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LOS ANGELES--(BUSINESS WIRE)--Pepperdine Graziadio School of Business and Management will host its 3rd Annual Future of Healthcare Symposium on March 23, 2017 at the Marina del Rey Marriott. Ezekiel Emanuel, a key architect of the Affordable Care Act, will serve as the keynote speaker. The Future of Healthcare Symposium: Delivering Value-Based Healthcare, will explore the healthcare industry's transition from legacy fee-for-service and volume-based reimbursement models to value-based payments. The Pepperdine Graziadio event will bring together healthcare experts and professionals to share their personal insights, experiences and ideas in order to inspire larger conversations about the future of healthcare as a business. The 3rd Annual Future of Healthcare Symposium explores how rapid changes to healthcare reimbursements are impacting healthcare providers, consumers and insurance plans. Attendees will also enjoy opportunities to network and share best practices while discussing potential collaborations. Register and view the full agenda here. Pepperdine Graziadio School of Business and Management will host a daylong symposium featuring an impressive line-up of speakers addressing a broad range of issues related to value-based care. Speakers are affiliated with Harvard Medical School, Mayo Clinic, Cedars-Sinai Health System and other leading healthcare organizations. Ezekiel Emanuel, Joint Appointment: Wharton School, University of Pennsylvania; School of Medicine, University of Pennsylvania. Founding Chair, Clinical Center of the National Institutes of Health. Former Special Advisor on Health Policy, Office of Management and Budget. Ezekiel Emanuel is one of the leading practitioners shaping the future of healthcare, with a long record of experience at the top levels of policy. Trained both as an oncologist (MD, Harvard Medical School) and a political scientist, Dr. Emanuel offers a uniquely thoughtful perspective on the most difficult issues in medicine today. From 2009 to 2011, he served as a special advisor for health policy to the White House Office of Management and Budget. As one of the most prominent voices advising the White House about healthcare, he had a significant impact on federal healthcare budgets and the Affordable Care Act. Samir Malik is the Senior Vice President and General Manager of Genoa Telepsychiatry, part of Genoa, a QoL Healthcare company. Mr. Malik came into this role through the acquisition of his company, 1DocWay, a New York City-based telepsychiatry company, which he founded and served as CEO. The company expands access to mental healthcare in rural America. Mr. Malik and his team have built the technology-enabled services company from scratch, treating 50,000 patients across the country. Thomas M. Priselac is President and Chief Executive Officer of the Cedars-Sinai Health System and has held the position since January 1994. From 1988 to 1993, he served as Executive Vice President. An author and invited speaker on health policy issues, Mr. Priselac has served the healthcare field in various roles. He is past Chair of the American Hospital Association Board of Trustees and past Chair of the Association of American Medical Colleges. Barbara McNeil, Professor of Radiology and Former Acting Dean, Harvard Medical School Barbara J. McNeil, MD, PhD, is the Ridley Watts Professor and founding head of the Department of Health Care Policy at Harvard Medical School. She is also a professor of radiology at Harvard Medical School and at Brigham and Women’s Hospital. Dr. McNeil’s research focuses on several areas, most notably technology assessment and quality of care, as well as the effects of alternative payment arrangements and organizational characteristics on quality and costs of care. Wyatt W. Decker, MD, is Mayo Clinic Vice President and Chief Executive Officer of Mayo Clinic in Arizona. As a vice president of the largest not-for-profit integrated multi-specialty group practice in the nation, Dr. Decker helps direct Mayo Clinic’s research, education and clinical operations in Arizona, Florida and Minnesota. Dr. Decker is directly responsible for Mayo Clinic operations in Arizona. Lou Silverman has a 15-year track record of success as CEO in healthcare information technology and healthcare services companies, translating a passion for the transformative benefits of innovative healthcare solutions into successful clinical and commercial organizations. In addition to his leadership role at Advanced ICU Care, Mr. Silverman serves on the board of directors for a variety of healthcare-related companies, both public and private. Hill Ferguson is Chief Executive Officer at Doctor On Demand. With nearly two decades of experience in mobile technology, Mr. Ferguson has led companies at all stages of growth, from being a founder to serving as a senior executive at PayPal, a high-growth public company. He holds deep commitment to putting customers first by delivering the best possible products, a value that resonates with Doctor On Demand's commitment to its industry-leading clinical quality and best-in-class customer experience. About the Pepperdine Graziadio School of Business and Management A leader in cultivating entrepreneurship and digital innovation, the Pepperdine Graziadio School of Business and Management focuses on the real-world application of MBA-level business concepts. The Graziadio School provides student-focused, globally-oriented education through part-time, full-time, and executive MBA programs at our five Southern California locations, Silicon Valley and Santa Barbara campuses, as well as through online and hybrid formats. In addition, the Graziadio School offers a variety of master of science programs, a bachelor of science in management degree-completion program, and the Presidents and Key Executives MBA, as well as executive education certificate programs. Follow the Graziadio School on Facebook, Twitter at @GraziadioSchool, Instagram, and LinkedIn.


"The loss of insulin-producing beta cells leads to type 1 diabetes, making it an ideal target for cell replacement therapy," said James Shapiro, MD, PhD, FRCSC, Director of the Clinical Islet Transplant Program, University of Alberta.  "Islet transplants from scarce organ donors have offered great promise for those with unstable, high-risk type 1 diabetes, but the procedure has many limitations.  With an unlimited supply of new islets that the stem cell-derived therapy promises, we have real potential to benefit far more patients with islet cell replacement." The PEC-Direct product candidate delivers stem cell-derived pancreatic progenitor cells, called PEC-01™ cells, in a device designed to allow direct vascularization of the cells in the device.  After implantation, these cells are expected to proliferate and mature to human islet tissue including well-regulated beta cells producing insulin on demand.  The direct vascularization of the implanted cells is expected to allow for robust and consistent engraftment but will necessitate the use of maintenance immune suppression therapy. The PEC-Direct product candidate is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or severe hypoglycemic episodes.  It is estimated that about 140,000 people in Canada and the U.S. have such high-risk type 1 diabetes.  In addition to providing an unlimited supply of cells for implantation, the PEC-Direct approach has the potential to provide other advantages relative to cadaver islet transplants such as delivering a more consistent product preparation under quality-controlled cGMP conditions, with a more straightforward and safer mode of delivery. "ViaCyte was the first to differentiate human stem cells into glucose-responsive, insulin-producing cells, and now we are running the first and only clinical trials of stem cell-derived islet replacement therapies for type 1 diabetes," said Paul Laikind, PhD, President and CEO of ViaCyte.  "While insulin therapy transformed type 1 diabetes from a death sentence to a chronic illness, it is far from a cure.  Type 1 diabetes patients continue to deal with the daily impact of the disease and remain at risk for often severe long-term complications.  This is especially true for the patients with high-risk type 1 diabetes, who face challenges such as hypoglycemia unawareness and life-threatening severe hypoglycemic episodes.  These patients have a particularly urgent unmet medical need and could benefit greatly from cell replacement therapy." "Those living with hypoglycemia unawareness are at constant risk of life-threatening complications, and even death, because they do not sense the physical symptoms of low blood sugar," said Dr. Jeremy Pettus, Principal Investigator of the clinical trial and Assistant Professor of Medicine at UC San Diego.  "An islet cell replacement therapy could be significant for patients with this type of high-risk diabetes."  At UC San Diego, the trial will be performed at the School of Medicine's Altman Clinical Trials Research Institute with support from the California Institute for Regenerative Medicine (CIRM)'s Alpha Clinic and the Sanford Stem Cell Clinical Center. PEC-Direct is one of two product candidates in clinical development to treat patients with diabetes.  ViaCyte's PEC-Encap™ (also known as VC-01) product candidate delivers the same cell therapy as PEC-Direct but uses a proprietary device called the Encaptra® Cell Delivery System that is designed to protect the cells from the patient's immune system.  The PEC-Encap product candidate is being developed as a transformative therapy for all patients who require insulin to control their disease.  Early clinical evidence with the PEC-Encap product supports the potential of the replacement cell therapy approach.  However, the clinical results also indicate that further work to optimize the performance of the PEC-Encap product is required.  ViaCyte recently announced a collaboration with W. L. Gore & Associates focused on modifying the Encaptra device to improve engraftment in patients. About PEC-01 Cells ViaCyte's PEC-01 cells are the biological component of both PEC-Direct and PEC-Encap product candidates.  PEC-01 pancreatic progenitor cells are manufactured from pluripotent stem cells and are designed to further differentiate and mature after implantation, not only to fully functioning insulin-producing beta cells, but also to the other endocrine cell types that make up the normal healthy human pancreatic islet.  This mixture of pancreatic cell types is expected to produce on-demand the necessary insulin, along with other hormones that are important for the regulation of glucose (sugar) in the blood including glucagon, somatostatin, and amylin. About ViaCyte ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte's product candidates are based on the derivation of pancreatic progenitor cells, which are then implanted in a durable and retrievable cell delivery device.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two products in development.  The PEC-Direct™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have severe hypoglycemic episodes, extreme glycemic lability, and/or impaired awareness of hypoglycemia.  The PEC-Encap™ (also known as VC-01) product candidate delivers pancreatic progenitor cells in an immunoprotective device and is currently being evaluated in a Phase 1/2 trial in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/viacyte-receives-ind-allowance-from-fda-and-clearance-from-health-canada-to-commence-international-clinical-trial-of-pec-direct-cell-therapy-for-high-risk-type-1-diabetes-300461166.html


News Article | April 26, 2017
Site: www.eurekalert.org

Shortening consent documents makes no significant difference to how well potential research participants understand a clinical study, according to a study published April 26, 2017, in the open-access journal PLOS ONE by Christine Grady from the NIH Clinical Center, US, and colleagues. Informed consent is a central tenet of ethical clinical research, but over time the documents used to obtain informed consent from participants have grown longer, more complex, and harder to read. Grady and colleagues developed a "concise" alternative to consent documents used in the multinational START trial, which was shorter by almost 70 percent at 1,821 words. The new document also contained bullet points and tables, and had a simpler reading level. The authors tested these documents with 4,229 HIV-positive participants at 77 sites across the world seeking enrollment in the START trial between 2009 and 2013. The sites were randomly allocated to either the concise or the standard consent documents for participants to review. Participants who reviewed the concise version showed no significant difference in their comprehension, satisfaction, or willingness to volunteer compared to participants who reviewed the standard form. However, comprehension was better when sites mailed the consent forms in advance and when site leaders explained the study to participants in person. One potential advantage of shorter, more concise consent forms, is that they could be reviewed more quick by an ethics committee. This could allow site leaders more time to discuss the important points of the study with their patients before enrollment in the trial, but this theory needs testing. Whilst the study only examined one type of concise document in the context of a single clinical trial, the authors state that it is the largest test to date of modified clinical research consent forms among patients in a real clinical trial setting. They note that their results support continued efforts to make consent forms more efficient. In your coverage please use this URL to provide access to the freely available article in PLOS ONE: http://journals. Citation: Grady C, Touloumi G, Walker AS, Smolskis M, Sharma S, Babiker AG, et al. (2017) A randomized trial comparing concise and standard consent forms in the START trial. PLoS ONE 12(4): e0172607. doi:10.1371/journal.pone.0172607 Funding: This study was funded through National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) Grants UM1-AI068641 and UM1-AI120197, as well as the NIH intramural program through the Clinical Center. The funder of this substudy, the US National Institutes of Health (NIH), provided support in the form of salaries for some authors [CG, MS], and grant support for some authors [AB, SS, ASW] but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of all authors are articulated in the 'author contributions' section. Genentech Research and Early Development had no role in this study. Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: CG, FH, JT, ED, NP, AP, AS, GT, MS declare no competing interests. AB, SS, SW report receipt of grants. EE reports stock ownership, paid consultancies, Board memberships, and speaking honoraria. There are no commercial or other interests that alter our adherence to PLOS One policies on sharing data and materials.


News Article | April 21, 2017
Site: www.prnewswire.com

The Global Translational Regenerative Medicine market is expected to grow significantly over the forecast period. The Global Translational Regenerative Medicine market was valued at $5.8bn in 2016. Visiongain forecasts this market to increase to $14.5bn in 2021. The market is estimated to grow at a CAGR of 19.9% in the first half of the forecast period and 17.7% from 2016 to 2027. How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 316-page report you will receive 107 tables and 66 figures - all unavailable elsewhere. The 316-page report provides clear detailed insight into the Global Translational Regenerative Medicine market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Forecasts from 2017-2027 of the leading products in the Global Translational Regenerative Medicine market: - Osteocel Plus - Trinity ELITE - TEMCELL /Prochymal - Apligraf - Dermagraft - Epifix - ReCell - Neovasculgen - Glybera (alipogene tiparvovec) - IMLYGIC (talimogene laherparepvec) • SWOT and Porter's Five Force analysis of the translational regenerative medicine market Visiongain's study is intended for anyone requiring commercial analyses for the Translational Regenerative Medicine Market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 List of Organisations Mentioned in the Report Arthritis Research UK Associazione Infermieristica per lo Studio delle Lesioni Cutanee (AISLeC) [China] Australian Regenerative Medicine Institute Australian Sports Anti-Doping Authority (ASADA) Biomedical Advanced Research and Development Authority (BARDA) British Heart Foundation [UK] California Institute of Regenerative Medicine (CIRM) Cambridge Stem Cell Biology Institute [UK] Case Western Reserve University Catalan Institution for Research and Advanced Studies Center for Biologics Evaluation and Research (CBER) [US] CHA General Hospital [Korea] Cryocenter Saint Petersburg Drugs Controller General of India (DCGI) European Group for Blood and Marrow Transplantation (EBMT) European Medicines Agency Food and Drugs Agency (FDA) [US] Haute Autorité de santé [France] Heriot-Watt University Human Fertilisation and Embryology Authority (HFEA) Institute of Biomedical Research and Innovation Hospital [Japan] International Society for Stem Cell Research (ISSCR) Karolinska Institute [Sweden] Massachusetts General Hospital (MGH) Mayo Clinic [US] Medical Research Council [UK] MiMedx Ministry of Food and Drug Safety, MFDS) [Korea] Ministry of Health, Labour and Welfare (MHLW) [Japan] Ministry of Science and Technology [China] Moorfields Eye Hospital National Tissue Engineering Center (NTEC) [China] New York Blood Center Riken Center for Developmental Biology RUSH University Medical Center [US] Russian Ministry of Healthcare and Social Development Scottish Centre for Regenerative Medicine St. Jude's Children Research Hospital State Food and Drug Administration (SFDA) [China] SUNY Upstate Medical University The Genetico Center [Russia] The StemGen Organisation Therapeutics Goods Administration (TGA) [Australia] UH San Diego Sanford Stem Cell Clinical Center UK Medicines and Healthcare Products Regulatory Agency (MHRA) Universitat Autònoma de Barcelona [Spain] University College London University of Edinburgh MRC Centre for Regenerative Medicine [UK] University of Massachusetts (UMass) Memorial Hospital University of Modena Centre for Regenerative Medicine [Italy] University of Wisconsin US National Institute of Health Wake Forest Institute Wellcome Trust World Health Organization To see a report overview please email Sara Peerun on sara.peerun@visiongain.com


News Article | April 21, 2017
Site: www.prnewswire.co.uk

The Global Translational Regenerative Medicine market is expected to grow significantly over the forecast period. The Global Translational Regenerative Medicine market was valued at $5.8bn in 2016. Visiongain forecasts this market to increase to $14.5bn in 2021. The market is estimated to grow at a CAGR of 19.9% in the first half of the forecast period and 17.7% from 2016 to 2027. How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 316-page report you will receive 107 tables and 66 figures - all unavailable elsewhere. The 316-page report provides clear detailed insight into the Global Translational Regenerative Medicine market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Forecasts from 2017-2027 of the leading products in the Global Translational Regenerative Medicine market: - Osteocel Plus - Trinity ELITE - TEMCELL /Prochymal - Apligraf - Dermagraft - Epifix - ReCell - Neovasculgen - Glybera (alipogene tiparvovec) - IMLYGIC (talimogene laherparepvec) • SWOT and Porter's Five Force analysis of the translational regenerative medicine market Visiongain's study is intended for anyone requiring commercial analyses for the Translational Regenerative Medicine Market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 List of Organisations Mentioned in the Report Arthritis Research UK Associazione Infermieristica per lo Studio delle Lesioni Cutanee (AISLeC) [China] Australian Regenerative Medicine Institute Australian Sports Anti-Doping Authority (ASADA) Biomedical Advanced Research and Development Authority (BARDA) British Heart Foundation [UK] California Institute of Regenerative Medicine (CIRM) Cambridge Stem Cell Biology Institute [UK] Case Western Reserve University Catalan Institution for Research and Advanced Studies Center for Biologics Evaluation and Research (CBER) [US] CHA General Hospital [Korea] Cryocenter Saint Petersburg Drugs Controller General of India (DCGI) European Group for Blood and Marrow Transplantation (EBMT) European Medicines Agency Food and Drugs Agency (FDA) [US] Haute Autorité de santé [France] Heriot-Watt University Human Fertilisation and Embryology Authority (HFEA) Institute of Biomedical Research and Innovation Hospital [Japan] International Society for Stem Cell Research (ISSCR) Karolinska Institute [Sweden] Massachusetts General Hospital (MGH) Mayo Clinic [US] Medical Research Council [UK] MiMedx Ministry of Food and Drug Safety, MFDS) [Korea] Ministry of Health, Labour and Welfare (MHLW) [Japan] Ministry of Science and Technology [China] Moorfields Eye Hospital National Tissue Engineering Center (NTEC) [China] New York Blood Center Riken Center for Developmental Biology RUSH University Medical Center [US] Russian Ministry of Healthcare and Social Development Scottish Centre for Regenerative Medicine St. Jude's Children Research Hospital State Food and Drug Administration (SFDA) [China] SUNY Upstate Medical University The Genetico Center [Russia] The StemGen Organisation Therapeutics Goods Administration (TGA) [Australia] UH San Diego Sanford Stem Cell Clinical Center UK Medicines and Healthcare Products Regulatory Agency (MHRA) Universitat Autònoma de Barcelona [Spain] University College London University of Edinburgh MRC Centre for Regenerative Medicine [UK] University of Massachusetts (UMass) Memorial Hospital University of Modena Centre for Regenerative Medicine [Italy] University of Wisconsin US National Institute of Health Wake Forest Institute Wellcome Trust World Health Organization To see a report overview please email Sara Peerun on sara.peerun@visiongain.com

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