Sentences with phrase «clinical cell therapy products»
In this overview, authors from AllCells provide deeper insight into supply - chain considerations for procuring and qualifying donated tissue as a starting material for generating clinical cell therapy products.
http://www.bioprocessintl.com/ Not exact matches
These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).
Early clinical evidence with the PEC - Encap product supports the potential of the replacement cell therapy approach.
ViaCyte's PEC - EncapTM (also known as VC - 01TM) product candidate is the first pluripotent stem cell - derived islet cell replacement therapy for the treatment of type 1 diabetes in clinical - stage development.
Between partnerships with Pharma, grants from the California Institute for Regenerative Medicine, and other sources of cash, Lewis says that Novocell is «well positioned to ensure we are able support our cell therapy program for the foreseeable future,» and predicts that an ESC product will enter clinical trials in 2012, «if not before then.»
We wanted to take that challenge off the plates of cell therapy developers so that they could focus on the clinical aspects of the field without having to worry about how to make the products once they are approved.
World Advanced Therapies and Regenerative Medicine Congress Speaker: Mark Zimmerman, Ph.D., Vice President, Operations and Business Development Presentation: New data on a novel stem cell combination product for diabetes — development and clinical update Date / Time: May 17, 3:30 PM BST Location: Business Design Centre, London
San Diego, January 8, 2015 — ViaCyte, Inc., a privately - held regenerative medicine company with the first stem cell - derived islet replacement therapy for the treatment of diabetes in clinical trials, has received a No Objection Letter from Health Canada providing clearance to proceed with sites in Canada for the Company's Phase 1/2 clinical trial of its VC - 01TM product candidate.
Embryonic stem cells, Adult stem cells, Reprogramming to pluripotency and lineage conversion, Directed differentiation, Germ cells, Genetic and epigenetic mechanisms, Stem cells in development, Stem cell niche, Cancer stem cells, Disease modeling and drug screening, Stem cell therapy, Clinical studies in regenerative medicine, Tissue engineering and biomaterials, Imaging and diagnostics, Stem cell products, manufacturing, and quality control, Ethical, legal, and social issues Read Journal
The initial phase of clinical investigation is focusing on the safety of the cell replacement therapy combination products in patients.
Based on these advances in stem cell technology, Novocell has begun a development program to prepare its stem cell products for human clinical therapy.
The VC - 01 product candidate is the first embryonic stem cell - derived islet replacement therapy to reach clinical testing and is currently being evaluated in patients with T1D who have minimal to no insulin - producing beta cell function.