Research & Development: Page 70

PharmaVoice Team/PharmaVoice

On the Calendar

October 15 3rd Leadership Summit on Medicare Enrollment and PDE Data Reconciliation Hilton Old Town, Alexandria, Va. PharmaVOICE subscribers receive $300 discount; register using keycode HYU957. For more information, contact Jodi Bova, Center for Business Intelligence, at 781-939-2563, email jodi...
By PharmaVoice Team • Sept. 30, 2008
PharmaVoice Team/PharmaVoice

E-Media

NEW ELECTRONIC AND WEB BASED APPLICATIONS, SITES, AND TECHNOLOGIES inVentiv Health has relaunched The Rx Law Book, an online library that provides pharmaceutical companies with convenient, centralized access to comprehensive state and federal regulatory information pertaining to product marketing...
By PharmaVoice Team • Sept. 30, 2008
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
PharmaVoice Team/PharmaVoice

What's New

NEW HEALTH CARE RELATED PRODUCTS, SERVICES, AND COMPANIES Julie Kampf has launched Career Central, a consulting firm that provides executive skill building to job seekers ranging from recent college graduates to senior level managers to professionals seeking a second or third career. Career Centr...
By PharmaVoice Team • Sept. 30, 2008
PharmaVoice Team/PharmaVoice

PharmaTrax

Cubist Pharmaceuticals’ Cubicin (daptomycin), the first of the cyclic lipopeptides to gain U.S.market approval, is currently the fastest growing product in the antibiotic class, with 2007 sales surging 53% to $290.4 million. The first oxazolidinone to win U.S.Food and Drug Administration approval...
By PharmaVoice Team • Sept. 30, 2008
PharmaVoice Team/PharmaVoice

Michael Pucci — The Man, The Mission, The Message

BY TAREN GROM He started as one man with a mission five years ago. Today Michael Pucci is inspiring legions as one of the industry’s staunchest advocates as he strives to improve the image of pharma with a message based on science and solid data. MAN THE MISSION THE MESSAGE THE PV0908LayoutFINAL ...
By Taren Grom • Aug. 27, 2008
PharmaVoice Team/PharmaVoice

The Green Movement: Rethinking Chemistry

BY DENISE MYSHKO Major pharmaceutical companies are working together to minimize the environmental impact of how they make their products. The GREEN MOVEMENT Rethinking Chemistry GREEN IS THE NEW BLACK. The push to make prescription drugs more efficient, cleaner, and safer is gaining momentum ami...
By Denise Myshko • Aug. 27, 2008
PharmaVoice Team/PharmaVoice

On the Calendar

4th Integrating Electronic Health Records and eClinical Technologies Conference Baltimore Marriott Waterfront Hotel,Baltimore For more information, contact Jasmaine John, ExL Pharma,at 2124006235, email [email protected], or visit exlpharma.com. September 1516 Biotech Patents Royal Sonesta Hote...
By PharmaVoice Team • Aug. 27, 2008
PharmaVoice Team/PharmaVoice

UpFront

MARKET BUSTERS Global Drug Market to Exceed $1 Trillion According to a new market research report from BCC Research, the global market for pharmaceuticals is expected to reach more than $1.0 trillion in 2013. The 2008 estimated market value is $737.6 billion. The market is broken down into brande...
By PharmaVoice Team • Aug. 27, 2008
PharmaVoice Team/PharmaVoice

Cover

PharmaVOICE PharmaVOICE 100 THE FORUM FOR THE INDUSTRY EXECUTIVE July/August 2008 SPECIAL ISSUE 100 of the Most Inspiring People www.pharmavoice.com Download PDF
By PharmaVoice Team • July 28, 2008
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
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