Pressemitteilungen zu dem Thema drug development


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PresseMitteilungen zu dem Schlagwort drug development


PAREXEL and CHA Medical Group Partner to Enhance Early Phase Clinical Research in Korea

Collaboration combines best-in-class offerings from CHA and PAREXEL to enhance early phase clinical trials in growing hub for drug development BOSTON, March 13, 2018 - PAREXEL International Corporation, the world''s leading innovator of biopharmaceutical services, today announced an alliance with CHA Medical Group (CHA) to enhance early phase clinical development in Korea. The collaboration is designed to provide biopharmaceutical companies with comprehensive services that leverage PA ...


13.03.2018

Enabling the Next Generation of Pre-Filled Syringes from Design to Manufacturing

SMiexperts and senior industry specialists from Belgium, Finland, France, Japan, United Kingdom and USA. Agenda highlights will include a unique spotlight on feeding back human factors and end user considerations into PFS design with keynotes from Shire, Sanofi Pharmaceuticals, Terumo Pharmaceutical Services and Matchstick. As well as providing attendees with a critical insight from a patient perspective, the session will discuss leveraging performative research, the future of combination prod ...


13.12.2017

Pharmaceutical Companies Poised to Build Infrastructure to Accommodate Real World Evidence, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 11/08/17 -- Real world evidence is poised to play a growing role in drug development during the next three years, but the availability and cost of acquiring data remain key challenges, according to a recently completed study conducted by the .Large pharmaceutical, biotechnology, and contract research organizations plan to increase internal staff dedicated to collection and analysis of real world data by 25% between now and 2020, according to a survey conducted by ...


08.11.2017

Cardiovascular Drug Approval Rate in the U.S. Fell as Development Time Rose, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 09/12/17 -- Although the rate at which investigational drugs received marketing approval in the United States has declined in recent years, the cardiovascular approval rate trailed other drug approvals as a whole, while the time needed to develop cardiovascular drugs rose, according to a recently completed study conducted by the .Approval success rates for cardiovascular compounds fell from about 5.2% for compounds that began clinical testing during 1995-00, to ab ...


12.09.2017

Abuse-Deterrent Opioid Development and Uptake Are Tied to Efficacy and Regulatory/Payer Policies, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 07/13/17 -- Although 10 new opioid products with abuse-deterrent formulations (ADF) have received regulatory approval in the United States, lack of willingness by insurers to reimburse patients for their use is seen as a primary challenge limiting ADF uptake, according to the .According to Tufts CSDD, 96% of all opioid products prescribed in the U.S. in 2015 lacked abuse-deterrent properties, and only four of the 10 opioid products with abuse-deterrent properties ...


13.07.2017

PAREXEL introduces its Connected Journey™ of newly integrated data-driven services to simplify drug development and commercialisation

LONDON, June 19, 2017 – As life science companies increasingly seek to gain insights from diverse data sources to make drug development more efficient and effective, PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, is launching its Connected Journey™ of data-driven services. This newly integrated network, powered by PAREXEL® Analytics capabilities, combines PAREXEL’s technology, processes, and expertise to deliver critical intelligence suppo ...


19.06.2017

Canadian-based Neopharm Labs Completes Acquisition of Boston-Based Averica Discovery Services

MONTREAL, QC and BOSTON, MA -- (Marketwired) -- 11/03/16 -- Neopharm Labs Inc., a leading Quebec-based full-service pharmaceutical testing laboratory, announces its expansion into the United States this morning with the strategic acquisition of Averica Discovery Services Inc. (Averica), a Contract Research Organization (CRO) based in the Greater Boston area with specialized expertise in early stage contract research and analytical development. The addition of Averica to Neopharm Labs'' ...


03.11.2016

Exosome Diagnostics Enters Agreement with Amgen

Cambridge, MA, October 06, 2016 -- Exosome Diagnostics, Inc. has entered into an agreement with Amgen to evaluate the potential to advance drug development with Exosome’s proprietary liquid biopsy diagnostics technology and platform. Under the terms of the agreement, the companies will collaborate to identify a potential liquid biopsy diagnostic. Financial terms of the agreement were not disclosed. Liquid biopsies are effective in advancing therapeutics because of their distinct advantage over ...


06.10.2016

Questex to Launch FierceBiotech Drug Development Forum in Boston

NEWTON, MA -- (Marketwired) -- 08/15/16 -- , a leading global business information and events company, today announced the debut of , which will bring together leading pharmaceutical and biotech professionals for an exclusive discussion about the latest challenges, trends and innovations in drug discovery, research and development.The inaugural event, to be held Sept. 19-21 at the InterContinental Boston, is expected to draw more than 250 industry participants including more than 85 speakers, s ...


15.08.2016

Global Regenerative Medicine Market Is Poised for Strong Growth, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 07/14/16 -- A strong development pipeline for regenerative medicine (RM) therapies aimed at treating a broad range of unmet medical needs signals rapid growth in global RM product sales that could have significant and positive impacts on public health, according to a newly completed analysis by the .Today, there are 640 privately held and publicly traded companies in Europe, Japan, and the U.S. that are actively engaged in developing RM therapies, said Christopher ...


14.07.2016

Joseph Lamendola, Ph.D. Joins YourEncore Regulatory Practice as Senior Vice President

INDIANAPOLIS, IN -- (Marketwired) -- 11/10/15 -- YourEncore (), a company that helps firms in the , and industries solve complex innovation, compliance and productivity challenges announced that Joseph Lamendola, Ph.D., has joined the company as senior vice president of the company''s Regulatory Practice.YourEncore launched the earlier this year, bringing together a group of high-profile pharmaceutical, consumer packaged goods (CPG) and FDA executives and opinion leaders with deep ...


10.11.2015

Insight Genetics Launches Insight RET Screen(TM), a Novel Solution for Biomarker-Driven Lung Cancer

NASHVILLE, TN -- (Marketwired) -- 09/02/15 -- Insight Genetics, Inc. today announced the launch of its Insight RET Screen™, a Clinical Laboratory Improvement Amendments (CLIA)-validated assay available through , that detects oncogenic RET (Rearranged during Transfection) expression in non-small cell lung cancer (NSCLC) patients. The Insight RET Screen is a qPCR assay that detects RET expression driven by chromosomal fusions regardless of the fusion partner.The current standard in diagnostic ass ...


02.09.2015

New Consensus Recommendations Announced for Standardized Imaging Protocol in Brain Tumor Clinical Trials

BOSTON, MA -- (Marketwired) -- 08/13/15 -- The Jumpstarting Brain Tumor Drug Development Coalition (JBTDDC) today announced a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials to help better assess if a new treatment is effective. The coalition''s Brain Tumor Imaging Standardization Steering Committee new standards for acquisition of imaging data in multicenter clinical trials, called the Brain Tumor Imaging Protocol (BTIP), in the advanced ac ...


13.08.2015

YourEncore eBook and Infographic Highlight 10 Trends Shaping the Pharmaceutical Industry

INDIANAPOLIS, IN -- (Marketwired) -- 06/11/15 -- The PDUFA VI renewal cycle (and other regulatory policies), rising development and prescriptions costs, and potential supply chain vulnerabilities are a few of the trends impacting the pharmaceutical industry, according to a new eBook and infographic from YourEncore (), a company that helps firms in the , and industries solve complex innovation, compliance and productivity challenges. ."" eBook details 10 of the most pressing trends t ...


11.06.2015

Highly Satisfied Participants at the Sixth International Drug-Drug Interaction (DDI) Workshop 2015 at Marbach Castle, Germany

The Drug-Drug Interaction Workshop series at Marbach Castle enjoys an unbroken popularity and the number of participants has remained consistently high over the years. The organizers of the DDI Workshop are highly pleased to see that the DDI Workshop is widely recognized and well established. This year the DDI Workshop was fully booked several weeks before the Workshop started. Robert Hermann, member of the organization team, states: “Again the feedback of the participants was very positive and ...


21.05.2015

Personalized Medicine Is Gaining Traction, but Faces Multiple Challenges, Tufts Center for the Study of Drug Development Study Concludes

BOSTON, MA -- (Marketwired) -- 05/14/15 -- While development of personalized medicines has grown since the human genome was first sequenced in 2001, biopharmaceutical sponsors face a number of hurdles that are impeding more rapid market uptake, according to a recently completed study by the .Fourteen years after the human genome was initially sequenced, paving the way for development of personalized medicine, 13% of drugs marketed in the United States today post pharmacogenomic information on t ...


14.05.2015

National Brain Tumor Society''s Annual "Head to the Hill" Lobby Day Draws Record Crowds to Advocate on Behalf of Brain Tumor Community

WASHINGTON, DC -- (Marketwired) -- 05/07/15 -- National Brain Tumor Society, the largest nonprofit dedicated to the brain tumor community in the United States, yesterday rallied more than 200 brain tumor advocates from across the country for its fifth annual "Head to the Hill" advocacy day in Washington, D.C. This year''s Head to the Hill was the largest to date. Advocates from 38 states and the District of Columbia conducted more than 180 meetings with congressional offices ...


07.05.2015

YourEncore Pharmaceutical Regulatory Policy Conference Planned for May 20 in Boston

INDIANAPOLIS, IN -- (Marketwired) -- 05/07/15 -- Pharmaceutical regulatory policy experts will discuss how to prepare for and implement game-changing Food and Drug Administration (FDA) policy initiatives at a conference May 20, 2015, from 8:30 am - 10:30 am EDT, at the . The conference is organized by YourEncore (), a company that helps firms in the , and industries solve complex innovation, compliance and productivity challenges. .will feature a panel of policy insiders and key influencers, ...


07.05.2015

The Sixth International Drug-Drug Interaction (DDI) Workshop at Marbach Castle, Germany 2015 Started Yesterday with More than 80 Experts

The overall objective of the Drug-Drug Interaction Workshop series at Marbach Castle is to improve and disseminate the scientific knowledge about drug-drug interactions (incl. food-drug and herb-drug interactions), to foster their proper preclinical and clinical investigation and communication, thereby improving the safe use of drugs in the light of ageing populations and increasing polypharmaco- therapy. The organizers of the DDI Workshop are highly pleased to see that the DDI Workshop is wid ...


04.05.2015

YourEncore Assembles Top-Level Experts for Regulatory Practice

INDIANAPOLIS, IN -- (Marketwired) -- 04/29/15 -- YourEncore (), a company that helps , and solve complex product development and regulatory challenges, is bringing together a group of high profile pharmaceutical, consumer packaged goods (CPG) and FDA executives and opinion leaders to launch a Regulatory Practice.The YourEncore Regulatory Practice will be comprised of experts who have deep experience running regulatory departments for the world''s largest pharmaceutical companies. In ...


29.04.2015

Biopharma Summit Set for May 12 on Re-Engineering Clinical Trials to Improve Drug Development and Performance

BOSTON, MA -- (Marketwired) -- 04/21/15 -- Responding to the mounting challenges of highly inefficient and costly clinical trials, which have stymied R&D productivity, the Tufts Center for the Study of Drug Development and ICON plc will host a one-day Biopharma Summit May 12 in Washington, DC, to outline innovative approaches and insights to "fixing the clinical trial conundrum.""There is widespread agreement across the pharmaceutical and biotech industry that the clinical tr ...


21.04.2015

Early BTD Projects Offer Lessons for Drug Companies, Tufts Center for the Study of Drug Development Says

BOSTON, MA -- (Marketwired) -- 04/14/15 -- Flexibility and a willingness to learn from each other are key factors that enable drug companies and regulators to engage successfully in development projects that have been accorded breakthrough therapy designation, or BTD, according to R&D executives participating in a roundtable recently hosted by the .Since its launch by the U.S. Food and Drug Administration (FDA) in 2012, the BTD program has been associated with lower total approval and devel ...


14.04.2015

U.S. Biosimilar Approvals Poised to Grow, but Market Uptake Faces Several Challenges, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 03/05/15 -- Biosimilar approvals in the United States are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake, according to a study recently completed by the .A new U.S. regulatory pathway, called 351(k), is widely expected to speed the development and marketing of biosimilars, a process that began early this year with ...


05.03.2015

Sponsors and CROs Implementing New Ways to Better Leverage Investigative Site Relationships, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 01/29/15 -- Improved investigative site relationship use and effectiveness are top objectives in 2015 for pharmaceutical companies and contract research organizations, according to drug industry R&D executives participating in a roundtable recently hosted by the .Drug sponsors and contract research partners said specific strategies that are helping to improve clinical trial performance include soliciting more input from investigative sites to guide study plann ...


29.01.2015

High Turnover and Protocol Noncompliance Continue to Plague the Global Investigative Site Landscape, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 01/15/15 -- Global clinical trial performance and efficiency are hampered by high turnover and noncompliance among principal investigators and wide variation in investigative site experience, according to a recently completed assessment by the .While the number of investigators globally now stands at nearly 40,000, a record, half of them were new to the job in 2013, the most recent year for which data are available, according to Tufts CSDD. In addition, although t ...


15.01.2015

Drug Sponsors Challenged to Contain Health Care Costs While Boosting Productivity, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 01/08/15 -- Drug developers will implement strategies over the next year to improve clinical study performance to help control R&D costs and boost overall productivity, while increasing their focus on the development of cost-effective therapies that can help lower health care spending, according to the ."The key challenge for drug sponsors, policy makers, and payers is to balance the need for new, innovative medicines with the equally pressing need to bri ...


08.01.2015

The sixth International Drug-Drug Interaction (DDI) Workshop at Marbach Castle, Germany will take place in May 2015

The overall objective of the Drug-Drug Interaction Workshop series at Marbach Castle is to improve and disseminate the scientific knowledge about drug-drug interactions (incl. food-drug and herb-drug interactions), to foster their proper preclinical and clinical investigation and communication, thereby improving the safe use of drugs in the light of ageing populations and increasing polypharmaco- therapy. The DDI Workshop series started in May/June 2010 as an initiative of a group of internat ...


19.12.2014

Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 11/18/14 -- Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development.The $2,558 million figure per approved compound is based on estimated:Average out-of-pocket cost of $1,395 millionTime costs (expected returns that investors forego while a drug is in development) of $1,163 millionEstimated ...


18.11.2014

ADVISORY - Tufts CSDD to Disclose Cost of Developing a New Drug at Nov. 18 Briefing

BOSTON, MA -- (Marketwired) -- 11/10/14 --Tufts Center for the Study of Drug Development, Tufts University, Boston, Mass.Press briefing at which Tufts CSDD will present results of its latest study, updating the total average cost of developing a new prescription drug.The Tufts CSDD estimate is the number that industry, governments, payers, and others depend on for strategic planning and formulation of prescription drug policy.Invited to attend the briefing. Please register in advance by emailing ...


10.11.2014

CNS Drugs Take Longer to Develop and Have Lower Success Rates Than Other Drugs, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 11/04/14 -- Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are less than half as likely to obtain marketing approval than other drugs, according to a newly completed study by the Tufts Center for the Study of Drug Development.Mean clinical development time for CNS drugs approved for marketing in the United States from 1999 through 2013 was 12.8 months, or 18%, longer than for non-CNS compounds, according to Tufts ...


04.11.2014

Drug Companies Outline Ways Strategic Partnerships Can Boost Innovation, Tufts Center for the Study of Drug Development Reports

BOSTON, MA -- (Marketwired) -- 10/09/14 -- Strategic relationships between drug developers and contract research organizations (CROs) are generating innovative approaches to clinical trial design and execution, but creating lasting value for both parties requires them to act in new ways, R&D executives from the pharmaceutical and biotech industry said at a gathering recently hosted by the ."Despite the fact that a growing number of developers and CROs have now had three to five years o ...


09.10.2014

The International Drug-Drug Interaction (DDI) Workshop at Marbach Castle, Germany is celebrating its fifth anniversary

On May 25th the fifth DDI Workshop started with come together activities and a come together dinner. Today and tomorrow four scientific sessions are focused on drug interactions involving regulatory aspects of drug-drug interactions (US FDA draft guideline, Japanese PMDA draft guideline), herb-drug and food-drug interactions, and drug-drug interactions involving drug transporters. It’s the first time that herb-drug and food-drug interactions will be addressed in detail. Robert Hermann, member ...


26.05.2014

Biotech Products in Big Pharma Clinical Pipelines Have Grown Dramatically According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 11/14/13 -- The pharmaceutical industry, especially Big Pharma, has dramatically shifted its R&D focus from its historical concentration on small molecule drugs to include a rapidly increasing number of biotechnology products, according to a newly completed analysis from the Tufts Center for the Study of Drug Development.Tufts CSDD found that biotech products, which accounted for only 7% of revenue generated by the 10 top selling pharmaceutical-biotech product ...


14.11.2013

Biotech Products Dominate Clinical Trial Pipelines and Sales of Big Pharma, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 11/14/13 -- The pharmaceutical industry, especially Big Pharma, has dramatically shifted its R&D focus from its historical concentration on small molecule drugs to today's dominant focus on biotechnology products, according to a newly completed analysis from the Tufts Center for the Study of Drug Development.Tufts CSDD found that biotech products, which accounted for only 7% of revenue generated by the 10 top selling pharmaceutical-biotech products worldw ...


14.11.2013

Drug Sponsors and Their External Service Partners Say Adjusting Relationship Models Offers a Path to Greater Performance and Efficiency, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 10/08/13 -- While drug sponsor use of strategic relationships with contract service providers has increased dramatically during the past five years, improvements in clinical trial efficiency has fallen short, suggesting that both parties need to better align practices, processes, and systems, according to leaders from the research-based drug industry, recently convened by the Tufts Center for the Study of Drug Development to discuss the issue."Sponsors and CR ...


08.10.2013

Clinical Study Failures Vary Widely by Phase of Study and Therapeutic Class, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 09/10/13 -- While lack of commercial viability is the leading cause of Phase I failures for new drug candidates, efficacy issues dominate as the reason for Phase II failures, according to a new analysis from the Tufts Center for the Study of Drug Development.Based on a study of products that entered clinical development from 2000 through 2009, Tufts CSDD found that commercial reasons accounted for 40.9% of all Phase I failures, but only 27.3% of Phase II failures. ...


10.09.2013

Global Companion Biomarker Market to Catapult to $319 Million by 2018

NEW YORK, NY -- (Marketwired) -- 08/15/13 -- TriMarkPublications.com cites in its newly published " in Drug Development" report that the global market will catapult to $319 million by 2018. For more information, visit: .can be categorized into four main therapeutic areas: oncology, cardiovascular, neurology and autoimmune. Oncology is the largest segment, commanding 30% of the market. Market opportunities for are focused in drug development targets, drug development efficacy and cli ...


15.08.2013

ISCTM Tackles De-Risking Phase 3 Investments in CNS Drug Development

PHILADELPHIA, PA -- (Marketwired) -- 08/13/13 -- Over the past several years, R&D investment has been moving out of CNS drug development and into disease areas with simpler human biology and genetics, which offer greater promise for the identification of relevant targets and the advancement of specific pharmacological therapies. Since R&D funding, even in some of the largest pharmaceutical companies, is limited and competition for dollars can be intense, many companies have shifted thei ...


13.08.2013

Drug Industry Leaders See Collaboration as Key to Greater Productivity, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 08/13/13 -- Responding to a widely shared need to improve the probability of R&D success, leaders from the research-based drug industry, recently convened by the Tufts Center for the Study of Drug Development, agreed that collaboration holds strong promise for improving the rate at which much needed medicines can be developed and brought to market."Nearly everyone involved in drug development, including pharmaceutical and biotech companies, contract resea ...


13.08.2013

AMC Health Taps Michael J. O'Brien to Head Newly Formed Clinical Trials Division

NEW YORK, NY -- (Marketwired) -- 07/29/13 -- , a leading provider of end-to-end telehealth solutions, today announced the appointment of Michael J. O'Brien as President of its Clinical Trials Division, signaling the company's commitment to expand telemonitoring into broader areas of healthcare. O'Brien will leverage his 30 years of broad-based C-suite experience in the life sciences and information technology industries to build upon AMC Health's success and meet the surging ...


29.07.2013

Number of Annual New Drug Approvals to Treat Neglected Diseases Has Nearly Doubled Between the Early-2000s and 2009-12, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 07/11/13 -- The annual number of new drug approvals worldwide to treat neglected diseases has nearly doubled in recent years, with HIV/AIDS and malaria drugs accounting for 60 percent of the most recent approvals, according to a newly completed analysis from the Tufts Center for the Study of Drug Development.From 2000 to 2008, an average of 2.6 new drug products -- including new molecular entities, vaccines, indications, combinations, and formulations -- were appr ...


11.07.2013

China Investing Billions in Bid to Catch Up With Western Pharma

BOSTON, MA -- (Marketwired) -- 07/11/13 -- China's biomedical sector is rapidly transforming itself from a manufacturing base to an innovation hub, investing billions of dollars and setting up innovation centers in a bid to catch up with the west by the end of the 12th Five-Year Plan, according to .The R&D investments -- reaching a cumulative $160 billion last year and close to surpassing Japan's spending -- are paying off with exponential increases in pharmaceutical-related paten ...


11.07.2013

Clinical Success Rates for New Cancer Drugs Doubled From the Mid-1990s to Early-2000s, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 05/07/13 -- Clinical success rates for new cancer drugs doubled between the mid-1990s to the early 2000s, while the number of new cancer drugs entering clinical testing increased 50 percent during the same time, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.Clinical success rates -- which reflect the share of investigational new compounds entering clinical testing that eventually obtain marketing approval from th ...


07.05.2013

New Protocol Design Approaches Will Improve Clinical Trial Performance and Efficiency, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwired) -- 04/09/13 -- Growing protocol complexity -- responsible for longer clinical study times, greater difficulty in recruiting volunteers, and rising drug development costs -- is spurring new approaches to optimizing protocol design, according to leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.A key challenge for drug developers is to design protocols -- plans detailing the methodology of a clinical s ...


09.04.2013

ICRC-Weyer Joins CDISC®, Expands Data Management

As part of a continuous growth process, ICRC-Weyer has added further members to its data management team enabling the company to meet the increasing demand for a complete range of services for phase I-IV clinical trials as well as post-marketing studies. In addition, the company has recently joined the Clinical Data Interchange Standards Consortium (CDISC®) on a gold-level membership. For several years now, the company has been working compliant to CDISC® standards in data management and biost ...


26.03.2013

Investigative Site Landscape Remains Highly Fragmented as the Number of Active Investigators Worldwide Reaches an All-Time High, According to the Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 03/12/13 -- More than half of all clinical trials worldwide that are regulated by the U.S. Food and Drug Administration (FDA) were conducted by independent, community-based principal investigators, as opposed to universities, hospitals, and government clinics, with the number of active principal investigations reaching a record high, according to a newly completed analysis from the Tufts Center for the Study of Drug Development.Whereas the proportion of community-b ...


12.03.2013

Nature Publishing Group Releases Open-Access Article Containing Next Generation Epigenetics Drug Target Dashboard Powered by Relay Technology Management

CAMBRIDGE, MA -- (Marketwire) -- 02/01/13 -- Relay Technology Management Inc. is pleased to announce that a series of six articles featuring Relay Innovation Engine-powered interactive dashboards will be published open-access in Nature Reviews Drug Discovery. The first article, which was published this morning, features Relay's Epigenetics Drug Target Explorer interactive dashboard. Its publication marks the start of a new era in interactive scientific research exploration, offering reader ...


01.02.2013

Companion Diagnostics, Key to Development of Personalized Medicines, Face Hurdles, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 01/24/13 -- Companion diagnostics, which are central to the creation of personalized medicines, have captured the interest of many drug companies, but face a number of hurdles that could impede development, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development.Still mostly in the early stages of development, companion diagnostics -- tests linked to a therapeutic medicine that he ...


24.01.2013

New Research From Tufts Center for the Study of Drug Development Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices

BOSTON, MA -- (Marketwire) -- 01/15/13 -- While nine out of 10 clinical trials worldwide meet their patient enrollment goals, reaching those targets typically means that drug developers need to nearly double their original timelines, according to new research from the Tufts Center for the Study of Drug Development, benchmarking patient recruitment and retention practices.Tufts CSDD said its recent analysis, based on more than 150 clinical studies involving nearly 16,000 sites, will help clinica ...


15.01.2013

Drug Developers Need to More Fully Identify and Address Root Causes of R&D Inefficiency, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 01/08/13 -- While patent expirations on many top selling medicines are spurring the research-based drug industry to embrace new development paradigms to replenish sparse R&D pipelines, drug developers need to more fully identify and address root causes of R&D inefficiency, according to the Tufts Center for the Study of Drug Development."Many companies are taking steps to improve clinical success rates and reduce the cost of new product development, inc ...


08.01.2013

Extraneous Data Collected in Clinical Trials Cost Drug Developers $4 Billion to $6 Billion Annually, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 11/06/12 -- One out of every five procedures performed during later stage clinical trials collects extraneous data and costs drug developers more than $1 million per trial, a newly completed study by the Tufts Center for the Study of Drug Development has found.According to Tufts CSDD, 18 percent of a typical clinical trial budget, or $1.1 million, is spent on direct costs to administer procedures for supplementary secondary, tertiary, and exploratory endpoints.&quo ...


06.11.2012

Contract Support and Technical Service Providers Expected to Play a Growing Role in Drug Development, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 10/17/12 -- Drug sponsors and their contract service providers are using more sophisticated, integrated, and coordinated relationship structures to deliver greater speed and efficiency, a trend that is expected to accelerate, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development."Sponsors are adopting relationships with their technical and support service providers much the ...


17.10.2012

Relay Technology Management Taps Marc Krellestein as Its Chief Technology Officer

CAMBRIDGE, MA -- (Marketwire) -- 10/11/12 -- Relay Technology Management, Inc. is pleased to announce the addition of Dr. Marc Krellenstein as Chief Technology Officer. Dr. Krellenstein brings 20+ years of industry leadership in search technology, text mining, and life science applications to Relay's growing technology platform. Dr. Krellenstein was the founder of Lucid Imagination and the former Chief Technology Officer and Vice President of Search and Discovery at Elsevier, and brings ov ...


11.10.2012

Pharma Companies Seek Help With Potentially Toxic Drugs

NEW YORK, NY -- (Marketwire) -- 09/19/12 -- The is an important concern for pharmaceutical manufacturers, as seen with fairly recent scares such as Vioxx, FenPhen and Baycol -- products that seemed to be free of toxicity challenges during testing but caused damage to patients once launched. For many companies, this means considering these issues early, at the discovery stage, and often requires the assistance of an outsourcing company. Kalorama Information projects that there could be a $1.1 ...


19.09.2012

Oncology Drugs Get Faster Approvals Than Non-Oncology Drugs in U.S., but the Opposite Is True in the EU, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 09/05/12 -- Approval times for new oncology drugs in the United States during the last decade were shorter than approval times for non-oncology products, while the reverse was the case in the European Union, according to a study recently completed by the Tufts Center for the Study of Drug Development.For drugs approved by the U.S. Food and Drug Administration from 2002 through 2011, approval times were 10 months shorter for oncology vs. non-oncology drugs. In contr ...


05.09.2012

Drug Companies Are Teaming With Academic Medical Centers to Create New Medicines, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 08/07/12 -- Drug developers are forging new ways to work with academic medical centers to create the next generation of breakthrough medicines, which is changing the way drug companies do science, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development."The research complexities associated with the most challenging diseases and medical conditions means that few companies have ...


07.08.2012

Advinus Therapeutics and P2D Bioscience Enter Into a Research and Development Collaboration for Attention Deficit Hyperactivity Disorder (ADHD)

CINCINNATI, OH and BANGALORE, INDIA -- (Marketwire) -- 07/24/12 -- Advinus Therapeutics Ltd., a drug discovery and development company, and , a CNS-focused specialty pharmaceutical company, announced today the initiation of a research and development collaboration to develop therapies for Attention Deficit Hyperactivity Disorder (ADHD).ADHD is the most commonly diagnosed psychiatric disorder in children, with symptoms continuing into adulthood in up to 50% of cases. Recent estimates show that a ...


24.07.2012

Medpace Welcomes Dr. med Manuela Niewel, MD, PhD as Sr. Medical Director, Oncology, in Europe

CINCINNATI, OH -- (Marketwire) -- 07/18/12 -- Medpace, Inc. today announced the addition of Manuela Niewel, MD, PhD, as a Sr. Medical Director in the area of Oncology. Dr. Niewel is a senior-level medical oncologist, with over 20 years of clinical research experience at prominent clinical research companies specializing in studies for oncologic indications.Dr. Niewel was most recently a Sr. Medical Director Oncology with PharmaNet in Germany. In addition, she has led research teams for both pha ...


18.07.2012

Medpace Completes Construction on a New Clinical Pharmacology Unit -- Expanding Phase I-IIA Clinical Research Capabilities

CINCINNATI, OH -- (Marketwire) -- 07/16/12 -- Medpace, Inc. today announced the opening of the new . The CPU unit will operate at 5355 Medpace Way, Cincinnati, OH. The existing facility in Norwood will close at the conclusion of the move. The new Medpace CPU is a 60,000 square foot state-of-the-art facility doubling the size of the previous CPU -- increasing Medpace's ability to conduct multiple studies with a total of 96 beds for overnight stays. The facility houses a pharmacy, processing ...


16.07.2012

U.S. Cancer Patients Get Faster Access to More Oncology Drugs Than European Patients, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 07/10/12 -- Cancer patients in the United States get faster access to more oncology drugs to treat their disease than patients in Europe, according to a newly completed study by the Tufts Center for the Study of Drug Development.In addition, the study found, new oncology drug approvals in the U.S. outpaced European approvals by 33% between 2000 and 2011."While greater access to more treatment options is definitely a positive for patients in the U.S., it is no ...


10.07.2012

Hepregen Corporation Receives National Science Foundation Grant Under SBIR Phase II-B Program

MEDFORD, MA -- (Marketwire) -- 06/27/12 -- Hepregen Corporation, a leading provider of bioengineered solutions for drug development, announced today that the company has received a grant for $500,000 from the National Science Foundation under the SBIR Phase II-B Program. This latest award, along with a Challenge Grant from the National Institutes of Health (NIH), a Mass Life Science Center Small Business Matching Grant and earlier grant awards, total nearly $3.0M in state and federal non-diluti ...


27.06.2012

Cytomedix Announces Participation at 2012 BIO International Convention

GAITHERSBURG, MD -- (Marketwire) -- 06/19/12 -- Cytomedix, Inc. (OTCBB: CMXI) (OTCQB: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, today announced that Martin P. Rosendale, Chief Executive Officer, will be a panel participant in a breakout session titled, "Patient Centered Drug Development Strategy & Market Opportunity in Major Disease Categories," taking place on Wednesday, ...


19.06.2012

Declining R&D Budgets Drive Outsourcing of Drug Discovery Functions

NEW YORK, NY -- (Marketwire) -- 06/06/12 -- Once an activity kept in-house at global pharmaceutical companies, the discovery of new compounds with a possible pharmacological effect is now increasingly handled by outside firms, according to Kalorama Information. The said that companies are now routinely a number of core functions including clinical trial management, manufacturing, and, increasingly, portions of the process. With R&D expenditures declining, companies seek these services wi ...


06.06.2012

Drug Sponsors' Regulatory Experience Was Mixed During PDUFA IV, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 05/09/12 -- Drug sponsors experienced a mixed regulatory burden under the FDA Amendments Act, which was also the fourth iteration of the Prescription Drug User Fee Act (PDUFA IV), according to new research from the Tufts Center for the Study of Drug Development.The analysis found that, since 2007, the regulatory burden decreased for new drug applications (NDA) and biologics license applications (BLA) approvals, but increased for supplemental new drug applications ( ...


09.05.2012

Drug Companies Are Looking to Shorten Time to Early Clinical Development, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 04/26/12 -- Drug companies looking to increase the efficiency and productivity of their R&D pipelines are turning to a host of techniques and approaches aimed at shortening the time from nonclinical to early clinical development -- with promising results -- according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development."New paradigms for the exploratory phase of drug developmen ...


26.04.2012

Medpace Announces the Addition of Cheri Lindberg, MD, Medical Director, Strengthening Medpace's Therapeutic and Regulatory Expertise in Psychiatry

CINCINNATI, OH -- (Marketwire) -- 04/25/12 -- Medpace, Inc. today announced the addition of Cheri Lindberg MD, as a Medical Director in the area of Psychiatry. Dr. Lindberg is a board certified psychiatrist who has been active in clinical and academic practice. Dr. Lindberg was most recently a Clinical Reviewer with the FDA, Center for Drug Evaluation and Research (CDER). As the newest addition to the Medpace team charged with design and conduct of clinical trials in the central nervous system ...


25.04.2012

Medpace Welcomes Piotr Krzeski, MD, PhD, MFPM, Medical Director Adding Expertise in Gastroenterology

CINCINNATI, OH -- (Marketwire) -- 03/28/12 -- Medpace, Inc. announced the addition of Piotr Krzeski, MD, PhD, MFPM as a Medical Director, adding expertise in gastroenterology clinical research studies. Dr. Krzeski has over 10 years of experience in drug development with global expertise in the design and medical oversight of clinical trials in the area of gastroenterology, cardiology, and rheumatology."An internist with a broad background in pharmaceutical research, Dr. Krzeski is recogni ...


28.03.2012

Medpace Opens an Office in Lyon, France -- Strengthening European Clinical Operations

CINCINNATI, OH -- (Marketwire) -- 03/06/12 -- Medpace, Inc. today announced the opening of a new fully-staffed, clinical operations office in Lyon, France. This addition brings the total number of Medpace offices across Europe to eleven. The office will be led by Patrick Winkler, MBA, MS, Medpace Country Manager, France.The Medpace France location will provide full service capabilities across Europe integrating global studies. The office -- located at: 55 rue Baraban, 69003 Lyon, France -- wil ...


06.03.2012

Drugs to Treat CNS Diseases Take 35% Longer to Develop Than Other Drugs, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 03/06/12 -- Drugs developed to treat central nervous system (CNS) diseases take 35% longer to complete clinical trials and receive regulatory approval compared to other new prescription medicines, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.Between 1996 and 2010, mean clinical-plus-approval phase time for U.S.-approved CNS drugs was 32 months -- or 35% longer than that for non-CNS drugs approved during the same ...


06.03.2012

Drug Company Executives Are Expanding Their Use of Strategic Partnerships, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 01/26/12 -- Pharmaceutical and biopharmaceutical companies, under pressure to increase R&D productivity, are expanding their use of strategic partnerships to bring new drugs to market more quickly and at lower cost, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development."Drug developers know that they need a new business model if they are to thrive in the face of major ...


26.01.2012

Tufts Center for the Study of Drug Development Establishes Workload and Utilization Benchmarks for Global Clinical Research Associates

BOSTON, MA -- (Marketwire) -- 01/17/12 -- The Tufts Center for the Study of Drug Development today announced that it has established the first global benchmark for clinical research associate (CRA) workload and utilization, giving managers insights into improving CRA effectiveness and efficiency.CRAs are based in the field and they are responsible for overseeing and closely monitoring clinical studies conducted by research centers."Over the past 15 years, demands on study monitors have in ...


17.01.2012

Drug Companies Are Taking Steps to Improve R&D Productivity, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 01/05/12 -- Although drug companies are pursuing innovative approaches to increase the pace and reduce the cost of drug development, the greatest advances will come from better coordination with development partners and improved clinical trial design, according to the Tufts Center for the Study of Drug Development."The next few years will show how well the research-based pharmaceutical and biopharmaceutical industry, not just large pharma, has been able to ad ...


05.01.2012

Bioanalytical Systems to Present at LD Micro IV Conference Thursday, December 8, 2011 at 10:30 a.m.

WEST LAFAYETTE, IN -- (Marketwire) -- 12/01/11 -- (NASDAQ: BASI) today announced that Tony Chilton, Chief Executive Officer, will make a presentation at the LD Micro IV Conference on Thursday, December 8, 2011 at 10:30 a.m. PST, Track 3, at the Lux Sunset Bel Air Hotel, Los Angeles, CA. You can contact LD Micro to schedule one-on-one meetings with Mr. Chilton or with Michael Cox, Chief Financial Officer, who will be attending the conference as well.A simultaneous webcast of the slide presentat ...


01.12.2011

Number of Monoclonal Antibody Products in Development Continues to Increase, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 11/08/11 -- Developers are steadily increasing the number of monoclonal antibody products -- known as mAbs -- for which they are initiating clinical studies, extending a trend that began in the 1990s, according to the Tufts Center for the Study of Drug DevelopmentThe number of novel mAbs entering clinical study worldwide annually rose from 19 in 1997 to 53 in 2010, peaking at 54 in 2008, continuing a trend dating back to the mid-1990s when about a dozen mAb candid ...


08.11.2011

Hepregen Corporation and Partners Present Findings at Key Research Meeting

MEDFORD, MA -- (Marketwire) -- 11/02/11 -- At the annual meeting of the International Society for the Study of Xenobiotics (ISSX), and two of its pharmaceutical customers, Boehringer Ingelheim Pharmaceuticals, Inc. and Elan Pharmaceuticals presented new preclinical data in poster presentations that tested Hepregen's proprietary microliver technology platform, , for predicting clearance of drugs which are slowly removed by the liver. Of the commercially available drugs tested, 89 percent w ...


02.11.2011

Drug Companies Are Using Innovative Partnerships to Spur Development, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 10/06/11 -- Responding to strong and growing pressure to reduce development times and increase the output of new medicines, drug companies are engaging in innovative partnerships that are leading to, among other things, more molecular entities entering Phase I trials and shorter study times, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development."Drug developers have gotten ...


06.10.2011

INC Research, LLC Second Quarter 2011 Results of Operations Release Date and Conference Call

NEW YORK, NY -- (Marketwire) -- 08/19/11 -- INC Research, LLC (the "Company"), a leading late stage contract research organization, will conduct a conference call to discuss its second quarter financial results at 11a.m ET on Wednesday, August 24, 2011. The second quarter financial results will also be available on the Company's secure website at the opening of business on Monday, August 22, 2011.To access the financial results and dial-in information for the conference call, a ...


19.08.2011

Growing Regulatory Requirements Worldwide Challenge Drug Developers, According to Tufts Center for the Study of Drug Development

BOSTON, MA -- (Marketwire) -- 08/09/11 -- As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate, according to a panel of leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development."What a company does in one region can very likely affect how regulators treat it elsewhere," sa ...


09.08.2011

Pricing Activities Approach $1 Million Budget to Support Innovative Pharmaceutical Products

RESEARCH TRIANGLE PARK, NC -- (Marketwire) -- 08/04/11 -- The cost to set a price on an innovative drug is nearly $1 million, according to a new study by Cutting Edge Information. Compared to follow-on products, which spend an average $660,000 on pricing activities, companies' investments in innovative drugs are significantly higher.According to "Pharmaceutical Pricing Strategy," the average cost for pricing activities supporting innovative drugs is $974,000 from Phase I through ...


04.08.2011

FierceBiotech Announces Drug Development Forum

WASHINGTON, DC -- (Marketwired) -- 05/11/16 -- FierceBiotech, the most highly regarded media and news outlet in the biotech market, announced today that registration is now open for the FierceBiotech Drug Development Forum (DDF). This multi-day conference with exhibits will take place September 19-21 at the InterContinental Hotel in Boston, Massachusetts. The event will bring together leading pharmaceutical and biotech professionals to discuss and evaluate the latest challenges, trends and inno ...


11.05.2016

ICON Selected by Genomics England to Support the Largest Genome Sequencing Project of Its Kind for Cancer and Rare Diseases

DUBLIN, IRELAND -- (Marketwired) -- 02/25/16 -- (NASDAQ: ICLR), a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that is has been selected by as data management partner for the .A ground-breaking project announced by the British Prime Minister David Cameron in 2012, the 100,000 Genomes Project is sequencing 100,000 whole genomes from 70,000 National Health Service (NHS) cancer and rare disease pati ...


25.02.2016



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