Because Process Matters » pharmaceutical

Think Big: Extending BPM Across Your Organization

Sandra Moran — Wed, 30 Nov 2011 14:48:03 +0000

In my blog post last month I covered a few of the lessons learned by early BPM adopters on how to begin a business process management (BPM) initiative. Based on many early BPM successes, we have seen the focus of BPM projects shift from just streamlining and improving a few key processes within their organization tonow turning to BPM to help them understand, visualize and optimize their operating model and business practices. However, to fully reap the rewards that BPM has to offer, organizations have had to stop looking at BPM as a tool to improve a handful of easy, high ROI projects and start thinking about BPM as change agent to instill agility into the enterprise.

From my experience working with our customers, the companies who have embraced BPM practices as essential to their management approach have had far greater success than those who have leveraged BPM to solve a few problem processes.

How AmerisourceBergen Transformed Their Business with BPM

For example, at last month’s User Summit, our customer AmerisourceBergen showed us just how far their “BPM way of thinking” has transformed their business. Their first BPM initiative was to implement an automated, collaborative Contract & Chargeback process which was not supported by their SAP application. The Contract & Chargeback process is used to manage the established pricing and terms for each of AmerisourceBergen’s manufactures and then controls compliance with pricing terms and payment of rebates from the manufacturer if the company is forced to sell at a lower price to compete- a multi-billion dollar exercise for the company. The project was a huge success and delivered a high return on investment through lower headcount, fewer and faster dispute resolution, and more accurate pricing information. AmerisourceBergen identified many additional processes for BPM and expanded its use of Metastorm BPM to support an enterprise-wide business transformation initiative. More specifically, the company created six new processes in Metastorm BPM that extend and augment SAP’s capabilities around managing and automating high volume, highly-specialized supplier credit processes. Today AmerisourceBergen has over 3,000 users and almost 300 processes automated in Metastorm BPM. They have also established a Process Center of Excellence (COE) consisting of key business and IT people to access new processes for automation, build business cases for BPM and oversee BPM projects.

Rather than taking the one project at a time approach, AmerisourceBergen and other cutting edge BPM adopters have seen a significant pay-off from adopting an enterprise-wide, business transformation approach to BPM. By building a Process Center of Excellence, your organization can bring together both IT and business people and resources to start thinking about how to deploy BPM across your entire organization.

If you’re interested in learning how to extend your BPM implementation beyond a few projects, or have any thoughts on this subject, feel free to leave a comment below!

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Battling Regulatory Pressures in Life Sciences

Ethan Smith — Tue, 26 Jul 2011 14:09:22 +0000

It’s no secret that Life Sciences is one of the most highly regulated industries with ever-increasing obligations and scrutiny. As these requirements increase it is essential that you are prepared for changes that you can expect will continue to come. Life Sciences companies should build into their operational structure a plan for continuous change and the technical agility to respond quickly to new requirements. The motivation is clear, without it, your company will not only face major financial penalties, but suffer massive blows to your image and credibility in a highly criticized marketplace.

Many companies today have handled regulatory requirements by leveraging a business process management (BPM) tool to help them understand and improve their processes. At the same time, some companies believe they’re solving their regulatory compliance problems by using an enterprise content management (ECM) tool to help them capture, manage and store highly valuable documents.

While both of these tools are helpful in managing specific components of regulatory burdens, the power of marrying the capabilities of BPM and ECM can help your organization ensure compliance on both existing and new regulatory requirements. By using BPM and ECM, you can design your process improvements to be integrated with critical content that can be accessed by users anywhere in your enterprise. You can imbed content directly into a process, ensuring all documents are up-to-date and in the correct place for users to obtain. With access directly into process and content, it is easier to monitor, track and provide audit trails to meet regulatory requirements. Systematic alerts allow you to stop relying on individuals to manually initiate next steps, such as knowing when clinical data is available for medical writing to complete a submission. By combining these two powerful technologies, you can ensure processes are completed as efficiently as possible, while also maintaining the content in the validated document management application and having a consolidated Part 11-compliant audit trail documenting every step.

The integration of process and content isn’t easy, but when viewed holistically it can put your company ahead of the curve and allow you to successfully answer any new regulatory pressures on the horizon. Our conversation around this topic doesn’t end here. Let’s continue the conversation. Join us this Thursday, July 28^th at 11:00 a.m. EST for our live webinar, Compliance for Life Sciences: Improving business process and content management to deliver results.

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Five Benefits of Using BPM for Regulatory Document Submission

Process Matters Blogger — Tue, 19 Jul 2011 12:25:45 +0000

Regulatory Document Submission is one of the most time consuming, yet critical steps pharmaceutical, biotechnology and medical device companies must take to meet government requirements, ensure patient safety, and get a new product introduced to the market. While it is essential to the health of a pharmaceutical company to get its submissions issued efficiently, many companies are still unaware of the dramatic benefits they can reap from utilizing a business process management suite to handle these submissions and greatly improve the utility of its existing document management system(s).

Five reasons you should start using BPM for regulatory submissions

1. Reduce cycle times and increase efficiency
There’s no need for the last-minute rush to get documents completed and submitted on time. In fact, you would be surprised by how many companies have very little understanding of how their documents are produced, reviewed and approved before they are submitted. BPM helps companies capture, analyze, understand and optimize critical submission process data, letting you get the job done faster and more efficiently, while ensuring you are meeting all submission deadlines.

2. Complete process visibility
With BPM, you can know exactly where you are in your process at anytime. You can pinpoint the exact process you wanted automated, understand what it does and the interrelationships of the people, systems and technologies it involves, and optimize the process in a way that gives you the best advantage. Leveraging these capabilities users are able to initiate next steps, track deadlines and set up alerts to signal when specific users must take action based on clinical data becoming available. In addition, BPM processes can be easily updated and improved without requiring revalidation of other systems (e.g., Document Management, CTMS).

3. Better manage resources and roles
Social BPM capabilities allow you to define your users and what skills, training, certifications, and capabilities they have to ensure the right task is being assigned to the best person to complete it in the shortest amount of elapsed time. Work can be routed to the most appropriate employee, keeping in mind their current workload, to ensure projects don’t pile up and deadlines are met whether they are down the hall or across the globe.

4. Establish universal metrics and standards
Real-time, personalized dashboards give you the ability to monitor and track the entire document creation, compilation and submission process. From planning, document writing, scientific review, QA and approval and issuing – you know who needs to complete and approve a task at any specific time. You can also generate customizable reports on different processes, establish performance metrics and see how you’ve improved your regulatory submission processes.

5. Global accessibility
Web-based BPM suites give you the ability to access a wealth of information anywhere, eliminating geographical barriers. Work can be assigned to different users by adding a role attribute for users’ locations – ensuring people with enough hours in their work day and the right skill set can complete a task. Globalizing your customer operations not only helps you gain access to everything you need anywhere in the world, but also cuts down on operational costs. This feature gives companies the ability to truly leverage their global workforces to gain strategic advantage by effectively creating more working hours in a day.

A great BPM suite has the power to cut costs, increase productivity and transform the way your business operates. Stay tuned as we continue to discuss BPM’s influence within the pharmaceutical industry and how the combination of BPM and enterprise content management (ECM) can improve the way you get submissions done.

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AmerisourceBergen Recognized for Business Process Improvement Initiatives

Process Matters Blogger — Tue, 05 Oct 2010 14:13:03 +0000

Metastorm customers are continuing to receive tons of recognition for their business process improvement initiatives! Last week Metastorm announced that the City of Richmond, VA has received multiple awards for its CommonCents initiative built on Metastorm BPM® software platform. Today, Metastorm announced that our valued customer AmerisourceBergen has been named runner-up in the 2010 Business Agility and Process Optimization Enabled by BPM and SOA contest, for its success in implementing business process initiatives using Metastorm BPM software!

The Business Agility and Process Optimization Enabled by BPM and SOA contest highlights the business success stories and lessons learned to provide proof points and insights for other organizations considering or pursuing BPM, SOA or combined BPM-SOA adoption.

AmerisourceBergen is one of the world’s largest pharmaceutical services companies serving the United States, Canada and selected global markets, and works closely with manufactures of branded pharmaceuticals, generic pharmaceuticals, biotech and specialty drugs, over-the counter remedies, and health and beauty aids.

AmerisourceBergen has deployed over 200 processes using Metastorm BPM! To govern its business process management initiatives, AmerisourceBergen has created a Center of Excellence and has seen millions of dollars in savings to date. In one of its most recent projects, AmerisourceBergen was able to leverage Metastorm BPM to extend and augment is new SAP implementation.

At Metastorm, we are dedicated to building software that helps organizations focus on the right business improvements to drive business change, optimization and effectiveness. We are very proud to see AmerisourceBergen, and all of our customers, recognized for their commitment to implementing strategic business process improvement initiatives. Check out AmerisourceBergen’s customer success story to learn more about its success in deploying BPM in the pharmaceutical industry.

Metastorm solutions can be tailored to fit all of your organizational needs. Visit our solutions page to find more information about how your organization can benefit from implementing Metastorm’s leading suite of Business Process Management, Business Process Analysis, and Enterprise Architecture software.

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A Prescription for Compliance Controls to Address a $600M Problem

Ethan Smith — Wed, 08 Sep 2010 13:42:20 +0000

Among the litany of headlines recently blasting pharmaceutical, biotech and medical device companies, Allergan – the makers of Botox – has been the latest scapegoat. The past week’s news has been full of stories relating to Allergan’s agreement to settle “off label promotion” charges to the tune of $600M. While the specifics of pleas and allocation of all the dollars is not the focus of this post, a half- billion-dollar-plus fine and formal, very public settlement agreement for a $4.5B company[i] is no small matter. Aside from the fine itself, the legal costs and negative publicity cannot be understated. At the time of this writing, a simple Google News search on “Allergan” returns over 300 articles relating to the settlement with headlines like:

“Allergan to Pay $600 Million to Settle Botox Probe” –ABC News
“Allergan Settles Charges It Went Too Far Marketing Botox” –NPR News
“Allergan Will Pay Fine, Plead Guilty to Misdemeanor” –Bloomberg
“Botox Whistleblower Case Settles for $600 Million” –Trading Markets
“Feds Wrest $600 Million Settlement from Botox Maker” –Consumer Affairs

Clearly there is a very strong negative sentiment regarding this issue. The last headline above is one all pharma companies should be worried about – because the same risk could be looming for other companies in the space. The notion of the U.S. Federal government wringing money from a corporation in the name of protecting consumers is a strong driving force behind the recently passed Federal Physician Payments Sunshine Act, as well as numerous state laws that are already in force and several that are currently being debated. The new mantra is transparency – under the banner of promoting safety, consumer protection and ethical business practices.

From my point of view as an industry consultant, pharma companies (and biotech and medical devices too) need to hear loud and clear the underlying message in the Allergan incident and in recent legislation, and take decisive action to prepare for the onslaught of potential inquiries and investigations they may face. Most importantly, companies need to take immediate steps toward defining and implementing a compliance and governance foundation, along with a set of agile controls, to manage within the guidelines of current regulations and have the flexibility to adapt to future changes and extensions.

Unfortunately, what you won’t find in any of the 300+ articles referenced above – apart from one – is any mention of the proactive steps that Allergan has taken to address not only this specific instance but to implement go-forward controls and systems to enhance transparency, better enforce compliant business practices, and ensure they are prepared for future regulatory change. In addition to developing a formal compliance program subject to regular reviews, Allergan “further enhanced its compliance program by developing additional comprehensive policies and procedures, supported by significant technology investments, including its state-of-the-art Business Execution Automated Compliance Navigator (BEACON) compliance system.”[ii] This seemingly minor, yet crucial omission in the media coverage of this event should not go overlooked by industry peers.

Every Life Sciences company can and should learn from what happened to Allergan and how it handled the resolution of these serious issues. The BEACON application referenced was envisioned to provide both compliance process controls as well as flexibility to support future changes. It is built on the Metastorm Business Process Management (BPM) software platform to provide the controls, rules and documentation necessary for resolving the current situation as well as preventing future incidents.

Recently, the area of payments and promotions has exploded in both regulatory and public scrutiny. Most Life Sciences companies are now actively thinking about or looking for process controls and technology capabilities to prevent these costly events from occurring.

Leveraging our experience in helping pharmaceutical companies implement flexible, unique compliance systems that conform and adapt to changing regulations – with business process management and improvement at the heart of the platform, Metastorm has developed an Aggregate Spend Management solution that addresses the two fundamental aspects of the business problem. The first component is the management and reporting of expense data that must be reported to multiple state governments and soon the federal government as well. Secondly, and more importantly in my view, the business processes that are invoked to request/approve/execute/reconcile spend are critical to ensuring the spend data is not only accurate, but also compliant with various jurisdictional regulations and policies. In contrast to legacy vendors who focus solely on data aggregation for reports, Metastorm delivers both simplification of the state reporting in addition to automated, web-based processes and forms for spend request, review, approval, execution, reconciliation and documentation. This distinction is critical because, ultimately, Life Sciences companies will have to demonstrate to regulators, investigators and the public the ability to immediately generate justification for each reported expense, prove each expense’s business value and cite who provided the advanced authorization of the expenditure before it was released.

As evidenced in Allergan’s own press release on the settlement, Metastorm’s Aggregate Spend Management solution and its underlying BPM software platform have been a major component of Allergan’s approach to resolving the systemic issue by approaching it holistically and proactively. Watching a 6-minute demo of the solution is a good first step to help Life Sciences companies understand what is needed to put a solid compliance and governance solution in place now – to avoid potentially disastrous issues later.

_______________________________
[i] 2009 Total Revenue as reported in Allergan’s 2009 Annual Report
[ii] “Allergan Resolves United States Government Investigation of Past Sales and Marketing Practices Relating to Certain Therapeutic Uses of BOTOX(R)” official company press release dated September 1, 2010

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IDC: serious problem for pharmaceuticals – revenue leakage

Process Matters Blogger — Mon, 18 Jan 2010 14:49:14 +0000

A recent study from IDC shows that pharmaceutical manufacturers will lose an estimated 11 billion dollars through channel inefficiencies this year.

According to the corresponding release this number is “the equivalent to total revenue for a top 20 pharma simply disappearing each year.”

The culprit? Revenue leakage.

According to the release, one of the major sources of revenue leakage, which costs pharmaceutical companies 4.4% of their overall revenue per year, is chargeback discrepancies. The release also states that “63% of manufacturers believe chargeback-related revenue leakage is a serious problem. This is up nearly 25% from a similar survey in 2006.”

With these staggering numbers it is very apparent that pharmaceutical companies have a huge problem on their hands. Fortunately, there are technologies available that can alleviate revenue leakage, and help these companies realize significant ROI along the way.

For example—one of America’s largest pharmaceutical services companies, which ranks among the Fortune 25, has utilized the functionality of Metastorm BPM® to streamline and automate its contracts management and chargeback processes as well as over 175 other process across the enterprise, enabling it to:

Establish more efficient and accurate tracking capabilities,
Reduce chargeback disputes,
Rapidly and efficiently respond to changing market conditions, and
Improve transaction transparency and supplier collaboration.

With the help of Metastorm BPM, these and many other benefits have been realized, enabling this company to achieve an exponential return on its investment, and helping it to avoid revenue leakage from poor process management.

Want to know more? Watch this customer video testimonial, and read this solution sheet.

You can also check out the Solutions for Life Sciences page on our website.

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Pharmaceutical company recognized for process excellence

Process Matters Blogger — Tue, 24 Nov 2009 21:47:38 +0000

Today we are proud to announce that, AmerisourceBergen – one of the world’s largest pharmaceutical distributors – has won the Silver award for North America in the 2009 Global Awards for Excellence in Business Process Management (BPM) and Workflow for its implementation of the Metastorm BPM® software.

The award recognizes organizations that have excelled in implementing innovative process improvement solutions to meet strategic business objectives.

AmerisourceBergen has certainly done exactly that—to date the organization has established a BPM Center of Excellence, deployed and optimized nearly 200 processes throughout the enterprise, and has approximately 3,000 users on the Metastorm software globally.

The AmerisourceBergen award entry highlights the company’s senior executive support for Metastorm BPM as an enterprise solution. It also outlines some of the key objectives that BPM software helps the company meet on an ongoing basis, including:

maintaining high quality standards while managing growth,
creating efficiencies,
making better and faster decisions, and
ensuring regulatory and legal compliance

“The pharmaceutical industry is extremely complex and competitive, and AmerisourceBergen has embraced the Metastorm BPM suite as an enabler to help effectively address market demands in a highly competitive environment,” stated Manoj Kumar, manager of Business Process Automation at AmerisourceBergen. “The results and return on investment have been significant.”

We congratulate AmerisourceBergen and Manoj Kumar, the company’s manager of Business Process Automation, for their dedication and hard work. Receiving this award is a great recognition of the broad scope and remarkable success of its BPM initiative.

To hear more comments from Manoj Kumar, listen to this audio clip

Watch the video below to learn more about how AmerisourceBergen leverages Metastorm BPM.

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Use BPM to Standardize Best Practices Globally

Metastorm PR — Thu, 29 Oct 2009 14:38:04 +0000

This PharmaManufacturing.com article discusses how one pharmaceutical organization used Metastorm BPM® to standardize business processes on a global scale and to provide employees with access to the real-time data and business metrics needed to run the enterprise.

“As we rolled out standard end-to-end business processes to users, BPM tools enabled users to see the big picture and put their role in context by understanding upstream and downstream process and data flows,” said an executive of the pharmaceutical company.

The article highlights how the company used BPM for various purposes from clinical trials to supply chain optimization. It started adopting BPM so much in fact; that it established a BPM Center of Excellence.

The article further discusses how BPM can be used for other purposes within the pharmaceutical industry such as integrating and managing communications between various manufacturing-related systems

Read the full article for more details on how the pharmaceutical company was able to fully adopt BPM throughout the company.

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Life Sciences corporations and BPM

Metastorm PR — Tue, 08 Sep 2009 13:56:36 +0000

With healthcare efficiency in the spotlight, one pharmaceutical company that’s using Metastorm BPM® to automate its clinical submissions process is definitely ahead of the technology curve.

Needing to coordinate clinical submissions with a global workforce while meeting FDA pharmaceutical guidelines, the company decided to use Metastorm BPM to create a 24 x 7 automated lifecycle of its clinical submissions. Deploying BPM, the company was able to generate metrics and reports quickly, increase employee productivity and decrease the standard turnaround time required to submit reports to the FDA while handling all document preparation offshore.

Below a senior systems analyst delves further into the advantages of using Metastorm BPM in his global clinical team.

Please visit Metastorm’s Web site to learn more about its solutions for pharmaceutical companies.

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