Research & Development: Page 69

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    Phase III Trials: Patient Recruitment and Data Collection

    Two of the biggest bottlenecks in the drug development process, particularly at the Phase III juncture, are patient recruitment and data management. Experts say technology, partnering, and strategic planning can improve Phase III clinical trial efficiency. Phase III: Recruitment ­Technologies Acc...

    By Robin Robinson • March 4, 2010
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    Phase II: Testing Efficacy, Planning for Marketing

    Pharmaceutical companies and their partners are working to address productivity and create efficiency in Phase II development. New types of trial designs, such as adaptive trials, are being considered as solutions to these perennial issues. “There are innovative ways in which biopharmaceutical co...

    By Denise Myshko • March 4, 2010
  • clinical trial diversity Explore the Trendline➔
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    Trendline

    Clinical trial diversity

    As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.

    By PharmaVoice staff
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    Phase I: Patient Recruitment

    According to Peter Smith, Ph.D., senior VP, nonclinical development sciences at Millennium Pharmaceuticals: The Takeda Oncology Company, shortages in funding, manpower, and patient availability have created the proverbial perfect storm in the current clinical trial system. “The fact that traditio...

    By Denise Myshko • March 4, 2010
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    Phase I: From Animals to First-in-Human Studies

    The simple study designs of the past have been replaced with more complex designs with the addition of more screening and study procedures, biomarkers, and pharmacokinetic samples requirements, as well as longer study exposure periods. The trend today is conducting more rigorous, early-phase clin...

    By Denise Myshko • March 4, 2010
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    CROs and Preclinical Development

    To create efficiency and offload the need to maintain staff, instruments, and consumables for irregularly scheduled projects and projects that extend beyond their scope, more labs are engaging CROs as outsourcing partners, according to a recent report by BioInformatics LLC. Thomas Jones, Ph.D., s...

    By Denise Myshko • March 4, 2010
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    Preclinical Development: Linking the Lab to Human Trials

    The challenge of pharmaceutical discovery and development as a whole is that a large number of conditions need to be met in order for a single molecular entity to successfully reach the market, says Thomas Jones, Ph.D., senior director, toxicology and pathology, Eli Lilly and Company. “The molecu...

    By Denise Myshko • March 4, 2010
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    Drug Discovery: From Compound to Product Candidate

    The first step in finding a drug to bring to the clinic is screening chemical compound databases against a protein target. There are several phases that comprise early development, including target identification and validation, hit finding, and lead optimization. Activities during these steps, w...

    By Denise Myshko • March 4, 2010
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    A Long and Winding Road

    In today’s biopharma economy, declining R&D productivity combined with increased development costs have made investment portfolio managers skittish, says Chip Gillooly, VP, capital, at Quintiles. “The risks associated with investments are high, and the lack of output is making everyone nervou...

    By Taren Grom • March 4, 2010
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    Last Word

    Pfizer’s Mark Swindell discusses the ­integration of Wyeth’s vaccine business after the acquisition by Pfizer. As President of Vaccines, Mr. Swindell is helping to create a seamless process for melding the former Wyeth specialty business with Pfizer. One of the stated goals for the combined Pfize...

    By PharmaVoice Team • March 4, 2010
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    Talent Pool

    Pharmaceutical POOL John DUCKER, APP Pharmaceuticals Dr. Julie GERBERDING, Merck Dr. Michael ROSENBLATT, Merck Sean NOLAN, Lundbeck Inc. Derica RICE, Lilly Biotechnology POOL Dr. Mark BAGARAZZI, Inovio Biomedical Hans BISHOP, Dendreon Suzanne CADDEN, ImmunoGen Dr. Thomas HOFSTAETTER, VaxInnate Dr...

    By PharmaVoice Team • March 4, 2010
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    E-media

    New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: Perceptive Informatics Introduces E-Clinical Suite Elsevier Launches Online Resource Center for ARRA Updates Thomson Pharma Database Integrates Trial Protocol, Outcome Info Take Supply Chain Releases Multi-Tenant ...

    By PharmaVoice Team • March 4, 2010
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    What's New

    New Healthcare-related Products, Services, and Companies Featured Briefs: GxP Consulting Adds Statistical Analysis Support Former Wyeth VP Launches Petkus Communications Consultants GlobalHealth Provides Corporate Training, Degree Programs Newly Formed Durata Therapeutics Acquires Pfizer’s Vicuro...

    By PharmaVoice Team • March 4, 2010
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: Process Inefficiencies Cause $11 Billion in Annual Pharma Revenue Leakage Sidebar: Key Findings of Revenue Leakage Study Drug Companies Still Under Pressure to Increase Pace of Development Sidebar: Key Near-Term Trends i...

    By PharmaVoice Team • March 4, 2010
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    Letter from the Editor

    As PharmaVOICE enters its 10th year, the basic premise on which we founded the publication, and the company, remains as true today as it did on that February afternoon back in 2001: there is a fundamental need to understand the life-sciences industry from a holistic perspective that cuts across i...

    By PharmaVoice Team • March 4, 2010
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    Last Word

    Rewarding Performance Procter & Gamble is a recognized leader in ­consumer goods marketing. What, if any, ­learnings from the consumer-goods side of the business did the Prilosec OTC brand team employ in developing this program? Cleveland: Procter & Gamble and the Prilosec OTC new sponsor...

    By PharmaVoice Team • Jan. 26, 2010
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    Talent Pool

    Biotechnology POOL Dr. Paul LAMMERS Mirna Appoints Chief Executive Mirna Therapeutics has named Paul Lammers, M.D., president and CEO. As head of Mirna, Dr. Lammers is responsible for driving the company’s discoveries in the field of microRNA (miRNA) into the clinic. Dr. Lammers was previously pr...

    By PharmaVoice Team • Jan. 26, 2010
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    E-media

    New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: IntraLinks, Adobe ­Collaborate on ­Data-Capture Solutions for Clinical Trials Maestro eLearning ­Creates e-Learning Library Deloitte Recap Helps Biopharma Executives Make Portfolio Decisions Thomson Reuters Unveil...

    By PharmaVoice Team • Jan. 26, 2010
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: Companies Advised to Communicate with Payers Earlier in Drug Development Sidebar: Average Allocation of a Managed ­Markets Department’s Personnel Pharma Companies Add Employer Market to the Mix Sidebar: Employer Programs...

    By PharmaVoice Team • Jan. 25, 2010
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    Letter from the Editor

    In our lifetime… There are few, if any, of us who can say we have been lucky enough to escape the ravaging effects of cancer — be it ourselves, a significant other, family member, or friend. For more years than I care to remember, “a cure for cancer" has been just around the corner. Recently, Pre...

    By Taren Grom • Jan. 25, 2010
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    Dr. Alan E. Guttmacher — In the genes

    AS THE RECENTLY APPOINTED SECOND DEPUTY DIRECTOR OF THE NATIONAL HUMAN GENOME RESEARCH INSTITUTE,THE INSTITUTION RESPONSIBLE FOR LEADING THE HUMAN GENOME PROJECT, DR.ALAN GUTTMACHER’S EXTENSIVE CLINICAL GENETICS BACKGROUND WILL BE INVALUABLE AT A TIME WHEN RESEARCHERS ARE BEGINNING TO TRANSLATE T...

    By Kim Ribbink • Jan. 18, 2010
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    The Package Deal

    PharmaVOICE Container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, pro cessor, packer, or distributor other than the per son or persons who in fact manufactured, pro ce...

    By Elizabeth Pena • Jan. 18, 2010
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    E-Media

    E-MEDIA NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES FDAnews has launched Drug Industry Daily, an electronic daily publication that provides news coverage of what’s happening on Capitol Hill, in the courts, and at the Food and Drug Administration, the Federal Trade Commission...

    By PharmaVoice Team • Jan. 14, 2010
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    What's New

    NEW HEALTHCARERELATED PRODUCTS, SERVICES, AND COMPANIES Doctors+Designers has changed its company name to HealthEd to reflect a change in business strategy focusing on developing patient-centered health education programs. “With noncompliance costing the pharmaceuti cal industry $15 billion to $2...

    By PharmaVoice Team • Jan. 14, 2010
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    PharmaTrax

    SALES, MARKETING, AND R&D TRENDS AFFECTING THE HEALTHCARE INDUSTRY NestEggz Survey Suggests PATIENTS WHO SAVE ON PRESCRIPTIONS TAKE THEIR MEDICATION Almost 90% of cholesterol patients enrolled in NestEggz were found to take their medication daily, almost double the national average.NestEggz,a...

    By PharmaVoice Team • Jan. 14, 2010
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    Dr. Jon Adler — Medicine Man

    Man FROM THE EMERGENCY ROOM TO THE BOARDROOM, Jonathan N. Adler, M.D., is committed to the practice of medicine. As a physician, lecturer, and president and chief medical officer of eMedicine, he balances all endeavors with one goal in mind: fostering better medicine. BY KIM RIBBINK JON Adler Pha...

    By Kim Ribbink • Jan. 14, 2010