Jaleel Shujath

Jaleel Shujath
Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

Clarity First. Clarity Always – Managing Marketing Content in the Life Sciences

life sciences marketing

Marketing from the Life Sciences industry is constantly under the spotlight. US state and federal governments have handed out some eye-watering fines to pharmaceutical companies for false claims. Yet, consumers, physicians and Life Sciences companies all want the same clarity and transparency in the information delivered. Life Sciences marketing management systems need to change before the industry loses its most important asset: stakeholder trust. Operating within any heavily regulated industry is challenging and the penalties for non-compliance are rightly severe. When people’s lives are at stake, it’s clear that the marketing information has to be reliable and trustworthy. A 2016 Public Citizen showing that pharmaceutical companies had paid over $35 billion in fines over the last 25 years demonstrates that these standards have not always been achieved. However, research suggests that the public retain high levels of trust in the marketing information they receive. Kantar Media suggests that 86% of adults have had some form of medical test and 66% have had an annual physical as a result of being exposed to TV advertising. In addition, Harvard University found that over three quarters of people felt that pharmaceutical companies did adequately explain the side affects and risks of their drugs. So, most people think that Life Sciences companies are doing the right thing. They just want to be sure they can rely on what they’re being told. The limitation of modern marketing systems This is where the marketing environments within many Life Sciences companies – especially large global organizations – are currently acting as an impediment. They are constraining the agility companies need in order to fully grasp the opportunities in innovation and market conditions. They are inhibiting the ability to deliver excellent and consistent customer experience in an increasingly omni-channel world. More importantly, the lack of end-to-end control and visibility across all marketing activity and assets leaves huge potential for the type of error or over-sight that can lead directly to huge fines. The situation is totally understandable. The last decade has seen an explosion of sales, marketing and creative solutions. The result is siloed marketing ecosystems where many solutions that are incompatible with each other. Sales enablement, marketing automation, social media management, creative production systems and more all handle vital, sensitive information – almost always without any centralized control. Project management systems are often localized and provide little or no integration into the other marketing and creative systems. Add to this the need to collaborate and share information with partners and external agencies – frequently on a country-by-country basis – and the full scale of the challenge becomes apparent. The holistic approach to Life Sciences marketing What is required is a change in thinking. Life Sciences companies have to move away from a project-based tactical approach to marketing – focused primarily on campaign delivery – to a more strategic approach around the effective management and optimization of all the company’s digital assets. OpenText calls this Marketing Content Management. Marketing Content Management enables a Life Sciences company to take complete centralized control of all its digital assets and marketing activities across the entire global organization and its extended marketing supply chains. It brings together all the disparate systems that currently form the marketing ecosystem and allows the organization to take a holistic quality approach to the marketing information lifecycle for the first time. Embedded analytics help companies assess the efficiency of their processes as well the effectiveness What is most important about this approach is the level of control that the company now has. It can now ensure that information is up-to-date and correct as it passes through the marketing process. Policies and procedures can be put in place to manage all digital assets from initiation to disposal. In addition, information can be securely shared with partners and agencies. The organization can ensure that everyone works to its standards and adheres to its policies. This delivers a new level of brand protection as the marketing department will have full visibility of how its marketing materials are amended and deployed by trading partners such as resellers and distributors. Marketing Content Management eases the burden of regulatory compliance on the Life Sciences marketing organization. It delivers the transparency and auditability that means the company can ensure the information within this marketing activities is correct and reliable – and it is easy to provide the information should a regulatory agency require. It is the foundation upon which customer trust can be built and maintained. Download our infographic on the 10 Best Practices for Life Sciences Marketing Content Management to take the first steps toward improving marketing quality and process harmonization.

Read More

Documentum and OpenText for Life Sciences – Moving Beyond FUD

documentum

Now that a couple of months have passed since the ink dried on the OpenText deal for Dell EMC’s Enterprise Content Division (ECD), I thought it was good time to offer my viewpoint on what this acquisition means specifically for Life Sciences. Some have questioned OpenText’s commitment to Documentum and future investment in the platform. Some have questioned the amount of investment that will be made to product/solution enhancements and innovation. However, only OpenText has the depth and breadth of Enterprise Information Management (EIM) solutions that can deliver the future that Documentum customers deserve – while offering a whole series of synergies for existing OpenText customers. Sir, step away from the FUD… I don’t want to dwell too much on the past but I’d be sharing no great insight to say that Documentum was never a perfect strategic fit for Dell or EMC. EMC had made it explicit that continued investment in the platform might be limited. It was an open secret that the company would look to divest itself of ECD. The only question was to whom. Many industry experts had suggested that the venture capital route was most likely, but this would always have left the shadow of future disintegration and sell-offs of the Documentum solution set. OpenText offered a completely different approach. Our solution sets are complementary and together offer a path to further develop and innovate in the ECM space. Our competitors – even those that have tried to spread some FUD (fear, uncertainty, doubt) – would struggle to suggest that we are not a perfect fit. More importantly, the OpenText deal ensures the investment that the Documentum platform requires to fulfill customer needs. In technology solutions, as we are all acutely aware, if you’re standing still then you’re going backwards. It would have been unthinkable to let that happen to Documentum. In reality, this deal marks the end (not the continuation) of the uncertainty about Documentum’s future. Where do we go from here? The Documentum Life Sciences Solutions Suite was the pinnacle of EMC’s approach to take a solutions-based approach to delivering on customers’ pain points. I’m afraid the first thing we’ve done you may find fiendish. We’ve put the word ‘OpenText’ in front of it! The next thing we’re doing is setting out a roadmap to ensure the platform meets your needs today and into the future. We’re doing exactly the same thing with other ECD product sets – such as LEAP – so that existing Documentum customers can be reassured that our solutions will always remain a strategic investment. But, as I said, standing still is going backwards. Our belief in the Documentum platform was only part of the reason that OpenText was interested in this deal. Our strategic direction has long been to assist our customers to access the full potential of EIM. This means bringing ECM together with enhanced records management, analytics, and BPM into a single, coherent, end-to-end platform. We believe that this approach is the only way to fully release the value of information held within an enterprise and provides the foundation for Digital Transformation. Life Sciences companies can select (or maintain) either the OpenText or Documentum ECM platforms and expect to receive the same level of native integration into OpenText’s Discovery, Case Management and Customer Experience portfolios, as well as industry-specific solutions, reflecting our combined decades of experience and best practice. Bringing immediate value to customers Beneath this strategic direction, there are a number of actionable synergies that can immediately benefit both OpenText and Documentum Life Sciences customers: Extended solution portfolios – In areas such as analytics and B2B integration, existing Documentum customers can build out the capabilities of the Documentum for Life Sciences Solution Suite and leverage best-in-class OpenText solutions, such as Marketing Content Management for Life Sciences. Existing OpenText customers can benefit from ECD solutions such InfoArchive. Enterprise Application Integration – OpenText’s close relationships within its partner network introduce seamless integration with enterprise applications such as SAP, Oracle, Salesforce, and Microsoft for Documentum customers. Cloud and IaaS – The OpenText Cloud delivers the ideal platform as Life Sciences companies to transition from on-premise to Cloud-based solutions. You have the confidence that you are with one of the world leaders in Infrastructure as a Service (IaaS). I know it is natural to be cautious when large deals like this happen – and only time will show that what I’m saying will happen – but I’d like to think that you are as excited as I am about what this means for current and future customers. To summarize, the OpenText Documentum for Life Science Solution Suite has the investment it needs and a talented team to drive its functionality forward. Additionally, we’ll continue to help Life Sciences organizations realize the potential of EIM to deliver the real benefits of Digital Transformation. If you’d like to find out more about how this new union will affect your organization, please contact your Account Executive or click here and someone (maybe even me!) will call you. In addition, OpenText will be unveiling its strategic plans in more detail at this year’s Enterprise World, in Toronto, Canada, where we will have a full Life Sciences program designed to help maximize your investments in OpenText (including Documentum) platforms.

Read More

Regulatory Matters: Collaboration is key for Life (Sciences) in 2017 – Part Two

Regulatory

The Life Sciences sector is very innovative. The Boston Consulting Group found that almost 20% of the world’s most innovative companies came from the sector. In fact, PwC suggests that Healthcare will surpass Computing as the largest industry by R&D spend by 2018. Shining a light on the innovation paradox Yet, for all the effort, there is still a lack of new products. Last year marked a six-year low for new drug approvals by the FDA. The rise of treatment-resistant superbugs has shone a light on the fact that there hasn’t been a completely new antibiotic for over 30 years. The poor return on R&D investment explains the paradox between innovation increase and new product decrease. Deloitte found that returns on research and development investment at the top 12 pharmaceutical companies fell to just 3.7 percent in 2016 from a high of 10.1 percent in 2010. While many Life Sciences executive remain upbeat about the development of new medicines, it’s clear that two factors will drive success: achieving improved operating efficiencies internally and creating more strategic alliances externally. The Internet of Things will increase the focus on cybersecurity In 2014, the Financial Times found that cyber security for the healthcare and pharmaceutical industries worsened at a faster rate than any other sector. As the sector becomes more and more IT driven in terms of innovation, R&D and manufacturing, cyber crime has been increasing in areas such as intellectual property (IP) theft, international espionage and denial of service attacks. As the sector looks to embrace digital transformation and the Internet of Things (IoT), cyber security is likely to be top of every CIOs priority list. The trend towards preventative and outcome-centric models relies on the ability to monitor and measure the health of individual patients. Whether wearables or other intelligent medical devices, the requirement for some form of online connectivity creates a vulnerability. At a recent cyber security conference, experts showed how items such as an insulin pump can be hacked. This represents a real threat to the individual but also raises the possibility of devices such as pace makers being used to launch denial of service on other targets. Addressing cybersecurity concerns, the FDA has issued guidance to medical device manufacturers to mitigate and manage cybersecurity threats. The excitement around IoT has to be tempered with the need to deliver water-tight security. This stretches way beyond the ability to gain access to user devices. It has to encompass data in transit and the management and storage of data within the life sciences company itself. Security-by-Design – built into all OpenText solutions – will become a foundational element of every part of the IT infrastructure for healthcare and pharmaceutical companies. Achieve operational efficiencies to improve margin and time to market With the focus firmly on value-based medicine, personalized care and population health, the Life Sciences sector is experiencing new levels of convergence and collaboration. Companies have begun to transform their business operations through collaborative product development and new service development. The ‘not invented here’ model is no longer appropriate for increasingly complex and expensive product lifecycles. As Deloitte points out: “Collaborating throughout the product development lifecycle is becoming an increasingly common and effective way for biopharma and medtech companies to offset mounting R&D costs, funding shortfalls, increasing disease complexity and technology advances”. In 2017, life sciences companies are transforming their traditional, linear supply chain into a supply chain of dynamic, interconnected systems that integrate their ecosystem of partners. This new supply chain modality allows organizations to extend their value chain beyond product development into the enablement of care in an increasingly outcome-based healthcare environment. By creating a secure, open and integrated supply chain, organizations are able to reduce cost, increase quality and manage risk across the partner ecosystem. It provides the foundation to quickly and easily extend the partner network for Life Sciences. As you evaluate your business strategies and priorities over the next 12-18 months, collaboration with trusted partners like OpenText can prepare your organization for the challenges ahead. Contact me at jshujath (@opentext.com) to discuss how we can help. If you missed the first blog in this two part series, you can view it here.

Read More

Regulatory Matters: Collaboration is key for Life (Sciences) in 2017 – Part One

Life Sciences

Life Sciences, like life itself, is constantly evolving. The rigid, product-based environment of complementary but discrete healthcare specialists is rapidly being replaced with a fluid ecosystem where growing and global value chains and strategic alliances drive innovation and price competitiveness. Secure collaboration is key as Greg Reh, Life Sciences sector leader at Deloitte says: ” All of the pressures that life sciences companies are under, be they cost, regulatory or operational, in some way shape or form can be de-risked by adopting a much more collaborative approach to R&D, to commercialization, to manufacturing and distribution”. As increased collaboration touches every part of a Life Sciences business, there are a number of trends that will affect most companies during 2017. Prepare for uncertainty in the compliance landscape There has been a great deal written about the affect that the Trump administration will have on regulatory compliance.  Amid all the uncertainty, Life Sciences companies can’t take a ‘wait and see’ attitude. One thing we do know for certain is that new legislation and regulations will keep coming. Whether the pending regulations on medical devices in the EU  or MACRA  (the Medicare Access and CHIP Reauthorization Act) in the US, regulatory change does not stand still – not even for a new president! We also know that there is greater focus on enforcement. According to law firm, Norton Rose Fulbright, almost one third of all securities class actions in the US in 2016 were against Life Sciences companies, a figure that had risen in each of the previous three years. The company noted that 56% of claims in 2014 were for alleged misrepresentations or omissions. In response, companies have been placing focus on effective marketing content management to develop appropriate quality control on promotional and advertising materials. In addition, enforcement is becoming more stringent is areas such as TCPA and FCPA – where last year the global generic drug manufacturer Teva International agreed to pay $519 million to settle parallel civil and criminal charges. Within extended value chains, compliance becomes an increasingly collaborative process to ensure that information is available to the regulators. However, in compliance, collaboration is working both ways. Life Sciences companies need to be more collaborative as global regulators and enforcement agencies are already cooperating with each other. As global regulators and agencies share information and work together, it becomes even more important to manage compliance risk across the organization and beyond. Consumer price sensitivity continues to drive value-based pricing models According to Statista, the sales of unbranded generic drugs almost doubled between 2005 and 2015. In Japan, the government has an objective of substituting 80% of branded drugs with generics by 2020. There is increasing price sensitivity within both the buyer and regulator communities. Within many economies, the depressed fiscal environment limits the potential for healthcare spending. Governments and insurance companies want to shift payment for product sales to patient outcomes. In fact, the U.S. Centers for Medicare and Medicaid Services (CMS) wants 90% of all Medicare payments to be value-based by 2018 . This value-based pricing model places extra burdens on drug companies but also offers opportunities for the organzations to maintain the profitability within branded drugs. It provides the opportunity to look ‘beyond the pill’ to look more at the patient and what they’re doing. This requires end-to-end evidence management systems that exploit the masses of data created through managing patient outcomes to deliver value-added services around patient wellbeing, rather than simply selling more or more expensive drugs. At OpenText, we would expect most digital transformation efforts to include an element to enable the correct environment for value-based pricing, especially as operational efficiencies and time to market are improved. Part Two of this blog is available to read here.

Read More

Digital Disruption is here! What are you doing about it?

dis·rup·tion ( disˈrəpSH(ə)n/) – disturbance or problems that interrupt an event, activity, or process. There’s a whole new conversation happening at this year’s OpenText user conference around Digital Disruption and the emergence of the Information Enterprise: What it is, how to manage it, and why it offers unprecedented opportunities for everyone involved. Despite the negativity of the definition above, disruption is not necessarily a bad thing for your organization…if you’re prepared. The only way to compete in the midst of this whole digital disruption thing is to evolve, transform, and fully embrace digital technologies. Period. At this year’s Enterprise World, our Industry experts will discuss how you, our customers, can utilize next generation OpenText solutions to transform and take advantage of digital disruption rather than just being…disrupted. This new platform promises a better way to work, and it helps customers meet the changing nature of work with: Better Engagement– relentless focus on the customers Better Productivity – maximize output from employees, teams, and the ecosystem Better Innovation – foster visibility and business processes Better Insight – make well-informed decisions Better Control – mitigate risk for your organization and its takeholders Read on to see what our Industry Strategists have to say about Digital Disruption and how OpenText can help… Life Sciences Jaleel Shujath Wearable devices, 3D printing, the Internet of Things, Personalized Medicine, Digital Healthcare. These concepts and technologies are rapidly transforming the way how therapies are discovered and manufactured and how healthcare is delivered. Nowadays, it’s not uncommon for counseling to be delivered via a smartphone app and it won’t be long until prosthetic devices will be created while the patient waits. Maintaining regulatory compliance with the need to innovate is a delicate balance indeed. But how can Enterprise Information Management solutions help your company navigate these treacherous shoals, to determine the right course of action, to manage risk appropriately in the face of ever increasing regulatory scrutiny, to ensure that patients are safe? These are tough questions to answer and for each company the answer can be different, but the answers are there. Here are some steps to get started: 1. Decide to evolve sooner than later – evolution happens when an organism responds to the environmental pressures around it and adapts accordingly. In life, adaptation can be random and not every response will work. In business, you have the power of information to calibrate and guide you. 2. Partner with your vendors – have open discussions with your vendors about your long term goals and find out what your vendors goals are. We’ve already begun to do this with many of our existing and prospective customers. You may learn that you already have the technology in house, but haven’t evolved its use within the organization. Explore your options. 3. Develop your best ideas – you know you can’t do everything but there are low hanging fruit that can deliver quick results and drive efficiencies. Often, this gives you the breathing room and confidence to tackle that Big, Hairy, Audacious Goal. 4. Use your data – analytics comes in three major buckets: reporting, proscriptive, and predictive. These all have great potential in any enterprise if used effectively to ground your organization in reality and take some of the subjectivity out of risk analysis. If you’re coming to Enterprise World, look for me at the Disruption Zone or at our Life Science User Group meeting, to discuss some of your initiatives. If you won’t be at Enterprise World, email me at jshujath (a) opentext.com to start the conversation. Let’s evolve! Public Sector Patricia Burke For decades, government organizations have pursued the goals of “effective” and “efficient” by streamlining and consolidating operations. During that same period, however, the world has changed dramatically. Computers, emails, electronic documents are the way we all work and that work takes place in an increasingly smaller, highly converged world. It’s a world where all organizations, including the former government monopolies, are in competition for public engagement and to contribute to their countries’ prosperity and security. Yet, for many, the paper-dependent bureaucracy still exists. Fast-moving technology developments now enable governments to make moderate investments to rationalize their existing IT landscape and move aggressively to truly digitize operations—creating interactive web capabilities and online transparency and moving beyond those to take advantage of opportunities for connectivity at all levels with citizens. Connectivity with inanimate objects through the IoT is broadening governments’ capacity to rethink how to use this new capabilities to move to a new paradigm of service delivery and regulation. So for government organizations, the challenge is huge—materially transform the way we work to move to Digital Government. But government agencies are not alone in that pursuit. OpenText has committed the last several years to acquiring top-of-the-line technology and invested in developing the market’s most advanced fully-integrated technology stack to enable that transformation. We help you at every stage to move from paper to digital: to engage and manage interactions with citizens personally; to connect documents and email to your system transactions; to store, govern and analyze videos and other rich media; to find the right information in seconds; to analyze it and use analytical dashboards to monitor performance. If that sounds like an agency of the future that your government should embrace, come share that vision at Enterprise World next week. Financial Services and Insurance Susan Feinberg and Gerard Gibney Corporate bankers face an unprecedented set of challenges as they attempt to fend off digital disruptors while also meeting the demands from clients for better and faster integration, real-time transaction processing and enhanced transparency. This is further complicated by an ever-evolving regulatory regime that requires continual investment in systems, processes and analytics for risk reduction and reporting. Identifying strategic partners that can assist in achieving digital transformation in this challenging environment by offering solutions that enable better ways to work without “breaking the bank” — not only for the banks themselves but so they can position themselves to offer better ways to work for their corporate clients — is of the utmost strategic importance in 2015. The traditional paradigm of implementing a particular technology to solve a single problem no longer works when digital disruption is threatening the banking industry’s role as trusted intermediary. In order to survive, banks must find ways to transform themselves in order to be as innovative as their non-bank competitors while staying engaged with the clients to ensure that innovation is being focused in the right places. Leveraging the cloud to enhance agility and time to market and using analytics to better understand client behavior and anticipate their needs are two key areas of investment for forward-thinking financial institutions. Having a platform that supports innovation and client engagement without sacrificing the control and governance needed in a highly regulated industry is not a nice-to-have, it is a requirement. Insurance companies continue to seek ways to meet the challenges of Digital Disruption, as well as declining agent numbers and lost profits from near zero interestrates. While they want to sell more insurance policies, investments and annuities online this is not as easily accomplished as some would think. It is still a truism that these products are sold, not bought. Insurance companies will need to transform themselves to survive in a world with fewer and fewer agents to rely on. To be successful in this new world, especially with the Millennial eneration, they must provide rich, personalized omni-channel customer experiences, so they can take advantage of a 360-degree view of the customer to better engage with them at every touch-point. The heart of digital transformation is a relentless focus on the customer. However, that focus needs to be translated into the preferred communication method in order to be extremely effective. Insurance companies will need to become much more digitally adept. Doing this will allow them to gain better understanding of their customers, markets, and business in order to make smarter decisions and personalized recommendations.This will give them the ability to differentiate themselves and their products and succeed in the future. Manufacturing Mark Morley Today’s manufacturers need access to a single source of truth relating to digital product information. Information management technologies are advancing quickly and manufacturers have a choice of how they manage their enterprise information, either on premise, cloud or a hybrid approach comprising of part cloud and part on premise. The days of implementing a collection of servers in a new plant to manage operations are long gone; the advances in network connectivity, mobile technologies and information management capabilities are changing the ways in which manufacturing CIOs manage their IT infrastructures. At Enterprise World 2015, we will be showcasing our next generation information management solutions which can be managed either on premise or in the cloud. These new platforms will introduce new ways in which to access, manage and interpret enterprise related information. Many manufacturers are now taking the opportunity to restructure global supply chains and redesign information management platforms, here at OpenText we certainly believe we have the best in class Enterprise Information Management solutions to provide internal and extendedenterprise users with a better way of working with digital information. To find out more information about some of the breakout sessions that may be of interest to manufacturing companiesattending Enterprise World 2015 in Las Vegas, then please click here for further information.

Read More

Regulatory Matters: The Year Ahead in Life Sciences

As I began to write this article to prognosticate on the year ahead, I recalled a Ladies’ Home Journal article from 1900, where an engineer named John Elfreth Watkins, Jr. predicted what life would be like in the year 2000. Surprisingly, many of his predictions, such as the use of cell phones, had actually become reality by 2000. Luckily, government regulations ensure a somewhat predictable rate of change making my job somewhat easier than Mr. Watkins’. But first, let’s take a quick look back at 2014… 2014 was a great year for life sciences, particularly the pharmaceutical industry. Forty-four drugs were approved by the FDA, an 18-year high. When compared to the dismal 27 approvals in 2013, there seems to be some much needed innovation occuring, especially considering the estimated $100 billion loss in patent protection this year. In 2015, the biggest challenge will remain to innovate and launch products faster while maintaining the highest degree of patient safety amidst increasing global regulatory scrutiny. The industry is poised to meet this challenge head on. In fact, seven drugs have already launched for 14 indications in January. At the heart of this challenge is to solve the dual Big Data and Quality problems. Every year, exabytes of data are being created within our industry. Digital technologies, such as remote monitoring and wearable devices, are only increasing the data points. However, data quality is a critical issue. Corporate data warehouses are rapidly becoming akin to landfills with ever growing piles of digital garbage obscuring the nuggets of information which can have a truly transformative effect on the business. I predict that, this year, much effort will be placed on developing and refining methodologies and technologies to make sense of the massive amounts of data generated by our industry. Improved statistical tools, real-time analytics and information exchange will yield important correlations and allow life science companies to discern which data and which process improvements enhance the business. In effect, quality processes and metrics will be applied to functions beyond manufactuing in building better models for everything from drug safety and efficacy to supply chain operations. For those companies with ECM and BPM platforms, incorporating new digital technologies into their workflows will dramatically improve their business but only if aligned with a solid EIM strategy based on industry best practice. For those companies without an EIM strategy, the time to move forward is now. Come hear how OpenText is helping global organizations to utilize information to transform their businesses at one of the Innovation Tour events near you. Keep innovating!

Read More

Regulatory Matters: Why the FDA cares about your spam emails

Does anyone read the emails in their spam folder? If you did, you would most certainly find emails from online pharmacies based abroad advertising Cialis, Viagra, and other well-known pharmaceutical brands, available sometimes without a prescription. These medicines are often counterfeit, stolen, or expired and represent a major threat to global health. Activities from counterfeit medications are estimated to cause thousands of deaths globally and generate between $75-100 billion annually (representing about 10% of global pharmaceutical revenue!) There are many reasons why adulterated drugs are so prevalent, but the main reason is perceived cost savings by the consumer. As I spoke about in my last blog entry, securing the pharmaceutical supply chain has become a major focus of the US FDA. With the passage in late 2013 of the Drug Quality and Security Act (specifically Title II, entitled Drug Supply Chain Security Act), the US Congress has outlined the plan over the next 10 years to develop and build an “ electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” These “track and trace” laws, as they are commonly known, are part of an ongoing effort over the past 30 years to establish a federal track and trace system. This law in particular will allow the FDA: · to enable verification of the legitimacy of the drug product identifier down to the package level · enhance detection and notification of illegitimate products in the drug supply chain · facilitate more efficient recalls of drug products (1). Along with other laws, such as FDA Safety and Innovation Act (FDASIA), the FDA has been granted broad powers to investigate instances of counterfeit and illegally diverted medication, conduct seizures, and levy fines. In a recent demonstration of enforcement this past May, the FDA worked in conjunction with Interpol and law enforcement, regulatory agencies and postal authorities from 111 countries to seize over 19,000 packages containing illegal prescription drugs obtained through online pharmacies, in Operation Pangaea VII (2). This was followed in June by the FDA’s shutdown of nearly 1700 online pharmacies and the arrest of 58 people and seizure of $41 million of counterfeit medications (3). While certainly a blow to online pharmacies, these operations highlight the severity of the problem. Certainly, this isn’t the first attempt to establish an electronic track and trace system. A 2006 compliance document on the Prescription Drug Marketing Act of 1987 defined the concept of an ePedigree document to accompany a drug which incorporates manufacturing and distribution information and is amended by each touchpoint along the supply chain. In 2007, EPCglobal, a global standards organization, ratified an XML standard (EPCIS) to enable electronic transmission and appending of drug information, as well as allowing for serialization. However, most states which currently mandate Pedigree information allow for a variety of formats, such as text files, spreadsheets, and PDF. California has adopted the EPCglobal XML standards which will be phased in starting January 2015. Given the size of the California market, this will likely be the de facto national standard until the FDA releases its own standard in the coming years (4). So what does this mean for pharmaceutical manufacturers and distributors? The implications are wide and far reaching, especially with billions of dollars at stake, and will require these companies to evaluate their IT infrastructure needs within their lines of business, particularly finance, quality, manufacturing, and distribution, as well as among their suppliers and vendors. By November 27th of this year, the FDA aims to publish draft guidance on establishing standards for interoperable exchange of transaction information, history, and statements in paper or electronic format. Whether this information will be stored within RFID, barcodes, or some other system is unclear. However, OpenText, with its ECM (documentation) and Information Exchange (EDI) solutions, is well suited to handle these types of information, regardless of whatever the standard ultimately turns out to be. To begin the conversation on how OpenText can help, please feel free to contact me at jshujath (@) opentext.com and don’t forget to empty out your spam folder once in a while… 1 Source: FDA.gov 2 Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398499.htm 3 Source: http://usatoday30.usatoday.com/money/industries/health/drugs/story/2011-10-09/cnbc-drugs/50690880/1 4 Source: http://www.pharmacy.ca.gov/laws_regs/e_pedigree_laws_summary.pdf

Read More

Regulatory Matters: What you should know about new FDA Supply Chain Security regulations

Last week, the European Medicines Agency sent warning letters to healthcare professionals across Europe about falsified and/or tampered vials of Herceptin, Roche’s potent drug for breast cancer. It appears that the vials were stolen in Italy, had their lot numbers modified, and reintroduced into the supply chain. This is a growing problem, not only in the EU, but in the US as well. In response to the growing threat of counterfeit, adulterated, stolen and diverted medications entering the pharmaceutical supply chain, the US Food and Drug Administration (FDA) has implemented several important regulations highlighted within the Drug Supply Chain Security Act and the FDA Safety and Innovation Act (FDASIA). As with any global enterprise, the risks of maintaining supply chain integrity from manufacturing to distribution across international borders are massive. These risks are multiplied when we’re talking about a nearly trillion dollar industry and where a breakdown can mean injury or death. The FDA estimates that 40% of finished drugs and 80% of active ingredient precursors are imported and has defined a rigorous process of inspections with the stated goal of preventing any type of illegal activity within the supply chain. Title VII of the FDASIA, signed into law in 2012, grants the FDA new authority to address these new challenges and better ensure the safety, effectiveness and quality of drugs imported into the United States. As stated on the FDA’s website, “ Implementation of these authorities will significantly advance its globalization and harmonization strategies and support FDA’s ongoing quality-related initiatives. Further, these authorities will allow FDA to collect and analyze data to make risk-informed decisions, advance its risk-based approach to facility oversight, strengthen its partnerships with foreign regulators, and drive safety and quality throughout the supply chain through strengthened tools. At the same time, implementation of Title VII of FDASIA is difficult and complex, and requires not only the development of new regulations, guidances and reports, but also major changes in FDA information systems, processes and policies.” Pharmaceutical companies and API manufacturers will need to become familiar with these regulations and determine how to leverage existing or implement new technologies to interface with the FDA. These include registration and listing of all drug/excipient manufacturers and importers. One critical aspect of Title VII is outlined in Section 706 which speaks to the types of records required by the FDA and timelines to produce the records prior to an inspection or audit. Having a robust document and records management and recovery strategy has always been important, but under these new guidelines, getting the right information quickly to the FDA is essential to prevent delays in manufacturing or distribution. With over 300 life science implementations, OpenText has long provided validated ECM solutions for pharmaceutical records and process management, and through its tight integration with SAP, ensure compliance with current and emerging FDA and EMA regulations. In the next Regulatory Matters, I’ll go into more detail about the Drug Supply Chain Security Act, which outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, also known as “Track and Trace.” In the meantime, feel free to contact me if you have any questions on how an Enterprise Information Management strategy can increase efficiency and innovation at your organization, while maintaining regulatory compliance. I will also be at the Gartner Supply Chain Executive Conference, May 20-22 in Phoenix, so if you’re in the area stop by the OpenText booth and say hello!

Read More

Regulatory Matters – The Life Sciences EIM Blog

Life science companies, such as pharmaceutical, biotech, diagnostic, food quality, and cosmetic, operate in a highly regulated and rapidly evolving environment. Their operations are both data and document-intensive. Recent demands for increased public accountability against a trend of fewer new products and expiring patents are threatening traditional profitability and revenue growth. Business leaders are tasked with transforming their organizations into innovation centers while maintaining tight regulatory compliance with emerging governmental guidelines such as the US Drug Supply Chain Security Act and the EU’s Regulation (EU) No 1235/2010 . CIOs must enable disparate and often distally located departments to share key information among team members and make the best decisions possible, while dealing with vast amounts of data and information often housed within legacy systems. Organizations that can streamline drug pre-approval processes will have a greater advantage in meeting the challenges posed by emerging regulatory requirements. Streamlining will allow for more investment in research, the development of more candidates, the approval of more drugs in more regions, and the ability to reduce risk. An enterprise strategy for content management results in quicker time-to-market on patented drugs by automating review and approval steps and enabling more rapid creation and submission of regulatory applications. Opportunities for improvement also lie in the areas of distribution, sales, and marketing. How do we improve innovation and growth while maintaining regulatory compliance? Patent expirations and the increasing failure rate for candidates in the pipeline has greatly reduced life science companies’ ability to grow organically. It is estimated that over 150 billion dollars in sales will be lost to pharmaceutical patent expirations by 2018! Additionally, regional price controls on new and existing medications and challenges in marketing pharmaceuticals abroad have further eroded the lifetime value of a drug for these companies. In order to stay competitive and avoid large punitive actions and fines, life science organizations have become increasingly proactive, rather than reactive, in addressing these key areas. The goal of this blog is to discuss emerging regulations and other challenges related to the life science industry and how EIM can help life science organizations maintain regulatory compliance and information governance. I hope you find this blog useful in your daily work. If you’re interested in hearing about how OpenText solutions can help with specific regulations, please comment below or email me at jshujath (at) opentext.com and I will write about it in a future blog. Stay tuned for the next blog on the US FDA’s Drug Supply Chain Security Act.

Read More

Big Data and Information Governance in Life Sciences

The clamor around big data’s applications and how best to tame them was one of the key themes which emerged at this year’s BIO International Convention, held in Chicago. Hosted by the Biotechnology Industry Organization(BIO), the event drew 13,594 industry leaders from 47 states, theDistrict of Columbia, Puerto Rico, U.S. Virgin Islands and 62 countries. I was there and fortunate to have the opportunity to gain first-handinsight into the industry’s challenges and opportunities, as well as thestrategies and tactics that forward thinking companies are utilizing toextract value from Big Data and improve the therapeutic options ofpatients. The volume of datagenerated by all aspects of life sciences is staggering. Estimated to bearound 150 exabytes in 2011, this almost inconceivable aggregate ofinformation has been increasing at a rate of 1.2-2.4 exabytes per year.To put this in context, one estimate holds that all words ever spoken byhuman beings could be stored in five exabytes of data. And just howmuch is an Exabyte? An exabyte is 10^18 bytes, or one million terabytes. Truly staggering! Theincredible vastness of this information presents an unprecedented set ofopportunities for the biopharma enterprise, particularly aroundpersonalized medicine and companion diagnostics. It also presents somestiff challenges regarding information governance: All this data must becaptured, curated, stored, searched, shared, transferred, analyzed, andvisualized while maintaining 21 CFR Part 11 compliance. The scene at BIO was set in the first day’s Personalized Medicine and Diagnostics Forum. One of the sessions, Big Problems Need Big Solutions–Fixing the Health Care System Using Big Data, addressed the potential value biopharmaceutical companies could realizethrough exploring the databases of payers, hospital groups, and CROs,in addition to their own datasets. An integration of these datasetswould allow researchers to determine which patients will benefit fromcertain drugs and which could experience side effects. It would alsoassist in identifying patterns and causality in complex diseases,potentially feeding back into the drug development process. How might an integration, synthesis, and governance of data such as this be achieved? OpenText specializes in providing Enterprise Information Management(EIM) solutions that can help life sciences organizations deal with thechallenges of Big Data. From Electronic Lab Notebooks and LIMS to FDAfilings, OpenText Pharmaceutical & Life Sciences solutions ensure compliance with federal regulations for data governance while helping solve critical process challenges. What about the future? New ways of delivering solutions are being explored. Is innovation in the cloudthe answer – might it be the new “space” to accelerate scientificdiscovery and development? Subsequent sessions at BIO delved into thisquestion and others, exploring the trends, challenges, and bestpractices of drug development in the cloud as it relates to ecosystempartnerships, data analytics, and compliance. Aswe work to implement current capabilities and aim toward futurestandards-based collaboration, the conclusion is clear: Collaborationacross biopharma, technology providers, and regulatory agencies will beessential to develop the standards, technology, and approaches necessaryto critically evaluate data and generate useful information forimproved health outcomes in patients. The taming of Big Data is not asimple task for Life Sciences, but the innovation that can flow fromthat is well worth the effort! Now is the time to get on board and explore the possibilities.

Read More