Research & Development: Page 81


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    Flexibility & Agility The New Outsourcing Paradigm

    32 June 20 08 VIEW on Clinical Operations OUTSOURCING I t’s no secret that outsourcing processes are constantly changing based on industry needs and regulatory require ments. Additionally, workflow reengineering is occurring in every corner of the industry, from the FDA to the top 20 global bioph...

    By PharmaVoice Team • June 9, 2008
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    A Prescription for Change

    30 June 20 08 VIEW on Clinical Operations OUTSOURCING everaging pharmacy outreach services in clinical operations can improve the overall study life cycle by adding value and precision to a sponsor’s milestones. Companies can use an evidencebased resources enabling the study team to make advantag...

    By PharmaVoice Team • June 9, 2008
  • Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
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    The "Glocalisation" of Patient Recruitment & Retention

    28 June 20 08 VIEW on Clinical Operations GLOBAL TRIALS T here’s a new twist on globalization. It’s called “glo calisation” — a combination of thinking globally and acting locally. And, it’s changing how patient recruit ment and retention literature needs to be devel oped. To meet this need, new ...

    By PharmaVoice Team • June 9, 2008
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    Power of Site

    26 June 20 08 VIEW on Clinical Operations ECLINICAL T wo down, one to go. Electronic patient reported outcome (ePRO) solutions and electronic data capture (EDC) systems have replaced untrustworthy paper processes for data collection at patients’ homes and clinical sites, respectively. Most questi...

    By PharmaVoice Team • June 9, 2008
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    The New Frontier: EDC and eProtocol, the Clinical Process Gets Even Smarter

    24 June 20 08 VIEW on Clinical Operations ECLINICAL W hen life sciences companies in the previous millennium tried to figure out how the application of IT could help them save time and money in their clinical development processes, electronic data capture (EDC) and clinical data management (CDM) ...

    By PharmaVoice Team • June 9, 2008
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    Intelligent Trials: A New Approach or an Oxymoron?

    20 June 20 08 VIEW on Clinical Operations CLINICAL TRIALS I s the industry ready to change its long entrenched and inefficient approach to implementing clinical trials? We think so. We’ll leave the good science to the scientists, however, the time is here to drop the rhetoric and apply smarter st...

    By PharmaVoice Team • June 9, 2008
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    Letter from the Editor

    ing to Mr. Getz, and the rise in protocol complexity represents a significant challenge for drug developers. The Tufts CSDD study, which quantified the impact of changes in protocol design on clinicaltrial performance, found that: . The annual growth rate of unique pro cedures per protocol grew 6...

    By PharmaVoice Team • June 9, 2008
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    Keeping Pace with Changes in Clinical Operations

    Managing the Challenges The challenges facing today’s clinical operations director are many, including accurately measur ing siteperformance,managing partner relation ships,andovercomingthecommunications barriers between clinical and data operations. Our experts discuss these and other hurdles th...

    By Robin Robinson • May 29, 2008
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    ACRP 2008 Wrap Up

    ACRP 2008 Global Conference & Exhibition — Boston,April 2529 4 11 12 1 2 7 9 A record crowd of about 3,000 people attended the Association of Clinical Research Professionals (ACRP) 2008 Global Conference & Exhibition in Boston in April. Held in conjunction with the Academy of Pharmaceutic...

    By PharmaVoice Team • May 28, 2008
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    Shifting the Long-term Care Dynamic

    Managed MARKETS Big payer changes have been taking place in the long-term care arena as a result of the introduction of Medicare Part D. Before 2006, the pri marypayers in longtermcarewere the state Med icaid plans. Now, multiple payers are covering patients, and insurance companies in particular...

    By Denise Myshko • May 28, 2008
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    Matt Emmens — Driving Success

    In the engine room of a company, leaders and internal experts conceptualize and form direction. The decisions they make determine a company’s success rate. It’s in this capacity that Matt Emmens takes a lead. He knows how to diagnose what’s wrong with the engine and how to get all the components ...

    By Kim Ribbink • May 27, 2008
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    A Growing Community of Good Citizens, Part II

    SPECIAL FEATURE # CITIZENS PHILANTHROPY HAS BECOME PART AND PARCEL OF CORPORATE LIFE IN MANY NATIONS.FOR SOME COMPANIES IN THE LIFESCIENCES, HOWEVER,THERE IS A GROWING DESIRE TO TAKE THAT ONE STEP FURTHERWITH GRASSROOTSVOLUNTEERISM. Last month, PharmaVOICE told its readers about some of the remar...

    By Kim Ribbink • May 27, 2008
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    Last Word

    Michelle GadsdenWilliams is VP and Global Head of Diversity and Inclusion at Novartis Pharma AG.She was one of 75 women honored for her accomplishments at the 2005 Tribute to Women in Industry (TWIN) Gala, Harvard’s 2008 BMF Businesswoman of the Year, the Rainbow Push Coalition’s Bridge Builder A...

    By PharmaVoice Team • May 27, 2008
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    PharmaTrax

    As patients live longer and are increasingly diagnosed with chronic and often debilitating ailments, pharmaceutical decisionmakers find themselves examining ways to adapt their organizations to address the resulting healthcare needs in both human and business terms. According to the report, the p...

    By PharmaVoice Team • May 27, 2008
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    17th Annual Partnerships with CROs

    17th Annual Partnerships with CROs Hundreds of clinical development and outsourcing professionals gathered in Las Vegas for the annual conference. Attendees were treated to a packed lineup of workshops, tracks, and keynote addresses covering the hot topics in clinical research and development. .E...

    By PharmaVoice Team • April 30, 2008
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    Dr. Bob Sliskovic — A Quest for Discovery

    keeps scientists like Dr. Sliskovic in search of the next great compound. “The anticipation of success is an extreme ly powerful stimulant,” he says. “I’ve watched scientists receive the cruelest blows in terms of having a pet compound die, but the next morning they would be back and raring to go...

    By Kim Ribbink • April 30, 2008
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    On the Calendar

    ONTHE CALENDAR May 1516 13th Annual Pharmaceutical &Biotech Licensing &Deal Making Summit Hyatt Regency NewBrunswick,New Brunswick,N.J. For more information, contact Cheryl KahanRadhuber,Strategic Research Institute, at 2129670095, email [email protected], or visit srinstitut...

    By PharmaVoice Team • April 29, 2008
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    E-Media

    NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES eDrugSearch has unveiled the eDrugSearch.com Community, a social network for Americans seeking safe, lowcost prescrip tion medications online. The Health 2.0 community comple ments eDrugSearch’s specialized search engine for prescr...

    By PharmaVoice Team • April 29, 2008
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    What's New

    NEW HEALTHCARERELATED PRODUCTS, SERVICES, AND COMPANIES Immune Tolerance Institute (ITI), a new nonprofit company, is bringing economies of scale to translational and critical path science to build partnerships with the pharmaceutical and biotech industries, and accelerate the development of new ...

    By PharmaVoice Team • April 29, 2008
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    PharmaTrax

    Expansion in size and number of clinical trials. The increase in clinical trials has been prompted by regulators seeking more extensive study data to validate drug safety. Greater numbers of postmarketing Phase IV studies and a rising level of drug development activity have also contributed to th...

    By PharmaVoice Team • April 29, 2008
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    The Fourth Hurdle: The Call for Pharmacoeconomic Data

    Managed MARKETS What began as a movement by government payers in other parts of the world is now making its mark here in the United States. Pharmacoeconomics — the scientific discipline that compares the value of one pharmaceutical drug to another to assess its value and costeffectiveness — has b...

    By Denise Myshko • April 29, 2008
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    PharmaOutlet

    Study Coordinator A is an early adopter of technology on the cutting edge of the next generation processes who is always eager to try something new. Study Coordinator B is a risk averse, technological laggard who subscribes to the “if it isn’t broken, don’t fix it” mantra. Herein lies one of the ...

    By Gil Kampfer • April 29, 2008
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    UpFront

    SOURCE:CEGEDIMDENDRITE,BEDMINSTER,N.J. DTC ALERT Shift to Physician Offices, Online Programs Cegedim Dendrite’s annual survey indicates DTC marketing is moving away from traditional mass media promotion. According to the survey, almost twothirds of marketers want to see more spending on emerging ...

    By PharmaVoice Team • April 29, 2008
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    Letter from the Editor

    Every month our goal is to feature thought leaders who have the ability to change the course of the industry. This month we exceeded this goal in spades. We are pleased to pay homage to the HBA’s 95 Rising Stars, some of the industry’s brightest and most talented individuals. These executive wome...

    By Taren Grom • April 29, 2008
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    From Scorpion to Cancer

    MOTHER NATURE BUILT IT, MAN IS IMPROVING IT. TransMolecular’s 131 ITM601 is a synthetic version of a peptide from the venom of scorpions combined with a radioactive iodine. In Phase I/II trials to treat glioma,a deadly form of brain cancer, the product can deliver a targeted dose of radiation to ...

    By Denise Myshko • April 25, 2008