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New Research Identifies Need for Patient-Centric Clinical Trials and Role for CROs New Research Identifies Patient-centric Strategies for Clinical Development with over 125 Global Research Opinion Leaders. Recognizing the upcoming need of distinct patient populations and understanding how CROs can play a role in running patient-centric trials, Life Science Strategy Group (LSSG) conducted research with 126 global opinion leaders involved in preclinical and clinical research at small, mid-sized, and large biopharmaceutical companies. LSSG found that up to 87% of respondents are discussing patient-centric approaches to clinical development, with half of the surveyed companies expecting to implement patient-centric approaches for clinical development within the next 1-3 years. "It is important to realize where Pharma is in its implementation of patient-centric strategies for clinical development today and to understand their needs in the future," said Jon Meyer, Life Science Strategy Group’s CRO Industry Practice Leader. Further, the research identifies that CROs need to play an increasing role as an enabler of success in patient-centric clinical trials. "Sponsors would like to see CROs research new and existing technologies such as data collection devices, patient-oriented websites and applications, and sample storage options, that enhance patient-centric trial approaches. This study gives us a glimpse at which CROs are best prepared to meet Pharma’s needs today and in the future," said Meyer. To learn more about LSSG’s new study examining patient-centric development trends as well as which CROs such as Covance, ICON, inVentiv Health Clinical, INC Research, Parexel, PPD, PRA International and QuintilesIMS are best prepared to address the new development needs, please contact Life Science Strategy Group or click on the link below. http://lifesciencestrategy.com/publications/cro-industry/pubs-cro-patient-centric-april-2017/ About Life Science Strategy Group, LLC Life Science Strategy Group, LLC specializes in strategic consulting and market research engagements across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics and drug discovery. Menlo Park, CA, April 28, 2017 --( PR.com )-- Life Science Strategy Group (LSSG) the leading strategic consulting firm to the CRO industry, is pleased to announce the results of a new 2017 study, "Patient-Centric Clinical Development Status and the Role of the Contract Research Organization (CRO)." which focuses on the current status and emerging trends of patient-centric clinical trials and the role CROs will play.Recognizing the upcoming need of distinct patient populations and understanding how CROs can play a role in running patient-centric trials, Life Science Strategy Group (LSSG) conducted research with 126 global opinion leaders involved in preclinical and clinical research at small, mid-sized, and large biopharmaceutical companies. LSSG found that up to 87% of respondents are discussing patient-centric approaches to clinical development, with half of the surveyed companies expecting to implement patient-centric approaches for clinical development within the next 1-3 years."It is important to realize where Pharma is in its implementation of patient-centric strategies for clinical development today and to understand their needs in the future," said Jon Meyer, Life Science Strategy Group’s CRO Industry Practice Leader.Further, the research identifies that CROs need to play an increasing role as an enabler of success in patient-centric clinical trials. "Sponsors would like to see CROs research new and existing technologies such as data collection devices, patient-oriented websites and applications, and sample storage options, that enhance patient-centric trial approaches. This study gives us a glimpse at which CROs are best prepared to meet Pharma’s needs today and in the future," said Meyer.To learn more about LSSG’s new study examining patient-centric development trends as well as which CROs such as Covance, ICON, inVentiv Health Clinical, INC Research, Parexel, PPD, PRA International and QuintilesIMS are best prepared to address the new development needs, please contact Life Science Strategy Group or click on the link below.About Life Science Strategy Group, LLCLife Science Strategy Group, LLC specializes in strategic consulting and market research engagements across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics and drug discovery. Click here to view the list of recent Press Releases from Life Science Strategy Group, LLC


New Research Explores Wearable Technology Utilization in Clinical Trials and the Role of CROs New Report Identifies Current and Future Wearable Technology Utilization and CRO Implications with 130 Clinical Outsourcing Decision Makers. The data, representing input from small, mid-sized and large biopharmaceutical companies globally, indicate that biopharmaceutical companies are not yet fully educated on the rationale for and use of wearable technology in clinical trials, which presents an opportunity to those CROs investing time and resources in the capability. “The findings are surprising. While many biopharma decision-makers are actively incorporating wearable technology into their clinical trials, a significant portion are not. Furthermore, many do not feel the need to do so. Our research uncovers key challenges limiting wearable technology use, and identifies opportunities for CROs to better serve the biopharmaceutical market,” said Jon Meyer, Life Science Strategy Group’s CRO Industry Practice Leader. To learn more about LSSG’s new study revealing wearable technology trends and preparedness of leading CROs including Covance, ICON, inVentiv Health Clinical, INC Research, Parexel, PPD, PRA International and QuintilesIMS, please contact Life Science Strategy Group or click on the link below. Wearable Technology Utilization in Clinical Trials and the Role of CROs About Life Science Strategy Group, LLC Life Science Strategy Group, LLC specializes in strategic consulting and market research engagements across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics and drug discovery. Menlo Park, CA, December 01, 2016 --( PR.com )-- Life Science Strategy Group, (LSSG) the leading strategic consulting firm to the CRO industry, is pleased to announce the launch of a new report, "Wearable Technology Utilization in Clinical Trials and the Role of CROs: Current and Future Outlook," which focuses on the adoption of wearable technology in clinical trials and perceived preparedness of CROs to incorporate wearable technology into clinical development services. Quantitative research with approximately 130 biopharmaceutical outsourcing decision makers with clinical development responsibilities reveals current implementation levels of wearable technology in clinical trials, satisfaction with wearable technology, benefits, hurdles and future wearable technology needs and implications to the CRO market.The data, representing input from small, mid-sized and large biopharmaceutical companies globally, indicate that biopharmaceutical companies are not yet fully educated on the rationale for and use of wearable technology in clinical trials, which presents an opportunity to those CROs investing time and resources in the capability.“The findings are surprising. While many biopharma decision-makers are actively incorporating wearable technology into their clinical trials, a significant portion are not. Furthermore, many do not feel the need to do so. Our research uncovers key challenges limiting wearable technology use, and identifies opportunities for CROs to better serve the biopharmaceutical market,” said Jon Meyer, Life Science Strategy Group’s CRO Industry Practice Leader.To learn more about LSSG’s new study revealing wearable technology trends and preparedness of leading CROs including Covance, ICON, inVentiv Health Clinical, INC Research, Parexel, PPD, PRA International and QuintilesIMS, please contact Life Science Strategy Group or click on the link below.About Life Science Strategy Group, LLCLife Science Strategy Group, LLC specializes in strategic consulting and market research engagements across a variety of therapeutic, technology and service industries including contract research services, pharmaceutical, biotechnology, medical devices, diagnostics and drug discovery. Click here to view the list of recent Press Releases from Life Science Strategy Group, LLC


Chey W.D.,University of Michigan | Webster L.,PRA International | Sostek M.,Astrazeneca | Lappalainen J.,Astrazeneca | And 2 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Opioid-induced constipation is common and debilitating. We investigated the efficacy and safety of naloxegol, an oral, peripherally acting, μ-opioid receptor antagonist, for the treatment of opioid-induced constipation. METHODS: In two identical phase 3, double-blind studies (study 04, 652 participants; study 05, 700 participants), outpatients with noncancer pain and opioid-induced constipation were randomly assigned to receive a daily dose of 12.5 or 25 mg of naloxegol or placebo. The primary end point was the 12-week response rate (≥3 spontaneous bowel movements per week and an increase from baseline of ≥1 spontaneous bowel movements for ≥9 of 12 weeks and for ≥3 of the final 4 weeks) in the intention-to-treat population. The key secondary end points were the response rate in the subpopulation of patients with an inadequate response to laxatives before enrollment, time to first postdose spontaneous bowel movement, and mean number of days per week with one or more spontaneous bowel movements. RESULTS: Response rates were significantly higher with 25 mg of naloxegol than with placebo (intention-to-treat population: study 04, 44.4% vs. 29.4%, P = 0.001; study 05, 39.7% vs. 29.3%, P = 0.02; patients with an inadequate response to laxatives: study 04, 48.7% vs. 28.8%, P = 0.002; study 05, 46.8% vs. 31.4%, P = 0.01); in study 04, response rates were also higher in the group treated with 12.5 mg of naloxegol (intention-to-treat population, 40.8% vs. 29.4%, P = 0.02; patients with an inadequate response to laxatives, 42.6% vs. 28.8%, P = 0.03). A shorter time to the first postdose spontaneous bowel movement and a higher mean number of days per week with one or more spontaneous bowel movements were observed with 25 mg of naloxegol versus placebo in both studies (P<0.001) and with 12.5 mg of naloxegol in study 04 (P<0.001). Pain scores and daily opioid dose were similar among the three groups. Adverse events (primarily gastrointestinal) occurred most frequently in the groups treated with 25 mg of naloxegol. CONCLUSIONS: Treatment with naloxegol, as compared with placebo, resulted in a significantly higher rate of treatment response, without reducing opioid-mediated analgesia. Copyright © 2014 Massachusetts Medical Society.


Peroutka S.J.,PRA International
Headache | Year: 2016

This section of Headache annually reviews the status of recently completed and ongoing major clinical trials involving common headache disorders. The review will focus on multicenter trials of new therapies, as well as novel formulations of previously approved therapeutics. The Table summarizes the major therapeutic headache trials that were ongoing at the end of 2015, according to data obtained from both the "ClinicalTrials.Gov" website and from corporate press releases and presentations. © 2015 American Headache Society.


Leisner T.M.,University of North Carolina at Chapel Hill | Moran C.,University of North Carolina at Chapel Hill | Moran C.,PRA International | Holly S.P.,University of North Carolina at Chapel Hill | Parise L.V.,University of North Carolina at Chapel Hill
Oncogene | Year: 2013

CIB1 is a 22-kDa regulatory protein previously implicated in cell survival and proliferation. However, the mechanism by which CIB1 regulates these processes is poorly defined. Here, we report that CIB1 depletion in SK-N-SH neuroblastoma and MDA-MB-468 breast cancer cells promotes non-apoptotic, caspase-independent cell death that is not initiated by increased outer mitochondrial membrane permeability or translocation of apoptosis-inducing factor to the nucleus. Instead, cell death requires nuclear GAPDH accumulation. Furthermore, CIB1 depletion disrupts two commonly dysregulated, oncogenic pathways-PI3K/AKT and Ras/MEK/ERK, resulting in a synergistic mechanism of cell death, which was mimicked by simultaneous pharmacological inhibition of both pathways, but not either pathway alone. In defining each pathway's contributions, we found that AKT inhibition alone maximally induced GAPDH nuclear accumulation, whereas MEK/ERK inhibition alone had no effect on GAPDH localization. Concurrent GAPDH nuclear accumulation and ERK inhibition were required, however, to induce a significant DNA damage response, which was critical to subsequent cell death. Collectively, our results indicate that CIB1 is uniquely positioned to regulate PI3K/AKT and MEK/ERK signaling and that simultaneous disruption of these pathways synergistically induces a nuclear GAPDH-dependent cell death. The mechanistic insights into cell death induced by CIB1 interference suggest novel molecular targets for cancer therapy. © 2013 Macmillan Publishers Limited All rights reserved.


Peroutka S.J.,PRA International
Headache | Year: 2014

This section of Headache annually reviews the status of recently completed and ongoing major clinical trials involving common headache disorders. The review will focus on multicenter trials of new therapies, as well as novel formulations of previously approved therapeutics. Table 1 summarizes the major therapeutic headache trials that are ongoing at the present time, according to data obtained from both the "ClinicalTrials.Gov" website and from corporate press releases and presentations. © 2013 American Headache Society.


Peroutka S.J.,PRA International
Headache | Year: 2011

This section of Headache annually reviews the status of recently completed and ongoing clinical trials involving headache disorders. The review will focus on multicenter trials of new therapies as well as novel formulations of previously approved therapeutics. Table 1 summarizes major migraine therapeutic trials that have been completed recently, according to data obtained from the "ClinicalTrials.Gov" website as well as from corporate press releases. Table 2 summarizes the major therapeutic trials that are ongoing at the present time. © 2010 American Headache Society.


News Article | May 28, 2015
Site: www.businesswire.com

NASHVILLE, Tenn.--(BUSINESS WIRE)--Sarah Cannon Research Institute (SCRI), the research arm of HCA’s global cancer enterprise, Sarah Cannon, today announced it has named Dawn Sauro as the new president of the company’s full service contract research organization (CRO), Development Innovations. In her role, Sauro will provide executive oversight for Sarah Cannon’s line of business that specializes in clinical research management for first-in-human through proof-of-concept trials. “Dawn brings more than 20 years of experience in clinical development and operations from the pharmaceutical and healthcare industry,” said Dee Anna Smith, SCRI chief executive officer. “Her executive leadership will help us continue to enhance our service offering and further our mission of advancing therapies for patients.” Most recently, Sauro served as senior vice president and general manager of hematology and oncology at inVentive Health Clinical in Raleigh, N.C. Previously, she served as vice president of operations for PRA International in Raleigh and director of clinical operations for PPD Inc. at the company’s Seattle office. Sauro holds a bachelor’s of science degree from the University of Rhode Island. “Throughout her career, Dawn has gained deep industry expertise in the design and development of clinical trials,” said Smith. “With her leadership, we look forward to expanding our capabilities and achieving new milestones with our pharmaceutical and biotech company partners to improve patient outcomes through clinical research.” Sauro will join the SCRI leadership team in Chicago for the American Society of Clinical Oncology (ASCO®) annual meeting and formally begin her position at the company’s Nashville headquarters in June. Sarah Cannon Research Institute (SCRI) is the research arm of HCA’s global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom. SCRI has led more than 170 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in nearly 80 percent of approved cancer therapies in the last 10 years. Additionally, SCRI offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), SCRI Development Innovations. For more information, visit sarahcannon.com. SCRI Development Innovations (SCRI Innovations) is a global, full-service, oncology-focused contract research organization (CRO) specializing in clinical development services. As the CRO of Sarah Cannon’s research arm, Sarah Cannon Research Institute (SCRI), SCRI Innovations leverages SCRI’s expert physician leadership to design and implement optimal clinical trials that effectively and efficiently lead to rapid clinical decisions.


News Article | May 28, 2015
Site: www.businesswire.com

NASHVILLE, Tenn.--(BUSINESS WIRE)--Sarah Cannon Research Institute (SCRI), the research arm of HCA’s global cancer enterprise, Sarah Cannon, today announced it has named Dawn Sauro as the new president of the company’s full service contract research organization (CRO), Development Innovations. In her role, Sauro will provide executive oversight for Sarah Cannon’s line of business that specializes in clinical research management for first-in-human through proof-of-concept trials. “Dawn brings more than 20 years of experience in clinical development and operations from the pharmaceutical and healthcare industry,” said Dee Anna Smith, SCRI chief executive officer. “Her executive leadership will help us continue to enhance our service offering and further our mission of advancing therapies for patients.” Most recently, Sauro served as senior vice president and general manager of hematology and oncology at inVentive Health Clinical in Raleigh, N.C. Previously, she served as vice president of operations for PRA International in Raleigh and director of clinical operations for PPD Inc. at the company’s Seattle office. Sauro holds a bachelor’s of science degree from the University of Rhode Island. “Throughout her career, Dawn has gained deep industry expertise in the design and development of clinical trials,” said Smith. “With her leadership, we look forward to expanding our capabilities and achieving new milestones with our pharmaceutical and biotech company partners to improve patient outcomes through clinical research.” Sauro will join the SCRI leadership team in Chicago for the American Society of Clinical Oncology (ASCO®) annual meeting and formally begin her position at the company’s Nashville headquarters in June. Sarah Cannon Research Institute (SCRI) is the research arm of HCA’s global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom. SCRI has led more than 170 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in nearly 80 percent of approved cancer therapies in the last 10 years. Additionally, SCRI offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), SCRI Development Innovations. For more information, visit sarahcannon.com. SCRI Development Innovations (SCRI Innovations) is a global, full-service, oncology-focused contract research organization (CRO) specializing in clinical development services. As the CRO of Sarah Cannon’s research arm, Sarah Cannon Research Institute (SCRI), SCRI Innovations leverages SCRI’s expert physician leadership to design and implement optimal clinical trials that effectively and efficiently lead to rapid clinical decisions.


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