Research & Development: Page 80
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PharmaVoice Team/PharmaVoice
Letter from the Editor
PharmaVOICE is delighted to publish the fourth annual special issue featuring 100 of the most inspiring individuals in the life-sciences industry. This issue has become one of my favorites and, from all accounts, one of yours as well. What’s not to love? This issue celebrates the men and women of...
By Taren Grom • July 27, 2008 -
PharmaVoice Team/PharmaVoice
The Mentors
Brian Corvino Mary Lacquaniti Lelia O’Connor Danita Sutton, Ph.D. MENTORING AND SHAPING THE CAREERS OF OTHERS ARE VENERABLE AND ADMIRABLE TALENTS. MENTORING TAKES PATIENCE, FORESIGHT, AND UNSELFISH DEVOTIONTO OTHERS’ SUCCESS and is a skill that is often unheralded — until now. We salute those who...
By PharmaVoice Team • July 24, 2008 -
Explore the Trendline➔
Stock via Getty Images
TrendlineArtificial 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 -
PharmaVoice Team/PharmaVoice
The Technologists
Valdo Arnera, M.D. Bill Byrom, Ph.D. Philip A. Garland Keith Howells Don Schenker Rodney Spady A creative and passionate approach to pioneering new areas of technology applications and new products has enabled Dr. Bill Byrom to engender real improvements in the drug development process. For the p...
By PharmaVoice Team • July 24, 2008 -
PharmaVoice Team/PharmaVoice
The Patient Advocates
The PATIENT ADVOCATES Jon Butko Jaime Cohen Steven V. Edelman, M.D. Linda Kitlinski Kristin Patton Dorothy Smith, Pharm.D. Joseph Tonning, M.D., M.P.H., R.Ph. Meg Walsh Jeanne Zucker The Patient Advocates PATIENT CENTRIC IS AN UNDERSTATEMENT WHEN DESCRIBING THESE INDUSTRY LEADERS. THEY TAKE THEIR...
By PharmaVoice Team • July 24, 2008 -
PharmaVoice Team/PharmaVoice
Intensive QT Trials — "The Not-So-Thorough QT Study"
38 June 20 08 VIEW on Clinical Operations QT TRIALS T he ICH E14 gives guidance regarding the conduct of socalled “Thorough QT Trials (TQT).” While discussions around this guidance occurred well before the final adoption of the doc ument, little was said about classes of drugs where a classic TQT...
By PharmaVoice Team • June 9, 2008 -
PharmaVoice Team/PharmaVoice
Evaluating and Allocating Advertising Budgets: A Sponsor's Responsibility
36 June 20 08 VIEW on Clinical Operations PATIENT RECRUITMENT E valuating and allocating costefficient, yet costeffective advertising bud gets for a patient recruiting campaign is an issue that rarely receives the attention it deserves. A wellplanned budget is absolutely integral to the success o...
By PharmaVoice Team • June 9, 2008 -
PharmaVoice Team/PharmaVoice
Direct-to-Patient Advertising Enhances Study Recruitment
34 June 20 08 VIEW on Clinical Operations PATIENT RECRUITMENT re the needed patients available at the investigator sites? Answer ing this question incorrectly means that the clinical trial will fall short of its goal, and most trials run late due to patient enroll ment issues.The following case s...
By PharmaVoice Team • June 9, 2008 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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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