Dr. Joseph Kozikowski will present on designing a successful program for bone morphogenic protein at the global research headquarters of Korea’s leading pharmaceutical company.
NATICK, MA – April 5, 2010 – Clinivation, Inc. announced today that clinivation Founder and CEO Joseph Kozikowski, M.D. will present at the Daewoong Life Science Research Institute.
As an authority on the development and commercialization of advanced medical technology, and having led thousands of new submissions, renewals, refilings, novated submissions for major multinationals worldwide, Dr. Kozikowski will share his perspectives in a presentation entitled “Achieving U.S. FDA Concurrence on Regulated Development Plans of Bone Morphogenic Protein for Orthopedic and Orodental Indications and Applications.”
The presentation of nonconfidential information will address the complexities of simultaneous development and process validation, important industry precedent and best practices, and will include:
- How unlike native and CHO-expressed BMP-2, Daewoong’s 26 kDa BMP-2 is not glycosylated, and how no glycosylation- and Daewoong’s E. coli expression system- may offer advantages of reduced solubility and local retention, an established regulatory track record, easy scale-up, no viral or prion contamination risk, and other advantages;
- How Daewoong’s HA carrier- “Bongros”- may also have important advantages, including: advantages of the porous hydroxyapatite scaffold in bone tissue engineering, such as biocompatibility, biodegradability, osteoconductive ability (can achieve 90 vol% porosity), and osteogenetic ability (when complexed with BMP-2); and a favorable global regulatory history and long-term clinical experience of the porous hydroxyapatite scaffold;
- A full review of the development, quality, regulatory, and U.S. FDA enforcement histories in the public-domain of the Medtronic INFUSE bone graft product line, Stryker OP-1 bone graft product line, BioSET AMPLEX spinal fusion product line, and the Cerapedic i-Factor cervical fusion and orodental product line;
- Recommended approaches to multicenter U.S. FDA reviews, which include CDRH, CBER, and CDER; and
- Key considerations in the design of the preclinical development program, which include: the range of more than 15 required biocompatibility and toxicity studies; approaches to pharmacokinetics, critical local retention and dosing evaluations, dose-response studies for direct and indirect support of trauma and spinal fusion indications, and interaction studies; alveolar ridge and sinus reconstruction studies in dogs, goats, rabbits, and primates; and the expectation of postmarket studies to evaluate tumor promotion, immune response effect on embryonic development, and any remaining process validation issues (e.g., for antibody detection)
The audience will include Daewoong program and executive leadership, research staff, and regulatory professionals. The presentation will be held in on April 10, 2010 at the Daewoong Life Sciences Research Institute in Yongin, Korea.
Following the presentation, Dr. Kozikowski will be available for discussions and meetings to discuss the topics in greater depth.
Quotes & Commentary:
“It is an honor to have been invited to present, and I thank Chief Executive Jong-Wook Lee and Program Director Eui-Nam Lee for their efforts in arranging this opportunity for international learning,” said clinivation Founder and CEO Joseph Kozikowski, M.D.
About Daewoong Pharmaceutical:
The Daewoong Life Science Research Institute is focused on developing new chemical entities, biologics and incrementally modified drugs, etc.
Established in 1945, Daewoong Pharmaceutical Co., Ltd. has the largest prescription drug sales in Korea and envisions itself to become a top 50 global healthcare company by 2015.
In addition to its product portfolio, which includes 15 blockbuster products, Daewoong has built strong core competency for new drug development and has cultivated a cooperative culture for collaboration with global partners.
In the future, Daewoong will expand its global business with its foreign branches and global partners and become a global healthcare group which contributes to improving the quality of life for people worldwide.