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:
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, 211At, 225Ac, 212Pb, and others
Full capability quality control and sterility labs, fitted for biologics, peptides, and small molecule analytics
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 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…
Regulatory Advisor
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…
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…
QA & QC Manager
Kyle Powell brings experience in the management of the Quality Assurance and Quality Control of pharmaceutical products marketed in the US, Canada, and Europe to the team at Evergreen Theragnostics. Kyle is a former Quality Assurance and Regulatory Consultant to industry…
Production Manager
Dr. Kyle Hoffmann brings his experience as Facility Manager and Pharmacist-in-Charge of a radiopharmaceutical manufacturing pharmacy where he led a team in the daily manufacture of PET pharmaceuticals and general facility operations…
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 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.
Advisor
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.
Advisor
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.
SPRINGFIELD, N.J., July 15, 2021 /PRNewswire/ — Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), has undertaken an important strategic expansion…
Brussels, Belgium and Jersey City, USA, 28 April 2021 – Precirix NV, a clinical-stage biotechnology company developing novel radiopharmaceuticals in oncology, and Evergreen Theragnostics, Inc.,…
JERSEY CITY, NJ, September 23, 2020 – Evergreen Theragnostics, Inc., a radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), today celebrated the groundbreaking for its new…
We are dedicated to the high quality manufacturing, development and distribution of therapeutic and diagnostic radiopharmaceuticals.
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). During this time, James built the AAA US organization from its inception, established a state-of-the-art radiotherapeutic manufacturing facility in New Jersey, and oversaw two successful product launches – the first commercial Ga-68 based diagnostic product and the first commercial Lu-177 based therapeutic product. Prior to that, James held a series of roles at Siemens Healthcare, including head of PETNET sales and business development, and head of strategy for the Molecular Imaging business unit. James originally entered the industry in 2005, when he consulted on the post-merger integration of CTI Molecular Imaging with Siemens Healthcare. James holds an MBA from INSEAD in Fontainebleau, France.
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 registrational efforts (IND, CTA, IMP, NDA, BLA, and ANDA) in the rapidly expanding field of radiopharmaceuticals, focusing on molecular imaging and radiotherapy. Phillip has extensive experience interfacing with the Food and Drug Administration, Health Canada, and The European Medicines Agency. Phillip has held management and leadership positions at Memorial Sloan Kettering Cancer Center, New York University, Baxter Healthcare, and Progenics.
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 in New York City. He started off his career as a research and development laboratory scientist and quickly progressed into building successful office and laboratory operations.
Kyle Powell brings experience in the management of the Quality Assurance and Quality Control of pharmaceutical products marketed in the US, Canada, and Europe to the team at Evergreen Theragnostics. Kyle is a former Quality Assurance and Regulatory Consultant to industry and counsel. While in a consulting role, Kyle managed the development and optimization of multiple Quality Management Systems for clients marketing pharmaceutical products in the US, Canada, and parts of Europe. Kyle’s combined experience in Quality and Regulatory provide him with a unique perspective as a Quality Manager and enable him to create an effective GMP environment for which products are manufactured in, from initial product development through end-use distribution. Kyle has extensive experience in technical writing, QMS development, GMP operations, and regulatory submission development. Kyle holds a Master’s in Animal Physiology from West Virginia University.
Dr. Kyle Hoffmann brings his experience as Facility Manager and Pharmacist-in-Charge of a radiopharmaceutical manufacturing pharmacy where he led a team in the daily manufacture of PET pharmaceuticals and general facility operations. Prior to this, he was a Pharmacy Manager with a retail pharmacy chain. He provides experience with Current Good Manufacturing Practices (cGMP), radiopharmaceutical preparation and dispensing, and ability to manage flexible and time-sensitive production schedules. Kyle holds a Doctor of Pharmacy degree from Massachusetts College of Pharmacy and Health Sciences University and has been a registered pharmacist since 2017.