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The book tells the reader how a niche business can develop in a complex context and a peculiar market, such as that of PET radiopharmaceuticals. The narrative gathers three different views, and allows the reader to focus on multiple aspects that may remain hidden at the beginning of a PET radiotracer project. Nevertheless, many of the considerations in the book may be useful to approach other emerging high-tech fields of biomarkers and health indicators. The successful implementation of the Quality Assurance system is a key point of a PET organization, as well as skill identification and the selection of personnel in operational and managerial duties. The development of a GMP PET manufacturing site inside a public organization from an in-house hospital radiopharmacy and the hurdles to face and become a third party site in a public-private cooperation, are detailed and commented. Finally, the book discusses how a PET site can achieve great results despite limited resources, andwhat are the key strategies to choose and develop new radiotracers or ensure coexistence of multiple tracers on the market. Globally, the book provides "food for thought" and may be a valuable tool for professionals in the radiopharmaceuticals industry and managers at universities or hospital willing to develop a GMP PET Production site.
Dr. Pecorale is an accomplished professional in the field of radiopharmaceutical technologies, where he is operating since 1994 (SPECT and PET productions). He obtained his Master's Degree in Chemistry and Pharmaceutical Technologies from the University of Padua in 1993, with a thesis focusing on radiopharmacy. As a member of the Italian Pharmacist Association, he is a registered pharmacist.
Currently, he holds a position at GE HealthCare, where he serves as the PET Manufacturing Manager for Drug Product in Europe. In this capacity, he is responsible for managing a network of PET third-party sites across Europe that produce PET products for neurological, cardiac, and oncological diseases. His role involves ensuring the quality and efficiency of the manufacturing processes within this network.
Dr. Pecorale is also recognized as an author, having published the book "Essence of the PET Radiopharmaceutical Business, A Practical Guide" with Springer in 2022.
Dr. Inzerillo pursued a career dedicated to quality assurance in the radiopharmaceutical industry. She obtained a Master's Degree in Biology from the University of Turin in 1984, laying the foundation for her future endeavors. Until her retirement in 2020, she was an esteemed employee of General Electric (GE) in the Healthcare division, where she served as a Quality Assurance Manager.
Her responsibilities in Quality Assurance encompassed PET and SPECT ready-to-use tracers, cold kits, generators, and contrast media. She played a vital role in developing the annual quality planning, coordinating quality projects, establishing standard operating procedures, and designing training plans extended also to CMOs sites. She was also responsible for validation activities and auditing to ensure compliance with laws, regulations, and guidelines.
Dr. Inzerillo was one of the first quality assurance specialists in Italy to handle the conversion of radiopharmaceuticals intodrugs, since 1993.
1. Management of a PET site, the ability to reach great results through a small organization.- 1.1. Differences between the management of the production of SPECT and PET radiopharmaceuticals.- 1.2. An Italian Technician in Europe and in the World: what of our way of managing the production of radiopharmaceuticals can be an excellence? When the imagination can be an advantage.- 1.3. Commercial PET, "the spider out of the hole".- 1.4. A good practice on communication to customer.- 2. PET third party collaborations.- 2.1 Development of a new tracer: connection between Research & Development (R&D) and industrial production.- 2.2. The selection of a new PET radiotracer.- 2.3. Three different manufacturing contracts with the CMO: for mature, new, investigational tracers.- 2.4. Customer order management: CMO or Corporate responsibility?.- 2.5. Collaborations with non-industrial entities (hospitals or research centers). Two different mindsets, how to reconcile them?.- 2.6. Monitoring of production and distribution reliability in a PET network.- 3. Elements to take into account for an EU PET company acquisition.- 4. An old laboratory, in the cyclotron building front lake, and its strange inhabitants.- 5. A Sustainable PET Quality Assurance (QA).- 5.1. The reasons for a choice: why working in Quality Assurance?.- 5.2. QA team of a PET site: how to do a selection for the recruitment of operational and managerial personnel.- 5.3. PET site network: skills development, relationship with management, performance monitoring.- 5.4. Organization of the QA system in a PET Pharmaceutical Facility.- 5.5. Movie or reality?.- 6. The PET manufacturing experience in a public department, a witness.- 6.1. Reasons of a decision: developing a PET radiopharmacy for internal use in a public structure.- 6.2. From a research lab (or a clinical internal service) to an industrial set up.- 6.3. From words to deeds.- 6.4. Now that you got the horse, ride it.- Conclusions.- Final Greeting.- Glossary.-Recommended readings.
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