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SAP for Life Sciences

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The Challenge: Pressure from Authorities

Yes, we need to talk about Compliance! In the end, all core business processes in pharmaceuticals, be it procurement, manufacturing, sales or services are impacted by legislation and regulations. In this particular case, compliance even is the main driver behind probably all track & trace projects that are currently being executed in the industry. And even though some companies are already looking beyond pure compliance, trying to figure out how to derive additional value (and I will cover this in Part 3 of this blog-trilogy), the primary goal is to become compliant with the various track & trace regulations.

 

 

It Won’t Stop: Ever-Changing Global Track and Trace Requirements

As mentioned in a previous blog, the legislation to be applied is the one in force in the product’s target market. This means, the target market where a product ends up, determines which regulation actually takes effect; the only exception to this basic rule is India which established legislation for the export of drugs. So it is extremely important to get a good sense of the world wide legislation and to keep eyes and ears open for new emerging ones. So far, Turkey, China, Korea, India and Argentina have active legislation with Brazil being next in Dec. 2015 and the two largest markets following in 2017 (US) and 2018 (EU), respectively. Also look out for news from Saudi, Jordan, Russia and some more… but ultimately it’s a moot point to list them all as they change so quickly. So make sure to connect to your local sales subsidiaries who are dealing with the local legislators anyhow, reach out to service providers in this space or SAP as a matter of fact to get the current details. At SAP, we have established a serialization round table where more than 40 pharma companies meet regularly to exchange news on current and upcoming legislation as well as serialization project details and roadmaps.

 

 

Becoming and Staying Compliant: Key Considerations and Recommendations

All legislation includes a change on the product packaging, at a minimum the application of the serial number. In some markets, like the European Union, additional safety features are required by law, for example to prevent the replacement of the content of a valid package. These changes to the art work of the sales package have to be executed along very elaborated processes within the company and will require approval or reporting to the various authorities. This takes time and processes should be started way in advance.

Also, as serialization, i.e. the application of a unique identification on the product package, is a product attribute required by law, all related processes will become subject of validation in a GxP-sense, e.g. following GAMP standards. So basically all the requirements which are well known in GxP-scenarios like for example Part 11 rules for security, and electronic records, apply (check out the SAP Global ERES Regulations Whitepaper for details). This implies a solid validation plan to be in place for the entire “computerized process” including a potential vendor audit.

The validation of the computerized process will also include a re-validation of the packaging line. In most case, the packaging line will undergo significant reconfiguration changes as additional components like printers and scanners are added.  The validation must also include the software connected to printers and scanners and their interface to e.g. SAP solutions for track and trace.

 

 

In a nutshell:

  • Build a network with your peers and suppliers to align on national legislation as well as best practices
  • Prepare for an end-to-end validation of the packaging process including any computer system
  • Ensure during the vendor selection process that all your software can actually be validated.

To always stay on top of latest developments and best practices on track and trace in Life Sciences, watch out for the next blog! Please also feel free to approach us and to follow us on @SAP_Healthcare. We very much look forward to hearing from you, soon!

Several years ago I decided it was time for a lifestyle change.   I had been a college athlete who, like many of my peers, spent my post college years running, lifting and playing sports to try and stay fit while enjoying some healthy competition.   As the years went by, the high imact routine began to take its toll on my body and, although I didn’t have any major injuries, I decided I needed to do something new.

 

My youngest son introduced me to Bikram yoga in the middle of a cold January several years ago.   Bikram yoga, also known as “hot yoga”, effectively translates to yoga in 105 degrees and 40% humidity.    The heat is provides warmth to your muscles and, consequently, improves your flexibility as you put yourself thru series of poses that is unlike any workout I’ve done before.   After years of practice, I have greater flexibility, eliminated the majority of my chronic body aches and pains and improved my core strength.    Not what I would have expected but it seems to work for me.

 

Interestingly, I see many similarities in my yoga journey to that of the many recent Life Science innovations.  Clearly, the patent cliff and decreasing R&D productivity of the 2000’s mandated that things had to change.   Fast forward to 2015 and we are beginning to see the initial results of the industry’s early efforts.   Personalized medicine continues to progress as researchers and physicians leverage advances in genomic research to identify patient populations who have improved therapeutic outcomes resulting from common genomic footprints.   Researchers are using modified HIV cells to successful treat leukemia patients with staggering results.   Amgen is demonstrating tremendous potential using a genetically modified form of the polio vaccine to treat brain cancer.         Bristol-Myers Squibb’s cancer immunotherapies are teaching the body to kill cancer cells with little or no side effects.    Simply stated, these are  remarkable innovations as the industry begins to rebuild their R&D momentum.

 

Further, the chronic body aches and pains of decreasing margins are beginning to ease as the industry is returning to profitability.   Although the M&A churning continues keep muscles tense as organizations look for the ideal portfolio of branded, generic and consumer pharmaceutical products while others look to combine drug and devices to provide a unique delivery system that improves the outcome and experience for the patient. 

 

All right, so maybe my yoga analogy isn’t perfect but it is exciting to the see the industry that basically defined the term R&D begin to produce the lifesaving innovations that we have come to expect from them.   I look forward to continuing to work with the industry in enabling these and the many other innovations that will change the lives of patients across the globe.   Namaste!

Life sciences companies have an extremely high responsibility to make sure that they bring to market drugs and medical devices:  they need to be safe, high quality and efficacious. For manufacturing organizations in life sciences, this means they need to focus on risk, quality, and time to market. The Internet of Things (IoT) brings new opportunities for life sciences companies to achieve that.

Connected-by-Michael Josh Villanueva-flickr.jpg

Photo credit: "Connected" by Michael Josh Villanueva, Jan 2, 2010 on flickr

 

High quality, high productivity, speed – the IoT makes it all possible

 

The IoT enables direct machine-to-machine interactions, it can provide real-time detailed insights through sensors, and consequently facilitate remote tracking, monitoring, management and networking. Because of this, the IoT can improve speed and precision of production planning. Direct real time information from product components, batches and machines enables the use of predictive analytics tools to foresee and proactively mitigate quality risk.  Similarly, sensor data from machines can trigger insights that can be used to maintain the assets before any failures occur sooner rather than later. All this helps life sciences companies secure patient safety and fulfill their needs timely and efficiently.

 

Enabling personalized medicine

 

The most exciting aspect is that the IoT enables efficient manufacturing processes for products used in personalized medicine. The IoT allows plants to produce batch sizes of one, since parts or batches can communicate directly with machines, which then interact with software that concludes the next work orders from this information that the machine directly applies. This video illustrates how it works.

 

Stronger patient-centricity for medical device companies

 

For medical device companies, the IoT can increase customer-centricity around customer service and of the product itself. They mostly deal with products that are not only at very high value, but also impact patients’ health. Because medical devices are often used long term, the patient experience with these products should be leading edge. Continuous signals from these devices can be monitored in order to anticipate maintenance needs, proactively initiate processes for service technicians, and/or alert the doctors to act on time before any issues occur. All this sensor information can go back to the manufacturer, which can further help to improve manufacturing processes or to develop a more customer-friendly design. Before, neither the depth and quantity of data nor the technology to deal with Big Data were available to draw these kinds of conclusions.

 

Not only from a pure product quality point of view, the IoT has great potential for the life sciences industry. It can also improve therapies, the patient experience, and doctor to patient collaboration. Through wearables, body traits can be measured constantly, which enables patients to control their health better, and physicians to adapt therapies according to the patients exact condition. Roche Diagnostics Accu-Chek is one example that points in this direction.

 

The ability to connect machines, people and processes in real time boosts collaboration like never before. Combined with predictive analytics tools that are able to handle Big Data and to separate valuable pieces of information from the noise, IoT will bring completely new opportunities beyond  saving time and increased precision; time will tell!

 

If you want to discuss with us how SAP solutions can help Life Sciences companies make IoT a reality and benefit from its opportunity today, attend the SAP Manufacturing Industries Forum June 23-25, 2015 in Lombard, IL, USA. View the event brochure to learn more.

On May 6, Bill 276/2015 (Original in brazilian Portuguese) was submitted to the Federal Senate of Brazil that intends to postpone the implementation of the traceability system in Brazil. The bill proposes a staged implementation throughout 10 years counting from January 2015:

 

  • Until Jan. 2019: Requirement to serialize all products both locally produced and imported,
  • Until Jan. 2022: Establish drug chain communication system for transmission of data for the National Drug Control System,
  • Until Jan. 2025: Establish consultation mechanism for data access of ANVISA

 

In its newsletter dated 13 May, Interfarma, the association of the research-based pharmaceutical industry, has re-iterated that it is "in favor of the traceability, because it is an important step towards a more ethical market with a better protection to patients and fairer competition conditions". Interfarma has offered to support a postponement in view of the "delay of other sectors of the industry and the difficulties of other segments, such as the public sector, distribution, and retailers" to implement the Track&Trace regulation in Brazil along the current timeline. It suggests a revision of the the existing deadlines that would result in the need "to present the first lots only in 2016 or 2017 and the final deadline would be 2018". The association has emphasized the goal to implement traceability in the shortest possible time frame and therefore has refused to support the request of the other sectors of the pharmaceutical chain to get a 10-year postponement.

Patients’ needs around the world sound pretty simple: they need best therapy outcomes, the right drugs and devices at the right time, and the costs to be covered by payers or at least be affordable.

 

The truth is that fulfilling these needs is challenging for the life sciences industry. Complexities include:

  • Long, complicated, and costly research cycles for new drugs and devices that can slow availability of better therapies that improve patient outcomes
  • Disjointed global supply chain and manufacturing processes for drugs and devices that can delay delivery of high-quality products to patients
  • Inability to communicate consistently to all segments from wholesaler to physician across channels, slowing the time to value for drugs or devices used in therapies

 

Moving forward, life sciences companies must analyze genomic, proteomic, scientific, and other data in real time, collaborate with research partners effectively, align demand and supply efficiently, establish global process and quality standards, and provide a unique customer experience to the entire target market and ecosystem. To achieve this as quickly as possible, simplifying processes wherever possible will be the first step.

 

But simple is not easy! How can life sciences companies fight complexity? The following areas are the best starting points on the journey to simplification:

  • Increase R&D productivity by analyzing Big Data in real time to drive personalized medicine
  • Streamline sourcing and procurement by using business networks to collaborate with third parties
  • Ensure traceability of drugs and devices through automated and accountable processes
  • Achieve operational excellence by harmonizing inside and outside manufacturing and by minimizing risk through predictive analytics
  • Consistently demonstrate product and services differentiators to payers, patients, physicians, and caregivers through one easy-to-use platform available across channels

     

These examples show that running more simply enables life sciences companies to achieve benefits such as accelerated growth rates, optimized spend and working capital, compliance across the enterprise, and increased market share and customer loyalty. Life sciences companies can also accelerate  integration processes after M&A and maximize shareholder value by using flexible and real-time analytics on one single platform across the enterprise.

 

Simplification is not just a bold idea; it is becoming real across the industry. Here are some successes of first movers: Medtronic has accelerated global complaint handling and global sales processes significantly, MKI analyzes genomes quickly, Himedia Laboratories generates reports fast, and Roche Diabetes Care facilitates personalized health management.

 

These are just a few of many best practices in the dynamic life sciences market. What are your observations and greatest stories? Please let us know your thoughts in the comment area, and discuss with us on twitter @SAP_Healthcare!

As promised in an earlier blog I want to shed some light on how SAP is approaching the existing and emerging requirements around track & trace in the pharmaceutical supply chain and share our view on how these projects should be approached.

 

When companies approach this subject they first and foremost do so to be compliant with certain regulations that already exist or are emerging worldwide. This is not a question of whether to react or not! Pharmaceutical Market Authorization Holders (MAHs) have to do so just to stay in business. So the key questions are: How can I become compliant and what does this cost me? And how can I stay on top of emerging regulations so that I stay compliant? But also, thinking beyond compliance: Shouldn’t there be some benefits that I can harvest to at least create some return on investment? And to achieve all this, how should I shape my track & trace strategy overall to be successful?

 

Today, I will focus on the strategic view and will address the compliance details as well as potential benefits in separate blogs.

 

Establishing track & trace (aka. serialization) within a pharma company requires executive sponsorship. The efforts spread too far and are too expensive to look at this as a tactical effort. Just the costs for implementing serialization printing and inspection on the packaging line range from €250k for pure serialization to €500k if aggregation is in scope (with similar numerical values in US$ for North America). Therefore companies should involve all business areas like:

 

  • Package Engineering for changes to the package artwork,
  • Procurement for any changes that might impact the supply of e.g. packaging materials, equipment and services like outsourced manufacturing,
  • Engineering for implementing printers and scanners in the packaging line, as well as aggregation stations and enhancements to palletizers,
  • Logistics to implement the changes in warehouse operations, pick and pack operations and shipping,
  • and of course IT as all this needs to be supported by an integrated and global track & trace solution.

 

Here are some thoughts on how to approach such a project:

 

Make yourself knowledgeable

This should be a given, and there is plenty of good content out there in the internet free of charge. However, most of this is rather high level and the famous GS1 “flag” slide has probably been copied a million times by now. But to understand this topic you have to go deeper, so talk to your peers in the industry. There are some good conferences out there with my favorite being the one hosted by Movilitas (like the last one in Frankfurt… and this is not just because of some cool videos from the explosives industry that also has dedicated requirements for track & trace).

 

In general it is my impression that people dealing with this topic are willing to share their knowledge, as everybody gains from collaboration. SAP has for example established a serialization round table for our customers where traceability experts of more than 40 companies meet regularly to exchange news on upcoming legislation, share successes as well as challenges within the projects and with the software being used. This round table was the driving force to shape SAPs track & trace strategy. In that context we have also established a collaboration group on SAP JAM where all participants can document and exchange world-wide legislation news and information.

 

 

Act now!

Even if current legislation doesn’t affect you, new legislation is just around the corner. My urgent recommendation is that pharma companies start their projects now to comply with e.g. EU Falsified Medicine Directive (FMD) to be ready when it becomes effective by late 2018. Even though this seems to be far away, do not underestimate the effort to equip your packaging lines, adjust your processes, train people and establish the central IT infrastructure. Most companies are going after the same resources, both on the hardware equipment as well as the consulting side, and if you want the best, you should secure these resources now. There are already signs of skill shortages in the market.

 

Select you vendors wisely

To successfully implement your track & trace strategy you must engage with hardware providers to equip the packaging lines, software vendors to provide the central IT infrastructure (like the repository and serial number management capabilities), as well as consultants.

 

Serialization projects are a little different from classic SAP projects. Very often the setup for one plant or one packaging line cannot be copied easily to another location 1:1, so only parts of the project can be “rolled out”. Other aspects may need to be looked at for every country, every plant or even every packaging line. So you should make sure you engage with a consulting company with dedicated know-how in the area of serialization that understands the vertical integration requirements from the line all the way to a global repository.

 

Different strategies exist for connecting the packaging lines to the central track & trace infrastructure. While some hardware vendors propose an end-to-end solution including the full plant site-server capabilities others go for a best of breed. While the first eases the integration it locks you in to a specific hardware vendor. The second option provides more flexibility and allows introducing latest scan and printing technology but of course adds the burden of integration. However with the creation of the new “Track and Trace Working Group”, the industry is trying to standardize the connectivity between packaging lines and IT systems.

 

And last but not least, think about how you want to setup you central repository. Make sure that this repository is truly global, capable to handle the future volumes and allowing to be extended for whatever serial number requirements may emerge. Make sure to get the deployment flexibility you need so it’s you to decide whether to deploy the solution in the cloud, on premise or in a hybrid approach. And remember that track and trace solutions must be validated so a vendor audit may be necessary. Ensure that your vendor has a roadmap for upcoming legislation and is actually able to execute this.

 

 

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Now what’s next? SAP engaged with 13 leading companies, including 9 of the top 20 pharmaceutical companies to co-innovate a next generation track & trace solution capable to handle the upcoming volumes at a reduced TCO. During this co-innovation process our customers helped SAP define and review the specification, and even the design of the target solution, to ensure that SAP delivers the right capabilities in time to provide immediate value.

 

In addition, to address the headaches caused by the need for collaboration between supply chain partners, SAP has started an adjacent initiative to solve this problem as well. I will cover this in a separate blog soon.

 

 

To further discuss and to share best practices, come and meet us at SAPPHIRE NOW in Orlando  May 5-7, 2015 at the Life Sciences demo station  as well as in the interactive micorofurm “Fulfill Track and Trace Requirements in Life Sciences”.

 

And ultimately, if you want to learn how SAP approaches supply chain integrity for pharma, please watch the video:

 

 

According to Thomson Reuters, the Life Sciences industry had 119 merger & acquisition (M&A) transactions reported in Q4 2014.   Although the number of deals was only slightly more than the 117 transactions from Q3 2014, the value of those deals was more than twice the previous quarter increasing from $50 billion in Q3 2014 to $114 Billion in Q4 2014.   The M&A activity is primarily fueled by access to R&D pipelines as the pressure to get new drugs and devices to market continues to grow. 

 

 

But as organizations grow through acquisition, they are faced with a new set of priorities and complexities that threaten the expected benefits of any transaction    CFOs must quickly understand their new cost structures, demand curves and operating models across the entirety of the IT system landscape while creating a business plan to operationalize their new company.     Further, this process needs to be automated to ensure scalability, repeatability and reliability of the information generated.

 

 

SAP’s recent announcement of the new S/4 HANA platform is both timely and transformational for the Life Sciences industry.   First, SAP’s S/4 HANA is the only enterprise system in the world that allows users to have real time access to transactions and analytics on the same platform that can radically transform and simplify business processes in ways that were not previously possible.    Further, S/4 HANA has unique capabilities that allow it to import transactional level data from SAP or non-SAP systems, in real time, to allow complete financial visibility for companies involved in M&A.

 

 

For example, an organization runs SAP acquires a company who runs SAP and non-SAP IT systems.   Typically, organizations would begin the process of integrating the systems, generating endless spreadsheets, aggregating all types of data and then repeating the process for every reporting period.    SAP’s S/4 HANA platform allows an organization to transmit, in real time, its line level transaction data, no aggregations, no indexing and/or no integration, into the S/4 HANA system where the new company can use the SAP Simple Finance application to generate financial documents, do cash projections and/or view the quarter close, all in real time.  The systems remain in sync due to the continuous real time replication of any source system transaction into the SAP S/4 HANA system.      

 

 

Additionally, SAP S/4 HANA has real time transactional data from the new company that can create operational views at any level or function.   One scenario could leverage all the transactional data with the SAP’s Sales & Operations Planning application to enable a consensus planning process that integrates demand, inventory, finance, manufacturing and sales transactional information from across the new organization.  The information is manipulated and simulated in real time based on the executive recommendations to generate the consensus forecast for the new company.    Executives can quickly assess how and where they will realize the synergies of the acquisition and focus on generating the procurement and operational savings that will be realized months and quarters earlier than without S/4 HANA.

 

 

Lastly, the new world of Life Sciences requires companies to be nimble, flexible and responsive to a rapidly changing and challenging business climate.    Mergers & acquisitions, healthcare reform, serialization legislation and emerging market expansion are just some of the many critical business issues that require technology platforms that can deliver information to users in real time and in context of the business process while still allowing for flexibility when the market inevitably changes.   SAP’s S/4 HANA has the ability to deliver the transformational technology, elegant user interfaces and simplified processes that will enable the success of Life Science companies in 2015 and beyond.         

Medical wearables and mobile health apps are hot in the press, as these technologies promise to be a fast growing market given the ability to bring huge advantages to patients of being better informed, and to get better treatments. Numbers seem to confirm that there is not just a buzz behind this topic, but a real trend around mobile health technology evolving – if players get data security concerns resolved, as you can see in the infographic “Healthcare on the move: Changing outcomes and lives”.

 

Inforgraphic-mobile-health_aaa.jpg

 

These numbers are the result of an investigation by The Economist Intelligence Unit where 144 leaders in healthcare organizations and manufacturers of pharmaceuticals, biotech, and medical devices in 23 countries were interviewed. It also states that a majority of 65% of all private companies in the survey responded that they expect mobile solutions to help patients to benefit from better health outcomes through better medical information, and 62% of all private companies think that an increase about personal data will help patients and doctors improve decision-making about therapies and health.

 

Overall, the future looks bright for mobile health apps and most probably also wearables. For today, we are still at the starting point of a whole new market to evolve. First steps have been done already, for example by Roche Diabetes Care. SAP and Roche created a mobile app based on the SAP HANA Cloud Platform to help physicians and patients collaborate better, sharing data online and gaining a constant view of health parameters, which enables both to intervene before the disease worsens.

 

To find out further which trends, opportunities and challenges healthcare organizations and life sciences companies are considering as key, please read the full Economist report “Power to the patient: How mobile technology is transforming healthcare”.

Imagine multiple GMP critical systems across different plants, departments and across the globe… No wonder this creates a lot of complexity for the people who control access to these systems.

 

Authorisation checks for access to systems is often cumbersome and, more importantly, not risk-free. In my experience, the processes around Access Control often face these problems:


  • It is manually managed in disparate systems
  • Authorisation on access approvals is poorly documented and managed
  • Segregation of duties is often completely overlooked, unclear, not documented and subject to change during the life cycle of systems
  • Authorisation on access approvals has no relation with training/qualification records
  • Emergency or temporary access is not supported and poorly documented
  • Access Control is not audit-ready at every moment in time


Needless to say, the problems above can lead to inappropriate, unauthorised access, which ultimately can lead to higher risks in the operation, non-compliance with 21 CFR Part 11 paragraph 11.10(d)/(g)/(i), loss of proprietary information and misuse of systems.

 

The graph below shows quality and effort of authorisation checks without an automated Access Control tool:

 

 

Figure 1: Quality and effort without AC tool


It is clear that this graph is very reactive, and therefore volatile. In a controlled/regulated environment this is of course undesirable.

Creating a business case for automated Access Control

That said, making a case for an automated Access Control system can actually be quite straightforward because you can measure direct impact by recording and analysing:


  • The access request process, with requests, changes and their throughput times and documentation
  • The efficiency of the approval process
  • A list of systems that are (or should be) subject to Access Control
  • The internal and external audit findings
  • Possible risks of SoD
  • Extent of compliance with GMP regulations such as 21 CFR Part 11 (Electronic records; Electronic signatures)


In the following figure, we have mapped the quality and effort of an automated tool onto the same graph. It is obvious that the effort is high when kicking off an implementation project like this, but the return on investment on quality and reduction of effort is achieved relatively quickly.

 

 

Figure 2: Quality and effort with AC tool


In my opinion, manually managing Access Control within (large) GMP critical environments is nearly impossible. The risks of non-compliance due to human error increase as new applications are introduced more rapidly and the IT landscape becomes increasingly more complex.

 

Introducing automated tools can help in structuring the requesting and management process. The additional benefit is that you have an extensive check on the current state.

 

Looking for help to build your business case? Get in touch!

Necessary Evil

 

As a Computer System Validation (CSV) consultant I've participated in numerous SAP ERP implementation projects. Whereas most SAP SCN blogs are written from a functional or technical point of view, through this blog I'd like to share my experiences from an alternative perspective. CSV is often perceived as documentation overhead. Validation is often seen by project members as a necessary evil that does not make a useful contribution to the actual development and progress of the project. I too have concluded from recent discussions in the LinkedIn CSV and SAP groups I often visit that this perception is very widespread. But is it valid? In my opinion it isn’t. Not only does CSV reduce your regulatory risk, it also increases understanding of your SAP business processes during the implementation project and enforces a structured, well-defined method of project execution, with the potential to save both time and costs. While this is not an easy task, the CSV consultant (or CSV SME) has a major role to play in achieving these benefits.


Acting after the event

 

Speaking as a CSV consultant, it unfortunately is not unusual to join a project as the validation SME to discover that the implementation of SAP is well underway, the ABAP’ers have completed their work and the users are geared up for acceptance testing. You have been requested to dig up some specification documentation, to take care of traceability retroactively and to please the Quality Assurance (QA) resource so he or she will not pose a risk in terms of meeting the project go-live date. Fine. You get started and give it your best shot, but given the circumstances it will probably not be the most rewarding assignment you have had, nor will the validation be of real value from a regulatory perspective.

 

Engagement is key

 

The situation described in the example above could have been very different if there had been a better common understanding of the value of CSV and acknowledgement of the position that QA and the validation role should have in a typical SAP implementation project in a regulated environment. There are many professionals – even in life sciences – who do not  realise that Regulatory Affairs (RA) and Quality Assurance (QA) are ultimately running the show in a GMP world, not a Project Manager (PM) or IT. This is why I would advise to kick off SAP projects with a GAMP 5 and/or GxP awareness training. While most of the life sciences professionals are familiar with GxP, it turns out that a brief refresher helps the project team to better understand the context in which they will be carrying out their project responsibilities. It is actually a kind of a preventative session that helps “sell” CSV to fellow team members and avoid friction at an early stage. It’s also done in order to clarify to the group that CSV is an extension of RA/QA and should not be confused with an activity carried out on the side by an IT department.


Leverage the things you will do anyway

 

On a positive note, I’ve worked with team members on many SAP projects who understand that “validation” means documenting the good things that they were doing as part of the implementation anyway. For example, why not leverage your blueprint documentation by converting it into a Functional Design Specification as deliverable and input for the validation package? From a project management perspective, why shouldn’t you integrate the main validation activities in your project planning and combine them with your ASAP milestones?


The CSV consultant’s mission


In addition to the aforementioned enabling factors, the CSV consultant’s influence is key in turning CSV into a beneficial project activity. A professional CSV consultant will always defend good validation practice for the actual value it adds and not hide behind regulators such as the FDA in order to justify its use. Anyone can read a procedure or Part 11/Annex 11, but it is the CSV consultant’s task to understand the underlying quality requirements and their implications for SAP ERP, explain the intent of those requirements and transform them into validation practice.

 

The mission of every CSV consultant should be to ensure that the design, customizing and ABAP developments are specified and that the SAP system is verified as fit for its intended use. This can’t be done by over-testing, over-documenting, obtaining numerous approvals or pulling the “but what if the FDA…” card. Educating fellow project team members and being an enabler through active participation across all project phases is key in completing your mission. Personally I strive to minimize the documentation effort by working risk-based, leveraging existing and supplier documentation (if possible, making use of SAP Solution Manager!), without compromising on regulatory and procedural compliance. Based on a good rationale, you should dare to say ‘no’, instead of generating huge piles of documentation just for the sake of it. After all, validation isn’t done by the kilogram.

 

Making CSV work in an SAP implementation

 

Difficulties in interpreting regulations and applying CSV techniques “from the book” have shaped the perception of CSV as being a project burden in SAP implementations. But in the hands of a competent consultant, CSV will likely yield time and cost savings at project start-up and even greater downstream savings by avoiding costly retrospective validation and project delays. CSV must be a risk-based effort that focuses on the regulator’s core concerns of product quality, patient safety and data integrity. By integrating it with your project management and ASAP processes, CSV ultimately delivers a SAP system that is as robust as it is compliant.

In the previous blog, UCB’s strategic approach how to achieve complete visibility in the pharmaceutical supply chain and to comply with serialized track and trace regulatory requirements was outlined.


In this blog, Stéphane Aubert, Director IT – SAP Logistics Execution and Program Manager Serialization Track&Trace – IT with UCB, shares five principles which were followed to successfully run the implementation project.

 

1. Anchor the business value firmly

 

Defining the business value was vital to get business buy-in, as well as to keep on track with the right focus. In this case, the key value was easy to determine: compliance. Non-compliance would lead to the inability to distribute our products on various markets, meaning numerous patients not receiving their treatments, so the investment was clearly justified.

 

2. Determine requirements early on

 

When the project started in 2012, regulatory requirements for serialized pharmaceutical products were not clearly defined. UCB needed to base the project on assumptions. The first key decision was to keep technical requirements as simple as possible to be able to adapt when regulatory requirements would become clearer. Further, the advantages of corporate standardization had to be balanced with the requirements of the local specificities. Consequently, a top-down and a bottom-up approach had to be combined. To minimize cost and complexity, the SAP standard was applied where possible and a pilot was also implemented to confirm the selected design before rolling-out solution to production environment.

 

3. Cooperate with stakeholders and use staff project carefully

 

The high level of dependencies across business domains, locations and suppliers required strong integration to ensure alignment and accountabilities. Legal and process requirements had to be checked on global and local levels, joint validation of key rules were agreed on early, and close collaboration helped promote acceptance.

 

The project was staffed with executives, talented employees from UCB and top consultants from implementation partners, e.g. Accenture and Advanco. In addition, strategic resources were allocated to build the final solution, coordinate the parties, and manage the transition to support organizations.

 

4. Ensure timely delivery, effective tracking and proper risk management

 

The program was complex. The solution involved new technology and high level of interdependencies. This meant UCB had to be prepared to deal with unforeseen issues. To ensure on time delivery, a close pulse was taken on the development progress and testing. Corrective measures were taken on a weekly basis, especially on prioritization and parallel phase execution to ensure maximum adherence to plans.

 

In order to anticipate issues, the team built a tool that mapped processes, scenarios, developments and tests scenarios. This gave visibility of interdependent components that enabled the team to quickly identify how an issue in one area cascaded into others and thus better assess the true impact.

 

Risk management was run carefully, as UCB was dealing with a validated environment with GxP relevant components and as the project touched upon core business processes, i.e. production, warehousing and distribution. A centralized issue and risk management log was used as of day 1 and placed in the central collaboration site for continuous project control.

 

5. Manage change and achieve operational readiness

 

Lastly, before going live, change management and training played a key role. Expectations were managed proactively, organizational and cultural changes prepared in detail, and strategies had to be in place to overcome possible resistance.

 

Disciplined project management was worth the effort. UCB achieved readiness to existing serialization and track & trace regulations, prepared for upcoming ones, and improved performance and quality of the manufacturing processes.

 

 

Stéphane Aubert                                                                                                    Susan Rafizadeh

Director IT – SAP Logistics Execution                                                                   Life Sciences

Program Manager Serialization Track&Trace - IT                                                 SAP

UCB

Drugs can save lives and give us relief from illnesses and pain – people rely and trust in them. But high quality of drugs is not a natural given. Recent incidents on product counterfeits have raised the awareness that an effort is needed to make sure that patients actually get what they think to be sold, and also other unexpected events may require companies to recall products – which should happen quickly and entirely.


Here is how UCB developed a best practice in cooperation with Accenture and Advanco to secure patient safety, which was awarded with SAP Quality Award 2014 in Belgium and Luxembourg with Gold in the category “Business Transformation”.


Challenges: achieving regulatory compliance and patient safety

 

The question drug manufacturers need to solve is how to secure patient safety. How can drug counterfeits and other unexpected events be avoided proactively, how can product recalls be done quickly and efficiently, and how can drug expiries be detected early enough?


This is a task UCB, a global pharma and biopharma company located in Brussels, has identified as priority to solve at the highest quality level. There are global regulations for track and trace in pharma in place, and the regulatory landscape for pharma serialization has been and will be continuously evolving further. On top of complying with all these existing, upcoming, and changing regulations, UCB wanted to go one step further by leveraging the investment made into compliance and also benefit from a process performance and quality perspective all across the supply chain. Not an easy task, but they did it!

 

Winning strategy: inclusion of all parties through standardized approach


The key to stay compliant with all global serialization requirements now and in the future, to ensure safe market supply all over the world and to further improve operational quality was standardization. All sites, product lines, and external partners like Contract Manufacturing Organizations (CMOs) or Third Party Logistics Providers (3PLs) should adhere to a standardized way of communication.

 

The reasons behind this approach can be explained as follows: The communication chain can be easily disrupted as they all work in siloes. They have different quality processes and different systems to capture and organize data. This means, it’s hard to stay updated at any point in time, and errors can occur easily through multiple data entries. The manufacturer of the product is accountable for compliance and to make sure that all data are accurate, complete and timely available. The standardized approach not only enabled UCB to gain complete and valid global visibility and cohesion on each product through the entire supply chain. It also saves IT cost and allows to adopt best practices quickly across the organization to maximize global performance.

 

Of course local specifics and constraints cannot be ignored to achieve realistic successes, so the IT solution driving the processes needed to allow room for flexibility on top of supporting a standardized concept. UCB running one single instance of SAP as corporate ERP system, the technology the project was based on was chosen quickly. The solution provides a single source of truth on product data from production to sales and distribution for all involved stakeholders including packaging and logistics of all plants globally, for CMOs, 3PLs, Wholesalers, as well as for authorities.

 

Creating an overall idea may sound easy, but probably everybody agrees putting it into practice can be quite challenging. How the way to success looked like will be outlined in the next blog “UCB Awarded for Pharma Serialization 5 principles leading to their success “.

 

 

 

Stéphane Aubert                                                                                                                                 Susan Rafizadeh

Director IT – SAP Logistics Execution                                                                                                Life Sciences

Program Manager Serialization Track&Trace - IT                                                                              SAP

UCB

Brazil is one of the markets that is pushing hard to implement legislation. While anti-counterfeiting is one of the drivers for the initiative the high risk of tax evasion is definitely an additional issue that the BRazilian Government wants to tackle.

 

The Brazilian government body ANVISA published Resolution RDC 54  on December 10th, 2013. RDC54 already covers quite some details about how track and trace in Brazil should look like. It clearly states the applicability to all prescription drugs subject to registration at the National Health Surveillance Agency and explicitely includes free samples!

 

In addition the following requirements are included:

  • Serialization on unit level is explicitly required.
  • It is also required by the Registration Holder to track any unit down to the point of dispensing.
  • Imported products have to be serialized before import.
  • Tracking will be based on the Unique Medication Identifier Code (UIM), which includes
    • Medication Record number at Anvisa (13 digits),
    • Serial Number (numeric 13 digits),
    • Expiration Date,
    • Lot Number.
  • Aggregation is required as per Art 9 §2 which states that the transport packaging must contain an identification code in which all IUM that composes the packaging is related.

 

Chapter 3, Art 7 explicitely calls for non-deterministic randomization of serial numbers and for serial numbers that must be unique across the product produced by the MAH. In the meantime it was clarified however that both requirements wil be implemented in a reduced fashion: deterministic randomization will be accepted and only the serial numbers for products that will be sold in Brazil have to be unique.

 

As per the orginal legislation as defined in RDC 54, no central government operated database was planned. However, in the recently published "Normative Instruction" of August 2014 a government database is explicitly mentioned. In addition, the Normative Instruction covers the following:

  • Necessity to communicate events from Medication Registration Holder (=MAH) to Anvisa (Art. 1, Art. 10)
  • Necessity to communicate events between supply chain participants (Art. 1,§1, Chapter III). This means that every participant in the supply chain has to send logistic events
    • to the MAH (Art. 4),
    • to the receiving chain member (Art. 6) and
    • to the previous supply chain member (Art. 4) .

Supply Chain members also have to send all communication received from the posterior chain member to the previous chain member and the MAH (Art. 5) and have to send differences between declaration and real product to both to previous supply chain member and MAH (Art. 6, §2)

  • The MAH is responsible to monitor logistic movements (Art. 1,§4) as defined in Art 2, Chapter II, including the Creation (medication “emerges”), Change of ownership (“passage between members”) and Decommissioning (“extinction”) of medicinal products.
  • Art. 3 cover the definition of "Logistic Events" and includes „purchase“ and „sales“ which in SAP‘s view are not logistic events and needs to be further clarified, but it also explicitely includes Free Samples.
  • The normative instruction also includes the requirement to report “anormalous events” (Art. 12) like movement of medication with IDs not generated by MAH, Duplication of IDs and rReporting of decommissioned IDs.

 

So overall, this will result in a huge number of messages being sent back and forth as layed out in the use cases below.

 

Brazil_Scenario_1.jpg

 

Brazil_Scenario_2.jpg

 

Brazil_Scenario_3.jpg

 

Brazil_Scenario_4.jpg

 

 

To ease the pain of sending all the messages back and forth a network model is currently in discussion and in the past few weeks some more details have emerged through the collaboration with the different stakeholder organizations like interfarma and Sindusfarma. Stay tuned for some more news!

 

PS: The original documents and english translations are available and can be shared with SAP Customers.

Biotech companies can differentiate already through the ability to process large amounts of data from different sources, i.e. to gather it, consolidate it, represent it in a comprehensible way and to deliver it safely. Some biotech companies already offer this as core service. Those ones who can validate the quality of data and extract the relevant information have a competitive advantage. In-memory technology even opens up more opportunities as different data formats including unstructured texts can be consolidated easily and quickly from various data sources.

 

Another way to positively stand out in the market is the ability to analyze raw data that biotech companies can get by collaborating with hospitals using smart
algorithms. To do this, a biotech company can pursue two possible strategies:

  1. Providing an added value by processing Big Data very rapidly through a comparably simple algorithm or
  2. Offering insights from relatively few data from various sources by using a highly complex algorithm.


Both approaches can be pushed by technology. Big Data solutions offer the necessary IT-capacities to process huge data masses in extremely short time periods as well as the capability to run data mining in an intelligent and quick way.


Examples indicating the future direction

There are many success stories to tell already how Big Data technology helped advance personalized medicine:

 

The National Center for Tumor Diseases (NCT) has gained new insights to fight cancer. The project “Medical Research Insights” which is based on the in-memory platform SAP HANA helps develop new personalized therapies. Employees can now capture enormous amounts of data per patient and analyze in  real time. No matter if we are looking at medical reports, MRT results, genetic analysis and cancer registry data, all information come together in one central place. It can be found out very quickly which therapy has the greatest probability to work best at which patient.

 

„ProteomicsDB“, a database focusing on the human proteome that was jointly developed by one of Munich’s universities, Technische Universität München (TUM), and SAP supports scientists to explore the human proteome and conduct fundamental research. When building up this database, the human proteome was captured in an unprecedented degree of completeness, assessed in a structured way and pooled. Extremely high data volumes and various scattered data sources were coped with.

 

Alacris Theranostics has come up with an innovative Virtual Patient Platform that allows to accurately analyze the exact type of cancer of a specific patient and to find the best therapy. In the background molecular data of the patient and algorithms are used to derive the behavior of the tumor and to simulate the efficacy of different therapies. The complex mathematical model contains thousands of variables like genes, proteins and tests for every drug and every dose. With SAP HANA these simulations could be reduced to only a few minutes.

 

Stanford School of Medicine has provided a database of genetic predispositions that was combined with thousands of genomes from the 1,000 genomes project in SAP HANA to allow analyzing the data interactively. Some analyses could be accelerated by a factor of 17-600 and others were not even thinkable with traditional setups. Through this database many new opportunities arise, e.g. finding personalized therapies for chronic diseases like diabetes.

 

Mitsui Knowledge Industry (MKI) leveraged SAP HANA to not only extremely accelerate DNA sequencing, but also lower cost for DNA extraction and analysis from 1m USD to less than 1,000 USD. DNA analysis became affordable for many more patients through this.

 

Summing up, new architectures of databases and new IT infrastructures enable to overcome hurdles like complexities as well as high amounts of data and/or data sources and find answers to questions that were not possible to solve before. Further, saving time and computing capacity can enable pharma companies to make sound decision in earlier R&D stages than before, which means saving cost and time to market. Big Data technology also allows understanding illnesses that were not much investigated through clinical studies much better than before. For example, many clinical trials geographically concentrate on Europe which means other regions are currently underrepresented. Big Data solutions can help fill the gap by identifying suitable participants worldwide and process the data. They can also help shift focus of R&D from investigating how to deal with symptoms towards the root causes of a chronic disease and to further advance personalized medicine quicker.

 

This blog was written jointly by Emanuel Ziegler and me. I would like to express to thank Emanuel for all his great insights and support! The content of this blog was first published in a shorter version in German in goingpublic.de

Pharma companies need strong partners for R&D

 

Data and scientific insights are the key to innovation for pharma companies. The need to increase R&D productivity has grown due to the patent cliff, intense global competition, and other reasons. As scientific advances progress rapidly, opportunities are certainly there – but currently paired with challenges.

 

Complex collaboration networks in R&D and personalized medicine

 

To be able to bring innovations to market more quickly and to understand earlier if a R&D project should be stopped or continued, the pharma industry collaborates closely with external partners like biotech companies and Contract Research Organizations from all over the world. From a practical perspective, this means that pharma companies need to be able to analyze data from a large number of partners, and from even more possible data sources – which mostly come in different formats. This especially becomes a challenge if historic data needs to be connected with most recent studies. If this hurdle cannot be overcome, potentially important new scientific results stay unexploited.

 

Not only the complex collaboration networks in R&D lead to massive amounts of data, also the advances in personalized medicine do so. As in personalized medicine, genomic profiles and other individual characteristics analyzed to develop tailored therapies, genomics, transcriptomics and proteomics offer huge opportunities for biotech companies. But the opportunities are tied with challenges from a pure data perspective already.

 

Data privacy

 

Owing to data protection laws, data can become available too late, or it can become less meaningful for further investigation of new scientific questions. One example: If you want to find out if and how traits like gender, region, nutrition or genetic preconditions are impacting an illness, and in which case which  therapy would have the highest efficacy, you simply need a certain set of information about patients. But data is not allowed to be shown in a way that you can draw conclusions about individual patients. The operative word is “can”: It is not allowed that single non-authorized persons are theoretically able to conclude which patient is behind the information – and this can quickly happen if you for example examine persons with a relatively rare illness in a small defined region.

 

This requires sophisticated setups protecting information from unauthorized access and still some problems remain touch to tackle.

 

Varying data quality

 

Data quality can vary extremely for various reasons. Biggest quality gaps can be found in the age of data, data maintenance, and incorrectness of data that can arise from measuring errors for example. Keeping the whole original data set instead of using pre-aggregated data allows finding and correcting such inconsistencies more easily.

 

In future, we can expect that data quality will improve more and more. But even if the amount of useful data won’t be the bottleneck for R&D in Life Sciences, the permanently growing amount of data can be still quite challenging.


Growing data volumes

 

Genome sequencing becomes more and more affordable and even proteomes can be analyzed more and more quickly. Consequently, new correlations can be found faster – e.g. the effect of specific therapies for dedicated genome mutations, which again can provide enormous opportunities to explore complex interrelationships of the human metabolism. Genomes, transcriptomes, proteomes, phenotypes – the amount of data for personalized medicine is growing at breathtaking pace.

 

Hospitals have a great potential to provide a vast amount of high quality insights about the causes of diseases and about clinical studies. In addition, data can be generated directly from patients through wearable medical devices or other mobile devices like smartphones. With growing acceptance from the patient side, data volumes could explode. To fully take advantage of the scientific power of this data, some hurdles have to be taken. Not only to comply with data protection laws, but also from a technical point of view, companies and hospitals need support to capture the data in a systematic way. In most cases, data is generated in different departments within clinics that mostly work in siloes. As an example, data from the internist division, from oncology, and from rehab are needed to better understand the situation of a patient, data capture alone can be cumbersome.

 

Biotech companies who will shine with faster and more precise results for R&D in pharma will be the winners of tomorrow. As outlined above, this is also a Big Data play which can be approached in various ways, which we will describe in the next blog “Big Data strategies for biotech companies”.

 

This blog was written jointly by Emanuel Ziegler and me. I would like to express to thank Emanuel for all his great insights and support! The content of this blog was first published in a shorter version in German in goingpublic.de

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