MEDIPOST Strengthens Leadership to Launch CARTISTEM in North America
MEDIPOST Expands Leadership Team for North American Growth
MEDIPOST, Inc., a prominent innovator in stem cell-based therapeutics, has embarked on a significant journey to elevate its presence in North America. With the strategic appointment of five seasoned executives, the company is well-poised to advance its flagship regenerative therapy, CARTISTEM, towards a Phase III clinical trial in the U.S.
Introducing CARTISTEM: A Revolutionary Therapy
CARTISTEM is recognized as the first regulatory-approved allogeneic human umbilical cord blood-derived mesenchymal stem cell product worldwide. Initially introduced in Korea in 2012 for treating knee osteoarthritis, it has since gathered over a decade of real-world clinical data, benefitting more than 30,000 patients. This impressive track record showcases its potential as a groundbreaking treatment option for degenerative conditions.
Strategic Focus on Regulatory Approval
The newly assembled U.S. team is laser-focused on securing Investigational New Drug (IND) approval, a critical step needed to initiate the Phase III clinical trial for CARTISTEM. This approval is an essential milestone that will serve as a foundation for submitting a Biologics License Application (BLA), paving the way for a successful commercial launch across North America.
Building Strategic Partnerships
Recently, MEDIPOST strengthened its operational capabilities through a partnership with OmniaBio, which opened a state-of-the-art facility focused on cell and gene therapy manufacturing in Ontario. This collaboration is expected to leverage MEDIPOST’s extensive experience in cell and gene technology, ensuring the scale-up and effective distribution of CARTISTEM to meet future demand.
Leadership Team: A Blend of Experience and Vision
Edward Ahn, the CEO of MEDIPOST, expressed enthusiasm about the newly appointed leadership team, stating, "Our new leadership team brings an unparalleled wealth of experience, aligning perfectly with our ambitious goals. Combined with our track record of success and strong partnerships, MEDIPOST is ready for its North American journey. We’re excited about transforming the lives of patients suffering from osteoarthritis."
The new executive appointments include:
- Adrian Orr, Head of Clinical Development: With 25 years of experience in clinical research, Adrian is dedicated to ensuring CARTISTEM leads the clinical trials, taking significant strides toward its U.S. introduction.
- Jagannadha Rao Kandula, Ph.D., Head of CMC & Operations: Rao, who has over 25 years of experience in scaling protein biologics and cell therapies, previously held a senior position at Bristol Myers Squibb. His leadership will be crucial as MEDIPOST navigates the complex regulatory landscape.
- Keith Bentlage, Head of Project Management Office: With a distinguished career spanning over 30 years, Keith has a proven record of guiding programs to their timely and successful completion, ensuring that CARTISTEM's development stays on track.
- Richard Ong, Head of Quality: Bringing extensive industry experience from renowned companies such as Amgen and Shire, Richard will ensure that the commitment to quality in CARTISTEM’s development remains unparalleled.
- Raymond Bergeron, Head of Accounting & Controller: With expertise in biotech and investment management, Raymond focuses on creating efficient operational strategies for future growth.
About MEDIPOST, Inc.
MEDIPOST, Inc. stands out as a leader in the biotechnology sector, especially known for pioneering umbilical cord-derived stem cell therapies aimed at combating inflammation-driven degenerative diseases. Its flagship product, CARTISTEM, is not only the first allogeneic stem cell therapy approved for knee osteoarthritis in Korea but has also successfully treated a significant patient population. Following its Phase 1/2a clinical trials in the U.S., MEDIPOST is actively preparing for the next phase, involving a rigorous regulatory process to initiate a Phase III study. Through its collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM), MEDIPOST has established OmniaBio as a specialized contract development and manufacturing organization (CDMO) in Hamilton, Ontario, further enhancing its capabilities to manufacture CARTISTEM.
Frequently Asked Questions
What is MEDIPOST, Inc. known for?
MEDIPOST, Inc. specializes in developing umbilical cord-derived stem cell therapies for treating degenerative diseases, focusing on knee osteoarthritis.
What is CARTISTEM?
CARTISTEM is the first regulatory-approved allogeneic stem cell product derived from human umbilical cord blood, introduced for knee osteoarthritis treatment.
What are the next steps for CARTISTEM in North America?
The immediate step is to secure IND approval to initiate a Phase III clinical trial, which is critical for a successful market launch.
When was CARTISTEM launched?
CARTISTEM was launched in 2012 in Korea and has since treated over 30,000 patients with knee osteoarthritis.
Who are the key executives at MEDIPOST?
The new executive team includes experienced leaders such as Adrian Orr, Jagannadha Rao Kandula, Keith Bentlage, Richard Ong, and Raymond Bergeron.
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