Imaging Biomarkers for Innovative Drug Development: Translation from Bench to Bedside and Back

2016 ◽  
pp. 177-202
Keyword(s):  
Drug Development ◽  
Imaging Biomarkers ◽  
Innovative Drug

scholarly journals Co-Clinical Trials: An Innovative Drug Development Platform for Cholangiocarcinoma

2021 ◽  
Vol 14 (1) ◽  
pp. 51
Author(s):  
Brinda Balasubramanian ◽  
Simran Venkatraman ◽  
Kyaw Zwar Myint ◽  
Tavan Janvilisri ◽  
Kanokpan Wongprasert ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Drug Development ◽  
Surgical Resection ◽  
Treatment Options ◽  
Standard Of Care ◽  
Time Data ◽  
Current Standard ◽  
Innovative Drug ◽  
Curative Intent

Cholangiocarcinoma (CCA), a group of malignancies that originate from the biliary tract, is associated with a high mortality rate and a concerning increase in worldwide incidence. In Thailand, where the incidence of CCA is the highest, the socioeconomic burden is severe. Yet, treatment options are limited, with surgical resection being the only form of treatment with curative intent. The current standard-of-care remains adjuvant and palliative chemotherapy which is ineffective in most patients. The overall survival rate is dismal, even after surgical resection and the tumor heterogeneity further complicates treatment. Together, this makes CCA a significant burden in Southeast Asia. For effective management of CCA, treatment must be tailored to each patient, individually, for which an assortment of targeted therapies must be available. Despite the increasing numbers of clinical studies in CCA, targeted therapy drugs rarely get approved for clinical use. In this review, we discuss the shortcomings of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy drugs. The increased availability of targeted therapy drugs for treatment is expected to facilitate the application of precision medicine in CCA.

scholarly journals The Use, Standardization, and Interpretation of Brain Imaging Data in Clinical Trials of Neurodegenerative Disorders

2021 ◽  
Author(s):  
Adam J. Schwarz
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Neurological Disorders ◽  
Amyloid Β ◽  
Development Program ◽  
Imaging Biomarkers ◽  
Common Disease ◽  
Structural Imaging ◽  
Target Engagement ◽  
Pharmacodynamic Effect

AbstractImaging biomarkers play a wide-ranging role in clinical trials for neurological disorders. This includes selecting the appropriate trial participants, establishing target engagement and mechanism-related pharmacodynamic effect, monitoring safety, and providing evidence of disease modification. In the early stages of clinical drug development, evidence of target engagement and/or downstream pharmacodynamic effect—especially with a clear relationship to dose—can provide confidence that the therapeutic candidate should be advanced to larger and more expensive trials, and can inform the selection of the dose(s) to be further tested, i.e., to “de-risk” the drug development program. In these later-phase trials, evidence that the therapeutic candidate is altering disease-related biomarkers can provide important evidence that the clinical benefit of the compound (if observed) is grounded in meaningful biological changes. The interpretation of disease-related imaging markers, and comparability across different trials and imaging tools, is greatly improved when standardized outcome measures are defined. This standardization should not impinge on scientific advances in the imaging tools per se but provides a common language in which the results generated by these tools are expressed. PET markers of pathological protein aggregates and structural imaging of brain atrophy are common disease-related elements across many neurological disorders. However, PET tracers for pathologies beyond amyloid β and tau are needed, and the interpretability of structural imaging can be enhanced by some simple considerations to guard against the possible confound of pseudo-atrophy. Learnings from much-studied conditions such as Alzheimer’s disease and multiple sclerosis will be beneficial as the field embraces rarer diseases.

Using imaging biomarkers to accelerate drug development and clinical trials

2005 ◽  
Vol 10 (4) ◽  
pp. 259-266 ◽  
Author(s):  
Homer H. Pien ◽  
Alan J. Fischman ◽  
James H. Thrall ◽  
A.Gregory Sorensen
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Imaging Biomarkers

scholarly journals The path to innovative drug development of cancer vaccine: From discovery of tumor antigens to clinical trials

2014 ◽  
Vol 37 (2) ◽  
pp. 90-95 ◽  
Author(s):  
Toshihiko TORIGOE ◽  
Yoshihiko HIROHASHI ◽  
Tomohide TSUKAHARA ◽  
Takayuki KANASEKI ◽  
Vitaly KOCHIN ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Cancer Vaccine ◽  
Tumor Antigens ◽  
Innovative Drug

Microdosing, Imaging Biomarkers and SPECT: A Multi-Sided Tripod to Accelerate Drug Development

2009 ◽  
Vol 15 (9) ◽  
pp. 928-934 ◽  
Author(s):  
Ernest Pauwels ◽  
Kim Bergstrom ◽  
Giuliano Mariani ◽  
Kalevi Kairemo
Keyword(s):  
Drug Development ◽  
Imaging Biomarkers
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