Results for 'Precision Medicine'
New Book Unites Oncology’s Brightest Minds To Innovate Cancer Cures
Voices of Oncology, Cancer cures, Oncology Voice Network, Kirk V. Shepard, Ramin Farhood, Forbes Books, Cancer treatment innovation, Oncology collaboration, Patient engagement in oncology, Precision medicine cancer
Voices of Oncology: Fostering a Collaborative Community of Experts to Accelerate Cancer Cures is a book by Kirk V. Shepard, M.D., and Ramin Farhood, PharmD, M.B.A., featuring insights from 33 contributors in the oncology field. It is available on platforms like Amazon and Barne…
Sep 9th • 5 mins read
Liquid biopsy in oncology: a consensus statement of the Spanish Society of Pathology and the Spanish Society of Medical Oncology
Liquid biopsy, ctDNA, Oncology, Genomic profling, Precision medicine
The proportion of cancer patients with tumors having potentially targetable genomic alterations is increasing. Diagnosing these alterations can lead to tailored treatments and provide additional predictive information on immunotherapy efficacy. In many cases, initial tissue biopsies are ina…
Sep 26th • 17 mins read
Precision medicine for pediatric cancers lags behind that for adult cancers: Citing hurdles in clinical trial recruitment and drug development, researchers are exploring ways to close gaps
Precision Medicine, pediatrics, clinical trials
Pediatric precision oncology faces challenges due to the rarity of pediatric cancers, which limits research and funding compared to adult cancers. Dr. Katherine Janeway highlights the need for more validated pre-clinical models and pharmaceutical interest in pediatric cancers. The RACE Act, effe…
Jan 9th • 2 mins read
Liquid biopsy in oncology: a consensus statement of the Spanish Society of Pathology and the Spanish Society of Medical Oncology
Liquid biopsy, ctDNA, Oncology, Genomic profling, Precision medicine
The proportion of cancer patients with tumours that have targetable genomic alterations is increasing, which is crucial for tailored treatment and predicting immunotherapy efficacy. Initial tissue biopsies are often inadequate for precision oncology, and obtaining new tumour tissues at pr…
Sep 26th • 16 mins read
Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
oncology, precision medicine, tumor evolution, dosing, FDA
Focus on tumor evolution, which leads to therapeutic failure and disease relapse. Emphasis on the effect of tumor evolution on the exposure-response (E-R) relationships of oncology drugs. Advocacy for prioritizing tumor evolution during clinical development to select optimal doses for targeted t…
Sep 2nd • 10 mins read
The evolving landscape of precision medicine in primary liver cancer
liver cancer, personalized care, precision medicine
The field of oncology and cancer research is changing. As our understanding of the underlying biology of the disease improves, the one-size-fits-all treatment model has been exposed as inadequate. PLC is among the hardest to treat malignancies and as such carries one of the worst prognoses. While th…
Mar 29th • 3 mins read
The FDA Oncology Center of Excellence and Precision Medicine
Biomarkers, drugs, hematology, medicine, oncology, precision medicine, regulation
The FDA is exploring real-world evidence to enhance understanding of the long-term safety and efficacy of oncology drugs. Initiatives like the Information Exchange and Data Transformation initiative are building infrastructure for big-data analytics. Additionally, patient-focused programs aim to inc…
Nov 6th • 3 mins read
AI-powered real-world evidence: Strategically enhancing value and access
Oncology, Clinical Development, Targeted Therapy, Immunotherapy, Genomic Profiling, CAR-T Cell Therapy, Precision Medicine
Real-world evidence (RWE) complements traditional randomized controlled trials by providing insights from diverse data sources, helping healthcare decision-makers with coverage, reimbursement, and treatment guidelines. Artificial intelligence (AI) and natural language processing (NLP) are pivotal…
Aug 22nd • 5 mins read
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
Oncology, Regulation, Testing, LDTs, FDA, CLIA, CMS
The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions. Since 2014, several regulatory proposals have been introduced following the FDA's draft guidance on laboratory-developed tests. There are ongoing …
May 22nd • 8 mins read
Defining the role of real-world data in cancer clinical research: The position of the
real-world data, real-world evidence, randomised, pragmatic trials, cancer, clinical research, add-on cohorts
Real-World Data (RWD) are increasingly used in cancer clinical research as an alternative evidence source. RWD studies primarily involve observational data, which offer insights into real-world conditions but may have quality limitations. Some research questions necessitate Randomized Controlled…
Mar 20th • 10 mins read
Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration
clinical trials, biologics, FDA approval, drug development
The study provides a crucial understanding of the role and impact of patient contributions in oncology drug development, focusing on their association with clinically impactful drug outcomes. Successful oncology drugs required an average of 12,217 patients in pre-license trials, with higher numbers …
May 18th • 5 mins read