Results for 'RSP'
John Devin Peipert, PhD, Karen Kaiser, PhD, Sheetal Kircher, MD, George J. Greene, PhD, Sara Shaunfield, PhD, Katherina Hauner, PhD, David Cella, PhD, and Daniel K. Mroczek, PhD
Medical Oncologists’ Knowledge and Perspectives on the Use of Biosimilars in the United States
oncologist, biosimilars, ASCO, FDA, RSP
Most oncologists (88%) treated patients with biosimilars, and 63% reported that biosimilars were required at their institutions. Approximately half (52%) correctly identified that biosimilars are not the same as generic medicines. Common barriers to biosimilar use included concerns abou…
Jan 9th • 9 mins read
iNIZIO
Expert perspectives live from ASCO® 2025
At the 2025 ASCO® Annual Meeting, three of our experts sat down with OncoDaily to share their unique perspectives in oncology – from amplifying the patient voice to unlocking real-world impact through data and AI. Watch the videos below. Matthew Hoelzle | Medical strategy, AI and real-wor…
Jul 2nd • 1 min 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
Jaques van Heerden, MD, Mohamed Zaghloul, MD, Anouk Neven, MSc, Teresa de Rojas, MD, PhD, Jennifer Geel, MD, Catherine Patte, MD, Joyce Balagadde-Kambugu, MD, Peter Hesseling, MD, Francine Tchintseme, MD, Eric Bouffet, MD, and Laila Hessissen, MD
Pediatric Oncology Clinical Trials and Collaborative Research in Africa: Current Landscape and Future Perspectives
pediatric oncology, clinical trials, research, Africa, collaborative research
Current childhood cancer survival rates in African countries range from 8.1% to 30.3%. The review focuses on pediatric oncology trials in Africa, highlighting challenges and suggesting research collaboration opportunities. Data were collected from the SIOP global mapping survey, ClinicalT…
Aug 7th • 10 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
Eric Q. Konnick
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
Qiyou Wu, Zhiwei Lian, Xin Wang, Hanchao Cheng, Jing Sun, Hui Yu, Gong Zhang, Fan Wu, Jian Liu and Chuanben Chen
Factors associated with the uptake of biosimilars for breast cancer treatment from the perspectives of physicians and patients-Evidence from China
biosimilar, breast cancer, uptake, physician, patient
In 2021, the trastuzumab biosimilar entered clinical use in the research setting with less than 20% uptake in China, significantly lower than in the EU. Older patients are more likely to adopt biosimilars due to price sensitivity and financial concerns. Only 11.3% of patients switched from …
Jan 12th • 13 mins read
Laurent Azoulay
Rationale, Strengths, and Limitations of Real-World Evidence in Oncology: A Canadian Review and Perspective
real-world evidence; RWE, real-world studies, RWS, oncology, real-world evidence, RWE, randomized controlled trial, RCT
Data obtained from real-world studies have an integral role in evidence-based medicine, serving as an essential source of safety information and a complement to efficacy data from RCTs. RWE is particularly useful for expanding the evidence base to encompass populations of patients who are not well r…
Apr 26th • 9 mins read
Meena N Murugappan, PharmD, MPH, PhD(c), Bellinda L King-Kallimanis, PhD, Gregory H Reaman, MD, Vishal Bhatnagar, MD, Erica G Horodniceanu, MPH, Najat Bouchkouj, MD, Paul G Kluetz, MD
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
cancer, pediatrics, product labeling, united states food and drug administration, childhood cancer, denosumab, surrogate endpoints, adverse event, patient self-report, pediatric oncology, selumetinib, benefit-risk assessment, tisagenlecleucel, statistica
PROs have been feasible to collect from patients as young as 7 years old and were included in trials from 2013 onward. PROs were used as exploratory endpoints in four product applications but not included in product labeling. To include PRO data in FDA labeling, early interaction with the FDA, c…
Apr 30th • 12 mins read
Marc Clausen MA, Chloe Mighton MS, Ruhi Kiflen MPH, Agnes Sebastian MSc, Wei Fang Dai MPH, Rebecca E. Mercer PhD, Jaclyn M. Beca MSc, Wanrudee Isaranuwatchai PhD, Kelvin K.W. Chan MD PhD, Yvonne Bombard PhD
Use of real-world evidence in cancer drug funding decisions in Canada: a qualitative study of stakeholders’ perspectives
RWE, RCT's, Canada, drug funding, Canadian Real-World Evidence, Data
The study emphasizes the need for a cultural shift, enhanced data infrastructure, investment in capacity building, and stakeholder collaboration for effective use of Real-World Evidence (RWE) in drug funding decisions. Cancer drug costs are escalating, with some offering substantial benefit…
Nov 4th • 12 mins read
Dominic H. Moon, Ronald C. Chen
Defining a Clinically Meaningful Benefit in Cancer Clinical Trials: From the Perspectives of the Clinical Trialist, Patient, and Society
cancer clinical trials, benefit of clinical trials, clinically meaningful, ASCO
In value-based medicine, clinical trials must show both statistically significant and clinically meaningful improvements, such as ASCO's recommendation of a 20% relative improvement in overall survival for metastatic solid tumors. Lawrence et al. found that while many phase III trials met statistica…
Jun 27th • 2 mins read
Forbes Books Press Release Official
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
Tom Caravela
How to Prepare for a Virtual or Video Interview
virtual interview tips, video interview preparation, mastering virtual communication, professional video interview setup, successful online interview
As we are quickly becoming thrust into the age of “virtual” meetings and video interviews, job seekers and industry professionals need to be completely prepared to master this new paradigm of interpersonal communication. Here are some important tips for acing your next video interview: …
Mar 19th • 1 min read
Tom Caravela
Promotability: How to Land Your Next Promotion
professional visibility, career advancement, promotion tips, career progression, networking strategies, mentorship benefits, resume upgrades, servant leadership, problem-solving skills, personal branding
“Promotability” may be defined as one’s suitability for being promoted. Is it your goal to obtain a promotion this year? If so, how suitable or promotable are you for that next step? Job-seekers and professionals often ask me what steps are necessary for advancement. I have broken …
May 5th • 10 mins read
Ioannis Tsagakis and Maria Papatriantafyllou
Safeguarding cancer research funding by European charities amidst the COVID-19 pandemic
cancer charities, cancer research, COVID‐19, funding, pandemic, policy, AECC, AIRC
The COVID-19 outbreak has had a significant impact on cancer research and cancer care. European cancer charities are required to reassess their strategies. There is a need to safeguard income and provide support to cancer researchers. It is crucial to sustain cancer research funding during thes…
Nov 22nd • 3 mins read
Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
European organisation for Research and Treatment of Cancer, EORTC, clinical research
Collaborations between academic institutions and industry have led to significant scientific breakthroughs in pharmaceutical research, particularly in the discovery phase. The role of multi-stakeholder partnerships in the clinical development of anticancer medicines requires further clarification…
Aug 16th • 8 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
Melissa H. Roberts & Gary T. Ferguson
Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
Real world evidence, RWE, payer decisions, RWD
Randomized controlled trials (RCTs) are preferred by payers for health technology assessments and coverage decisions, but they may not reflect real-world clinical practice. Real-world evidence (RWE) from observational studies can fill evidence gaps not addressed by RCTs and is valuable for payer …
Jun 18th • 6 mins read
Doreen A. Ezeife MD, Francois Dionne PhD, Aline Fusco Fares MD, Ellen Laura Rose Cusano MD, Rouhi Fazelzad BSc, MISt, Wenzie Ng BSc, MPharm, RPh, Don Husereau BSc Pharm, MSc, Farzad Ali BPharm, MSc, Christina Sit MSc, Barry Stein B.Com BCL, LLB, Jennifer
Value assessment of oncology drugs using a weighted criterion-based approach
anticancer therapy, multicriteria decision analysis, value assessment, value assessment framework
The rising cost of anticancer therapy has led to efforts to quantify the overall value of new cancer treatments. Multicriteria decision analysis is used to incorporate multiple criteria and perspectives into value assessment. A diverse, multistakeholder group developed a drug assessment framewor…
Dec 20th • 15 mins read
Envision Pharma Group
Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?
patient engagement in pharma, patient-centric drug development, life sciences industry innovation, patient insights in medicine, regulatory compliance in patient engagement, patient involvement in clinical trials, benefits of patient advocacy, patient-cen
The life sciences industry is in a constant state of advancement, bringing more and more groundbreaking medicines, cutting-edge technologies, and innovative solutions to market. Amidst these rapid changes, patients remain at the heart of these scientific developments. In recent decades, the l…
May 9th • 5 mins read