Mercurie Consulting provides regulatory consulting for radioactive medical products. The firm takes its name and inspiration from Marie Curie, whose pioneering work in radioactivity advanced human health and earned her Nobel Prizes in two different sciences. Informed by years inside the NRC, Mercurie Consulting offers clients deep radiation safety and policy expertise, along with access to a national network of health physicists, physicians, and regulatory contacts. That expertise ultimately serves a single purpose: helping bring radioactive products safely to the patients who need them.
Ashley Cockerham is the founder and owner of Mercurie Consulting, with over 20 years of experience in radiation safety and regulatory compliance. She worked as a health physicist for the U.S. Nuclear Regulatory Commission for more than 10 years before venturing into private industry. Ashley gained broad experience serving in numerous roles in Medical Affairs, Marketing, Regulatory Affairs, and Compliance with a global life-sciences company that manufactures and sells radioactive microspheres. She graduated from Texas A&M University with a Bachelor of Science in Radiological Health Engineering and holds a Master of Science in Jurisprudence with a concentration in Pharmaceutical and Device Law and Compliance from Seton Hall University School of Law.
Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, Final Report
NUREG-1556, Volume 9, Revision 3
Team lead and contributing author of technical report that provides program-specific guidance and assists individuals in preparing applications for materials licenses for the medical use of byproduct material.
Yttrium-90 Microsphere Brachytherapy Sources and Devices, TheraSphere™ and SIR-Spheres® Licensing Guidance
Team lead and primary author of licensing guidance issued between September 2007 and February 2016 for yttrium-90 microsphere brachytherapy for the treatment of liver cancer.
Radium-223 Dichloride Medical Use Licensing Memorandum
Federal staff member responsible for evaluating the radiation safety aspects of radium-223 dichloride, now known as Xofigo, and issuing the medical use licensing decision for regulation as unsealed byproduct material under Title 10, Code of Federal Regulations, Part 35.
Written Directives for Y-90 Microspheres
The information required in written directives for yttrium-90 microsphere brachytherapy changed significantly as product use increased after initial therapy adoption in the early 2000s. This presentation provides an overview of the changes in written directive requirements from 2002 to 2016 and an analysis on reported medical events for each type of yttrium-90 microsphere brachytherapy.
Authorized Users for Y-90 Microspheres
Physician training and experience requirements for yttrium-90 microsphere brachytherapy changed significantly as interventional radiologists took the lead to administer the therapy as Authorized Users. This presentation provides an overview of the changes in guidance from 2002 to 2016 with a focus on training and experience requirements for interventional radiologists.
Emerging Thorium-227 Radiotherapy
Targeted thorium conjugates are being developed and evaluated based on their alpha-emitting properties for treatment of breast, gastric, prostate, lung, ovarian, pancreatic, and many other types of cancers. This presentation provides an overview of Th-227-based radiopharmaceuticals, which have the potential to become effective new cancer therapies.