Results for 'Chemistry, Manufacturing and Controls (CMC)'
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P.S. Mishra-Kalyani, L. Amiri Kordestani, D.R. Rivera, H. Singh, A. Ibrahim, R.A. DeClaro, Y. Shen, S. Tang, R. Sridhara, P.G. Kluetz, J. Concato, R. Pazdur, J.A. Beaver
External control arms in oncology: current use and future directions
external controls, real-word data, Food and Drug Administration, FDA, external control arm
Considerations for using external controls in oncology clinical trials are complex and depend on their intended use. There is a review of recent research and marketing applications that describe the current usage of external control data in oncology. Incorporating external controls for prima…
Jan 9th • 9 mins read
Charles Oo, Barbara Ameer
Revamping the ever-changing landscape of drug development processes in the midst of COVID-19 pandemic
Oncology drug class, Cancer indication, Molecularly targeted, Drug Development
Oncology is the front-line of drug development. The current pharmaceutical pipeline is disproportional focused on oncology, where about 1/3 of all phases of development is in this therapeutic area. The emphasis brings about substantial breakthroughs and has made positive impact on the quality of lif…
Apr 29th • 2 mins read
Rinda Devi Bachu, Mariam Abou-Dahech, Swapnaa Balaji, Sai H. S. Boddu, Samson Amos, Vishal Singh, R. Jayachandra Babu, Amit K. Tiwari
Oncology biosimilars: New developments and future directions
biologics in cancer treatment, biosimilars development, high cost of biologics, healthcare system burden, biosimilars safety, regulatory guidelines for biosimilars, immunogenicity concerns, pharmacoeconomics of biosimilars
Biologics are essential in cancer treatment as both therapeutic and supportive care agents, but they are expensive and require extensive testing to ensure safety. The high cost of developing and manufacturing biologics can be a burden on healthcare systems, limiting patient access to necessary tr…
Nov 25th • 30 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
Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov, George D. Demetri
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
RWE, Biologics License, FDA, BLA, suplements
The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studies. Aligning RWE populations with pivotal trial populations is crucial, often achieved through criteria matching and propensity score methodologies. Major critiques include differences in tumor asse…
Jan 1st • 12 mins read
Aviv Ladanie, PhD, Andreas M. Schmitt, MD, Benjamin Speich, PhD, Florian Naudet, PhD, Arnav Agarwal, MD, Tiago V. Pereira, PhD, Francesco Sclafani, PhD, Amanda K. Herbrand, MD, Matthias Briel, MD, MSc, Juan Martin-Liberal, PhD, Thomas Schmid, MD, Hannah E
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016
cancer treatment outcomes, outcomes, drug approval, clinical data, FDA
Data from 17 years of studies on novel cancer drugs show limited information available at market entry. Randomized Controlled Trials (RCTs) data are available for only half of the drug indications. Lack of data is particularly problematic for patients with hematological cancers. Novel therapies…
Nov 10th • 6 mins read
Alison Betts, Piet H. van der Graaf
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology
bispecific antibodies, mechanistic quantitative, pharmacology, strategies, bsAbs, immune cells, MABEL aproach
Bi-specific antibodies (bsAbs) are crucial in cancer therapy research. BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity. Early clinical trials face challenges with dose selection and predicting effective doses. Clinical variability is influenced by factors like fun…
Jun 24th • 18 mins read