September 2009

Letter from the Editor

September 23, 2009

A target-rich environment

REMS Take Hold

August 24, 2009

The new legislation surrounding tougher REMS requirements is expected to effect marketing as well as drug development— but the impact might not be all bad. Risk Evaluation and Mitigation Strategies REMS Take Hold BY ROBIN ROBINSON “The key to mitigating risk is applying a rigorous, science-based approach to understanding how physicians and patients actually use […]

DIA Recap

August 24, 2009

The 2009 DIA Annual Conference San Diego Played Host to the 45th Anual Drug Information Association Meeting Thought Leaders Raise Their VOICE at DIA EDITOR’S TAKE VIDEO CLIPS pharmavoice.com Aureus Research Consultants Alicia Pouncey Alicia discusses using medical simulation for CRA training. Bioclinica Mark Weinstein Mark talks about the intersection of medical imaging and electronic […]

The Knowledge Revolution

August 24, 2009

In 20 to 25 years, pharmaceutical research and development will be multidimensional. Scientists will use artificial intelligence and robotics and interact through a global networked Web. Modeling and simulations that work at different levels, including digital models of “virtual patients,” will be common. These simulations will speed experimentation and help predict safety and efficacy of […]

Recognizing the Value of CME

August 24, 2009

SPONSOR: Medscape LLC, an accredited provider of continuing medical education. In 2008, Medscape LLC issued 5.2 million CME/CE certificates. www.medscapecme.comReferences: Accreditation Council for Continuing Medical Education. ACCME Annual Report Data 2004-2008. Available at http://www.accme.org/dir_docs/doc_upload/207fa8e2-bdbe-47f8-9b65-52477f9faade_uploaddocument.pdf. Accessed August 4, 2009. SPONSOR: Medscape LLC, an accredited provider of continuing medical education. In 2008, Medscape LLC issued 5.2 million […]

Adult Distance Learning in Promotional Education Programs

August 24, 2009

ProCom, part of CommonHealth Adult Distance Learning in Promotional Education Programs Karen Sullivan Editor/Writer, ProCom, part of CommonHealth Michael Zilligen General Manager, ProCom, part of CommonHealth Healthcare practitioners (HCPs) are constantly looking for the most current medical information, but are short on time to acquire it. With the advent of the Internet, medical education developers […]

Increased Regulation and Mature Web Technology: Fertile Ground for a New Generation of Clinical Opinion Leader Engagements

August 24, 2009

Mary Manna Anderson President, HLS, part of CommonHealth A heightened interest and concern about conflicts of interest between physicians and industry has led to increased federal, state and institution guidelines designed to monitor, and in some cases, limit, clinicians’ interactions with industry. These guidelines are a catalyst for industry to reassess approaches to engaging thought […]

View on Med Ed: The Devil is in the Details

August 24, 2009

The Devil is in the Details The ongoing effort by accreditation and monitoring groups to separate commercial interests from continuing medical education (CME) funding appears to be raising as many questions as answers. by Carolyn Gretton It has been a year since Pfizer rocked the CME sector by announcing it would no longer fund physician […]

Jeff George: Stamping a Brand on Generics

August 24, 2009

Stamping a BRAND on GENERICS BY KIM RIBBINK Leading a generics company today is a very different undertaking compared with a few years ago. Once considered interlopers in the pharmaceutical industry, generics companies are now big business and are playing a leading role in healthcare decision making. And Sandoz, a Novartis company, is one of […]

Patient Recruitment: Strategies for Multinational Studies

August 21, 2009

Finding appropriate study subjects is still one of the biggest stumbling blocks for timely and efficient drug development. Recruiting patients for multinational trials can be even more daunting, since global trials add to the complexity. While experts say some issues are no longer an obstacle — such as technology infrastructure or finding trained investigators in […]

What is the Business Case for Tweeting?

August 21, 2009

As of August 2009, only 18 pharmaceutical companies were using Twitter, only a few of those were actively Tweeting, and only one encompassed a branded effort. Johnson & Johnson has been the most active, with daily Tweets from Director, Media Relations Marc Monseau and Director, Video Communications Rob Halper. Novo Nordisk was the first pharma […]

Last Word

August 21, 2009

Making the Connection How does the diversity program alliance between Centocor and the University of Michigan align with J&J’s overarching diversity programs? Barbosa: Within Centocor, as well as across Johnson & Johnson, there are fundamental principles that define the company and how we work. The first is a deep passion for drug discovery and development; […]

Talent Pool

August 21, 2009

talent pool executive appointments and promotions in the healthcare industry Pharmaceutical POOL Dr. Ann MILLER Steven SEMBLER Eisai Appoints Two Senior VPs Eisai Inc. has expanded its leadership roster with the hiring of two senior VPs. Ann Miller, M.D., joins Eisai as senior VP, primary care and specialty business unit. Dr. Miller has more than […]

PharmaTrax

August 21, 2009

Biopharma Firms Increasingly Seek Marketing Role in Licensing Deals Large pharmaceutical companies’ growing reliance on alliances and in-licensing to gain access to technologies and new molecular entities from biopharmaceutical firms has strengthened the bargaining position for firms offering these assets. As a result, according to research from Business Insights, licensing deals are becoming more complex […]

E-Media

August 21, 2009

New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: M|C Communications Partners with Accela on Interactive Video Programming KMR Group Adds Site-Level Module to Patient Enrollment System Moonbay Technology Enters Life-Sciences Industry with EDM System ParagonRx Website Includes Hub for Assisting in FDA Compliance Sparta Systems Adds Clinical Quality Management Tool Sidebar: E-upgrades and […]

What’s New

August 21, 2009

New healthcare-related products, services, and companies FDA Anticounterfeiting Draft Focuses on Chemical Identifiers The FDA has issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers of solid oral dosage forms, which include pills and capsules, to make drug products more difficult to duplicate by counterfeiters and […]

UpFront

August 20, 2009

FDA Vision 6-part Plan to Support Public Health Commissioner of Food and Drugs Margaret A. Hamburg, M.D., has outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations. She highlighted six initial steps designed to hone the effectiveness and timeliness of the FDA’s regulatory […]

Letter from the Editor

August 20, 2009

A Cautionary Tale Commissioner of Food and Drugs Margaret A. Hamburg, M.D., who was confirmed May 18, 2009, by a unanimous Senate voice vote, recently outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations. In a statement to a group of industry representatives, […]

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