Research & Development: Page
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Cardiac Safety and Efficacy: An Open Discussion
On Aug. 11, 2006, 16 representatives from ECG core labs located around the world convened in Milwaukee, Wisc., for a one-day meeting with Dr. Norman Stockbridge, Head of the Cardio-Renal Board of the Food and Drug Administration. Topics covered ranged from recent developments instituted by the FD...
By PharmaVoice Team • Jan. 2, 2008 -
On the Calendar
April 15-19 Society for Biomolecular Sciences 13th Annual Conference & Exhibition Palais de Congres de Montreal, Montreal, Canada For more information, contact Marietta Manoni, Society for Biomolecular Sciences, at 203-743-1336, e-mail [email protected], or visit sbsonline.org. April 16-17 ...
By PharmaVoice Team • Jan. 2, 2008 -
Explore the Trendline➔
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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 -
PharmaTrax
Patient Eduction Programs to Grow in Use Patient education has a strong perceived value across multiple sectors of the healthcare industry. This value is expected to grow in 2007, according to results of a survey on patient education conducted by HealthEd. Among key findings of the first annual s...
By PharmaVoice Team • Jan. 2, 2008 -
Table of Contents
Table of Contents April 2007 On the Cover The Evolving Role of the Clinical Project Manager Clinical studies have become more complicated, are multinational, and must adhere to a variety of laws and regulations. As a result, the project manager role has become a core capability needed for drug de...
By PharmaVoice Team • Jan. 2, 2008 -
E-Media
etrials Unveils New Version of EDC Solution etrials Worldwide has unveiled EDC 2.0 solution. Combining more than 10 years of market validation and customer deployments, the newest solution builds upon existing Web-based software as a service (SaaS) solution for collecting, managing, and analyzing...
By PharmaVoice Team • Jan. 2, 2008 -
Raise Your Voice -- Letters
Making Personalized Medicine Understandable Education is Key As William D. Young, CEO of Monogram Bioscience, states in The Age of Personalized Medicine, (PharmaVOICE February 2007), honestly and clearly addressing the concerns of the stakeholders (drug makers, insurance companies, doctors, and p...
By PharmaVoice Team • Jan. 2, 2008 -
DNA-Based Diagnostics: Testing for Personalized Medicine
By Cynthia Borda Theranostic testing There will come a time when genetic testing will be as common in the physician’s office as a blood pressure reading or the use of an MRI. The pharmaceutical industry is making headway in the personalized medicine arena, and diagnostic companies are actively de...
By Cynthia Borda • Jan. 2, 2008 -
Table of Contents
May 2007 Table of Contents On the Cover Pharma’s Commitment to Public Health A natural extension of the industry’s mission of providing safe, lifesaving medicines is participation and sponsorship of myriad public-health initiatives around the world. Features Nanotech Comes of Age With products al...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaOutlet
Contributed by Nancy Smerkanich The U.S. Food and Drug Administration (FDA) called a Part 15 (21 CFR Part 15) hearing on Dec. 18, 2006, primarily as “a listening exercise” to gather information so that the agency could move forward to “an all electronic submission environment and electronic data ...
By Nancy Smerkanich • Jan. 2, 2008 -
Letter from the Editor
If you are feeling downtrodden by the continuing barrage of negative news about our industry, then this issue is the cure for what ails you. This issue showcases dozens of individuals who exemplify the best of the best in terms of their commitment, passion, and conviction to improving the health ...
By Taren Grom • Jan. 2, 2008 -
UpFront
Consumer-Driven Healthcare Retail Primary Care One in 10 retail clinic users is replacing his or her primary-care physician with a retail clinic for the treatment of common ailments, according to a recent study by Market Strategies Inc. The study indicates substantial interest by consumers to rec...
By PharmaVoice Team • Jan. 2, 2008 -
UpFront
PDUFA Update FDA Requests $87.4 million increase The FDA has put before Congress its recommendations for reauthorizing the Prescription Drug User Fee program (PDUFA). If adopted, PDUFA IV — the fourth reauthorization since the program began almost 15 years ago — would significantly broaden and up...
By PharmaVoice Team • Jan. 2, 2008 -
Looking Ahead: The Deficit Reduction Act
A prescription to adopt forward-looking strategies and ensure corporate and regulatory compliance excellence As government healthcare spending increases, Congress, states, and agencies will continue to put cost management and containment on their agendas. Given this reality, it is important to bu...
By PharmaVoice Team • Jan. 2, 2008 -
Table of Contents
Table of Contents March 2007 On the Cover Leadership Development: The Next Generation Industry leaders have to manage a complex and evolving environment. A company’s success will depend on its ability to identify and develop these executives. Features The Making of a Successful Publication Strate...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaOutlet
Overcoming Challenges to the Path to Combination Product Development Combination products have the potential to vastly improve medical care, making treatment more effective and safe, as well as improving compliance for patients. But because of the novelty and complexity of such products, companie...
By Christine Ford • Jan. 2, 2008 -
EDC: Crossing the Chasm
In the figurative but practical language of Silicon Valley marketing guru Geoffrey Moore, the leading EDC companies have “crossed the chasm” from the fluidity of the early adopter market to the more established needs of the mainstream market. This may be the dream of many an EDC company CEO, but ...
By PharmaVoice Team • Jan. 2, 2008 -
Moving Science Forward -- Dr. Russell M. Medford
By Kim Ribbink With a pioneering spirit that has led him to tackle emerging fields of science, Russell M. Medford, M.D., Ph.D., is striving to ensure that AtheroGenics, the company he cofounded in 1993, is creating breakthrough medications for chronic inflammation. March 2007 Entrepreneurial spir...
By Kim Ribbink • Jan. 2, 2008 -
Talent Pool
Pharma POOL Dr. Lou Barbato Tikvah Names VP, Clinical R&D, and Chief Medical Officer Atlanta-based Tikvah Therapeutics has named Lou Barbato, M.D., as VP, clinical research and development, and chief medical officer. Tikvah acquires, develops, and commercializes novel therapeutics related to ...
By PharmaVoice Team • Jan. 2, 2008 -
E-Media
Thomson Scientific Expands Pharmaceutical Regulatory Intelligence Coverage Thomson Scientific announces that three new country modules, India, Israel, and Turkey, are now available in IDRAC, the global pharmaceutical regulatory intelligence database. IDRAC is recognized by regulatory professional...
By PharmaVoice Team • Jan. 2, 2008 -
What's New
CommonHealth Celebrates Opening Of Paris Office The move is designed to allow CommonHealth to broaden its offerings to an increasingly global clientele. CommonHealth has opened an office in Paris. The move is designed to allow CommonHealth to broaden its offerings to an increasingly global client...
By PharmaVoice Team • Jan. 2, 2008 -
On the Calendar
March 15-16 Prescription Drug Pricing InterContinental The Barclay, New York PharmaVOICE subscribers are eligible for a $200 discount; register using priority code 656PHVC. For more information, contact Edward Santelices, American Conference Institute, at 212-352-3220, ext. 239, e-mail e.santelic...
By PharmaVoice Team • Jan. 2, 2008 -
Letter from the Editor
Leadership development is a concern for all executive management teams, no matter the size of their company or their business model. It’s vitally important to have processes in place that foster talent development for the next generation of leaders. The subject of this month’s Forum had been on t...
By Taren Grom • Jan. 2, 2008 -
UpFront
Movers & Shakers HBA Honorees Woman of the Year, Honorable Mentor, and Star Volunteer Meryl Zausner, VP and CFO of Novartis Oncology, has been named as 2007 Woman of the Year by The Healthcare Businesswomen’s Association. Ms. Zausner was a founding member of the Novartis Oncology global busin...
By PharmaVoice Team • Jan. 2, 2008 -
Raise Your Voice -- Letters
Site Value I think most agree the PI/coordinator/patient relationship is key to enrollment and most importantly retention. Therefore PROs should be viewed in the context of their value added to each site that agrees to participate in a study as opposed to being viewed as an added value to the stu...
By PharmaVoice Team • Jan. 2, 2008 -
CME: Measuring the Impact
By Denise Myshko Outcomes assessment of continuing education can help determine whether there is a change in participants’ knowledge and performance. March 2007 Barbara Winkelman CME LLC Over time, there is going to be a change in how CME is delivered and how outcomes are measured; there will be ...
By Denise Myshko • Jan. 2, 2008