PharmaVOICE - 
December 2004
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Letter from the Editor
2005 Year In Preview Taren Grom In keeping with PharmaVOICE’s [...]
By

Taren Grom, Editor

On The Cover

Introduction
The Pulse of the Industry By Taren Grom This first annual PharmaVOICE Year in PreVIEW is designed to provide an overview of the challenges and trends expected to impact the life-sciences industry in the coming year and beyond. For this special forum, a distinguished list of more than 100 industry executives, representing an array of [...]
By

Taren Grom, Editor

Features

Innovation
Innovation Drakeman. The engine that drives growth in the pharmaceutical industry is the discovery of new medicines for unmet medical needs. Much of the innovation in development now resides in the biotech sector. The challenge is to find the most efficient and productive ways to combine biotech’s innovation with the pharmaceutical industry’s strengths in research, [...]
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Risk Management
Risk Management Turett. The term risk management implies a defensive, prepare-for-the-worst strategy. While defensive preparation is certainly important, taking a fresh look at conducting business in a “patient-first” manner will reduce the need to implement a defensive approach. In other words, while the doctor is a key customer, the best interests of the person taking [...]
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Technology
Technology Cauwenbergh. Ideally, predictive tools, including assays, computer modeling techniques, and biomarkers could shorten development time, reduce the cost of development, and increase the accuracy of diagnosis, making sure that the right patient gets the right drug because of proper diagnostic tools rather than improper sales and marketing tools. Realistically, these technologies will add a [...]
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Multifunctional Teams
Multifunctional Teams Wilson. Historically, the pharmaceutical industry has faced two hurdles: achieving product registration and securing reimbursement. Today, demonstrating product value is becoming a much stronger issue. It’s not just a matter of product price, but the impact on total cost of care. The needs of marketing are changing, and it is becoming more essential [...]
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Medical Education
Medical Education Nash-Wong. Last year’s predictions on regulatory changes had us believing medical education was a thing of the past. Not so, if one considers the fact that physicians continue to attend educational meetings, despite limited food budgets and a ban on spouses. So rather than forecasting what will change this year, I’ll predict an [...]
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Business Models
Turett. The pharmaceutical industry needs to resolve multiple bipolarities: being a business and being a public utility; being doctor-focused and being consumer-focused; and being about medical innovation and being about marketing. The industry has begun a process of self-reinvention that in 2005 will lead to a period of further self-discovery where the industry will be [...]
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Regulatory
FDA Acts to Strengthen the Safety Program for Marketed Drugs On Nov. 5, 2004, Acting FDA Commissioner Dr. Lester M. Crawford issued the following statement: Modern drugs provide unmistakable and significant health benefits, but experience has shown that the full magnitude of some potential risks have not always emerged during the mandatory clinical trials conducted [...]
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Medicare
Medicare Campbell. Executives will continue to prepare for the new regulations approved under the Medicare Prescription Drug, Improvement and Modernization Act (MMA). These regulations will take effect as scheduled on Jan. 1, 2006. Before the full benefit’s official start, however, the industry faces far more imminent deadlines, which could have a significant impact on the [...]
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Patient Safety
Patient Safety Barrett. Patient safety is a cornerstone of clinical trials. But with the increasing pace of trials, it’s no longer efficient to be reactive; proactive, real-time monitoring can increase the safety of those participating in trials, spotting potential interactions, and flagging common side effects. One of the ways to accomplish these goals is a [...]
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Global Issues
Global Issues Bua. Corporate citizenship in the global society will face increasing pressure to provide innovative pharmaceutical products to third-world countries at a discount and to provide products that have no IP protection in the interest of public health. This will create opportunity losses for pharma, instead of the opportunity gains that could result from [...]
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Salesforces
Salesforces Stern. We are not doing a good job of listening to our customers when it comes to the number and quality of the sales representatives that we employ to sell our drugs to physicians. A 2003 Accel Healthcare study showed that we are letting our customers down; 60% of doctors believed that reps were [...]
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Importation/Price Controls
Importation/Price Controls Nash-Wong. Pharmaceutical price differential in the international markets will be top of mind. So extreme it’s been called a trade deficit; the U.S. market is currently carrying the cost of R&D for the world. This price differential is just adding fuel to the pharma PR fire. How can we successfully argue the value [...]
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CDISC Study Data Tabulation Model
CDISC Study Data Tabulation Model B. Thompson. We are carefully reviewing the new Study Data Tabulation Model (SDTM) to ensure that our company is doing everything possible to streamline submissions of data to the agency. It should be a goal of companies and the agency to find and implement greater efficiencies to shorten the time [...]
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Financing
Kolodny-Hirsch. As a long-time participant in this industry, it is certainly encouraging to finally see that more biotech companies are on the verge of profitability. Nonetheless, there are still hundreds of private and publicly traded biotech firms that are in the red and struggling to survive. This issue is not likely to go away soon [...]
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Drug Development
Drug Development Strong Clinical-Trial Management Systems Market Offers Opportunities for suppliers, Clinical Sponsors, and CROs Alike The U.S. clinical-trial management systems (CTMS) market is poised for steady growth through 2008, achieving a five-year compound annual growth rate (CAGR) of about 13%, a new research study from Life Science Insights reveals. Analysts expect the market for [...]
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Reputation Enhancement
Reputation Enhancement Ahn. The biopharmaceutical industry has blindly relied on the argument that high prices are needed because of increasing research and development costs. Focusing on innovation without discussing access is disingenuous. We risk alienating ourselves precisely when we have so much to contribute to the political and social debate. It is no coincidence that [...]
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Marketing/Promotion
Marketing/Promotion Stern. The great thing about marketing today is that we have more methods to choose from to get our messages out to our customers: patients and healthcare providers. As marketers, though, the challenge is to use the methods in ways that the strengths can be advantageous. It seems clear now that DTC advertising on [...]
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Shareholder Value
Shareholder Value Freedman. The ability to consistently deliver more novel new chemical entities and therapies is a huge challenge but it is the way to increase value for shareholders and patients. Innovative companies, the ones with superior ROIs, seem to be more receptive and willing to adopt the new ideas and methodologies to make R&D [...]
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Intellectual Property
Intellectual Property Shanahan. The ability to codify and share intellectual property (i.e., scientific understanding) can bring the 20% R&D cost closer to 16% to 18% of revenue. The current inability to codify and share is at the root of the following challenges: bringing new drugs and therapies to market in an increasingly regulated environment; accelerating [...]
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Supply Chain
Supply Chain Szwast. Pharmaceutical manufacturers face the challenges of accelerating new product introductions, shifts in global sourcing and distribution, the intensifying need for companies to meet regulatory and customer compliance rules, and enhancing shareholder value. Product introductions are a challenge because new products are frequently a poor fit within a pharmaceutical company’s traditional supply chain. [...]
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