Commercialization: Page 71

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    Molecule to Market: A Drug-Development Timeline

    According to the most recent report from the Tufts Center for the Study of Drug Development, it takes about 10 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000 compounds that enter preclinical testing make it to human testing, and of these five...

    By Taren Grom • March 5, 2010
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    Experts

    John C. Andrews, Ph.D. Director of Regulatory Affairs, Americas, Chiltern, a global CRO. For more information, visit chiltern.com. Jerome Bailey. VP, Early Phase Business Center, Omnicare Clinical Research, a full-service CRO with diverse therapeutic expertise and comprehensive clinical service o...

    By PharmaVoice Team • March 4, 2010
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    PostLaunch: A REMS Focus

    According to industry experts, the impact of the updated REMS policy in 2007 has had limited impact on the industry thus far. The FDA was granted expanded authority to require REMS (risk evaluation and mitigation strategies) for new drug applications or for existing drugs where the FDA has determ...

    By Robin Robinson • March 4, 2010
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    Launch: Safety Counts

    Approval is no longer the final step," says Anne Tomalin, president of i3 CanReg. “Companies need to consider the possibility that their product may have to be removed from the market one to two years down the road because a safety signal develops." In addition to collecting data and managing a d...

    By Robin Robinson • March 4, 2010
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    Registration and Launch: The Next Steps of a Long Journey

    The registration and launch phase is evolving like the rest of drug development, and the industry must evolve its practices along with it. One big aha moment for the industry is to understand that data, study reports, and other regulatory documents are not the end, but rather integral parts of th...

    By Robin Robinson • March 4, 2010
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    Phase III: Market Preparation

    How the brand begins to be positioned across the spectrum of medical communications — specifically how the science behind the brand and trial results begin to be discussed at global and local congresses, from interactive and traditional exhibit stands to symposia, from posters to special social e...

    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
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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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    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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    Upfront

    According to industry experts, the impact of the updated REMS policy in 2007 has had limited impact on the industry thus far. The FDA was granted expanded authority to require REMS (risk evaluation and mitigation strategies) for new drug applications or for existing drugs where the FDA has determ...

    By PharmaVoice Team • March 4, 2010
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    Opportunities in Oncology Development

    Advances in cancer research, knowledge, treatment options, and awareness have increased tremendously in the past 25 years. Rates of new diagnoses and deaths from all cancers have declined significantly for men and women overall and for most racial and ethnic populations in the United States, acco...

    By PharmaVoice Team • Jan. 28, 2010
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    Help Wanted: Pharma Bloggers

    Social media specialist positions are growing exponentially — just Google the term to view the jobs that pop up. Many colleges and universities are now offering degrees in how to write, publish, and strategize in this new media field. Hospitals, clinics, and other healthcare organizations have en...

    By Robin Robinson • Jan. 26, 2010
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    A 360-Degree View of E-Patient Connections

    Healthcare information technology has created the platform for the exchange, collection, and documentation of health data and information, but it is up to the crucial players — patients, physicians, pharma companies, and service providers — to make e-connections work. The patient, the physician, ...

    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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    What's New

    New Healthcare-related Products, Services, and Companies Featured Briefs: Pharma Industry ­Veteran Launches Online ­Recruitment Site FlightPath Enables Interactive ­Commercialization Planning Expanded SDI Media Services Measure Pharma Ad Campaign ROI New Team Aligns Parexel Experts With ­Biopharm...

    By PharmaVoice Team • Jan. 25, 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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    Upfront

    Honors and Awards G&A Receives ­Recognition The Rx Club presented Goble & Associates (G&A) with nine Awards of Excellence for a variety of ad campaigns, sales aids, launch campaigns, patient education brochures, and Web sites. In addition, G&A received two Gold and five Silver Awa...

    By PharmaVoice Team • Jan. 25, 2010
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    Brand Champions

    The role of the is being played by branding companies, advertising agencies,by the companies that are in charge of producing materials and giving strategic advice to pharmaceutical companies.There are few companies that have a brand champion. Vince Parry TOO OFTEN BRANDING IS MISTAKEN FOR AN ADVE...

    By PharmaVoice Team • Jan. 18, 2010
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    No Pain, Big Gain

    Daily injections are a painful way of life for an estimated 3.7 mil lion Americans who are insulin dependent diabetics. The condi tion, characterized by high blood sugar levels that result from defects in the body’s ability to produce and/or use insulin, is the fifth leading cause of death by dis...

    By PharmaVoice Team • Jan. 18, 2010
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    The Patient Pipeline

    CLINICAL TRIAL RECRUITMENT AND ENROLLMENT EFFORTS ARE OFTEN NOT GIVEN HIGH PRIORITY, causing costly delays in the develop ment of new drugs. Unfortunately, there are no quick fixes, but companies are beginning to institute wellthought out and designed processes to bring the right patients to the ...

    By PharmaVoice Team • Jan. 18, 2010
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    Talent Pool

    Pharma POOL Mark BOOTH Takeda Pharmaceuticals North America Names President Takeda Pharmaceuticals North America Inc. (TPNA), a wholly owned subsidiary of Takeda Chemical Industries Ltd., has restructured its senior executive team and named Mark Booth president. Mr. Booth, an 18year veteran of th...

    By PharmaVoice Team • Jan. 14, 2010