JERSEY CITY, NJ, September 23, 2020 – Evergreen Theragnostics, Inc., a radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), today celebrated the groundbreaking for its new…
Quality. Innovation. Trust.
Evergreen Theragnostics was established in 2019 to be a leading US-based radiopharmaceutical Contract Development and Manufacturing Organization (CDMO). Our team’s unmatched expertise and track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management, make us your ideal partner for all of your radiopharmaceutical development, manufacturing, and commercialization needs
We offer a broad range of services for centrally distributed radiopharmaceuticals from Phase 0 through commercialization:
- Manufacturing process development
- GMP contract manufacturing through the entire product life-cycle
- Easy and efficient technology transfer and method validation
- Regulatory support services
- 21 CFR 211 compliant commercial manufacturing
- Nationwide logistics and distribution
- All variations of commercialization support incl. customer service, order
handling, demand planning, and full supply chain management
- Successful commercialization of theragnostic radiopharmaceuticals
- Extensive clinical production of antibody, peptide, and small molecule-based radiopharmaceuticals using alpha, beta, and gamma-emitting radionuclides
- Regulatory and QA expertise in both radiopharmaceutical and non-radioactive drug manufacturing settings, essential for a seamless and efficient transition of radiopharmaceuticals from the clinical investigation phase to the commercial marketing stage
- Specialization in:
- Radiolabeled biologics manufacturing process automation
- Batch size scale-up to allow commercial viability
- Novel agent analytical method development and validation
- Global distribution logistics
- Planned opening in Q3, 2021
- A 21CFR 211 compliant facility designed for GMP manufacture of therapeutic radiopharmaceuticals. Facility design complies with both US and EU GMP regulations
- Optimally located in New Jersey, USA, with easy access to global distribution networks and strong pharmaceutical talent pool
Multiple fully equipped production suites designed for manufacture of biologics, peptides, and small molecules radiolabeled with radionuclides of intermediate radioactive half-lives, including 177Lu, 131I,123I,124I, 89Zr, 64Cu, 67Cu, 161Tb, and others
Full capability quality control and sterility labs, fitted for biologics, peptides, and small molecule analytics
- Dedicated radiopharmacy dispensing capability for syringe delivery
- Direct isotope sourcing and supply management capability
Unrivaled radiopharmaceutical expertise and the gold standard for North American radiopharmaceutical production facilities.
Our Management Team and Board of Directors bring proven experience from all facets of the radiopharmaceutical industry.
CEO – CHIEF EXECUTIVE OFFICER
James Cook is a hands-on radiopharmaceutical executive with operational and commercial management experience in PET and radiotherapy products. From 2014-2019, James served as COO and then General Manager of the US division of Advanced Accelerator Applications (AAA).
Dr. Serge Lyashchenko
Dr. Serge Lyashchenko has extensive experience in the development and GMP manufacture of radiopharmaceuticals intended for both diagnosis and treatment of cancer. His primary professional interest is in the development of novel antibody-based immunoPET and radiotherapeutic…
Dr. Phillip DeNoble
As a regulatory affairs and quality professional, Dr. Phillip DeNoble is responsible for the development, registration, and quality assurance of radiopharmaceuticals manufactured for human use under Current Good Manufacturing Practices (cGMP). Phillip has led many…
HEAD OF PROJECT MANAGEMENT
Kevin Staton brings a unique combination of technical, administrative, and project management experience to the team at Evergreen Theragnostics. Kevin is the former business administration and project management lead for the Memorial Sloan Kettering…
Dr. Olena Lyashchenko
Dr. Olena Lyashchenko has over a decade of experience in the oncology setting. Previously she worked as an outpatient clinical dispensing pharmacist and pharmacy intern at Dana-Farber Cancer Institute. She also served as a preceptor for students…
BUSINESS OPERATIONS MANAGER
Austin Li has 15 years of combined experience in scientific research, business, and technology. Prior to joining Evergreen Theragnostics, Austin successfully orchestrated the new office setup and IT infrastructure for a biopharmaceutical company…
Board of Directors
Gérard Ber has more than 30 years of experience in molecular nuclear medicine. In 2002, Dr. Ber co-founded Advanced Accelerator Applications S.A. (“AAA”), and was its Chief Operating Officer from 2002 to 2018, when it was sold to Novartis AG for nearly $4 billion. Dr. Ber grew AAA from a start-up to a global leader in nuclear medicine and was member of its board of directors from 2002 to 2014, when AAA listed on The Nasdaq Global Select Market. Mr. Ber was responsible for all aspects of US and Worldwide commercial efforts, drug development, supply chain, and business development activities at AAA, including the successful launch of Lutathera® for the treatment of gastropancreatic neuroendocrine tumors and various diagnostic radiopharmaceutical agents . Prior to joining AAA, Mr. Ber served as the Director of OM Pharma’s Western European group from 2000 to 2002, the Director General and Director of Marketing and Commerce for CIS Medipro from 1994 to 2000, and in various management roles at CIS Bio International from 1984 to 1994. Mr. Ber serves as a Board member of Y-mAbs, a NASDAQ-listed late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. He received his PhD degree in Pharmacy from the Scientific and Medical University of Grenoble and a degree in marketing and international commerce from the Institut de Pharmacie Industrielle de Paris in Paris, France.
Enrico de Maria
Enrico de Maria co-founded Advanced Accelerator Applications (“AAA”), a pioneering biotechnology company in the Nuclear Medicine field. Enrico also served as General Manager of AAA’s Italy affiliate, and later oversaw integration into Novartis post-acquisition. Enrico trained professionally at Anderson Consulting – Accenture. Enrico attended the prestigious Polytechnic Institute of Turin where he studied Mechanical Engineering. Enrico continues to lend his experience and expertise further innovation and business development in the biotechnology field.
Dr. Paulus is currently the Senior Vice President of Regulatory Affairs at Abeona Therapeutics, a cell and gene therapy company headquartered in New York City. Victor has over 30 years experience in the pharmaceutical industry, including 20 years specializing in Regulatory Affairs. Prior to joining Abeona, he served as Vice President and Global Head of Regulatory Affairs at the clinical-stage immunotherapy company Hookpa Pharma. Previously, Victor was Global Head of Regulatory Affairs for Advanced Accelerator Applications, a Novartis Company, where he secured Orphan Drug Designations and product approvals for Gallium DOTATATE and Lutetium DOTATATE. Earlier in his career, Victor served as Director of Regulatory Affairs for pediatric vaccines at GlaxoSmithKine and Senior Director of Regulatory Affairs for biosimilar drug development at Dr. Reddy’s. He also held roles of increasing responsibility at Organon, Elusys Therapeutics, and the Population Council. Victor began his career as a laboratory technician at the Salk Institute manufacturing vaccines for us US Army and then managed a cell culture laboratory at Centocor and viral vaccine production at what is now Sanofi Pasteur. Victor has BSc degrees in biology and biochemistry, and MSc in biology and a Ph.D. in public health.
Professor Jason S. Lewis is the Emily Tow Jackson Chair in Oncology at Memorial Sloan-Kettering Cancer Center in New York. He is the Vice Chair of Research and Chief Attending of the Radiochemistry & Imaging Sciences Service in the Department of Radiology. He holds a joint appointment in the Sloan-Kettering Institute. He also holds appointments at the Gerstner Sloan-Kettering Graduate School and the Weill Cornell Medical College, New York, NY. He is an Adjunct Professor in the Department of Biomedical Imaging and Image Guided Therapy, The Medical University of Vienna, Vienna, Austria. He served as the President of the WMIS (2014-2015) and is the President-Elect of the Society for Radiopharmaceutical Sciences. He has received a Distinguished Investigator Award from the Academy of Radiology Research (2014), was the 2017 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Michael J. Welch Award winner and won the Paul C. Aebersold Award of the SNMMI (2019). He has been named a Fellow of both the World Molecular Imaging Society (2015), the SNMMI (2019) and the Royal Society of Chemistry (FRSC, 2019). His research interests are focused on the development of new molecular imaging agents and radiopharmaceuticals for the diagnosis and treatment of cancer. He has worked on the development of small molecules targeting cancer, as well as radiolabeled peptides and Zr-89-labeled antibodies targeting disease-specific receptors and antigens; this is always with the ultimate goal of clinical translation. He has published >280 papers, books, book chapters, and reviews in the field of molecular imaging.
Heinz Mäusli has over 15 years of experience in molecular nuclear medicine. He was one of the senior executives who built Advanced Accelerator Applications (AAA) from a start up to a global leader in this field. He served as AAA’s Chief Financial Officer from 2003 until July 2018. He also was the company’s general counsel from 2003 to 2015 and a member of its Board of Directors from 2008 to 2014. Prior to AAA, he was a management consultant with Accenture and Gemini Consulting. Heinz Mäusli serves on the board of Inventiva SA and will join the board of Lantheus Holdings. Mr. Mäusli received a lic.oec. from University of St.Gallen in Switzerland and an M.B.A. from Columbia Business School.