Associates

Cyclomedical is able to offer the convenience and economy of a full range of highly specialized services from experienced and talented people through one contractor, on an “as needed” basis.  Cyclomedical can thus provide exceptional technical resources.

A few of Cyclomedical’s Associates are the following:

 

Carroll & Ramsey Associates

provides service and technical support to the community of accelerator builders and users, including leading cyclotron manufacturers, U.S. Department of Energy National Laboratories, University Research and Clinical PET/Nuclear Medicine Imaging Centers, and commercial isotope producers.

Principals Fred Ramsey and Lewis Carroll are veteran contributors to the accelerator and PET fields. Their experience spans almost 50 years, first as members of the technical staff of The Cyclotron Corporation (TCC), then as founding members of CTI Cyclotron Systems (now Siemens Medical Systems), where they were lead members of the team that developed the RDS-112 and RDS-111 series of automated, self-shielded PET cyclotrons and, finally, as partners in an independent consulting firm.

Lewis Carroll

Lewis Carroll has worked in the accelerator field since 1969. He also led the development of innovative positron emission tomography (PET) Systems, including the first commercially- produced multi-slice BGO Neuro-Tomograph. Today, Carroll & Ramsey Associates’ radiation detectors such as the “EzScan” Radio TLC scanner are used in PET labs and radiopharmacies world-wide.

Professional craft skills and specialties include:

  • Specialized Cyclotron RF system design, troubleshooting, and repair;
  • Radiation Science, Instrumentation, Shielding, Health Physics, and Radiation safety;
Fred Ramsey

Fred Ramsey has worked in the accelerator field since 1962.

Professional craft skills and specialties include:

  • Specialized Engineering related to accelerator control, power, vacuum, and electro-mechanical system design and implementation 
  • Complete mastery and hands-on facility in all aspects of accelerator system operation, maintenance, troubleshooting, and repair
  • Project Management and leadership, with particular talent for efficient system implementa­tion, field installation, commissioning and de-commissioning, system start-up, testing, and user training.
Brian Abeysekera

Dr. Abeysekera holds a Ph.D. in synthetic organic chemistry from the University of British Columbia and has more than 25 years of experience in radioisotope and radiopharmaceutical development, including production, radiochemistry, quality control, quality assurance and regulatory affairs activities in the United States and Canada.

At MDS Nordion, where he held positions in R&D, safety, and regulatory affairs, Dr. Abeysekera helped establish the company as a cGMP supplier of sterile pharmaceuticals; designed, developed and validated aseptic manufacturing facilities; directed scale-up from clinical to commercial manufacturing; and developed chemistry and manufacturing sections to support FDA submissions.

He subsequently served as Vice President, Manufacturing, for Molecular Insight Pharmaceuticals where he was responsible for all aspects of supply chain management for drug products for clinical trials and commercial supply and for contract manufacturing contracts and services.

Currently Dr. Abeysekera is President of PharmaSPECT Inc, a company that provides cGMP and Manufacturing, Quality and Regulatory expertise to PET and SPECT radiopharmaceutical manufacturers.

Morgan Dehnel

Dr. Dehnel has worked in the accelerator field since 1989. He completed his research doctoral thesis at TRIUMF/UBC in the area of charged-particle optics for ion source, injection line, and inflector design and measurement and is an expert in industrial cyclotron beamline and injection line system design and operation.

Dr. Dehnel is President of Dehnel—Particle Accelerator Components and Engineering, Inc. (D-Pace). D-Pace provides products and services to the commercial accelerator industry, with a focus on providing custom equipment, consulting services and training to owners and manufacturers of commercial cyclotrons.  A recent development is the MiniPET Beamline which is only one metre long, has a mass of 50 kilograms, and provides XY steering and Horizontal/Vertical focusing to proton beams extracted from PET cyclotrons for optimized beam on target and more radioisotope production.   Some users find it advantageous to move production targets 1 metre from the cyclotron so that local target shielding cuts down residual radiation that cyclotron maintenance personnel are exposed to.

William C. Eckelman

Dr. William C. Eckelman is currently the editor-in-chief of Nuclear Medicine and Biology and sole proprietor of Molecular Tracer Consulting.  

Over the years, he initiated bench to bedside studies using both SPECT and PET radiotracers. At Brookhaven National Laboratory he and Jim Richards developed “instant kits” which became the basis for all subsequent Tc-99m radiopharmaceutical kits; at George Washington University he and Dick Reba developed I-123 IQNB which in 1983 led to the first SPECT neuroreceptor image in humans.

As Vice President of Diagnostics R&D in the Squibb Institute for Medical Research, he led the team that developed the strontium-82/rubidium-82 generator, Tc-99m labeled teboroxime, and Prohance, a gadolinium labeled MRI contrast agent. And as Chief of the PET Department, Clinical Center/NIH, he led the research group in developing several receptor binding radiotracers including a muscarinic receptor agonist, F-18 FP-TZTP, that showed promise as a biomarker for potential Alzheimer's disease in APOE4+ normal subjects. In addition, the PET Department cyclotron group developed techniques to prepare non-traditional PET radionuclides such as Tc-94m, Br-76, Ga-66, Y-86, and I-124.

He has also served on the faculty of the Radiology Department at George Washington University and at UCSD and as Chair of the Scientific Advisory Committee at Molecular Insight Pharmaceuticals.

Jonathan Ward Engle (Ph.D. Medical Physics)

Jonathan Engle describes himself as a cyclotron jockey and researcher with 10 years' experience in nuclear medicine research, operating and maintaining particle accelerators and performing a wide variety of F-18, C-11, N-13, Cu-61/64, Zr-89, Ga-66/68, Cl-34m, and other radionuclide-based targetry and radiochemistry for PET and environmental applications. He has experience as an analytical and preparative radiochemist and in both clinical and pre-clinical positron emission tomography (PET) scanning environments. He also has experience building and optimizing automated radiochemistry modules for routine and novel syntheses, building PET radiotracer production facilities from the ground up, and establishing necessary radiation safety policy and bringing GMP compliance to new and existing laboratories. He has degrees in Religion, Education, Nuclear and Medical Physics.

In 2012, Jonathan moved to Los Alamos National Laboratory (LANL) to work in the Department of Energy, Office of Science Isotope Production Program at the Los Alamos Neutron Science Center’s world-class linear accelerator, continuing his research in radioisotope production. With Brookhaven National Lab and international collaborators, the Isotope Program at LANL supplies the U.S. national need for Sr-82 (for Rb-82 cardiac PET) and Ge-68 (for PET scanner calibration and for Ge-68/Ga-68 generator production). He is currently working on a national supply of the alpha-therapy isotope Ac-225, contributions to nuclear databases and theoretical models in the 100-800 MeV (incident H+) range, and novel, large-scale production of many radionuclides of interest to medical research, neutrino mass measurements, environmental research, national security, nuclear nonproliferation and stockpile stewardship. 

From 2013-2015, Jonathan was a LANL Frederick Reines Postdoctoral Fellow in experimental science, and in 2015 he received a distinguished LANL Laboratory Directed Research and Development Early Career Research Award.

James Frost, M.D., Ph.D., MBA

James Frost’s M.D., Ph.D. (nuclear and radiochemistry) degrees are from Washington University; his M.B.A. from Johns Hopkins University, also completing diagnostic radiology and nuclear medicine residencies there, becoming board certified in both specialties, and serving as a faculty member for 26 years. With a university clinical practice since 1982, he is also a clinical trials reader.

He was on the Johns Hopkins’ team that accomplished the first imaging of a neuroreceptor and led the group that first imaged the brain opioid receptor in 1983. In 15 years on Johns Hopkins Institutional Review Board, he saw human investigation protocols spanning all areas of medical research and was Chairman of the Radioactive Drug Research Committee and Clinical Radiation Research Committee, reviewing all studies involving ionizing radiation.

Dr. Frost designed Yale University PET Center, creating a 10-year financial and strategic plan for molecular imaging research across multiple University departments, co-managing a 10-year bioimaging alliance with Pfizer. Director of the PET Center, he was responsible for 25 staff, acquisition of $8M in equipment, including cyclotron, PET scanner, and chemistry laboratory, and Medical Director and Authorized User for ionizing radiation, Section Chief for Nuclear Medicine’s clinical PET-CT imaging and general clinical nuclear medicine studies. Currently President of BioMolecular Imaging, LLC and a part-time Professor of Radiology at Johns Hopkins, Dr. Frost advises pharmaceutical, biotech, imaging CRO, and venture capital companies on the use of molecular imaging for the development of new drugs and diagnostics. He is also a board member of Applied Computational Technologies and a member of the Phrma Imaging Group and the Uniform Protocols for Imaging in Clinical Trials (UPICT) group.

Michael Jamieson

Michael Jamieson, DRSc., has built an international reputation around his ability to develop innovative regulatory solutions which enable companies to get their products and facilities through the regulatory hurdles in a timely fashion. He is an experienced senior manager with over twenty years of diverse international research and development, regulatory approval and regulatory compliance expertise.

Mike has been involved in numerous nuclear medicine projects including the clinical trial design and regulatory approval of a number of therapeutic and diagnostic radiopharmaceuticals and the implementation of radiopharmaceutical GMPs in both the private and academic sectors. In recent years Mike has spent a significant portion of his time in South America overseeing the building of GMP compliant manufacturing facilities. In 1991, Mike founded Pharmacon Research Inc. (Ottawa, Ontario and London, U.K), created to assist international companies in the development of integrated new product development programs for the North American market. In the fall of 2003, Pharmacon Research was renamed InSource Innovations Inc., and primarily focused on pursuing equity positions in university spin-offs in return for providing the clinical and regulatory expertise required to support the development of their product portfolios. He joined the faculty of the USC School of Pharmacy in 2007 after spending twenty-five years in the pharmaceutical and medical device industries.

Michael received his Master's from the University of Southern California in 2008 and was in the first graduating class for the Doctorate of Regulatory Sciences in 2011. Mike was appointed as the Associate Director of the University of Southern California’s International Center for Regulatory Science (http://regulatory.usc.edu/ ) in 2011. The Center includes an educational component which offers a graduate education program in regulatory science and management of drug development, an international outreach and support program, a research consortium with a focus on translational and regulatory research and a regulatory consulting group. Mike's research interests include the regulatory support of university-based researchers and the commercialization of medical products developed at universities.

Michael R. Kilbourn (BS Biochemistry, PhD Organic Chemistry).

Currently Professor Emeritus of Radiology at the University of Michigan Medical School, Dr. Kilbourn has more than 36 years of experience in all aspects of radiopharmaceutical chemistry, including cyclotron target design; development of new methods and reagents for radiochemical syntheses; design and synthesis of novel PET radiopharmaceuticals; preclinical validation of new radiotracers in animal models; and implementation of unique new radio-pharmaceuticals for human Positron Emission Tomography (PET) studies. He developed methods for radiolabeling with fluorine-18 and carbon-11 now used routinely in PET radiochemistry, and invented several PET radiopharmaceuticals utilized in human PET studies around the world. His contributions to the field or radiopharmaceutical chemistry, represented by more than 250 scientific papers, chapters and books, have been recognized by the Society of Nuclear Medicine and Molecular Imaging (2009 Paul C. Aebersold Award for Outstanding Achievements in Basic Science Applied to Nuclear Medicine; 2014 Michael J. Welch Award) and the Academy of Radiology Research (2012 Distinguished Investigator Award). 

From 1987 to 2012 he was Director of PET Radiochemistry at the University of Michigan, responsible for the administrative, personnel, financial, and regulatory aspects of the cyclotron and radiochemistry laboratory. In 2004-2005 he designed, equipped, and brought into functional use a new 7000-sq ft. cyclotron and radiochemistry facility for routine delivery of PET radiopharmaceuticals for both research (animal and human clinical studies) and patient care.  Dr. Kilbourn maintains an active research program at the University of Michigan, continuing a history of >35 years of continuous funding through research grants from the National Institutes of Health, U.S. Department of Energy, and various pharmaceutical companies. He is a co-founder of Synfast Consulting LLC, which provides consulting advice and practical assistance in the design, installation and operation of PET radiochemistry facilities for both research and clinical care.    

Jerry Rasmussen (Cyclomedical Associate and Manager – Wisconsin Medical Cyclotron)

Before becoming Manager, as Cyclotron Supervisor/Production Manager at Wisconsin Medical Cyclotron Jerry has been responsible for all aspects of manufacturing equipment maintenance, production processes, and day-to-day operations.  He is experienced in all areas of FDG manufacturing, quality control, dose drawing, and DOT packaging and shipping of radioactive material.  Utilizes proactive maintenance strengths combined with 25 years of experience installing, supporting, and maintaining complex electro-mechanical systems to ensure maximum system uptime and availability.  Instrumental in helping WMC achieve over 99% system reliability where doses that were ordered were received on-time.

As a member of Cyclomedical’s worldwide PET installation team, Jerry installed and qualified quality control laboratories in countries around the globe, solving problems for clients and vendors with dedication and humor.  He is an outstanding instrument operation trainer.

Jerry brings exceptional experience in instrumentation gained in 5 years as a District Service Manager for Agilent Technologies and 17 years as a Systems Engineer for Hewlett-Packard, providing both uptime maintenance and account management to customers with a wide array of complex instrument and computer systems utilized in high volume manufacturing environments.

Hector Francisco Valdovinos (M.Sc. Medical Physics)

Hector Valdovinos is currently a Ph.D. candidate in the Medical Physics program at the University of Wisconsin-Madison. There, he operates and maintains a GET PETtrace 800 cyclotron and a CTI RDS 112 prototype cyclotron. His research is focused on the development of novel targetry and separation chemistry approaches to introduce into the field of Nuclear Medicine uncommon radiometals that have favorable decay characteristics for positron emission tomography (PET) and even targeted radionuclide therapy. He has experience in the production of: 11C (CH4), 18F (F-), 13N (NH3), 44Sc, 45Ti, 52Mn, 55Co, 61,64Cu, 66,68Ga, 68,69Ge, 86Y and 89Zr; in the conjugation of proteins with chelators such as NOTA, DOTA, DTPA and Desferroxamine for labeling radiometals; in the automation of radiochemical separations; and in analytical measurements with HPLC, TLC, GC, AES and XRF. So far, he has collaborated in the installation of radiopharmacies in Ecuador, Mexico and Peru. He finished his B.Sc. in Engineering Physics at Monterrey Institute of Technology in Mexico.    

 

Samira Soares Waquil, Nuclear Pharmacist

Samira has more than 7 years of radiopharmacy experience with a strong background in [18F]FDG synthesis, quality control and good manufacturing practices.  Most recently she supervised quality control of [18F]FDG production at HCFMUSP (Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De São Paulo, São Paulo, Brazil), and at Cyclomedical-managed sites in the Middle East. 

Born in the United States, Samira has lived most of her life in the state of Minas Gerais in Brazil, where she earned her Universidade Federal de Minas Gerais, Belo Horizonte, Bachelor’s Degree in Pharmacy.  Samira’s advanced training in radiopharmacy PET research continued with specialized coursework and seminars with international experts.  She is completely fluent in both English and Brazilian Portuguese.

Additional skills in training and in maintaining regulatory compliance, including standard operating procedures, qualification and validation protocols, and in production site logistics control give Samira a full range of capabilities.  Her interpersonal skills are extremely helpful in managing tasks and interactions with people at all levels, and she is both smart and adaptable.

Bruce Wieland

Bruce Wieland has four decades of engineering research experience in the field of cyclotron targets for the production of 11C, 13N, 15O, and 18F used to label radiopharmaceuticals for PET/CT metabolic imaging. Bruce has a BS in Mechanical Engineering and a PhD in Nuclear Engineering, and has worked at national laboratories (ORNL, BNL), universities (UCLA, Duke), and private companies (CTI, BTI). 

He has numerous publications and targetry innovations, and is a founder of the International Workshop on Targetry and Target Chemistry (held every two years since 1984). He is President of BTI Targetry (founded in 2002), which has sold over 100 high performance retrofit targets for producing 18F with Siemens, GE, and IBA cyclotrons. He has also worked with 211At targets (monoclonal antibodies for brain tumor therapy).

Bruce has been the Principal Investigator on several SBIR grants (5 NIH, 1 NSF). His current focus is R&D on enriched 11B and 13C recoil-escape porous nanomaterial targets for producing high yields of 11C and 13N at low proton energies (7-11 MeV), in support of biotracers like 11C-choline for prostate cancer detection and 13N-ammonia for rest-stress cardiac studies.

Günter Firnau

Dr. Günter Firnau has contributed innovatively to the development of PET chemistry over the last 30 years, establishing the PET radiochemistry at McMaster University and the University of Ottawa Heart Institute in Canada. He has invented a number of novel PET tracers. One of his innovations, 6-[F-18] fluoro-L-dopa, is now used the world over. He has held academic appointments at McMaster University, University of Toronto and University of Ottawa. He can provide hands-on consulting for PET isotope production with facility design, cyclotrons, targetry, radiochemistry and engineering of radiopharmaceutical synthesis ([F-18] FDG, 6-[F-18] fluoro-L-dopa, C-11 labeled tracers, [N-13] ammonia and others), quality control analysis, license applications, radiation safety programs and training of personnel.  Dr. Firnau currently operates from Germany.

`