Global Vaccine Sales Up 16%, Market Exceeds $20B

August 19th, 2010

Vaccine sales hit $22.1 billion in 2009, up a healthy 16 percent from 2008. And forecasts predict that sales will continue to rise annually at a rate of 9.7 percent for the next five years. Wider adoption of currently available vaccines and the introduction of new products could push annual sales as high as $35 billion by 2015.

Merck, GlaxoSmithKline, Sanofi Pasteur, Pfizer and Novartis are the world’s largest producers of vaccines, according to Kalomora Information, with GSK dominating about a quarter of the total market. Pediatric vaccines account for more than half of the total market, and is growing at a fast rate than the adult segment. Pneumococcal and “combination” DTaP vaccines are driving growth in the pediatric sector, while influenza and hepatitis vaccine products fuel the adult segment of the market.

“We’ve forecasted a high growth rate for vaccines over the past few years and market events have matched our predictions,” said Bruce Carlson, publisher of Kalorama Information. “The vaccine business is not without its risks, but for some companies, vaccines were the only bright spot in their portfolio in 2009. It’s not a surprise therefore that development is heavy in this sector, and that will contribute to growth over the next five years.”

Read the full release:
Global Vaccine Market Exceeds $20 Billion: Kalorama

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Pharmaceutical Industry a “Market for Lemons”

August 18th, 2010

The pharmaceutical industry is a “market for lemons,” a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe, according to an analysis that will be presented at the 105th Annual Meeting of the American Sociological Association.

“Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs’ benefits,” said Donald Light, the sociologist who authored the study and who is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. “Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”

Three reasons why the pharmaceutical market produces “lemons” are: Having companies in charge of testing new drugs, providing firewalls of legal protection behind which information about harms or effectiveness can be hidden, and the relatively low bar set for drug efficacy in order for a new drug to be approved, Light said.

According to his study, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. Yet, toxic side effects or misuse of prescription drugs now make prescription drugs a significant cause of death in the United States.

Read more about the report:
Pharmaceuticals: A Market for Producing ‘Lemons’ and Serious Harm, Analysis Finds

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Study: Device Errors Cost $1.1B Annually

August 11th, 2010

A new study commissioned by the Society of Actuaries and completed by consultants with Milliman estimates that measurable medical errors cost the U.S. economy $19.5 billion in 2008. And medical device errors accounted for $1.1 billion of that cost.

In their report The Economic Measurement of Medical Errors, the authors calculate that there were 268,353 injuries as a result of a mechanical complication of device, implant or graft–60,380 of which were result of an error. The total cost per error was $18,771.

“We used a conservative methodology and still found 1.5 million measurable medical errors occurred in 2008,” says Jonathan Shreve, FSA, MAAA, consulting actuary for Milliman and co-author of the report. “This number includes only the errors that we could identify through claims data, so the total economic impact of medical errors is in fact greater than what we have reported.”

Read more: Study: Medical Device Errors Cost $1.1B Annually

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Vital Signs of the Medical Technology Industry

July 21st, 2010

While most sectors of the economy experienced a slowdown or decline during the recession, research shows that the medical technology industry fared better than most and continues to be a major contributor to U.S. economic health. In fact, the industry has emerged as one of the strongest drivers of the rebound. While challenges remain for the med tech field, technological and business advances paint a promising future.

The recession had a smaller effect on medical technology companies than on the general economy, with overall manufacturing employment falling 4.8 percent between 2007 and 2008, while med tech employment decreased only 1.1 percent. Moreover, manufacturing payrolls fell 1.4 percent while med tech payrolls dropped 0.7 percent, and U.S. product sales increased 2.8 percent while med tech sales grew 3 percent.

“This report paints an impressive picture of an industry that is a world leader in medical technology and a key economic engine for America in terms of job growth, payroll and sales,” Stephen J. Ubl, president and CEO of AdvaMed, said in an announcement of the findings. “However, our world leadership cannot be guaranteed in the future. It is essential that regulatory and payment policies support innovation while ensuring public health and safety and moving us toward a more efficient and quality-driven health care system.”

Read more of this industry market trend on ThomasNet:

Vital Signs of the Medical Technology Industry

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I Need to Reduce Ongoing Operating Costs in Order to Increase Bottom Line Profits

July 9th, 2010

Delivering high-quality products and services may be the number one priority for Life Sciences companies, but finding ways to reduce costs has become the number one imperative. The key lies in finding ways to streamline processes, eliminate inefficiency, increase productivity, and improve decision-making. The ultimate goal: enable employees to work together in integrated, collaborative teams focused on delivering appropriate, safe, and affordable products. 

The dual challenge is constantly trying to reduce operating expenses while responding to greater customer needs, and ultimately increasing profitability. All too often, the tendency is to cut all expenses that seem extraneous, especially during economic uncertainty. Although this sounds like the best short term business solution, in the long term, this may actually do more damage than good. Reducing operating costs should never simply be about keeping a business sustainable. It should be about making a company profitable, and maintaining an increase in the bottom line.

Learn more about how MAXLife can help reduce operating costs in order to increase bottom line profits.

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Merit Solutions Announces the Availability of Life Sciences Software for Microsoft Dynamics AX

July 6th, 2010

Merit Solutions, Inc., a leading Microsoft Gold Certified and Presidents Club Partner, is pleased to announce today the general availability of MAXLife software for Microsoft Dynamics AX for English, French, Spanish and German language markets.  For medium enterprise and large, global companies that manufacture, distribute and manage life sciences products, MAXLife for Microsoft Dynamics AX provides an enterprise wide business software solution to help companies gain insight and increase business performance. MAXLife enables life sciences organizations to connect with their business partners and customers, optimize business processes, and gain competitive advantages, while simplifying compliance processes mandated by the FDA, customers, and other regulatory agencies.  

MAXLife (http://www.maxlifesoftware.com) software extends the already strong core Microsoft Dynamics AX ERP and Advanced Distribution software to meet specific requirements for Life Sciences companies, including:

Corrective Action Preventive Action Resolution / Incident Tracking

MAXLife Corrective Action Preventive Action (CAPA) enables increased control and assuredness for how your organization captures, tracks and manages incidents, adverse events and non-conformances.  With MAXLife, companies can generate a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. This Corrective Action tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of incidents.

Cost of Quality Management

MAXLIfe Cost of Quality enables critical tracking, reporting and analysis of costs related to performing quality processes across the organization.  With MAXLife, companies have visibility on their complete product costs, including important quality processes, and are able to make better decisions, more timely.  Life Sciences companies can focus on quality management initiatives as a source of competitive advantage while responding to the market pressures to both reduce the cost of quality and improve finished product quality.

ePedigree Tracking

Every drug manufacturer is required to serialize drug products at the item, case, and pallet level to support the ability to generate an electronic pedigree (ePedigree) document.  This electronic document is required to track, trace and authenticate the product from the time it is initially sold to a distributor all the way through the supply chain to the point of distribution. MAXLife simplifies and accelerates the ePedigree process from receiving through shipment, simplifying compliance with government regulations.

Microsoft Part 11 SharePoint Document Management

MAXLife extends the capabilities of Microsoft SharePoint for document management and quality control solutions for life sciences companies.  The software helps address the regulatory requirements of FDA 21 CFR Part 11, as well as SOP management, clinical document management and a range of quality functions including CAPA, audits management, non-conformance and complaint management.

About MAXLife for Microsoft Dynamics AX

Built on the .Net architecture of Microsoft Dynamics AX and Microsoft SharePoint, MAXLife software increases your visibility into product performance, resulting in better decisions and increased revenues and profits. The software enables quality control and quality assurance processes to work together as part of the business system, and to be transparently available for reviewing and reporting. With MAXLife software for Microsoft Dynamics AX, you can track product quality, proactively see and respond to manufacturing variability, meet GxP, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

View a MAXLife for Microsoft Dynamics AX Demo.

About Merit Solutions, Inc.

Merit Solutions is a leading Microsoft Dynamics business consulting and software development firm helping clients plan their technology investments, design solutions, and implement projects that improve business performance and drive a competitive advantage. We deliver end-to-end solutions that enable our clients to streamline processes, reduce costs, and facilitate business growth.

Merit Solutions is a Microsoft Gold Certified Partner, a 2009 Microsoft Dynamics President Club member, and has been recognized in the past as a Microsoft Excellence Partner for working successfully and collaboratively with customers and partners across the world.

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Faster Time to Market with MAXLife and Microsoft Dynamics

June 29th, 2010

MAXLife’s technology platform makes compliant document management intuitive, easy and accessible to any authorized user — from anywhere. Our technology delivers on the promise of efficiency without sacrificing security and necessary controls.

MAXLife Software Restricted Permission

Our solutions seamlessly integrate compliance procedures and metadata storage. Metadata is automatically updated and stored every time a document is checked into the system. No time is wasted on manually entering new metadata upon check-in. And because the metadata is complete, document searches are more productive.

The Microsoft stack can help your business become more competitive and agile. With MAXLife, you can foster collaboration across global teams in a secure, compliant environment. Users can easily create, store and find relevant documents in a central repository that meets FDA regulations.

MAXLife SharePoint Document Management

MAXLife can help reduce the time and expense of getting drugs to market — improving your business and worldwide health.

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Foster Collaboration and Reduce Information Silos with Microsoft Dynamics

June 2nd, 2010

Life sciences firms need solutions that provide the right people with the right information exactly when they need it. The solution must be secure and easy to use, and it has to provide quick access to corporate databases. It must seamlessly integrate data from various departments and sources as well as smoothly operate across standard mobile devices and office platforms. The solution should lead to better information sharing, customer insight, and sales force management.

To increase marketing share in this changing environment, life science companies need secure, up-to-date business intelligence so they can determine the most effective channels for delivering timely messages to physicians, payers, hospitals, and consumers.

Existing customer relationship management (CRM) systems can be complex and cumbersome and do not support emerging requirements around the management of key accounts and key opinion leaders. The systems do not help salespeople understand complex influencer networks and past prescribing habits. Even worse, the time needed to enter data after visits can cause salespeople to lose their focus, resulting in poor data records.

CRM systems are often incompatible with standard mobile and office technologies, which can lead to information bottlenecks. Managers can’t get the real-time data they need to respond to a fast-changing marketplace. And it is difficult for users to obtain a 360-degree view of the customer across channels.

With new electronic channels on the rise, many existing CRM systems cannot integrate customer touchpoints from company Web sites, call centers, and direct channels — wasting valuable insight and creating the risk of inconsistent communication.

Microsoft Dynamics can help your business become more competitive and agile. It can help improve life sciences’ sales force productivity while controlling costs – which in turn can fuel revenue expansion. With Microsoft Dynamics, your life sciences company can maximize opportunities:

  • Increase sales force productivity with easy-to-use tools that eliminate time-wasting chores.
  • Facilitate collaboration and communication on the road and in the office.
  • Gain greater visibility into customer information to deliver the right messages.
  • Monitor key performance indicators and sales productivity to make the best management decisions and identify early trends.
  • Optimize the sales processes though more personalized interactions.
  • Help control sales costs and accelerate revenue growth.
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Real-Time Supply Chain and Manufacturing Visibility

May 25th, 2010

Many life sciences companies perform production planning, scheduling, and monitoring in isolated proprietary systems, which slows responses to changing conditions or problems. Plants are often managed in isolation, and systems do not support coordination among factories. Long production line downtimes, excessive waste, and high inventory levels often result. Even worse, without easy communication among factories, organizational learning becomes a challenge. Mistakes may be repeated across manufacturing plants and additional production batches may be lost.

When managers cannot monitor the manufacturing process in real time, they can face worrisome delays in detecting quality issues. Much production time is lost as life sciences firms investigate problems and work to solve them. Not only is production line utilization negatively affected, but in the worst case regulatory action may result, jeopardizing the entire business.

Without a comprehensive, real-time view of manufacturing operations, managers lack the information they need to best allocate production resources and ensure regulatory compliance. As inefficiencies mount, costs become harder to control and system upgrades become more challenging.

Life sciences firms need easy-to-use solutions that provide the right information to the right people – at the right time in the right place in the right format. These solutions should collect, share, and store information from disparate sources in an accessible, intuitive format. They should aggregate data across business functions and manufacturing sites in real time — fostering collaboration and giving managers greater visibility into manufacturing performance. The solutions must help provide security, which will facilitate regulatory compliance.

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Managing the High Costs of Compliant Content Management

May 20th, 2010

As electronic spreadsheets and text documents replace paper records, research-driven life sciences firms are turning to electronic content management (ECM) systems to control the flow of digital information. The Food and Drug Administration requires that these systems maintain the digital equivalent of a paper chain. Regulation 21 CRF Part 11 sets strict criteria for electronic signatures and documents. Non-compliance means fines and delays.

MAXLife for Microsoft Dynamics AX makes compliant document management intuitive, easy and accessible to any authorized user — from anywhere. Our technology delivers on the promise of efficiency without sacrificing security and necessary controls. With MAXLife, we can help your Life Sciences business become more competitive and agile. Our technology fosters collaboration among global teams in a secure, compliant environment. Users can easily create, store and find relevant documents in a central repository that meets FDA regulations.

Merit Solutions can help reduce the time and expense of getting drugs to market — improving your business and worldwide health. Benefits of MAXLife include:

  • Satisfy 21 CFR Part 11 requirements for audit trails, electronic signatures, restricted access, accurate copies of records, and proper storage. Give remote workers intuitive access to compliant content management — straight from their desktop.
  • Facilitate collaboration and role-based productivity.
  • Create and store valuable metadata directly within the document — even when it’s checked out of the ECM system.
  • Support workgroup collaboration, subscriptions, notifications, message boards and other tools in a secure environment.
  • Control R&D costs and accelerate ROI.
  • Help speed drugs to market, improving company performance and public health.
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