Results for 'response'
A. Haslam, M.S. Kim, V. Prasad
Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020
genome-targeted therapy, eligibility, response
Recent studies have been conducted to update the estimates of eligibility and response rates to genome-targeted therapies among US cancer patients, reflecting data up to 2020. The number of FDA-approved drugs targeting genetic indications has increased significantly since prior assessments. …
Apr 20th • 7 mins read
Sonoko Kawakatsu, René Bruno, Matts Kågedal, Chunze Li, Sandhya Girish, Amita Joshi, Benjamin Wu
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology
monoclonal antibodies, E-R analyses, tumour growth inhibition, drug development
Dose selection and optimization is crucial in drug development to maximize benefits for all patients. Exposure–response (E-R) analysis is useful for dose-selection strategy, but in oncology, prognostic factors can confound the analysis, especially for monoclonal antibodies. The review addr…
Nov 20th • 12 mins read
Haiqing Isaac Dai, Yulia Vugmeyster, Naveen Mangal
Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects
Complex E–R relationship, immuno-oncology, single-dose PK model, therapeutic monoclonal antibodies
Recent data from immuno-oncology clinical studies show that the exposure–response (E–R) relationship for therapeutic monoclonal antibodies (mAbs) is often confounded by various factors. The complex interplay involves patient characteristics, disease, drug exposure, clearance, and…
Jun 18th • 30 mins read
Emerson Y. Chen, MD, Vikram Raghunathan, MD, Vinay Prasad, MD, MPH
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate
FDA, RR, drug approvels, OS
Many cancer drugs come to market based on single-arm studies with modest RRs. Most of these drugs are tested in studies of over 100 patients prior to approval. Most (60%) of these approvals lack randomized clinical trials during the life cycle of the product. Our findings suggest greater room for th…
May 28th • 5 mins read
Tom Caravela
Interview Differentiator-Be a Story Teller
interview preparation, effective interviewing, behavioral interview questions, storytelling in interviews, successful interview techniques
When you search Google for the words “Interview Preparation,” you will come up with approximately 756,000,000 results. While I am sure you can find an abundance of valuable information, it is very difficult to navigate through all of the content available on the Internet to determine wha…
Mar 22nd • 1 min read
Tom Caravela
Job Search Checklist for Aspiring Medical Science Liaisons
Medical Science Liaison, MSL role, MSL career tips, Pharmaceutical industry jobs, Break into MSL career
Tips to Help Break into Your First MSL Role The Medical Science Liaison (MSL) role, has become one of the most sought-after career paths in the Pharmaceutical and Biotech industry. What does it take to land a role as a Medical Science Liaison? As an MSL Recruiter, this is a question that I am…
May 17th • 2 mins read
Tom Caravela
Resume Writing and Editing Tips for Pharma Professionals
Pharmaceutical recruiter, Resume writing tips, Professional CV, LinkedIn profile optimization, Job application keywords
As a Professional Pharmaceutical Recruiter, I read and evaluate resumes (as well as CVs), every day. While I am not a professional resume writer, I have a very strong understanding of what a good resume or CV looks like and what should be included. More importantly, I keep track of what is most effe…
Aug 8th • 1 min read
Tom Caravela
Combatting the “Summer Slow Down" – MSL Job Search Tips for Slower Months
Medical Science Liaison, Medical Affairs recruitment, job search strategies, networking in medical field, summer hiring trends
There is definitely a cyclical nature to hiring Medical Science Liaisons and Medical Affairs professionals. Typically, peak season for recruitment and hiring is from March to June, which is the time-frame in and around which MSLs collect their annual bonuses. However, Medical Science Liaison hiring …
Jun 23rd • 2 mins read
Tom Caravela
MSL People Skills: Top 10 Tips for Better Engagement
Medical Science Liaison, relationship building, business etiquette, social awareness, emotional intelligence, professional interactions, Dale Carnegie, How to Win Friends and Influence People, professional brand, engagement tips, digital communication
The cornerstone of the Medical Science Liaison role is RELATIONSHIP BUILDING. In a nutshell, better engagement equates to better relationships. The purpose of this article is to address the importance of proper business etiquette and the impact of social awareness and emotional intelligence as it re…
Apr 20th • 8 mins read
Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
biomarker, clinical trial, failure, analysis, NSCLC, oncology
Data from clinical trials across four oncology indications (breast cancer, NSCLC, melanoma, and colorectal cancer) from 1998 to 2017 were analyzed to assess drug approval likelihood based on biomarker status. Using multi-state Markov models, which describe stochastic processes, the study…
Feb 23rd • 8 mins read
Avi Cherla, MSc; Huseyin Naci, MHS, PhD; Aaron S. Kesselheim, MD, JD, MPH; Bishal Gyawali, MD, PhD; Elias Mossialos, MD, PhD
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
FDA, NHS, accelerated approval, NICE, clinical trial findings
The study evaluates the acceptance and coverage of FDA-accelerated approved cancer drugs by the National Health Service (NHS) in England, focusing on decisions made by the National Institute for Health and Care Excellence (NICE). A total of 93 cancer drug indications received accelerated approval…
Feb 22nd • 10 mins read
Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
ESMO, MCBS, FDA, ASCO-VF, EMA, QOL
Recent oncology therapies approved by the FDA and EMA often lack evidence of clinically meaningful improvements in quality of life (QOL). Only 40% of FDA-approved and 58% of EMA-approved oncology therapies had published QOL evidence. Clinically meaningful QOL improvements beyond minimal dif…
Feb 11th • 4 mins read
Siddharth Agrawal, Nidhi Bansal
Advances and Challenges in Pediatric and Childhood Cancers
CNS, central nervous system, ES, Ewing sarcoma, MB, medulloblastoma, PTSD, post traumatic stress disorder, RB, retinoblastoma
Pediatric cancers, while uncommon compared to adult cancers, include leukemia, CNS tumors, lymphoma, Wilms' tumor, and retinoblastoma. Challenges in pediatric cancer treatment encompass late diagnosis, varied immune responses, preserving fertility, minimizing late effects, and considering lo…
Jun 27th • 2 mins read
Peter N Morcos, Junyi Li, Iraj Hosseini, Chi‐Chung Li
Quantitative Clinical Pharmacology of T‐Cell Engaging Bispecifics: Current Perspectives and Opportunities
quantitative clinical pharmacology, T-Cell, TDB, bispecificss
The pharmacological response of TDBs involves complex interactions between T-cells, tumor cells, and TDBs, posing challenges in understanding pharmacokinetics, tissue distribution, target engagement, and exposure-response relationships. Dosing strategy is crucial for determining the therapeu…
Nov 18th • 15 mins read
Dean Bottino, Rachael Liu, Hojjat Bazzazi, Karthik Venkatakrishnan
Quantitative Translation in Immuno-Oncology Research and Development
Quantitative Translation, Immuno-Oncology, Research, Development, CIC
Exploring the therapeutic potential of the rapidly expanding field of immuno-oncology (IO) drug targets and diverse therapeutic modalities. Recognizing the need for principled decisions based on biologically sound quantitative translation in a competitive clinical research environment. High…
Jul 9th • 3 mins read
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read
Muneera Al Hussain
Comment on: Oncology research in Saudi Arabia over a 10-year period. A synopsis
oncology research, saudi arabia
An article in the Saudi Medical Journal by Alghamdi et al reported on oncology research progress in Saudi Arabia. The study compared research quantity and quality between two periods: 2008-2012 and 2013-2017. There was an increase in the amount of research over time, but quality and scienti…
Jun 24th • 3 mins read
Sean X Zhang, MSc , Dean Fergusson, PhD , Jonathan Kimmelman, PhD
Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved
cancer, biological markers, phase 1 clinical trials, drug approval, medical oncology, united states food and drug administration guidelines, adverse event, national comprehensive cancer network, American society of clinical oncology
Phase I oncology trials are often considered a therapeutic option, but this claim is primarily based on surrogate measures like objective response rates. A systematic search was conducted to evaluate the therapeutic value of phase I cancer trial participation, focusing on the likelihood of patien…
Apr 1st • 14 mins read
Barbara Kiesewetter , Nathan I Cherny, Nicolas Boissel, Francesco Cerisoli, Urania Dafni, Elisabeth G E de Vries, Paolo Ghia, Nicola Gökbuget, Verónica González-Calle, Brian Huntly, Ulrich Jäger, Nicola Jane Latino, Jean-Yves Douillard, Luca Malcovati, Ma
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
ESMO, hematological malignancies, Clinical benefit scale, EHA
The ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts. A feasibility test was conducted using 80 studies related to various haematological malignancies such as acute and chronic leukaemia, lymphoma, myel…
Jan 20th • 20 mins read
Kenji Omae, Yuki Kataoka, Yasushi Tsujimoto, Yusuke Tsutsumi, Yosuke Yamamoto, Shunichi Fukuhara, Toshi A Furukawa
Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation
Anticancer drugs, Clinical trials, Drug approval, Immune checkpoint inhibitors, Publications, United states food and drug administration
The study investigates the publication status of clinical trials for anticancer drugs approved by the FDA, focusing on immune checkpoint inhibitors (ICPis). Data from ICPis approved between 2011 and 2014 was analyzed, revealing that 58% of ICPis trials were published within two years …
Oct 24th • 18 mins read