Policy & Regulation: Page 29
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PharmaVoice Team/PharmaVoice
PharmaOutlet
FDA Draft Guidance Impact on the E-PRO Industry Contributed by Dr. Richard Piazza As some treatment effects are only known to the subject enrolled in a study, patient-reported outcome (PRO) measures have become a common metric in determining treatment efficacy and safety in clinical trials. Advan...
By Dr. Richard Piazza • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Stepping Up to Challenges Across the Board -- Theresa Kane Musser
Stepping Up to Challenges Across the Board For every idea and opinion, there are contrary points of view; this give and take is what feeds innovation, propels scientific thinking and discovery, and creates rounded, well-adjusted teams and companies. It’s a perspective that Theresa Kane Musser emb...
By Kim Ribbink • Jan. 2, 2008 -
Explore the Trendline➔
Stock via Getty Images
TrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
PharmaVoice Team/PharmaVoice
PharmaOutlet
Contributed by Donna Lee Yesner Donna Lee Yesner talks about the Medicaid rebate program. On Feb. 8, 2006, President Bush signed the Deficit Reduction Act (DRA) into law. Title VI imposes changes to the formula for state reimbursement of prescription drugs and changes to the Medicaid rebate progr...
By Donna Lee Yesner • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
PharmaTrax
Genomics Will Drive Drug Development Once clear, unambiguous pathways and procedures are laid out, genomic applications will blaze a path through the clinic, the physicians’ offices, and eventually into the hands of consumers, says Mike Goodman, General Manager of CHA Advances Reports. Mike Goodm...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Meeting the Needs of Patients with Rare Diseases
Incentives designed to bring drugs to the market to treat rare diseases have been successful, yielding 280 products, but there are still many patients without adequate treatment. The National Institutes of Health Office of Rare Diseases (ORD) lists more than 6,000 rare diseases affecting an estim...
By Cynthia Borda • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
A Rising Tide for Clinical Services
A Rising Tide for Clinical Services By Daniel Limbach June 2006 VIEW on Clinical Services Contract drug-development expenditures were $19 billion in 2005 and are expected to increase at an annual rate of 17%, eventually exceeding $42 billio...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Meet the R&D Leaders
By Denise Myshko Executives charged with R&D responsibilities within biotech and pharmaceutical organizations, both large and small, face myriad opportunities and challenges. Drug development is a costly and risky business. The pharmaceutical industry is challenged by many factors related to ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
UpFront
Office Visits — The Doctor Is In Docs Want More from Rep Calls Pfizer, Novartis, and GlaxoSmithKline have been identified as three companies whose sales reps are doing the best job of meeting the needs of physicians, but a TNS Healthcare study finds that there is room for improvement across the b...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
What's New
Ventiv Health Changes Name to Reflect Broader Capabilities Rebranding initiative integrates inChord nomenclature to more clearly communicate services. Ventiv Health Inc. has changed its corporate brand name to inVentiv Health as part of a rebranding initiative that began when Ventiv acquired inCh...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Combination Products: Drugs and Devices
The possibilities are endless. Emerging drug-delivery technologies and smarter drug-development strategies are providing a one-two punch for researchers and marketers who envision scientific advancements that could span multiple therapeutic categories. By Denise Myshko In the broadest sense, phar...
By Denise Myshko • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
E-Media
New Electronic and Web-based Applications, Sites, and Technologies DataLabs Launches Products to Enhance e-CDM DataLabs has released DataLabs Clinical, a single data-management system that unifies the functionality of paper data entry (PDE) with the flexibility of electronic data capture (EDC). D...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Table of Contents
On the Cover Drugs in the real world There is an increasing need for more information about prescription drugs once they are approved and available to the larger marketplace. Phase IV studies have become important vehicles for postapproval risk-management and drug-safety assessment. Features The ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Raise Your Voice -- Letters
Damn the Torpedoes, Full Speed Ahead Recent calls from academic ivory towers to end pharmaceutical and device company collaboration with doctors and medical centers are stupefying and potentially dangerous. Stupefying because pharmaceutical companies are often a patient’s best ally against pain, ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Phase IV studies appear to be the hottest thing in clinical research. More and more companies are fulfilling their regulatory commitments, more CROs are benefitting from the outsourced programs, and physicians have additional avenues for bolstering their resumes. But what about the patients — you...
By Taren Grom • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
PharmaTrax
Sales, Marketing, and R&D Trends from Industry Analysts Market for Biochips in Clinical Research Expected to expand As biochip technology makes the transition from bench to bedside in the clinical-trial process, improved patient therapies will result, according to a recent report from Frost &...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Courting Resolution
By Kim Ribbink Product Litigation is Straining the Industry Product litigation has become an onerous fact of life for the pharmaceutical industry. Roughly 50 products are currently under active litigation in the United States, according to various industry sources. Legal experts say it’s not so m...
By Kim Ribbink • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
UpFront
Star Volunteer Sharon Callahan, president of Summit Grey, has been named as the 2006 HBA Star Volunteer by the Healthcare Businesswomen’s Association (HBA). Aside from leading the interactive agency, Ms. Callahan dedicates much of her time to HBA activities. She began her involvement in 1989 and ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Drugs in the Real World
By Denise Myshko A greater regulatory focus on safety means companies are under pressure to provide more information about a prescription drug, as well as about the characteristics of patients, once a product becomes available to the larger marketplace. companies are being asked to provide inform...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
The Salesforce of the Future
With a plethora of obstacles to overcome — from busy doctors to Medicare to reimbursement — the sales rep of the future will not only need knowledge of the product and disease state but will need to be skilled in the art of relationship building and must become a true partner to physicians. By Ki...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
What's New
New Prescription Drug Information Format to Improve Patient Safety The FDA is seeking to reduce the complexity of information on prescription drug labels, making them more useful for physicians and patients. The U.S. Food and Drug Administration (FDA) has unveiled a major revision to the format o...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Prescription for Success in Globalization
Prescription for Success in Globalization VIEW on a common global language Sig Shirodkar, Principal, and Mark Mozeson, Principal and life sciences Practice Leader, both of Archstone Consulting, discuss why designing a set of corporate attributes and standards of behavior is the key to global succ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
PharmaTrax
Regulatory Deficiency is High Among Non-U.S. Clinical Investigators In a sharp reversal of previous trends, good clinical practice (GCP) deficiency rates for non-U.S.-based clinical investigators have surged past the corresponding rates for U.S.-based investigators. This is the finding of The Glo...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
UpFront
Device Trends Source: Booz Allen Hamilton Inc., New York Five Issues Expected to Shape the Industry In 2005, the device industry registered an average 12% growth in sales over 2004, with a few companies growing as much as 25%. Smaller industry players were buoyed by the Medical Device User Fee St...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Table of Contents
On the Cover Bridging the gap between sales and marketing One of the most challenging issues facing sales and marketing departments in life-sciences companies is integrating their internal communications for optimal product messaging. By working at senior levels to create a single vision for sale...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
E-Media
Skyscape Releases Mobile Drug Usage Reference Software Skyscape Inc. has released FamilyRx: AHFS Patient Drug Information, a mobile medical reference that places trusted, up-to-date information on proper medication usage into the hands of patients and their families. FamilyRx is available for use...
By PharmaVoice Team • Jan. 2, 2008
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