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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


News Article | December 12, 2016
Site: globenewswire.com

SOUTH SAN FRANCISCO, Calif., Dec. 12, 2016 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, announced that William D. Waddill has resigned as the company’s Senior Vice President and Chief Financial Officer due to his relocation outside Northern California.  Mr. Waddill’s resignation will be effective on or about December 31, 2016 in order to facilitate a smooth transition.   “On behalf of everyone at Calithera, I thank Will for his numerous contributions to our company during his tenure, including most notably his management of our 2014 initial public offering.  Will’s leadership has helped Calithera to build a clinical pipeline of novel cancer therapies targeting tumor and immune cell metabolism.  We wish Will the very best in future endeavors,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. The company also announced the recent promotions of Curtis Hecht to Senior Vice President, Business and Corporate Development, and Jennifer McNealey to Vice President, Investor Relations and Strategy.  Mr. Hecht joined Calithera in April 2014, and has worked in the biopharmaceutical industry for over 20 years. Most recently he served as Vice President of Business Development at inVentiv Health.  He also served as a partner of DNA Ink, and managed the Roche-Genentech joint development and operations committee.  Ms. McNealey joined Calithera in February 2015.  Before joining Calithera, Ms. McNealey served as an investor relations advisor to biotechnology companies.  She also founded Laurient, an independent research firm, and prior to that she served as a biotech analyst and portfolio manager. “These promotions reflect the leadership role these key individuals have played in developing Calithera Biosciences into a fully integrated biotechnology company,” said Susan Molineaux. Following Mr. Waddill’s departure, Susan Molineaux will become the company’s Principal Financial Officer and assume Mr. Waddill’s administrative responsibilities, and Stephanie Wong, the company’s Vice President Finance since April 2014, will become the company’s Principal Accounting Officer.  “With these changes and the increased responsibilities that Jennifer will be taking on in managing investor relations and that Curtis will be taking on in corporate development, the company is well positioned to move forward with a strong leadership team,” said Susan Molineaux. Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer.  Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents.  CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells.  Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells.  CB-1158 is currently in a Phase I clinical trial.  Calithera is headquartered in South San Francisco, California.  For more information about Calithera, please visit www.calithera.com. Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements.  These statements include those related to the Company’s clinical pipeline of novel cancer therapies.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release.  Such product candidates may not be beneficial to patients or successfully commercialized.  The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price.  Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.


News Article | November 15, 2016
Site: www.newsmaker.com.au

Future Market Insights (FMI) delivers key insights on the global pharmacovigilance market in its upcoming outlook titled “Pharmacovigilance Market: Global Industry Analysis and Opportunity Assessment, 2015 - 2020”. In terms of revenue, the global pharmacovigilance market is estimated to expand at a healthy CAGR of 14.2% through 2020. The global pharmacovigilance market was valued at US$ 2,759.1 Mn in 2014 and is expected to reach US$ 6,104.1 Mn in 2020, expanding at a CAGR of 14.2% from 2015 to 2020. The market is segmented based on phase of drug development, type of reporting methods and type of service providers. Based on phase of drug development, the market has been segmented into preclinical studies, phase I clinical trial, phase II clinical trial, phase III clinical trial and phase IV clinical trial or post-marketing surveillance. Based on type of reporting methods, the market has been segmented into spontaneous reporting, intensified ADR reporting, targeted spontaneous reporting, cohort event monitoring and EHR mining. On the basis of service providers, the market has been segmented into in-house and contract outsourcing. As the number of chemical entities has been growing in the global pharmaceuticals market, pharmacovigilance is increasingly become a mandate for drug manufacturers. Considering the change in regulations, phase III and phase IV studies are being increasingly conducted to monitor the long-term safety outcomes of pharmaceuticals and biological products. Implementation of active pharmacovigilance activities assists in the execution of long-term plans, such as in bringing improvement in patient outcome and minimisation of health care associated costs, particularly related to Adverse Drug Reactions (ADRs), and in the prevention of drug hazards. To provide deeper insights into the pharmacovigilance market, the report has also been segmented by phase of drug development, type of reporting method and type of service provider. By phase of drug development, the clinical trial phase III segment is projected to expand at a CAGR of 15.5% in the global pharmacovigilance market by phase of drug development by 2020 end in terms of value. Evaluation of real-time effectiveness of the drug and availability of a facility to conduct trials in state-of-the-art settings, thus complementing the outcomes of premarketing randomised control trials, are the prime benefits availed from pharmacovigilance in phase IV trials. It has also been reported that approximately 57% of the global pharmaceutical companies outsource post marketing operations to CROs in order to avoid the high operational cost associated with technological infrastructure and hiring skilled staff. The primary barriers in the market include high risk associated with securing data in case of pharmacovigilance outsourcing and lack of availability of skilled workforce specialising in drug monitoring. The primary trend in the pharmacovigilance market is an increase in dependence on third party services. Other trends include harnessing shorter turnaround times for faster market capitalisation and requirement of highly skilled personnel for monitoring side effects. Some of the key players identified in the global pharmacovigilance market report include: Accenture plc, Bristol-Myers Squibb, Clinquest Group B.V., Cognizant Technology Solutions, Covance, Inc., F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc (GSK), ICON plc, iGATE Corporation, iMEDGlobal Corporation, inVentiv Health, Inc., Novartis International AG, PAREXEL International Corporation, Pfizer, Inc., Pharmaceutical Product Development, LLC. (PPD), PRA Health Sciences, Inc., Quintiles Transnational Holdings, Inc., Sanofi S.A., Synowledge LLC and Wipro Limited. These companies specialise in pharmacovigilance services, and focus on market consolidation initiatives and analyses of their specific strengths, weaknesses, opportunities and threats to strengthen their position in the market. The report has been concluded with strategic recommendations for players already present in the market and new players planning to enter the market, which could help them in the near future. This report assesses factors driving growth of each segment of the market and presents analysis and key insights on the potential of the pharmacovigilance market as per region-specific trends. North America accounted for majority of the pharmacovigilance market revenue in 2014. However, incidences of increasing consumption of drugs and rise in cases of adverse drug reactions are expected to drive growth of the market in Asia Pacific and Latin American regions.


Pharmacovigilance Market is driven with growing public health awareness and expectation in relation to safe use of medicines and medical interventions, increasing number of national pharmacovigilance centers grows pharmacovigilance market, North America leads Pharmacovigilance Market. The increasing occurrence of adverse drug reaction (ADR) and the rising policies implemented by governments on drug safety regulations globally will fuel the growth of the global pharmacovigilance market. The market for pharmacovigilance has been growing in leaps and bounds owing to the increasing aging population, raising the introduction of new drugs. Furthermore, health regulatory authorities including EMEA and the U.S. FDA are pressurizing on submission of data through electronic mediums. This will also positively impact the growth of the global pharmacovigilance market. This report presents quantitative information sets and elaborates upon the market dynamics such as the future prospects, drivers, and challenges. The competitive analysis tools such as attractive investment proposition have also been employed in order to present an accurate understanding of the overall market. The top regional segment driving the growth of the global pharmacovigilance market also forms a key part of this study. In the competitive landscape section of the report, the main sustainability strategies implemented by the leading players and their impact on the development of the market have also been presented. The key market regulating factors have also been detailed under this study. Key monitoring tools such as SWOT analysis and Porter’s five forces analysis have also been utilized in order to provide a detailed understanding of the competition present in the overall pharmacovigilance market. The increasing awareness amongst individuals on the safe utilization of medical interventions and medicines is amongst the key factors providing impetus to the development of the pharmacovigilance market. In addition, the rising count of national pharmacovigilance centers worldwide is positively impacting the growth of the overall market for pharmacovigilance. These centers are increasing awareness regarding safety of drugs amongst individuals, hence catapulting demand for pharmacovigilance. On the other hand, the huge risk of data security and increasing perception on benefits or harmful effects of various drugs are amongst the key factors restraining the development of the market. In addition, the trend of web-based sales and drug information and the lack of skilled professionals may negatively impact the growth of the global pharmacovigilance market. On the basis of geography, the global pharmacovigilance market is segmented into Europe, North America, Asia Pacific, and Rest of the World (RoW). Of these, the North America pharmacovigilance market held a significant share in the past owing to the rising mortality rate in this region because of increasing occurrence rate of ADRS and the growing concern on patients about the efficacy and safety of pharmaceutical products. However, Asia Pacific is predicted to emerge as the most lucrative region in the market in the coming years. This is due to the rising demand for strict regulations on healthcare in Asia Pacific and the large pool of patients within this region. In addition, the growing need for effective pharmacovigilance services owing to the increasing count of clinical trials taking place in a number of Asia Pacific nations will also boost the development of the overall market. The top players in this market are Clinquest Group B.V., Accenture, Plc, Cognizant Technology Solutions, iMED Global Corporation, Covance, Inc. ICON, Plc, inVentiv Health, Inc., Pharmaceutical Product Development LLC, Parexel International Corporation, PRA Health Sciences, Inc., F. Hoffmann-La Roche Ltd., Quintiles Transnational Holdings Inc, Sanofi , Wipro Limited, and Synowledge LLC, among others. Transparency Market Research (TMR) is a market intelligence company, providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for thousands of decision makers. We have an experienced team of Analysts, Researchers, and Consultants, who us e proprietary data sources and various tools and techniques to gather, and analyze information. Our business offerings represent the latest and the most reliable information indispensable for businesses to sustain a competitive edge. Each TMR Syndicated Research report covers a different sector - such as pharmaceuticals, chemical, energy, food & beverages, semiconductors, med-devices, consumer goods and technology. These reports provide in-depth analysis and deep segmentation to possible micro levels. With wider scope and stratified research methodology, our syndicated reports thrive to provide clients to serve their overall research requirement.


NEW YORK, Dec. 12, 2016 /PRNewswire/ -- Healthcare PR veteran Bob Chandler, former President of inVentiv Health Communications and co-founder of Chandler Chicco Companies, has announced the launch of MaxAscent™ LLC, a communications consultancy aiming to work with industry-leading...


BURLINGTON, Mass., Nov. 10, 2016 /PRNewswire/ -- inVentiv Health, a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market, announced today that it has closed its previously announced transaction...


TORONTO, ON--(Marketwired - October 28, 2016) - During a live broadcast on Thursday, November 10 at 11:00am EDT, featured presenters from inVentiv Health will share data collected through a survey of managed market payers in the United States, and the potential issues and insights revealed at its ASCO 2016 Roundtable with Pharmaceutical Executive. Also included will be recommendations for how the industry will move forward to overcome the obstacles in the path of acceptance of PRO as an appropriate measure of the patient's voice in cancer care. Patient-reported outcomes (PRO) promise better information on the patient's actual experience in drug trials and treatment, and they are now receiving close attention from regulators, industry, and patient advocates. In May of 2016, inVentiv Health conducted a survey of managed market payers in the United States on the potential value of PRO in the evaluation of drugs. Despite the current focus on PRO including editorials in New England Journal of Medicine, Journal of Clinical Oncology, and JAMA Oncology, those surveyed express overt ambivalence about PRO as a decision-making tool, even in costly, hard-to-treat cancers. The full potential of a drug evaluation model that incorporates insights on the real-life patient experience hangs in the balance. A follow-up roundtable, sponsored by Pharmaceutical Executive, was conducted to discuss the results of this survey in Chicago at the ASCO 2016 Annual Meeting. The discussions there revealed that leaders representing different segments of the industry were disappointed, but not surprised, by the survey results. Patients may not feel the issues that matter to them are acknowledged in the information hierarchy that dominates clinical decisions. Industry builds PRO data instruments with exhaustive patient input and focuses on collecting more than 85% complete data, yet payers feel that this data is spotty, inconsistent, and lacking impact on the costs of care. Thus the onus is on all of those entrusted with the execution of modern clinical trials-including regulators, industry, as well as the patient-to make the case for PRO through greater methodological clarity and better alignment with safety, efficacy, and other data assessment approaches like patient registries. If PRO can be effectively used to fully characterize the impact of new therapies, they will have a greater acceptance in drug evaluation by payers. To learn more or register for this complimentary event, visit Xtalks' website: Patient Centered Strategies for Clinical Trials & Treatment: Reactions to Payer Perspectives on Patient Reported Outcomes. inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment. For more information, visit inVentivHealth.com. Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, health care centers, etc.) turn to Xtalks for access to quality content. Xtalks helps life science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit http://xtalks.com.


Patent
inVentiv Health | Date: 2015-05-11

A computer network system and method for printing accompanying information and prescription labels in pharmacies, comprises: a central CS; a PMS; a data transmission network through which said PMS and said central CS can communicate; wherein said PMS includes an I/O terminal, a scanner, and a first printer; wherein said PMS includes a PMS SO and a Catalina SO; said PMS SO is configured to receive and store prescription information for a prescription, and to associate a prescription identification with said prescription; said Catalina SO is configure to select accompanying information for said prescription, to format and save said accompanying information in an accompanying information print file; and said PMS is configured to print a prescription label for said prescription and said accompanying information print file.


Patent
inVentiv Health | Date: 2014-05-06

The invention provides a network computer system and novel pharmacy printers and their methods of use wherein the local CS includes a pharmacy printer for printing pharmacy orders including prescriptions, and the pharmacy printer includes a pharmacy printer database storing drug information and association of a drug identifier with information about a corresponding drug, and additional information, and obtains and uses instructions for printing the additional information in association with printing of a prescription label from characters contained in a prescription label print file for the prescription label.


Patent
inVentiv Health | Date: 2016-06-29

A computer network system and method for printing accompanying information and prescription labels in pharmacies, comprises: a central CS; a PMS; a data transmission network through which said PMS and said central CS can communicate; wherein said PMS includes an I/O terminal, a scanner, and a first printer; wherein said PMS includes a PMS SO and a Catalina SO; said PMS SO is configured to receive and store prescription information for a prescription, and to associate a prescription identification with said prescription; said Catalina SO is configure to select accompanying information for said prescription, to format and save said accompanying information in an accompanying information print file; and said PMS is configured to print a prescription label for said prescription and said accompanying information print file.

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