BIORCHESTRA appoints pharma veteran and Moderna and Akcea (Ionis) CMO "Dr. Louis St. L. O'Dea" as CMO of BIORCHESTRA
BIORCHESTRA is a bio-tech company focused on the identification of novel targets in neurodegenerative diseases using RNA-based therapeutics. To access these novel targets, BIORCHESTRA has also developed a proprietary nanoparticle formulation to deliver RNA-based drugs across the blood-brain barrier in sufficient amounts to be therapeutically effective. In addition, their proprietary exosome-based diagnostic that detects and quantifies markers of neuroinflammation and neurodegeneration facilitates patient selection and treatment monitoring.
Nonclinical models confirm the relevance of the neuroinflammation and neurodegeneration pathways targeted by BIORCHESTRA and confirm deep brain delivery of their proprietary drug, BMD-001, in rodents and primates and disease models of ALS and Alzheimer’s disease.
BIORCHESTRA has been recently recognized for its achievements by Johnson & Johnson in their Innovation QuickFire Challenge in Neuroscience in June, 2021. [i] [ii]
Reflecting the success of its research and development programs and anticipating its international expansion and entry into clinical development, the BIORCHESTRA has appointed Dr. Louis St.L. O’Dea as its first CMO (Chief medical officer) in September, 2021. CEO Branden Ryu mentioned “Dr. O’Dea has successfully has led 14 drugs including sNDA and ANDA, development program, regulatory interactions and drug approvals at Moderna, Akcea, Serono and Radius. He is a great fit for BIORCHESTRA having expertise and experience in all phases of drug development, trial design and execution, regulatory affairs and RNA. I am more than happy to be developing new drug with such a great expert Dr. O’Dea.
Dr. O’Dea will play key role in overall strategic direction, planning, execution and interpretation of clinical research, clinical operations and clinical pharmacology, data management, statistics and safety/pharmacovigilance for neurodegenerative diseases and mRNA vaccines. This will be a great opportunity for us to learn how great biotechs such as Moderna and Ionis(Akcea) have grown, overcome difficulties and develop products. I will be collaborating closely with Dr. O’Dea.” In addition to the responsibilities listed above, Dr. O’Dea has also joined the Board of Directors of BIORCHESTRA as of September 2021 and will become President of the North American subsidiary of BIORCHESTRA.
Dr. O’Dea said “my decision to join BIORCHESTRA was based on the innovative foundational science, the high social value of the work of BIORCHESTRA in addressing fatal neurodegenerative diseases, and the quality and commitment of the people. Hence, the decision to travel over 7,000 miles to Daejeon, South Korea, to join BIORCHESTRA. I am honored to steer this organization through its next phase of growth, to deliver life-saving drugs to patients. We will have the benefit of the best talent available in Boston and Daejeon to deliver on the promise of BIORCHESTRA’s scientific platforms.
Dr. Louis St.L. O’Dea (MB, BCh, BAO, FRCP has worked as CMO in global pharmaceutical companies such as Serono, Moderna, Akcea (Ionis), Radius and Oxford Immunotec for 28 years. He has successfully registered 14 NDAs including NCEs, sNDAs and ANDAs, 5 Orphan drug designations, and 1 medical device approval in USA, Europe, Canada, and Japan. He has expertise with RNA(oligo-nucleotides), proteins, peptides, small molecules and route of administration from numerous new drug development experiences. As CMO and head of regulatory affairs of Moderna, Dr. O’Dea was a member of the executive team that attracted research funds from DARPA (Defense Advanced Research Projects Agency) to initiate the mRNA vaccine program and significant investments from AstraZeneca and Alexion”.
In Akcea Therapeutics (Ionis’s subsidiary, developed treatment for rare diseases using oligonucleotide platform) Dr. O’Dea served as CMO and Executive Vice president and registered “WAYLIVRA® (volanesorsen)” in Europe. The Akcea executive team also successfully completed out-license deals with Novartis (>$1 billion) and Pfizer (>$1 billion) and listed Akcea Therapeutics on the NASDAQ in 2017.
Dr. O’Dea graduated in Medicine from University College Dublin and did postdoctoral research at McGill university hospitals, Massachusetts general hospital/Harvard university, and was a member of the Faculty of Medicine at McGill before coming to industry. He has published 36 papers, co-authored 11 book chapters, published more than 100 abstracts and filed 3 patent applications. He also has extensive experience in clinical trials and regulatory negotiations and meetings in EMA, Japan, Argentina, Australia, Belgium, Canada, UK, France, Germany, Ireland, Netherlands, Sweden, as well as the US FDA.