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Clinical Program Articles & Analysis
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 ...
Effective and Efficient Drug Development Challenge Increased Cost, Risk, and Competition in the Drug Development Processes Dr. Luis Rojas, the Executive Director Head of Biostatistics at Target Health, is a subject matter expert in study design and sample size calculations with more than 30 years of industry experience. He has worked in the leading CROs in the industry and has assisted ...
ByStatsol
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 ...
ByStatsol
The drug developer's latest capital raise, a $150 million private placement, comes during a difficult market environment. The strongest companies can raise money in any environment. Recursion Pharmaceuticals (RXRX) - Get Free Report recently raised $150 million in gross proceeds from a private placement of common stock, including half from a single fund that has never before invested in the ...
Start-up Alucent Biomedical is using a light-activated molecule, delivered via a balloon catheter, to create a natural vascular scaffold in diseased peripheral vessels, with the aim of providing a long-lasting treatment option that maintains patency while leaving nothing behind in the vessel. Alucent Biomedical Inc. is rethinking peripheral artery disease (PAD) treatment with a novel natural ...
By applying a proprietary operating system to drug discovery, the Utah clinical-stage biotechnology company expects to turn drug discovery from sequential testing into a search problem. Unmet clinical needs often serve as the fundamental driving force behind drug discovery programs. During lead discovery, an intensive search ensues to find a drug-like small molecule or biological therapeutic, ...
The Barbara Ann Karmanos Cancer Center, located in midtown Detroit, is the only National Cancer Institute (NCI)-designated comprehensive cancer center in metro Detroit and one of just 51 centers of its kind in the United States. The comprehensive cancer center designation means patients can access treatments exclusive to Karmanos, as well as clinical trials, cancer prevention programs, and ...
Annual planning is an opportunity to fix this long-standing clinical operations issue At the beginning of many pharma companies’ financial year, an annual planning process occurs. 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 ...
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 Managers and their teams must be able to rely on 4 things: A strong ...
Follow-up data from the landmark SPRINT study of the effect of high blood pressure on cardiovascular disease have confirmed that aggressive blood pressure management — lowering systolic blood pressure to less than 120 mm Hg — dramatically reduces the risk of heart disease, stroke, and death from these diseases, as well as death from all causes, compared to lowering ...
The third annual IMCAS Americas, held in Cartagena, Colombia in August, attracted a motivated crowd of more than 900 delegates from 30 countries who came to learn and network with colleagues and key opinion leaders. “The congress faculty featured 110 international experts leading 85 scientific sessions for a total of 88 hours of scientific learning dedicated to the most important topics in ...
Could this new drug delivery system for tranexamic acid optimize melasma treatment? Joel Cohen, M.D., thinks it could be just what the specialty has been looking for. Researchers using a novel transdermal drug delivery system to deliver tranexamic acid deep into melasma patients’ skin found the technology-assisted treatment quickly and notably reduced the skin pigmentation of ...
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 ...