BioPharmArena.com

Reps. Rosa DeLauro (D-Conn.) and Jan Schakowsky (D-Ill.) on Wednesday asked FDA to mandate that all prescription drug television advertisements include information for consumers to report serious side effects to the agency, the Los Angeles Times reports.

DeLauro and Schakowsky cited a recent Consumers Union survey that found 16% of respondents had experienced an adverse prescription drug side effect serious enough for them to seek treatment from a physician, but just 35% of respondents were aware that serious side effects could be reported to FDA. In addition, 7% of respondents named FDA as a place where they would report a serious side effect.

FDA monitors adverse events related to prescription and over-the-counter drugs through its MedWatch program. However, FDA officials said that they estimate only about one in 10 adverse events are reported to MedWatch (DuBose, Los Angeles Times, 4/3).

Last summer, Schakowsky co-sponsored an early version of legislation that required all print drug ads to contain reporting information, CQ HealthBeat reports. The measure passed in September 2007 and contained a provision that FDA conduct a study to see if it would be feasible for TV ads to contain similar information (Cooley, CQ HealthBeat, 4/2). The measure required the study to be completed by the end of March. FDA spokesperson Rita Chappelle said the study is still in progress (Los Angeles Times, 4/3). DeLauro has introduced legislation that would prohibit direct-to-consumer ads for new drugs during their first three years on the market to give time for adverse events to be reported before heavy marketing begins. DeLauro noted that spending on prescription drug ads increased from $650 million in 2001 to $1.1 billion in 2005 (CQ HealthBeat, 4/2).

Consumers Union has sent FDA a petition with more than 55,000 signatures requesting the agency require that a toll-free number and a Web site address to be included in TV ads to make it easier for people to report side effects. Chappelle said the agency has received the petition and is reviewing it (Los Angeles Times, 4/3). Comments
DeLauro said FDA “is failing to serve its most vital supervisory responsibility,” adding, “The more we know about serious drug side effects, the more we can do.”

Schakowsky said, “We’re working with and pushing the FDA” to require reporting information, adding, “The interest and signatures from consumers certainly help” (Los Angeles Times, 4/3).

A spokesperson for the Pharmaceutical Research and Manufacturers of America said that the trade group would not take a position on the petition until FDA completes the feasibility study (CQ HealthBeat, 4/2).

The survey is available online (.pdf).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Originally published in MedicalNewsToday.com

Total spending on advertising by the pharmaceutical industry has increased by an average of 10.6% annually since 1996, when a rule change allowed drug companies to advertise directly to consumers, according to a study published on Wednesday in the New England Journal of Medicine, Reuters/Newark Star-Ledger reports.

For the study, Julie Donohue of the University of Pittsburgh Graduate School of Public Health and colleagues analyzed industry data from three market-research firms that track drug industry advertising spending. According to the study, researchers “also obtained information from researchers and staff members at the FDA and other government agencies.”

The study found that overall spending on drug advertising increased from $11.4 billion in 1996 to $29.9 billion in 2005. Direct-to-consumer advertisements, which account for 14% of total advertising spending by the industry, increased by 330% from 1996 to 2005, the study found.

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Medicalnewstoday.com

IBM on Thursday launched an electronic “pedigree” system that will help fight prescription drug counterfeiting using radio-frequency identification tags, the AP/Houston Chronicle reports. The ePedigree system allows drug companies to create electronic certificates of authenticity for drugs and track them through the supply chain and into the hands of consumers. The tags also will keep track of expiration dates, batch numbers to be used in case of a recall and other information.

Chris Clauss, IBM Software’s director of sensor information management, said the RFID tags are not a guarantee against counterfeiting, but they will “raise the bar” and make such activity more difficult. A California law scheduled to take effect in 2009 will mandate that any drug distributed in the state has its pedigree attached, according to the AP/Chronicle. Past attempts to combat fake drugs — including holograms and watermarks — often were illegally “reproduced within months, to the point where brand managers could not tell the difference between the counterfeit and the real thing,” the AP/Chronicle reports (Ortutay, AP/Houston Chronicle, 8/9).

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Medicalnewstoday.com

As patents expire over the next five years for brand-name prescription drugs with more than $60 billion in combined annual sales, some health care experts predict that new generic equivalents will maintain single-digit drug price inflation for U.S. consumers, the New York Times reports. Generic drugs typically are 30% to 80% less expensive than brand-name versions, contain the same active ingredients and are approved by FDA under the same standards as brand-name drugs.

Expiring patent protection for some drugs, such as Sanofi-Aventis‘ sleeping pill Ambien, has been cutting into brand-name manufacturers’ revenue, and several blockbuster drugs are set to face generic competition over the next five years, including Fosamax, a drug that slows bone loss, and the cholesterol-lowering drug Lipitor, the Times reports. Some companies, such as pharmacy benefit manager Express Scripts, and Medicare prescription drug plans are encouraging use of generics by lowering copayments for the drugs versus their brand-name equivalent.

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Medicalnewstoday.com

The Los Angeles Times on Monday featured a series of articles titled “Sold on Drugs” that examines the effect of drug manufacturers’ marketing techniques on physicians and consumers. Summaries appear below.

• “Under the Influence: Savvy Marketing Whets Our Appetite for Prescription Pharmaceuticals. Consumers, Doctors, Researchers — No One Is Immune“: Drug makers “do everything in their considerable power to ensure that their brand-name prescription medications are on the lips of patients and in the minds of physicians every time the two meet across an exam table,” the Times reports. The Times continues, “A growing chorus of critics says their efforts have begun to rewrite the dialogue between patient and doctor, influence physicians’ judgments and open the act of prescribing to forces more profit-minded than sacred” (Healy [1], Los Angeles Times, 8/6).
• “From Funding to Findings: When Drug Companies Conduct Research on New Pharmaceuticals, Outcomes May Be Affected — Greatly“: “[M]edical researchers, academic authorities and influential specialists are key players” in the commercial success of a drug, the Times reports. Drug manufacturers “build a corps of respected university experts who have lengthy experience with a drug prospect, financial ties to the firm that paid them to study it and, often, a direct stake in its success” when the companies form “commercial partnerships with universities, endow academic programs and teaching chairs, and pay academic medical centers to run clinical trials,” according to the Times (Healy [2], Los Angeles Times, 8/6).
• “Doctor, Just a Little Something for You: Complex Sales Strategies Go Way Beyond Freebies“: Drug companies “focus the bulk of their marketing budgets to influence” physician prescribing habits, which “profoundly affect sales of a drug company’s products,” the Times reports. The Times notes that drug makers’ marketing tactics “reach into physicians’ offices, pervade their medical specialty organizations and often shape the messages that doctors receive in educational settings” (Healy [3], Los Angeles Times, 8/6).
• “Next Step: Create the Demand; Direct, Emotional Ads for Prescription Drugs Are Everywhere. But They’re Just One Way To Get to the Consumer“: “With vast and profitable markets up for grabs, drug companies are aggressively reaching beyond doctors and taking their marketing messages directly to consumers,” the Times reports. FDA in 1997 loosened regulation of direct-to-consumer advertising, a change that “set off explosive growth in marketing aimed at a general audience long on interest and — compared with physicians — short on professional skepticism,” according to the Times (Healy [4], Los Angeles Times, 8/6).
• “In Short, Marketing Works: By Targeting Consumers and Doctors — Directly and Indirectly — Drug Makers Are Driving Sales. Why Argue With Success?“: “The pharmaceutical industry defends its promotional spending as a service to science, physicians and patients,” and the ads “also, indisputably, boost sales,” the Times reports. The Times continues, “Physicians see marketing’s effects on their patients every day,” but “ask the doctors whether the marketing influences their clinical judgments or prescribing behavior, and a chill will descend upon the room,” according to researchers who have posed such questions to physicians (Healy [5], Los Angeles Times, 8/6).
• “And Now, a Push for Change: Legislators Have Begun To Question the Drug Industry’s Pervasive Influence in Health Care. Some Doctors Are Backing Them Up“: “In recent years, politicians, consumers and physicians have begun to question sharply the effect of drug makers’ commercial appeals,” the Times reports. “Medical societies and patients groups are quietly debating the wisdom of their dependence on drug companies’ largesse,” and physicians “are rethinking, or at least disclosing, their ties to drug companies,” according to the Times. In addition, lawmakers “are drafting and passing bills aimed at blunting the effects of prescription drug marketing,” the Times reports (Healy [6], Los Angeles Times, 8/6).

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Medicalnewstoday.com

Currently available drugs for the treatment of asthma do not demonstrate the desired outcome and are capable only of managing the symptoms. This situation, together with the increase in disease morbidity and mortality, is underlining the pressing need for improved asthmatic drugs that cure the disease rather than merely reduce its symptoms. Hence, the market is brimming with opportunities for innovative asthma therapies.

New analysis from Frost & Sullivan (http://www.pharma.frost.com) European Asthma Therapeutics Markets, finds that the market earned revenues of $4.90 billion in 2005 and estimates this to reach $9.30 billion in 2013.

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Medicalnewstoday.com

TRAYSS PRIME project management training for young international life science researchers accomplished in Gdansk.

The first TRAYSS PRIME workshop was successfully held during XIII Biotechnology Summer School of Gdansk University and Medical Academy Gdansk. The seminar in Lapino near Gdansk, Poland, was headlined “Project Management A secure way to success”. About 40 young international scientists from the fields of medicine and biotechnology undergraduated and post-graduated students as well as Ph.D. students and professors followed the lectures.

Henner Willnow, TRAYSS PRIME project manager, sums up: “The concept of giving management tools to young scientists in the region works out. The interest and positive words from the audience indicate the high demand for management trainings among young researchers. Moreover, I appreciate their understanding for research project management. Those young researchers are aware of the importance of project management tools to give the daily work in the laboratories more flexibility and more resources for excellent research in the ScanBalt BioRegion.”

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Medicalnewstoday.com

Manhattan Research, a healthcare market research services firm, today announced the leading pharmaceutical product website destinations for physicians from its new physician research study, “ePharma Physician(R) v7.0: The Future of Professional eMarketing.”

Top 10 Pharma Product Websites Among Physicians in 2007 Ranked by Number of U.S. Primary Care Physician Visitors

1. Januvia

2. Singulair

3. Advair

4. Chantix

5. Adderall XR

6. Byetta

7. Gardasil

8. Vytorin

9. Avandia

10. Concerta

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Medicalnewstoday.com

The Business Intelligence firm La Merie S.L. reported that the HMG-CoA-reductase inhibitor atorvastatin remained the no.1 best selling blockbuster drug in 2006 with ww sales of US$ 13.6 bln for Pfizer and Astellas Pharma. Among the TOP 10 blockbuster drugs are four biologics (antibodies and proteins). A total of 114 distinct blockbuster drugs were identified with 2006 sales of more than US$ 1 bln each. Total revenues from sales of all blockbuster drugs in 2006 were US$ 233.7 bln of which 23.1 % were achieved by biologics. The best selling classes of blockbuster drugs were again HMG-Coa-reductase inhibitors of which AstraZeneca’s rosuvastatin showed the highest growth rate with 59 % over the previous year. Among the TOP 10 blockbuster drug classes were three biologics: erythropoietin, anti-TNF and insulin & insulin analogs. Blockbuster drugs were in the product portfolio of 30 biopharmaceutical companies. Pfizer was the leader in the TOP 10 class of blockbuster drug companies with sales of US$ 28.7 bln originating from nine blockbuster drugs. The TOP 10 companies had between four and 12 blockbuster drugs each to generate 2006 sales between US$ 9.4 bln and 28.7 bln per company. These results and more were found in a search conducted by La Merie Business Intelligence and published in a complimentary report on July 6, 2007. The document entitled “Blockbuster Drugs 2006” can be acquired as a free download at La Merie’s News Center and Online Store PipelineReview.com (http://www.pipelinereview.com).

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Medicalnewstoday.com

The San Francisco Chronicle on Sunday examined how biotechnology companies soon could face generic competition under a bipartisan Senate bill (S 1695) proposed by Democrats Edward Kennedy (Mass.) and Hillary Rodham Clinton (N.Y.) and Republicans Orrin Hatch (Utah) and Mike Enzi (Wyo.). Under the legislation, biotech companies would get 12 years of market exclusivity after FDA approval, compared with five years for traditional brand-name medicines.

The Generic Pharmaceutical Association said a 12-year period of market exclusivity is “arbitrary and excessive.” Association CEO Kathleen Jaeger said, “It’s just going to unjustifiably delay access to consumers.”

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Medicalnewstoday.com

- Forecasting key to decision making and business strategies

- Challenges to define forecast measures against diversity in geography and varied time horizons

- Senior Forecasting executives from companies such as Novartis, Nycomed, Solvay and GE Healthcare now signed up to speak at EyeforPharma’s forthcoming Forecasting Excellence Summit.

- The EyeforPharma Pharma Forecasting Excellence Summit USA 2007 will take place in Boston MA, October 25-26th 2007

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Medicalnewstoday.com

The Philadelphia Inquirer on Sunday examined the competition between Merck and GlaxoSmithKline on the development and marketing of human papillomavirus vaccines (Stark, Philadelphia Inquirer, 7/8).

Merck’s HPV vaccine Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains. FDA in June 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC’s Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine, which is given in a three-shot series (Kaiser Daily Women’s Health Policy Report, 6/26).

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Medicalnewstoday.com

Hugh G. Davis

The price of pharmaceuticals has become a highly volatile issue, particularly in the United States where many consumers, over the past few years, have been alarmed to find that the prices of drugs, manufactured largely by U.S. companies, are consistently higher in the U.S. than in other industrialized countries. Shareholders of a number of pharmaceutical companies have developed resolutions that would reign in drug prices for retail customers.

Recent studies found that eight antidepressants and anti-psychotic drugs cost, on average, twice as much in the U.S. as in Canada or the European Union. The high prices of prescription drugs hit the elderly and underinsured hardest, due to a pricing structure that favors large health management organizations and government agencies.

Religious institutional shareholders, including religious-based health-care providers, sponsored shareholder resolutions with ten companies for this proxy season concerning their drug pricing policies. The coalition is administered by the Interfaith Center on Corporate Responsibility (ICCR), a shareholder advocacy organization of 275 religious and other institutions representing $100 billion in assets.

Concern about the high price of prescriptions for those who are un-insured or under-insured are what inspired the ICCR to support these resolutions, as it was widely publicized that people were having to choose between food or other necessities and needed drugs.

This is not the first time drug companies have been challenged for their pricing policies, but it has been a few years since the last attempts, between 1993 and 1995. A handful of resolutions came to a vote, such as with Upjohn and Johnson & Johnson, but most of them were withdrawn when the shareholders were satisfied with concessions from the companies.

Unfortunately, shareholders are no longer appearing to be satisfied with corporate attempts to placate them. With U.S. spending on prescription drugs rising 12 percent per year, more than double the 5.1 increase in national health expenditures, concerned shareholders are again bringing drug companies to the bargaining table.

In 1994, shareholders won a major precedent when the Securities Exchange Commission (SEC) decided that drug pricing could not be omitted by the company on the grounds that it was “ordinary business.” In 2000, the filers won another major victory when the SEC decided in their favor on an issue of misleading information raised by two companies.

Bristol-Meyers Squibb Co. and Warner-Lambert Co. challenged the resolutions’ wording of the 12 percent rise in drug spending, citing other factors such as increased consumer activity or increased number of products that could account for the rise. But the SEC allowed the resolutions to stand, contingent on minor changes in the text, bolstering the legitimacy of the issues raised in them.

Several of the drug pricing resolutions are part of an ongoing dialogue between shareholders and company management at many large pharma companies. None of these companies has shown to be positioned to make concessions on the shareholders requests, although some of them cited their patient assistance programs and the management of Merck at least agreed that there was a problem.

In 2000, shareholders withdrew their drug pricing resolution with Pfizer, due to demonstrated moderation in price changes and a public forum on their commitment to fair pricing policy. The company indicated an average price increase of 2.5 percent for 2000, and subsequent years have also been relatively low.

The renewed attention to unfair drug pricing policy is a fitting subject for socially responsible shareholder advocacy, and a significant step toward a more humane society. It remains to be seen how broad shareholder support is on the issue verses their financial interests.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh G. Davis

The pharmaceutical industry has spent billions on its web presence since the mid 1990s. Many did so because “everyone else had a web presence” and they wanted to go one better. It could almost be described as an online manifestation of the herd instinct, with decision-makers prepared to invest huge sums in the hope of a profitable return on investment.

The “money is no object” mentality still existed as recently as three or four years ago, but lately web investment has been severely cut back, with some companies only prepared to invest relatively small sums, sticking to a perfunctory annual update of basic web information. In fact, it is now believed that pharma companies are increasingly failing to effectively manage their web presence. As a result, a number of websites are being scrapped instead of refreshed. With more people than ever, both patients and in the healthcare professions, seeking information on the internet, companies are passing up on the opportunity to communicate effectively.

Around 30 per cent of health seekers visit pharmaceutical-sponsored websites - far more than most pharma firms think. Health and drugs/medical-related websites are the most popular on the internet. And with the balance of power in the healthcare sector shifting towards the consumer it is vital that the industry focuses on its web presence, where information is paramount.

The web environment is changing rapidly. Increased bandwidth (Broadband, ADSL, ISDN, cable modems) has meant bigger and better internet connections for consumers and healthcare professionals - all key customers.

Global expansion of the internet is also a huge factor for the pharmaceutical industry, with the Third World rapidly coming online. We are looking at the true globalization of information - the key currency of all websites. With increased bandwidth comes more “media rich” information. Even three or four years ago websites were text rich, but now video and high quality sound is readily available online. Modern websites use graphics much more widely, and even animation, to convey information in a more effective way.

A pharma company’s website is the first impression many people have of the company - and you never get a second chance to make a first impression. It represents the image, presence and key brand offering for your organization. It is also the reflection of your image - how you see yourself and how others see you.

Most pharmaceutical companies are simply anonymous to their customers. They buy brands like Aspirin or Colgate rather than corporate images from the big pharma companies. Even healthcare professionals tend to know them mainly through their representatives. They are effectively non-brands.

Enter a typical pharmaceutical website and what do you get? Options to go to treatment areas: click here, and what response do you get? Responses are at best variable and at worst non-existent. Customers are much less tolerant of poor service on the net than mail requests. So, for instance, while a customer is happy to wait a week or even a fortnight for a mail response to an enquiry, an internet response is demanded almost immediately - or at least within a day or so.

Research has suggested that pharma is one of the culprits when it comes to responding to enquiries made through their websites. It is important that the contact people make with pharma companies via the web is memorable for the right reasons. Your website is often the only contact many people have with your company.
In terms of good practice online, a few pharma companies recognize the need to give quality information to their audience. Broader issues need to be addressed, rather than plugging specific drugs and therapies. If the customer shows interest in certain areas - provide information in that area. It sounds simple, but more often than not, this is not happening. It is important to remember that your web presence, both good and bad, speaks volumes about:

You and your business
How you treat your customers
The quality of your communications.

Many marketers forget that their web presence is an extension of their brand. Companies invest billions on establishing their brand, and then neglect to spend resources on maintaining the manifestation of that brand online.

The quality of your offering should be reflected in the quality of your web presence. These days there, is no excuse for not having a luxury class or designer website to reflect a blue chip, expensively nurtured, brand. Pharma companies have been cutting back on their web investment drastically. A yearly update is about the limit many are prepared to invest in. What many people forget is that what’s happening offline should be reflected online. If a customer sees a newspaper cutting about a certain therapy or drug, he or she should be able to see that online. If you can go to a conference organized by a pharmaceutical company, you should be able to see this reflected online. We are talking integration, not isolation. But all this needs significant time, effort and investment.

Expect innovation…

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh G. Davis

Project management is a continuously evolving discipline. In spite of these changes and advances in project management skills and technology, however, the fundamental benefit remains the same. Project management helps your international organization respond faster to sponsors, accomplish its strategic goals, and recognize a return on investment. Being aware of the following essential concepts in project management will help you keep things in perspective in a world where everyone seems to have a new Project Management solution:

Project management is inclusive, not exclusive.
Project management used to be the exclusive domain of a privileged few with the skills and experience to succeed. Today everyone is a project management consumer, and many are assuming the role of project management — some by design, some by accident. Since not everyone is schooled in the techniques and obfuscation traditionally associated with project management, tools are rapidly being simplified, streamlined, and customized to support each person’s role on projects — whether they are a project sponsor, manager of key project resources, purchasing or contracting specialist, or assigned to do project-related work.
Project management is also the vehicle through which stakeholders are made aware of their assignments, interfaces, and progress. Project management must reach outside of an organization to vendors, suppliers, designers, subcontractors, to the client, and to the ever-curious public.

Project management is peer-to-peer, not top down.
Peer-to-peer project management invites participation from the very people assigned to do the work; after all, who knows better how long something will take than the resources themselves. This peer-to-peer model removes the middleman from decision-making. Project teams respond more quickly to self-identified project opportunities and threats, thereby keeping the project on schedule. Information rolls up so managers can focus on resolving conflicting priorities and resource bottlenecks.

Project management is collaborative, not hierarchical.
Project-team collaboration is the most important factor in minimizing project risks, maximizing project quality, and eliminating wasteful efforts and unnecessary rework. Since the majority of projects rely on teams that are not co-located, project management creates touch points for soliciting input and consensus throughout the project lifecycle.
Rather than enforce a rigid, hierarchical flow of information that slows down decision-making, project management enables internal and external project team members to collaborate beyond simply coordinating calendars and circulating project-based e-mail. Project management exposes relevant project information to others involved in the project, using workflow rules and routings to ensure all have access to information they need to accomplish their work better.

Project management is cooperative, not adversarial.
Two opposite examples of teams existing as virtual companies only to accomplish the project is demonstrated in both the biopharmaceutical industry construction industry where many independent skills sets need to be brought together. The people in these industries are generally independent and highly motivated. They each have their own profit motivations and may actually be competitors. This cooperation is essential for getting the project done better, faster, and cheaper. They must cooperate, not fight. They must learn to trust each other, sharing information that once was “theirs and theirs alone” in order to distribute the burden of project complexity and risk.

Project management raises the visibility of project risks, issues, and decisions for the mutual good of the project and its participants. Physicians, administrators, contractors and managers must work together to do the right things correctly the first time on behalf of their customer, the sponsor. The ascendance of design/build for project delivery proves this.

Project management is enterprise-wide, not standalone.
There isn’t a CEO alive who wouldn’t like to know what projects are underway in the organization, or to be able to evaluate the impacts of accelerating one project ahead of another. No CFO would be permitted to manage the business’ finances in the same standalone, disconnected, unrepeatable fashion that projects are often managed.
With an enterprise-wide perspective, executives can truly understand the health of their business and the ripple effects of their strategic project decisions. This enterprise-wide insight can only come from maintaining all of the projects within a centralized system, with a company-wide project structure — the project management “chart of accounts” — to facilitate this cross-project analysis.

Project management is portfolio management, not catch-all management.
Once a company has a handle on all of the projects that are underway or in the pipeline, it is in a position to decide effectively which of the many new project opportunities will compliment the project portfolio. Project management enables companies to determine which projects can be accomplished with the resources that are available (or that can be hired), which will provide the greatest payback given the opportunity and the investment the company is willing to make, and which combination of projects best achieves their strategic objectives within the required timeframe.

Successful projects don’t happen by themselves. However, your success rate is bound to go up because project management prevents you from inaugurating projects that are likely to fail or are poorly defined. It helps you increase speed of project delivery and efficiency of project execution. Project management helps you capture best practices so every project is more successful than the last one. It even bridges the gap between you and the other project participants so everyone is on the same page and working toward the same goals.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh G. Davis
What qualifications are required to be a team? What are the differences between a group of people and a team? And what strategies can a leader adopt to nurture the transformation from groups into teams? As you will see in this session, international teams in the biopharmaceutical industry are becoming the norm, rather than the exception. The following tips will assist you in forming international teams:

Develop Common Goals and Vision
Unless a common goal is held for a given venture and each individual holds the one vision of the shared destination, the journey will be confusing and the travellers hobbled. Lacking direction, such a group will fragment as energies are spent in moving against each other rather than as a team.
To create common goals and vision, consider the following strategies:
With your team members, individually record your perception of the team’s common goals and vision, then consider the differing perceptions you detect. This will provide a simple measure of the degree to which your team shares common goals and visions.
In developing common goals and visions, start by asking what goals and visions (which are also desirable for the organization) the team members can get truly passionate about. In an increasingly competitive world, only those destinations passionately sought will ever be reached.
Ensure the team members are clear on the distinction between their common ‘goals’ and their individual ‘roles’. We can share the same goal and vision, but take on differing roles in a collaborative venture. The captain of a steam ship and the stoker share the same destination, but perform vastly different tasks along the journey. Ask your team members to express their individual role in terms that articulate how that role contributes to the common goals and vision.
When setting collaborative goals, consider both a ‘benchmark’ goal and a ’stretch’ goal. The former can be defined as ‘the minimum we will accept from ourselves as professionals’, while the latter could be described as a ‘reach for the stars’ goal and should carry significant uncertainty as to its achievability. This will allow a team to keep energized and strive for improvement even beyond perceived limitations.

Value and Harness Diversity
The diversity of people on a team can be its greatest asset or its greatest threat. The determining factors will be the team’s ability to understand diversity, value it, and manage it. Diversity harnessed can be an awesome engine for achieving high goals. As a team leader, consider the following strategies:
Undertake a team survey that highlights the diverse work styles and roles within your team. Use the data to draw a ‘team map’ that clarifies which preferences and roles are well-represented and which are not. Ask your team to take an outside perspective on the ‘team map’ - what strategic advice would they give to themselves in developing the team further? Excellent instruments for this exercise exist and include the well used Myers Briggs Personality Type Inventory.
Target ‘understanding and managing diversity’ in your team’s training and development schedule.
When it comes to diversity, lead by example. If you do not value and are not seen to value diversity in your people, your team members certainly will not.

Foster Effective Communication
Most of our communication energy is expended on telling others what we need them to hear when we need them to hear it. Effective communication requires us to balance this with what they need to hear from us, and when they need to hear it. As a team leader, consider the following strategies:
Formulate a survey of satisfaction ratings on different forms and directions of communication within your team. Use the data to target aspects of communication that have the greatest potential for improvement. Avoid embarrassment by telling people why you are doing it!
Encourage paraphrasing as a strategy to enhance active listening.
Try to finish conversations with the question “Is there anything else you want to talk about?” to provide opportunities for others to ask about what they need to hear.
While many factors will make a team better, common goals and vision, the ability to harness diversity and the mastery of communication will be key differences between a group and a team.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh Davis
The giving of gifts to physicians as a promotional strategy is an aspect of pharmaceutical promotion that bears mentioning. Gifts to physicians from pharmaceutical companies are common and controversial. Although relationships between the industry and the medical community have resulted in important benefits for patient care, in recent years, however, many troubling practices have occurred. As a consequence the appropriateness of some of the gifts that are given to physicians by companies in the pharmaceutical and medical equipment industries has been questioned.

It is important to first distinguish between the different types of gifts that are generally provided because not all types of gifts will always cause inappropriate effects or consequences.

In the medical-pharmaceutical sector there’s a strong competition between equivalent or similar drugs. Pharmaceutical companies therefore try to persuade physicians about their products and try to establish a ‘tie of confidence’ between them and the physicians by means of a system of incentives via the principle of reciprocity, ‘do ut des’.

Generally, gift-giving practices can be subdivided in three main categories:

The first group consists of a whole range of small gifts, pecuniary advantages or benefits in kind. Some of them are small and inexpensive gifts such as ballpoint pens, penlights, note pads, coffee mugs, diaries, calendars, puzzles, etc. … upon which is often printed the name of the company or one of its products. Sometimes more valuable gifts are offered, such as subscriptions to (medical) journals, champagne, CD-players, cellular phones, stethoscopes, fax-machines, radios, camera’s, tickets for cultural, gastronomic or sports events, flights, vouchers or even cash.

Companies also (co-)organize or sponsor medical conferences, or invite physicians to dinners at which presentations are held. They often subsidize the participation, travel and lodging expenses, sometimes even for the participant’s partners. These meetings are typically held at attractive locations, often for a weekend of presentations, meals, recreation and entertainment, all or largely at company expense. It’s also mostly a public secret that some of the speakers at some of these conferences are listed on the pay-roll of the sponsoring drug firm (Often termed a “MOL”, Medical Opinion Leader). When the speakers are selected by the company, there are those who seriously doubt the objectiveness of the presentation, certainly when that speaker is on the pay-roll of that company. Sometimes physicians-attendees receive a fee to compensate for their time. In doing so, the companies indirectly defray the costs of the conference or meeting: the physician will initially have to pay for the meeting, conference or dinner, but afterwards he gets a ‘honorarium for the time spent’, which is nothing more nor less than a disguised compensation for participation, travel and accommodation expenses.
Finally there is the practice of gifts or cash to compensate for the performance of clinical studies. Gift-giving here comes attached with strings: the physician has to set up a study, spend time and energy to the study, has to analyze the results, might have expenses, etc. … Rather than a being profit, the gift here serves the purpose of remuneration.

Gift-giving practices towards physicians provoke heavy discussions between advocates and opponents. For the sake of convenience the arguments in favour of gift-giving practices can also be reduced to three major points.

First of all, according to a liberal vision, gift-giving practices are nothing more nor less than a promotional instrument and promotion is omnipresent in our modern society. The advocates find it inexplicable that such a common attempt to influence consumers is generally accepted, but towards physicians it is deemed to be unethical and even legally prohibited.

Secondly, the advocates claim that acceptance of gift-giving practices towards physicians would not be as a harmful (for health care, for patient care, for society,…) as is often contended by opponents. The advocates claim that there is no high quality scientific evidence that the prescription behavior of physicians is in fact influenced by the gifts from the pharmaceutical industry. They say that physicians are intelligent enough and experienced enough to ensure that patient welfare prevails. The physician has no interest in prescribing an inferior drug to a patient, only because of a pharmaceutical firm’s generosity, since patients will only return if they were carefully treated. There is no evidence that physicians knowingly or intentionally compromise their patients’ care as a result of gifts from industry.

Finally, the advocates believe that we should not lose sight of the fact that many gifts from the industry to physicians result in significant benefits to patients and health care, by serving educational purposes. For example, books and medical conferences contribute to the education of physicians, and meals at medical meetings or conferences provide a forum for colleagues to exchange information.

Opponents on the other hand point out to the specific nature of the profession, of which the key element is the tie of confidence between physician and patient. The profession needs to be distinguished from pure merchandising, since physicians not only enjoy the patient’s confidence, but the confidence of the entire society. Patients should be confident that they are receiving their physicians’ best care, uninfluenced by personal or financial benefits or by the interests of third parties.

But, according to the opponents, it is not only because of the honorable character of the profession, with which commercial principles are hard to combine, that gift-giving practices should be condemned. This strict vision states that even when gifts from the industry have no actual effect on a physician’s prescription behaviour, there might be a public impression of impropriety, especially if the gifts are of substantial value, which might undermine the trust of the public that physicians are above all dedicated to the welfare of their patients. Because of their social role physicians must not only act in an objective manner and be independent of direct or indirect financial incentives, they also must be seen to be independent.

Also, according to the opponents, although there are no published randomized trials to show that gifts have an adverse impact on prescribing there is good observational evidence to show that gifts can influence prescribing. The opponents also claim that gifts may mobilize subtle influences that create social relationships with real obligations. No company gives away its shareholders’ money in an act of disinterested generosity: The industry invests in promotional activities because promotions increase sales. The industry does not intend to offer free lunches that are really free of any obligation.

Pharmaceutical companies expect that by giving presents physicians will be ready to return a favour: the ‘do ut des’-principle, or ‘norm of reciprocity’. The most obvious way to fulfill this ‘social obligation’ is by being more responsive in granting interviews with sales representatives, or by changing prescribing behaviour. The opponents enforce this “social obligation argument” by pointing out at two conclusions of common sense. One is that, if pharmaceutical companies’ investments in gift-giving practices were not efficient, they would be wasting company resources, in which case they would cease these forms of marketing and promotion. The other is the conclusion that physicians remain skeptical towards the so-called ‘generic drugs’: although generics are identical to the brand drugs and are accompanied by guarantees as to their quality, so that there is no ‘reasonable’ argument not to discuss this alternative with the patients. According to recent statistics only 1% of all prescriptions of physicians are for generics.

Since from the point of view of the opponents there is influence on the prescription behaviour of physicians, albeit as a vague social obligation to return a favour, they also draw the attention to the fact that, although physicians are unlikely to knowingly compromise their patients’ care by using inferior drugs, it has indirect negative consequences for the patient as well as for society. The expenses pharmaceutical firms make for their promotional gifts or sponsorships are passed on to the public throughout the price of the drugs. In effect, then, patients may be paying for a benefit that in some cases is captured primarily by their physicians. Combined with the possibility of over-consumption because of altered prescription behaviour of physicians, this may lead to a serious drain on the resources for health care, because of the system of reimbursement. The opponents see this as misuse of public money.

As to the argument that gift-giving also serves educational purposes, either by sponsoring conferences or by giving medical books or journals, opponents rarely deny the need for physicians to receive the broadest possible exposure to new and different health care products nor the need to stay abreast of advances in medicine. They do however have questions about the educational value of some of the organized conferences and of the information published in medical journals. A company that donates funds for a conference may want a role in shaping the program, for instance by selecting speakers from its own panel of experts, selected for their knowledge and experience in the use of the company’s products. When companies schedule speakers that are on their pay-roll, these experts may show bias with regard to use of company’s products, thereby undermining the objectivity and impartiality of the educational event. Also when a meeting is not primarily, in both time and effort, dedicated to scientific presentations, it is difficult to view the meeting as serving a legitimate educational purpose. The same goes for the information (comments, studies, etc. …) concerning medicinal products in medical journals: for a journal to be of value, it must publish authoritative, up-to-date information that is free of commercial influence. Therefore financial associations of authors (often MOLs) should be disclosed so that readers will be cued to the possibility that the published articles were influenced by those financial associations.

Whatever your position on this issue, it is important to keep in perspective the fact that disallowing such practices will only serve to further raise the cost of drugs which will have a direct impact on patient availability.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh Davis

Physicians are facing financial pressure: declining managed care and government reimbursement, coupled with rising malpractice insurance costs, is forcing them to increase their patient loads.

In the U.S. since 1995 the physician population has grown just 15%, according to the American Medical Association (AMA), while over the same period, the number of pharmaceutical reps has grown 94%, to more than 81,000. A recent study found that high-prescribing physicians receive three to five times as many calls from sales reps as they did 10 years ago. This competition for physicians’ time is fierce and a health strategies group study found that only 7% of pharmaceutical rep visits lasted longer than two minutes. Also, half of rep calls last less than two minutes (known as the classic “doorknob detail”), and a full 43% of visits never get past the receptionist with at least 35% of physicians are not seeing pharmaceutical reps at all.

New strategies, intended to complement traditional direct-to-physician tactics, are needed. Efficient alternative channels are now available, and their potential reach and integration with current channels will build a broader, more effective marketing platform for the future.

Physicians have many sources of medical information from which to choose, but the credibility and importance of each varies significantly. AC Nielsen/HCI’s ongoing tracking of the importance of information sources has found that in many cases, pharmaceutical companies have relied heavily on sources that are not rated highly by physicians. Expanding the breadth of communication channels to provide greater physician value and credibility is critical for the future of pharmaceutical marketing.

Potent technologies in point of care e-prescribing (or electronic prescribing) and related integrated drug reference tools are on the verge of becoming the most powerful marketing tools yet devised. These technologies allow marketers to reach physicians at the moment of truth, when physicians are making the prescribing decision.
The use of PDA- and Internet-based practice management and patient care tools has shown a dramatic jump in the last year, jumping from 11% to 16% of physicians using the Internet according to one survey.

While many promising technologies have failed to realize their potential, the momentum behind e-prescribing appears to be virtually unstoppable. The point-of-care e-prescribi ng concept and technology initially gained acceptence as a medical practice tool, and now the other key players in the health care system are recognizing the significant benefits of e-prescribing and are making adoption a priority.

The National Council for Prescription Drug Programs, Inc. (NCPDP), an accredited standards development organization, has established standards for the purpose of transmitting prescription information electronically between prescribers and dispensers. The major pharmacy benefits managers, Merck-Medco , Advance PCS , and Express Scripts , formed RxHub in 2001 to accelerate the adoption of electronic prescribing. The major pharmacists groups, The National Association of Chain Drug Stores (NACDS) and The National Community Pharmacists Associations (NCPA), formed SureScript Systems in 2001 for the same purpose. Even a major employer coalition, Leapfrog Group , is promoting the adoption of electronic prescribing to help reduce medication errors.
A few hurdles still stand in the way. Several U.S. states still do not allow prescriptions to be transmitted electronically, and federal law does not yet allow electronic controlled substance prescriptions. But this fact is likely to change in the face of lobbying, current legislative initiatives, and other pressures. The bottom line is that electronic prescribing is virtually inevitable with such a broad consensus among all the major stakeholders.

Every health care stakeholder receives benefits from e-prescribing. Patients can get more time with their physicians, greater convenience in the prescription process, and, most importantly, improved medication safety. For the pharmacies, the NACDS estimates as much as 30% of pharmacists’ time is spent verifying prescriptions. Productivity cost savings could be dramatic. The accuracy of e-prescribing also reduces prescription errors and liabilities. Payers benefit from improved formulary and treatment protocol compliance.

But it is physicians who have the most to gain from e-prescribing. New e-prescribing applications can reduce medication errors, improve patient satisfaction, and reduce practice costs.

Electronic prescribing systems can have a significant impact on practice and clinical efficiency by dramatically reducing pharmacy call backs and streamlining the prescription renewal process. According to one study, 69% of prescribers say e-prescribing has had a positive impact on improving their overall efficiency; 79% reported e-prescribing has had a beneficial impact on delivering better patient care. The study also found that 16% of physicians currently use e-prescribing, nearly a 50% jump over 2001’s level. An additional 21% of physicians expect to use e-prescribing in the next 18 months, and various estimates have projected an adoption level of greater than 50% by 2005.

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Hugh Davis is a Senior Instructor , Kriger BioPharmaceutical Training Program http://www.kriger.com/training/ , info@kriger.com

Hugh G. Davis

Today’s Internet technologies have radically altered the dynamics of the traditional supply chain in virtually every major industry. But while the pharmaceutical industry has been fairly quick to embrace the efficiencies to be gained from e-procurement initiatives, it is just beginning to explore the potential of sell-side e-business applications. Manufacturers are beginning to look internally to control expenses. The industry is already using procurement technology applications to lower their costs for things like raw materials, but now they’re starting to shift their focus to the sell-side of the supply chain.

Pharmaceutical sales and distribution has changed a lot in the past 20 years. Most of the major manufacturers formerly had a direct detail force and were shipping direct up until the early 1990s. The value was derived from a rich sales and relationship channel, but then, as costs grew with all of these pharmaceutical reps, the pharma manufacturers started moving their reps out of the pharmacies and clinics and started shifting a lot of their distribution over to wholesalers.

Now manufacturers are only working in a direct fashion with the larger chains and major healthcare providers, leaving no one to call on the small pharmacies and clinics. There exists a fragmented population in the marketplace that would likely benefit from the opportunity to reconnect from a content, as well as a direct commerce, perspective.

And that population is a significant one, in terms of sales for manufacturers. This group is thought to represent 75% of the number of buyers, and about 35-40% of the actual revenues.

One strategy is to increase sales in fragmented markets with less than $100 million in annual purchases by reconnecting buyers and manufacturers through web-based tactics. As the relationship is Web-enabled a firm can use this new channel for marketing niche items and categories and focusing on new item launches.

Supply chain synchronization is an even bigger issue than reconnecting with fragmented buyers. The value in this area comes in reduced inventory carrying costs and a stronger predictability of workflow through the manufacturing and distribution practices. However, with 80% of the volume in the U.S. flowing through four large wholesalers, who make 70% of their profits by speculating against price increases, it causes a game of cat and mouse between the large manufacturers and the wholesalers. The manufacturers want increased visibility of the process, and the wholesalers aren’t willing to give that up.

One school of thought contends that an independent trading exchange is the answer to the industry’s sell-side supply chain challenges. A firm by the name of Channel Link instituted such a public marketplace, which became operational in the past year. The marketplace allows buyer and sellers to come together in a common, neutral area where the access to product details and pricing are completely controlled by the manufacturer. The marketplace platform leverages existing manufacturer messaging protocols and formats and back-end systems to electronically exchange product catalog information, catalog updates, inventory snapshots, orders, order acknowledgements, shipment status and invoices.

Thee two principle values gained from this setup are operational control and strategic control. From an operational perspective, manufacturers can literally launch new items to the entire market within 24 hours and they can dramatically start to improve their supply chain efficiencies on the front and back of the supply chain. For most of the larger manufacturers, this means a dramatic increase in their turns on inventory and starting to move toward eliminating the conventional chargeback process.

In terms of strategic control, such a marketplace offers a new sales channel for the approaching era of customized drugs with shorter shelf lives. Customized vaccines, AIDS, oncology and fertility drugs – all kinds of high-cost, low-sale items will require a new channel outside the ‘mainstream.’ The distribution chain of the future is clearly not going to look anything like it does now and the pharmaceutical industry must be prepared for the coming change in supply/distribution landscape.

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Hugh G. Davis is a Senior Instructor , Kriger Biopharmaceutical Career Training Program www.kriger.com/training , info@kriger.com

Hugh Davis

To find the proverbial needle of information in a haystack of data, biopharmaceutical organizations turn to knowledge management systems. Finding it is no small feat, but managers are increasingly focusing on ways to reuse that needle throughout the entire organization, to stitch together successful drug submissions and improve operational efficiencies.

Consequently, biopharmaceutical companies are turning to document or content management systems with workflow features to run more efficient organizations. Systems such as those from Canto, Documentum, Open Text, and Xerox, are being used primarily to create a searchable repository of files. Once a repository is in place, organizations will also add a structured, collaborative system that efficiently manages and reuses the information throughout a drug’s entire cycle, from R&D to post-approval marketing.

Most biopharmaceutical companies focus a large effort on setting up formal procedures for managing normal documents. Typically, documents start life as Microsoft Word files, which then get reviewed, edited, and approved. Later on, many companies convert these files to Adobe Acrobat PDF format because of more options to lock down the content.

At some stage, work on a document is completed. That usually results in a large collection of Word and PDF files, which is no problem for many document management systems.

But a shift is occurring that is altering some of the requirements for selecting a management system. For instance, it has been found, many times, that what started out as a traditional document management effort quickly expanded to include electronic documents, Web content, and rich media (such as artwork, packaging, and training information).

Incorporating these alternative types of data into one content management system allows re-use of information in additional ways. For example, products sold in Europe might require a package insert with information in 10 languages. The information is sent in English and goes to subsidiaries in the 10 countries to be translated into the native language permitting simultaneous dissemination to a much wider audience.

Today, most document systems that support these needs are traditional, where a Word or PDF file is handled by a content management system. But as the industry starts to adopt electronic submission using, for example, electronic common technical document (eCTD) specifications, companies must go through a great effort to put information in the right form, and they must do that many times over.

Indeed, when it comes to managing such documents, the pharmaceutical industry lags behind other industries such as automotive and manufacturing. These industries have lots of technical documents and continuously updated information that must be inserted into those documents. However, using eCTD within the life sciences would mean adopting a more ‘granular’ approach to handling information, with eCTD, the documents are broken down into very small fragments.

A good example is a clinical trial report. Currently, a revamped version might be sent to someone using Microsoft Word, who can see the modifications to the document by turning on the word processor’s Track Changes option.

A better approach would be to use a granular document and send only a page that lists which elements of the document changed, along with the date and version number of any changed items. But implementing such a change is unlikely to happen on a wide scale anytime soon.

Contemporary Pharma IT developers are already using traditional document management techniques in a granular approach to support multi-element package inserts, and a re seeing the benefits of having a standard operating procedure and workflow policies in place throughout an organization.

For all the options available to manage information, the common thread that cuts through all applications is the need to ensure that proper policies and procedures are followed when information is created, approved, and saved. In that way, many groups within an organization can safely reuse the information, thus realizing the benefits of operational efficiency.

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Hugh G. Davis is a Senior Instructor , Kriger Biopharmaceutical Career Training Program www.kriger.com/training , info@kriger.com