Expert Details

Radiology, Nuclear Medicine, Nuclear Pharmacy, Molecular Imaging, Patient Safety, Compounding

ID: 731800 North Carolina, USA

Director of Radiopharmacy and Associate Professor of Radiology and Medical Physics at a University Medical Center. He is also an adjunct faculty member at several colleges of pharmacy. Expert has expertise in research, development, and clinical use of radiopharmaceuticals for diagnosis and therapy. His clinical interests include use of PET drugs as diagnostic molecular imaging agents and SPECT drugs for both diagnostic imaging and therapy. He is an expert regarding medication use and patient safety in radiology. He is a consultant regarding current good manufacturing practices (cGMPs) for PET drug production facilities. He is also a recognized expert regarding USP 797 sterile compounding practices and most specifically to applying these evolving standards to compounding diagnostic and therapeutic radiopharmaceutical products.

Expert is highly experienced regarding supply chains for radiopharmaceuticals, contrast agents and drugs used in radiology. His research interests focus on the development of theranostic radiopharmaceuticals, which include Gallium-68 radiolabeled peptides for diagnostic imaging and Ytterium-90 and Lutetium-177 radiolabeled peptides for therapy of neuroendocrine tumors and other cancers.

Expert is a highly recognized expert in radiopharmacy, also commonly referred to as nuclear pharmacy. He has been a board certified nuclear pharmacist (BCNP) in good standing for nearly 30 years. Radiopharmacy is the branch of pharmacy concerned with procurement, compounding, quality control and dispensing of radiopharmaceuticals (radioactive drugs) intended for use in diagnostic imaging procedures and for use in therapeutic procedures. Diagnostic procedures include single photon emission tomography (SPECT) and positron emission tomography (PET) imaging. Therapeutic procedures include those for thyroid cancer, neuroendocrine tumors, liver tumors, metastatic bone cancer, brain tumors and others.

Nuclear Pharmacy (Radiopharmacy) ConsultantConsultant Assisted preparation and submission of a New Drug Application (NDA) for I-131 meta-iodobenzylguanidine (MIBG) a diagnostic adjunct in the diagnosis of pheochromocytoma and neuroblastoma.Nuclear Pharmacy Consultant, Clinical Pharmacists/Study Coordinator; management of clinical trials conducted at the University of Michigan leading to NDA approval of Adenoscan™ (adenosine) as a pharmacological adjunct in myocardial perfusion imaging.Nuclear Pharmacy Consultant, Member, Radioactive Drug Research Committee (RDRC).Nuclear Pharmacy Consultant, Consultant charged with providing comprehensive services to facilitate the clinical and research use of SPECT and PET radiopharmaceuticals for molecular imaging and therapy in pediatric populations.

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Education

Year	Degree	Subject	Institution
Year: 1975	Degree: BS,	Subject: Pharmacy	Institution: Prudue University
Year: 1977	Degree: MS	Subject: Bionucleonics - Nuclear Pharmacy	Institution: Purdue University

Work History

Years	Employer	Title	Department
Years: 1998 to Present	Employer: Undisclosed	Title: Associate Professor of Radiology; Director, Radiopharmacy Services	Department: Radiology / Nuclear Medicine
Responsibilities: Expert is directly responsible for the procurement, compounding, quality control, dispensing and safe use of all diagnostic and therapeutic radiopharmaceuticals employed in research and clinical settings. He also plays a major role in overall institutional compliance within radiology as member of various drug use and safety committees. Expert has knowledge and experience regarding the regulations and pharmacy practice standard governing the safe compounding of drugs and medications for patient care.
Years	Employer	Title	Department
Years: 1983 to 1998	Employer: University of Michigan Medical Center	Title: Director, Radiopharmacy Services	Department: Radiology / Nuclear Medicine
Responsibilities: Expert was directly responsible for the procurement, compounding, quality control, dispensing and safe use of all diagnostic and therapeutic radiopharmaceuticals employed in research and clinical settings. He also played a major role in overall institutional compliance within radiology as member of various drug use and safety committees.

Government Experience

Years	Agency	Role	Description
Years: 2013 to Present	Agency: North Carolina Board of Pharmacy	Role: Expert Radiopharmacy Consultant	Description: Expert has reviewed pharmacy practice cases under consideration for potential regulatory action and/or litigation. Currently serving as a member of the Compounding Working Group lead by NCBOP Executive Director

International Experience

Years	Country / Region	Summary
Years: 2011 to 2011	Country / Region: Hong Kong	Summary: Prepared and presented a three day training seminar entitled "Radiopharmacy & Radiochemistry for Nuclear Medicine" for the Hong Kong Hospital Authority, Central Commissioned Training Programme held at the Queen Elizabeth Hospital in February 2011. General topics included: Day 1 - Setting up a Hospital Radiopharmacy and Nuclear Medicine Laboratory; Day 2 - Operational Guidance on Hospital Radiopharmacy; and Day 3 - Clinically Useful Radiopharmaceuticals: Present and Future. Audience included nuclear medicine physicians, hospital pharmacists and radiopharmaceutical scientists.

Career Accomplishments

Associations / Societies
MEMBERSHIPS: American Pharmacists Association (APhA) American Society of Health-System Pharmacists (ASHP) Society of Nuclear Medicine and Molecular Imaging (SNMMI) North Carolina Association of Pharmacists (NCAP)

Licenses / Certifications
CURRENT PHARMACY LICENSURE: North Carolina, Reinstated SPECIALITY CERTIFICATION: Board Certified Nuclear Pharmacist: Certified: Re-Certified Authorized Nuclear Pharmacist (ANP) University of Michigan Medical Center Employer

Professional Appointments
Committee on Pharmacopeia, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). PET Drug Manufacturers Working Group, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). Committee on Scientific Program, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). Committee on Councils and Centers, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). Committee on Radiopharmaceuticals, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). SNMMI Board of Directors, Member. National Association of Nuclear Pharmacies (NANP), Board of Directors, Member.

Professional Appointments

Committee on Pharmacopeia, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). PET Drug Manufacturers Working Group, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). Committee on Scientific Program, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). Committee on Councils and Centers, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). Committee on Radiopharmaceuticals, Member, Society of Nuclear Medicine and Molecular Imaging (SNMMI). SNMMI Board of Directors, Member. National Association of Nuclear Pharmacies (NANP), Board of Directors, Member.

Awards / Recognition
PROFESSIONAL AWARDS AND SPECIAL RECOGNITION: Rho Chi Society (Pharmacy Honorary), Fellow of the American Pharmacists Association (FAPhA), Distinguished Achievement Award, Division of Nuclear Medicine, University of Michigan, Fellow – Leonard Davis Institute of Health Economics, The Wharton School, University of Pennsylvania, GlaxoSmithKline Executive Management Program for Pharmacy Leaders, Philadelphia, PA. William H. Briner Distinguished Achievement Award in Nuclear Pharmacy Practice, Academy of Pharmacy Practice and Management, American Pharmacists Association.

Awards / Recognition

PROFESSIONAL AWARDS AND SPECIAL RECOGNITION: Rho Chi Society (Pharmacy Honorary), Fellow of the American Pharmacists Association (FAPhA), Distinguished Achievement Award, Division of Nuclear Medicine, University of Michigan, Fellow – Leonard Davis Institute of Health Economics, The Wharton School, University of Pennsylvania, GlaxoSmithKline Executive Management Program for Pharmacy Leaders, Philadelphia, PA. William H. Briner Distinguished Achievement Award in Nuclear Pharmacy Practice, Academy of Pharmacy Practice and Management, American Pharmacists Association.

Medical / Professional
Nuclear pharmacy (radiopharmacy) residency (1 year) at the Indiana University Medical Center, Indianapolis, IN.

Publications and Patents Summary
He has 54 publications and 7 book chapters.

Additional Experience

Expert Witness Experience
He has served as an expert witness, given depositions, reviewed depositions and provided pre-trial consultation to defense law firms in state level courts. He has done some of this work as an expert consultant for the North Carolina Board of Pharmacy.

Training / Seminars
Prepared and presented a three day training seminar entitled "Radiopharmacy & Radiochemistry for Nuclear Medicine" for the Hong Kong Hospital Authority, Central Commissioned Training Programme held at the Queen Elizabeth Hospital in February 2011. General topics included: Day 1 - Setting up a Hospital Radiopharmacy and Nuclear Medicine Laboratory; Day 2 - Operational Guidance on Hospital Radiopharmacy; and Day 3 - Clinically Useful Radiopharmaceuticals: Present and Future. Audience included nuclear medicine physicians, hospital pharmacists and radiopharmaceutical scientists.

Training / Seminars

Prepared and presented a three day training seminar entitled "Radiopharmacy & Radiochemistry for Nuclear Medicine" for the Hong Kong Hospital Authority, Central Commissioned Training Programme held at the Queen Elizabeth Hospital in February 2011. General topics included: Day 1 - Setting up a Hospital Radiopharmacy and Nuclear Medicine Laboratory; Day 2 - Operational Guidance on Hospital Radiopharmacy; and Day 3 - Clinically Useful Radiopharmaceuticals: Present and Future. Audience included nuclear medicine physicians, hospital pharmacists and radiopharmaceutical scientists.

Vendor Selection
As a board certified nuclear pharmacist (BCNP) with over 30 years experience, he is a highly recognized and experienced expert regarding the manufacturers, suppliers and supply chains for molecular imaging agents most specifically radiopharmaceuticals (radioactive drugs) for diagnostic imaging and therapy.

Marketing Experience
He has actively followed the radiology, nuclear medicine, molecular imaging, medical physics industry of over 30 hears and keeps current on industry trends, growth, players, attitudes and new medical imaging and treatment technologies.

Fields of Expertise

medical physics, radiology, pharmaceutics, nuclear medicine, patient safety, radiopharmacy, radiology management, drug regulation, pharmacy, molecular imaging