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Radiopharmaceuticals for oncology drug development: a pharmaceutical industry perspective
Philip S Murphy1, Mats Bergström
1Oncology Research and Development, GlaxoSmithKline, Uxbridge, Middlesex, UB11 1BT, UK. philip.s.murphy@gsk.com
Abstract:
Oncology remains an increasingly important focus of therapeutic development yet there remain many scientific and operational bottlenecks to deliver optimum treatments efficiently. Radiopharmaceuticals constitute a group of methodologies able to support the many stages of drug development. Methods such as [(18)F]-FDG-PET continue to have a role, evaluating early metabolic response to treatment and supporting more conventional assessments of disease response. Improvements over such tracers (for example, use of [(18)F]-FLT) in certain settings can also widen the impact radiotracers have on clinical development. New categories of tracers able to provide molecular insight into therapeutic intervention are likely grow and aim to remove the ambiguity of how effective a new drug is. It is likely that newer tracers able to define processes such as angiogenesis and apoptosis will supplement other methods in supporting early development decision-making and de-risking expensive, late-stage programs. Labeled drugs themselves also offer the ability to study localised pharmacokinetics in vivo and study issues such as therapeutic combinations. Owing to the significant cost, resource and time investment in developing novel tracers, new opportunities need to be closely matched with emerging drug development needs.
Insights
Radiopharmaceuticals aid oncology drug development by assessing treatment response and providing molecular insights. Novel tracers can improve early decision-making and de-risk late-stage programs.
Area of Science:
- Oncology
- Radiopharmaceutical Development
- Drug Discovery
Background:
- Oncology drug development faces scientific and operational challenges.
- Radiopharmaceuticals offer methodologies to support various stages of drug development.
- Current methods like FDG-PET assess metabolic response, but advancements are needed.
Purpose of the Study:
- To highlight the role of radiopharmaceuticals in overcoming drug development bottlenecks.
- To discuss the potential of novel radiotracers in oncology.
- To emphasize matching tracer development with drug development needs.
Main Methods:
- Utilizing established tracers like (18F)-FDG-PET for metabolic response assessment.
- Exploring improved tracers such as (18F)-FLT for specific applications.
- Investigating new molecularly targeted tracers for angiogenesis and apoptosis.
- Employing labeled drugs for in vivo pharmacokinetic studies.
Main Results:
- Radiotracers like (18F)-FDG-PET evaluate early treatment response.
- (18F)-FLT offers improvements in certain clinical development settings.
- Emerging tracers provide molecular insights, reducing ambiguity in drug efficacy.
- Labeled drugs enable in vivo pharmacokinetic and combination therapy studies.
Conclusions:
- Radiopharmaceuticals are crucial tools for efficient oncology drug development.
- Novel tracers targeting processes like angiogenesis and apoptosis will support early decision-making and de-risk late-stage programs.
- Strategic development of new tracers must align with evolving drug development requirements due to significant investment costs.
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