CEO Meeting with Leading Companies in Japan, Korea, Taiwan, and India


CINCINNATI, Dec. 5, 2017 /PRNewswire=KYODO JBN/ --

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

Source: Camargo Pharmaceutical Services

CONTACT: Jennifer King, 888-451-5708,