Clinical Trial Program Articles & Analysis: Older
14 articles found
GMP growth factors and cytokines designed for therapeutic manufacturing are an essential component of defined media. To date, the cell therapy industry has accepted GMP terms for this reagent class, despite the fact that there is no direct oversight by regulators. These proteins are intended for use in further manufacturing processes and do not come into direct contact with patients. In fact, ...
GMP growth factors and cytokines designed for therapeutic manufacturing are essential components of defined media. To date, the cell therapy industry has accepted GMP terms for this reagent class, despite the fact that there is no direct oversight by regulators. These proteins are intended for use in further manufacturing processes and do not come into direct contact with patients. In fact, cell ...
Challenge Calculating the appropriate sample size for a first of its kind stage-II colon cancer trial As Chairman of the Department of Biostatistics, Professor Satoshi Teramukai leads a variety of investigator-initiated clinical trials at the Kyoto Prefectural University of Medicine. With over 35 years experience, hundreds of published papers and thousands of citations, Professor Satoshi ...
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He has worked in the leading CROs in the industry and has assisted pharmaceutical companies with the drug development process with clinical trials, programs, and portfolio designs. His experience extends from preclinical, phases I through IV, biosimilar, and bioequivalent using fixed, adaptive designs, stand-alone, and master protocols in ...
ByStatsol
For example, the drug developer has initiated four new clinical trials in 2022 alone. It's also a promising sign of strength for investors, although long-term performance will be driven by execution and clinical trial data. ...
” And, although this has not yet been studied in clinical trials, other vessel preparation techniques, such as debulking with atherectomy, could also be employed pre-procedure in highly calcified vessels, he says. ...
Unmet clinical needs often serve as the fundamental driving force behind drug discovery programs. ...
The comprehensive cancer center designation means patients can access treatments exclusive to Karmanos, as well as clinical trials, cancer prevention programs, and multidisciplinary teams of cancer specialists — a comprehensive approach you cannot find in many large hospitals or health systems. ...
This presents an opportunity for stakeholders to align on short-, mid-, and long-term goals. Clinical stage pharma companies focus on clinical-trial related goals. These include completing ongoing clinical trials and initiating new ones, in the context of the company’s commercial plans as well as market ...
Whether your clinical operations team sits in a large sponsor company, or in one that’s still growing, it must be supported by efficient systems to maintain high productivity. Clinical trial protocols must be conducted with quality, within budget, and within timelines. To achieve this, Clinical Program ...
MD, PhD., and Mahboob Rahman MD, investigators from University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, played a lead role in the design, conduct, analyses and publication of the SPRINT trial. UH and CWRU coordinated one of the five Clinical Center Networks (CCNs) across the country selected to conduct the ...
The plan is to run one or two more trials and then approach the US Food and Drug Administration in 2020.” Taking on psoriasis and eczema. ...
Data from our most recently completed melasma human proof-of-concept trial demonstrates how we can modulate our technology to optimize transdermal drug delivery," says Dr. ...
SAN FRANCISCO, CA--(Marketwired - Sep 11, 2015) - Aelan Cell Technologies announced today the addition of Meenakshi Gaur, Ph.D. to their stem cell clinical program. Dr. Gaur will serve as the Director of Research and Development of the Stem Cell Program, leading a research team that will develop technology aimed at rejuvenation of human mesenchymal stem cells for clinical applications. "Dr. Gaur ...