· Five industry experts with proven track records in phase 3 clinical trials and commercialization at global corporations recruited
· New hires to expedite IND and BLA processes for U.S. Phase 3 clinical trial
· Strengthening global pharmaceutical and biotech partnerships as MEDIPOST prepares for U.S. Phase 3 IND application next year
MEDIPOST (CEO Wonil Oh) is making significant strides in its North American debut of CARTISTEM®, its stem cell therapy for knee osteoarthritis, by recruiting a team of local experts to join its U.S. subsidiary, MEDIPOST, Inc.
CARTISTEM®, approved by Korea’s Ministry of Food and Drug Safety in 2012, is an allogeneic mesenchymal stem cell therapy derived from umbilical cord blood for the treatment of knee osteoarthritis. It is also the first advanced biopharmaceutical product from Korea to be administered to over 30,000 patients.
On December 3 (local time), MEDIPOST, Inc. announced the recruitment of five local experts for key leadership roles: Head of Clinical Development, Head of CMC & Operations, Head of Project Management Office, Head of Quality, and Head of Accounting & Controller. These strategic hires are expected to play a critical role in securing Investigational New Drug (IND) and Biologics License Applications (BLA) approvals for the Phase 3 clinical trial of CARTISTEM® in the U.S.
These five seasoned experts, each with at least 20 to 30 years of expertise in the global pharmaceutical and biotech industries, have proven track records of successfully managing Phase 3 clinical trials and commercialization processes.
Edward Ahn, Co-CEO of MEDIPOST, Inc., remarked, “The recruitment of these local experts has provided us with the expertise necessary to introduce CARTISTEM® to the North American market. Our mission is to improve the lives of North American patients suffering from knee osteoarthritis through the successful commercialization of CARTISTEM®.”
MEDIPOST is also actively exploring global business opportunities for CARTISTEM® to enhance its market presence worldwide. Last October, the company participated in a global conference in the U.S. and a bio-pharma event in Japan, engaging in business discussions with numerous multinational pharmaceutical and biotech companies for potential partnerships.
Antonio Seung Jin Lee, Head of MEDIPOST’s Global Business Division and Co-CEO of MEDIPOST, Inc. said, “We are currently preparing for the manufacturing of CARTISTEM® for clinical trials in partnership with our affiliate, OmniaBio, a CDMO specializing in cell and gene therapies.” He added, “Our focus is on guaranteeing that the IND application for the U.S. Phase 3 clinical trial progresses smoothly next year.”