scholarly journals Why Are We Failing to Implement Imaging Studies with Radiolabelled New Molecular Entities in Early Oncology Drug Development?

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Azeem Saleem ◽  
Philip Murphy ◽  
Christophe Plisson ◽  
Michael Lahn
Keyword(s):  
Drug Development ◽  
Imaging Techniques ◽  
Future Studies ◽  
Positron Emission ◽  
Modern Drug ◽  
Significant Barrier ◽  
Unique Decision ◽  
The Impact ◽  
Oncology Drug Development ◽  
Early Drug

In early drug development advanced imaging techniques can help with progressing new molecular entities (NME) to subsequent phases of drug development and thus reduce attrition. However, several organizational, operational, and regulatory hurdles pose a significant barrier, potentially limiting the impact these techniques can have on modern drug development. Positron emission tomography (PET) of radiolabelled NME is arguably the best example of a complex technique with a potential to deliver unique decision-making data in small cohorts of subjects. However, to realise this potential the impediments to timely inclusion of PET into the drug development process must be overcome. In the present paper, we discuss the value of PET imaging with radiolabelled NME during early anticancer drug development, as exemplified with one such NME. We outline the multiple hurdles and propose options on how to streamline the organizational steps for future studies.

Pharmacokinetic/Pharmacodynamic Modeling for Drug Development in Oncology

2017 ◽  
pp. 210-215 ◽  
Author(s):  
Elena Garralda ◽  
Rodrigo Dienstmann ◽  
Josep Tabernero
Keyword(s):  
Drug Development ◽  
Critical Issue ◽  
Pharmacodynamic Modeling ◽  
Attrition Rates ◽  
Drug Candidates ◽  
Probability Of Success ◽  
Disease Behavior ◽  
Oncology Drug Development ◽  
Proof Of Mechanism ◽  
Early Drug

High drug attrition rates remain a critical issue in oncology drug development. A series of steps during drug development must be addressed to better understand the pharmacokinetic (PK) and pharmacodynamic (PD) properties of novel agents and, thus, increase their probability of success. As available data continues to expand in both volume and complexity, comprehensive integration of PK and PD information into a robust mathematical model represents a very useful tool throughout all stages of drug development. During the discovery phase, PK/PD models can be used to identify and select the best drug candidates, which helps characterize the mechanism of action and disease behavior of a given drug, to predict clinical response in humans, and to facilitate a better understanding about the potential clinical relevance of preclinical efficacy data. During early drug development, PK/PD modeling can optimize the design of clinical trials, guide the dose and regimen that should be tested further, help evaluate proof of mechanism in humans, anticipate the effect in certain subpopulations, and better predict drug-drug interactions; all of these effects could lead to a more efficient drug development process. Because of certain peculiarities of immunotherapies, such as PK and PD characteristics, PK/PD modeling could be particularly relevant and thus have an important impact on decision making during the development of these agents.

scholarly journals Radiochemistry: A Useful Tool in the Ophthalmic Drug Discovery

2020 ◽  
Vol 27 (4) ◽  
pp. 501-522 ◽  
Author(s):  
Krishna R. Pulagam ◽  
Vanessa Gómez-Vallejo ◽  
Jordi Llop ◽  
Luka Rejc
Keyword(s):  
Drug Development ◽  
Single Photon ◽  
Imaging Techniques ◽  
Photon Emission ◽  
Nuclear Imaging ◽  
Living Organism ◽  
Ophthalmic Drugs ◽  
Positron Emission ◽  
Potential Applications ◽  
Ophthalmic Drug

Positron Emission Tomography (PET) and Single Photon Emission Computerized Tomography (SPECT) are ultra-sensitive, fully translational and minimally invasive nuclear imaging techniques capable of tracing the spatiotemporal distribution of positron (PET) or gamma (SPECT) emitter-labeled molecules after administration into a living organism. Besides their impact in the clinical diagnostic, PET and SPECT are playing an increasing role in the process of drug development, both during the evaluation of the pharmacokinetic properties of new chemical entities as well as in the proof of concept, proof of mechanism and proof of efficacy studies. However, they have been scarcely applied in the context of ophthalmic drugs. In this paper, the basics of nuclear imaging and radiochemistry are briefly discussed, and the few examples of the use of these imaging modalities in ophthalmic drug development reported in the literature are presented and discussed. Finally, in a purely theoretical exercise, some labeling strategies that could be applied to the preparation of selected ophthalmic drugs are proposed and potential applications of nuclear imaging in ophthalmology are projected.

scholarly journals Applications of Neuroimaging to Disease-Modification Trials in Alzheimer’s Disease

2009 ◽  
Vol 21 (1-2) ◽  
pp. 129-136 ◽  
Author(s):  
Adam S. Fleisher ◽  
Michael Donohue ◽  
Kewei Chen ◽  
James B. Brewer ◽  
Paul S. Aisen ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Drug Development ◽  
Imaging Techniques ◽  
Surrogate Endpoint ◽  
Treatment Development ◽  
Therapeutic Trials ◽  
Positron Emission ◽  
Clinical Measures ◽  
Significant Disease

Critical to development of new therapies for Alzheimer’s disease (AD) is the ability to detect clinical or pathological change over time. Clinical outcome measures typically used in therapeutic trials have unfortunately proven to be relatively variable and somewhat insensitive to change in this slowly progressive disease. For this reason, development of surrogate biomarkers that identify significant disease-associated brain changes are necessary to expedite treatment development in AD. Since AD pathology is present in the brain many years prior to clinical manifestation, ideally we want to develop biomarkers of disease that identify abnormal brain structure or function even prior to cognitive decline. Magnetic resonance imaging, fluorodeoxyglucose positron emission tomography, new amyloid imaging techniques, and spinal fluid markers of AD all have great potential to provide surrogate endpoint measures for AD pathology. The Alzheimer’s disease neuroimaging initiative (ADNI) was developed for the distinct purpose of evaluating surrogate biomarkers for drug development in AD. Recent evidence from ADNI demonstrates that imaging may provide more sensitive, and earlier, measures of disease progression than traditional clinical measures for powering clinical drug trials in Alzheimer's disease. This review discusses recently presented data from the ADNI dataset, and the importance of imaging in the future of drug development in AD.

The Impact of Plate Imaging Techniques on Flexographic Printed Conductive Traces

2012 ◽  
Vol 56 (4) ◽  
pp. 1-8 ◽  
Author(s):  
Bruce E. Kahn ◽  
Liam H. O’Hara ◽  
Chip Tonkin ◽  
Howard E. Nelson ◽  
William J. Ray ◽  
...  
Keyword(s):  
Imaging Techniques ◽  
The Impact

A Novel Secure and Robust encryption scheme for medical images

2020 ◽  
Vol 16 ◽  
Author(s):  
Siyamol Chirakkarottu ◽  
Sheena Mathew
Keyword(s):  
Medical Images ◽  
Technological Development ◽  
Imaging Techniques ◽  
Chaotic Map ◽  
Two Phase ◽  
Positron Emission ◽  
Medical Diagnostic ◽  
Wireless Medium ◽  
Health Care Applications ◽  
Magnetic Resonance Imaging Mri

Background: Medical imaging encloses different imaging techniques and processes to image the human body for medical diagnostic and treatment purposes. Hence it plays an important role to improve public health. The technological development in biomedical imaging specifically in X-ray, Computed Tomography (CT), nuclear ultrasound including Positron Emission Tomography (PET), optical and Magnetic Resonance Imaging (MRI) can provide valuable information unique to a person. Objective: In health care applications, the images are needed to be exchanged mostly over wireless medium. The diagnostic images with confidential information of a patient need to be protected from unauthorized access during transmission. In this paper, a novel encryption method is proposed to improve the security and integrity of medical images. Methods: Chaotic map along with DNA cryptography is used for encryption. The proposed method describes a two phase encryption of medical images. Results: Performance of the proposed method is also tested by various analysis metrics. Robustness of the method against different noises and attacks is analyzed. Conclusion: The results show that the method is efficient and well suitable to medical images.

Positron Emission Tomography for Future Drug Development

2011 ◽  
Vol 1 (2) ◽  
pp. 137-151
Author(s):  
Ryogo Minamimoto ◽  
Chumpol Theeraladanon ◽  
Akiko Suzuki ◽  
Tomio Inoue
Keyword(s):  
Positron Emission Tomography ◽  
Drug Development ◽  
Emission Tomography ◽  
Positron Emission ◽  
Future Drug

scholarly journals Detecting apoptosis as a clinical endpoint for proof of a clinical principle

2020 ◽  
Author(s):  
Piero Zollet ◽  
Timothy E.Yap ◽  
M Francesca Cordeiro
Keyword(s):  
Drug Development ◽  
Therapeutic Response ◽  
Imaging Techniques ◽  
Brain Diseases ◽  
Promising Strategy ◽  
Sight Loss ◽  
Apoptosis Detection ◽  
Novel Therapeutic Strategies

The transparent eye media represent a window through which to observe changes occurring in the retina during pathological processes. In contrast to visualising the extent of neurodegenerative damage that has already occurred, imaging an active process such as apoptosis has the potential to report on disease progression and therefore the threat of irreversible functional loss in various eye and brain diseases. Early diagnosis in these conditions is an important unmet clinical need to avoid or delay irreversible sight loss. In this setting, apoptosis detection is a promising strategy with which to diagnose, provide prognosis, and monitor therapeutic response. Additionally, monitoring apoptosis in vitro and in vivo has been shown to be valuable for drug development in order to assess the efficacy of novel therapeutic strategies both in the pre-clinical and clinical setting. Detection of Apoptosing Retinal Cells (DARC) technology is to date the only tool of its kind to have been tested in clinical trials, with other new imaging techniques under investigation in the fields of neuroscience, ophthalmology and drug development. We summarize the transitioning of techniques detecting apoptosis from bench to bedside, along with the future possibilities they encase.

Sign in / Sign up

Export Citation Format

Share Document