Radiopharmaceutical Therapy Expertise
The PPD™ clinical research business of Thermo Fisher Scientific has extensive experience supporting complex radiopharmaceutical (RP) trials on a global scale. Our focus is to provide clients with experienced sites that are committed to expedited startup and enrollment.
Radiopharmaceutical trials can be complicated, with challenges including:
- Availability of the required radioisotope
- Highly regulated use of radioactive substances
- Few skilled professionals available to run centers involving radiotheranostics
That is why advancing product development in this area requires special expertise and the ability to develop well-designed prospective trials based on established pre-clinical and clinical oncological principles.
Advancing Radiopharmaceuticals
Expertise for complex radiopharmaceutical product development
We have the necessary expertise to manage the unique complexities of developing a radiopharmaceutical product from the concept stage through trial execution and approval. Our expertise spans across Phases I-III and a broad range of disease areas including:
- Alzheimer’s disease
- Chronic obstructive pulmonary disease
- Coronary artery disease
- Liver tumors
- Metastatic colorectal carcinoma
- Ornithine transcarbamylase (OTC) deficiency
- Parkinson’s disease
- Prostate cancer
- Schizophrenia
In the past five years, we’ve supported 22 global radiopharmaceutical studies, which include seven healthy volunteer studies and range from Phase I to Phase III
7 Phase I studies
3 Phase II studies
5 Phase III studies
7 Other
The advantage in radiopharmaceutical trials
Drug developers turn to us to effectively manage the complexity of these trials. Our comprehensive in-house team of scientific, clinical operations and clinical supply logistics personnel use their expertise to execute radiopharmaceutical trials.
We provide support at every stage of the trial process and offer the knowledge and infrastructure needed to deliver successful outcomes in global trials involving radiopharmaceuticals. Our clinical logistics monitoring service offering — when combined with our total transportation management solutions — provides comprehensive management and oversight of radiopharmaceutical products from the contract manufacturing organization to the patient.
Raw Materials
Raw materials (e.g.) are sent to companies with nuclear reactors
Nuclear Reactors
Raw materials in nuclear reactors undergo nuclear flux reactions to generate radioisotopes
Radioisotopes
QC to check radioactivity levels
Manufactured RLT
Production of RLTs required hot cell line rooms or chemical synthesis with radioisotopes as well as the infrastructure for running chemical reactions
In-house Manufacturing Facility
Package Radioisotopes
Following CDMO production, a CDMO may need the RLT back to the MFG QC and to initiate shipment to clinical site.
Types of packages:
- Excepted packages
- Industrial packages
- Type A packaged
- Type B packaged
Contract Manufacturing Facility
IEAE, FDA, and eCFR
Type A packaging is an international regulation issued by the International Atomic Energy Agency (IAEA)
May go back to the in-house manufacturing facility, straight to the radiopharmacy, or to distribution
Distribution
Shipment to a radiopharmacy or an administrative site with specialty couriers for time and temperature management. PPD Clinical Logistics Monitors proactively solution transport escalations
Patient
Administration in the rad-onc clinical space given infrastructure requirements and authorized user availability
Administrative Site
Some administrative sites, especially at academic centers that have a large patient volume, have their own radiopharmacies that prepare their own RLTs for administration
Radiopharmacy
Radiopharmacies prepare the drug for administration (i.e., ensure radioactivity levels)
Clinical logistics monitor
As part of our services, a clinical logistics monitor is assigned to each trial. This role provides a wide range of support and serves as a single point of contact for all site communications, including trackability and traceability. They also oversee site allocation and infusion timelines with the radiolabeling manufacturer and site coordinator. The clinical logistics monitor liaises closely with the sponsor, Thermo Fisher Scientific and clinical teams, as well as coordinates scheduling and storage while maintaining a chain of custody for radio therapies. Subject matter expert training is provided along with mock shipment activities.
Total transportation management
Our total transportation management (TTM) service provides complete oversight of the supply chain process from shipment preparation to final mile delivery.
By using data to choose the best courier for your needs, risk is mitigated across your supply chain. We also provide traceability and trackability by having a product chain of custody, certificate of release, shipment order number, shipment records, and confirmation of condition and radioactivity. Logistics services use Type A packaging, which is an international regulation, guidelines on current good radio pharmacy practice for the small-scale preparation of radiopharmaceuticals, as well as DOT and 49 CFR requirements.
Global relationships and resources
Our strong relationships with key opinion leaders in radiopharmaceuticals, investigators, clinical sites and specialized vendors facilitate strategic site identification, startup and recruitment efforts. These relationships, combined with a robust feasibility strategy, translate into expedited site selection and patient recruitment to support our clients in meeting development objectives.
Choose the best for your radiopharmaceutical trial
studies using radioligand/radiolabeled drug or radiotracer-accompanied imaging
countries used to deliver those 22 studies
sites activated across 14 countries to deliver those 22 studies
patients enrolled in those 22 studies
Radiopharmaceuticals
Contact us to support your next radiopharmaceuticals trial.