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SAP for Life Sciences

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The Life Sciences industry is changing dramatically, for many reasons. Not only patent expirations are a driving force behind this. The needs from patients and care providers are rapidly evolving. For example, patients are hyper-connected to the internet and to one another. According to a survey by McKinsey in 2014, more than 75% of all patients expect to use digital services in the future, as long as those services meet their needs and provide the level of quality they expect. At the same time, scientific complexity is also increasing. Chronic diseases will continue to be hard to tackle, and due to ageing populations and other factors, as per WHO deaths by chronic diseases are projected to reach 52 million annually 2030. Further, there are also other incurable diseases, populations are ageing, globalization is unstoppable, and more and more countries are moving towards healthcare reforms that pay per outcomes, i.e. they will start reimburse according to the efficacy of a therapy.

 

In the face of these trends, true transformation will not come from smaller incremental improvements, but rather from finding innovative ways to do things fundamentally differently. The game has already started. Here just a few of many possible examples of front-runners:

 

  • Genentech launched the first drug for specific genetic markers to fight breast cancer. Herceptin was approved for all HER2 positive women in 1998. Herceptin is still very successful in sales, as it has been among the top 10 best-selling drugs in 2012, 2013 and 2014. Since the late 90s, many other therapies for specific genetic arrays have been introduced, and life sciences companies have been including genomics, proteomics, transcriptomics
    and other –omics into their research in order to further develop personalized medicine. The market for personalized medicine will have reached 2,452 billion USD by 2022 globally – and obtaining first-mover advantages will be key to become a market leader.

 

  • Novartis is working towards the ability to manufacture for batch-sizes of one in order to offer T-cell receptors to enable tumor-targeting therapies. In this therapy a patient's own T cells are reprogramed to "hunt" cancer cells that express specific proteins. After they have been reprogrammed, the T cells are re-introduced into the patient's blood; they proliferate and bind to the targeted cancer cells and potentially kill these tumor cells. This will imply
    to use technology for on a single patient level.

 

 

  • And, Alphabet, formerly known as Google, is developing smart lenses that read glucose levels in tears. This will not only be differentiating as it avoids inconveniently taking blood drops at specific times, but as it will continuously be able measure the values. The contact lens will further be able to communicate the values to other devices automatically, which can trigger alerts and workflows for the patients and doctors, and enable connected care scenarios. The market for glucose monitoring alone will grow to 568.5 million USD by 2020. Similar connected care scenarios are applicable for many other chronic diseases as well as for wellbeing and prevention.

 

There are of course a lot of more life sciences companies that have developed astonishing innovation. Other examples than personalized medicine, precise manufacturing, or connected health include bionic 3D-printing, artificial intelligence built into medical devices, as well as much smarter collaboration across the life sciences value chain. Behind the scenes, market leaders not only in pharma, medical devices, and biotech, but also from consumer products, high tech and other industries are researching on the next breakthrough business model that could change the landscape in life sciences.

 

What are your competitive advantages today, and how could latest business and technology trends disrupt them? What major challenges are you currently facing, and how might new technologies help you solve them?

 

Join the conversation on Twitter on @SAP_Healthcare and watch out for the hashtag #SAPDigital-LS-Enterprise. Last not least, don’t miss the SAP Digital Life Sciences Enterprise Event on September 22 in Princeton, New Jersey!

Oliver Nuernberg

Open-SCS Webinar

Posted by Oliver Nuernberg Aug 12, 2015
Serialization or Track&Trace is one of the key-topics in the Pharmaceutical supply chain today. In an effort to standardize communication between enterprise systems, site and line servers and the printers and scanners which is required to make serialization work, the Open-SCS group has been formed. In a webinar Charlie Gifford, Executive Director of the Open-SCS, discusses how the Open Serialization Communication Standard Working Group’s (Open-SCS) was specifically formed to address the lack of compliance standardization for healthcare packaging
serialization regulations.  The Open-SCS is focused on accelerating compliance to the global healthcare counterfeiting regulations. The industry urgency is explained for immediate development of standard inter-plant serialization solutions to accelerate deployment and lower
the high cost of available compliance systems. So please consider this webinar:

 

Title: Healthcare Providers Urgently Drive the Open- SCS Initiative as a Serialization Compliance Solution

 

September 3, 2015: 10:00 AM EST USA, 4:00 PM CET

 

Register: https://attendee.gotowebinar.com/register/8496286256348427522.

 

The Open-SCS was formed by distinguished group of founding members: Abbott, Teva Pharmaceutical Industries Ltd., Famar Health Care Services, Mylan Pharmaceutical, NNEPharmaplan, SAP AG, OptelVision Inc., Systech International, Werum IT Solutions GmbH, and Antares Vision Srl.

 

Open-SCS (www. opcfoundation.org/open-scs) operates as an OPC Foundation partner as a chartered working group evolving relationships with GS1, Rx-360, ISA and ISPE to accelerate work product releases in months and not years. With all healthcare providers and vendors
working together, the Open-SCS provides the right track with their new standard and implementation specifications by the end of 2015.

 

Join us on LinkedIn: Open Serialization Communication Standard Group (Open-SCS)

 

Contact for program scope and operations questions:

 

Charlie Gifford, Executive Director, Open-SCS

  www.opcfoundation.org/open-scs

Charlie.gifford@cox.net, +1 208-309-0990

 

Contact for a Member Subscription Program:

 

Thomas J. Burke, President, OPC Foundation

  thomas.burke@opcfoundation.org , +1 330-357-8013

 

About The OPC Foundation

 

Since 1996, the OPC Foundation has facilitated the development and adoption of the OPC information exchange standards. As both advocate and custodian of these specifications, the Foundation’s mission is to help industry vendors, end-users, and software developers maintain interoperability in their manufacturing and automation assets. The OPC Foundation is dedicated to providing the best specifications, technology, process and certification to achieve multivendor, multiplatform, secure, reliable interoperability in industrial automation and related domains. The organization serves over 440 members worldwide in the Industrial Automation, IT, IoT, Building Automation, Oil & Gas and Smart Energy sectors. For more information about the OPC Foundation, please visit

https://opcfoundation.org .

 

Internet of Things (IoT), health wearables and health apps can undoubtedly improve the collaboration between physicians, patients and payers. Sensors can continuously measure body traits such as blood sugar, body weight, electrodermal activities of the skin, heart beats, and many others, and transfer them to doctors and patients in real time. This can enable new therapy approaches for illnesses like diabetes, depressions, cardiovascular diseases and many others.

 

Faster, Better Patient Care

 

If doctors and patients detect unexpected trends – be it because a therapy does not show the efficacy as intended, or be it that the patient was not able to change behavior towards a healthier lifestyle, they can intervene immediately rather than waiting for the next regular appointment weeks or months later. The opportunity goes beyond increased transparency: Technology can send alerts, and you could also imagine that intelligent algorithms will recommend the right actions to get back on track.

 

Outcome-Based Payments in Healthcare

 

Health wearables can also trigger new opportunities to develop outcome-based payment models in healthcare. The collected data not only documents therapy adherence by the patient. It also shows if specific indicators have improved or worsened. In other words, if the key parameters measured by health devices and analyzed by IoT-technology improve as predicted or exceed expectations after the patient has taken the drug in the correct way, payers can be sure they invest in the right therapy. Even in the opposite case, doctors and patients get the ability to adjust therapies more quickly and flexibly than without this technology.

 

More Opportunities for R&D in Precision Medicine

 

All this can be taken one step further. If scientists are provided with the aggregated and anonymized data that has been collected by health wearables, they will have a much broader statistical base than before. They can slice and dice the data points in new wys and find new therapies that are tailored for specific patient populations. As a result, the individual preconditions of each single patient can be considered during the choice of a therapy much better than before.

 

A Push for Life Sciences Companies to Engage More Strongly in Prevention

 

Connected care can also provide an enhancement for life sciences companies to add value for doctors, payers and patients for prevention. They can just use the whole concept, but encourage starting measuring health indicators at a formally healthy person that is at risk to get a disease. One example of a life sciences company that steered competencies strongly into prevention of diabetes is Roche Diabetes Care with Accu-Chek. They offer a connected care package that measures steps, glucose levels in blood, and weight not only with the objective to manage diabetes better, but also to avoid diabetes through positive behavioral changes such as more exercise and healthier nutrition.

 

Data Privacy: A Show Stopper?

 

Data privacy is key to enable the main precondition to make it all work: trust from all players, especially doctors and patients, is needed before they participate and share data. It seems that optimism about the potential advantages are higher than concerns on data security risk. According to a study by The Economist Intelligence Unit in 23 countries, 79% of healthcare executives say that mobile technologies including health wearables provide education and information today already, while 50% believe that mobile health will help patients to proactively participate in their own care. McKinsey found out that more than 75% of patients expect to use digital services in the future.

 

What do you think about IoT in health sciences, connected care and patient engagement? Please join the discussion in the comment field below and on twitter @SAP_Healthcare!

These are exciting times for SAP Life Sciences.    SAP will be releasing our “next generation” product that is specifically designed to enable compliance to global pharmaceutical serialization regulations that can scale to address the massive volumes that will be generated from unit level serialization, provide “out of the box” country reporting to global agencies and seamlessly  integrate the contract manufacturers and packagers into the end to end process. In my previous blog “The Rapidly Changing World of Serialization in Life Sciences” I discussed how the evolving legislative landscape was creating a complex business environment to meet the global requirements. Because of the overwhelming positive customer feedback and validation on our new product release we are very excited. We believe the solution that we developed with our 14 co-innovation customers is very strong and will meet and exceed both the regulatory requirements but also our customer expectations as an outstanding solution for the industry.

 

 

Fast Forward to 2017 – Moving Beyond Compliance

 

 

With that in mind, let’s move the clock forward to 2017 when customers have deployed the SAP solution, I’m not able to use the product name until its official launch on September 15th,  and the market now has serialized products located across the pharmaceutical value chain.   Compliance is no longer a concern as the process is working smoothly and the industry now has near real time visibility into millions of serialized products moving across the value chain every day.   Is your company aware that they have a new treasure of data they can leverage to create incremental value?   And, if so, what will they do to leverage it?

 

 

For example, the pharmaceutical industry has one of the most complicated sales contract processes of any industry in the world.   Manufacturers create complex agreements with group purchasing organizations and wholesalers that leverage chargebacks and rebates against a variety of performance metrics.  As has been the case for years, wholesalers will continue to submit EDI documents listing millions of line item shipments that require a chargeback or rebate reimbursement.

 

 

In the new world of serialized inventory, all claims from the wholesaler to the manufacturer will reference the individual serial number in the electronic document that can be tracked and validated by the manufacturer.    This is a critical change in the flow as now the manufacturers can validate a variety of criteria including:

 

 

  • Is the serial number valid?
  • Did the wholesaler actually buy the serialized product from the manufacturer?
  • Has the wholesaler ever submitted the serial number previously on other chargeback or rebate documents?
  • Was the serial number sent to another wholesaler in the same or other global market?      

 

Putting the Finger on Product Counterfeits and Parallel Trade

 

 

As manufacturers begin to answer these questions, they will start to unlock tremendous opportunities to not only protect patients and their brand while generating tremendous value for the organization.   Clearly, if the serial number is not valid they could have identified counterfeit product and they can respond quickly to minimize any impact on patient safety.   If the wholesaler never purchased the serialized product from the manufacturer, they could have bought the product from the “grey” market, or they could have transacted with another wholesaler who is diverting product from one market to another in a parallel trade scenario.    In the past, organizations would not have been able to react in near real time based on the validity of the serial number let alone take action to quickly to stop these activities before they become costly problems that could injure patients as well as the corporate brand.

 

 

Accelerating the Process with Wholesalers: A Win-Win

 

 

Further, the serial number becomes a validation point on any chargeback or rebate and the serial number can only be processed once.   This is especially important as the EDI documents can have very large numbers of line items that could result in between 10% to 50% of annual revenue flowing back to the wholesaler in reimbursement.       An organization’s ability to quickly and accurately validate the processing of that information and eliminate duplicate chargeback and/or rebate entries will result in significant savings for pharmaceutical manufacturers.

 

 

It is clear that as we begin to move across the finish line on serialization compliance we need to shift gears and start to think about how we can leverage this new information in ways that could provide tremendous value to the manufacturers, wholesalers, physicians and patients.    Please feel free to comment on any use cases that your organizations are evaluating to leverage the serial number visibility and drive value for your organizations, and to discuss with us on SAP for Life Sciences on SAP Customer Network (SNC) or on Twitter at @SAP_Healthcare .

Where is the life sciences industry heading for?

 

4022566308_855b9c8934_m.jpg

 

Last week, I had the pleasure to attend the German SAP Life Sciences Infoday kindly held at the facilities of Boehringer Ingelheim. It was packed with trending topics. Here are my personal highlights from the event.

 

 

Hot Topic #1: Big Data Everywhere: in Manufacturing, R&D, Finance, Marketing

 


In-memory technology seems to be the key for the future of Life Sciences. In almost every discussion, new scenarios and business models enabled by real-time interactions came up. Some examples:

 

1. Life Sciences R&D: Big Data in Life Sciences R&D seems to be a natural fit.


It can help navigate through multiple data models to filter the right data in clinical studies. Often, a multitude of applications are used for clinical trial analysis – which consumes valuable time. One report can take up to four weeks due to validation of computerized systems. Processing all the different data formats in one platform can save all this time and allow for real-time reporting and prototyping.

 

Of course in precision medicine and in personalized medicine, the ability to work intelligently with Big Data is key. The majority of health data including genomic or proteomic data, images, medical publications, doctor letters, is unstructured. As a result, in many cases a lot of valuable data that could unveil new insights stays untapped. Big Data tools are able to run sematic researches that take into account different terminologies, analyze graphical data, slice and dice –omics data, and more. The nice thing is that it can also turn any kind of analysis into graphical representations, which are much easier to understand for us. Any kind of peaks become visible immediately and draw our attention to new insights, such as specific mutations in genes responsible for a specific kind of response to a medication.


2. Manufacturing and IoT: The Internet of Things (IoT) will mean a great leap forward for Life Sciences manufacturing. Sensors in machines can monitor and analyze characteristics like pressure or heat, and they immediately can send alerts if any exceptions occur or if limits are exceeded, so that maintenance staff can intervene to prevent any bigger damages or outages. All the data collected by sensors over time can be analyzed through predictive analytics in order to detect signals in even earlier stages, so that any disruptions can be avoided proactively. This technology could also support Continued Process Verification.


3. Precision Marketing: What if a life sciences company could analyze online and social media behavior in real time, sense trends and needs immediately and respond with their campaigns accordingly and timely? This would be actually a win-win, as customers from wholesaler to patient would receive the information they are looking for more quickly, and the brands awareness would increase. Big Data analysis makes it possible, as it can process any amount of data in any formats in real time.

 

4. New Business Models: One key message at the event was that Big Data analysis does not only mean higher speed and higher precision. It also can  open up opportunities for new business models. One concrete example at the event covered SAP HANA Cloud Platform: Roche put an IoT scenario into practice with their connected health package “Accu-Chek” to fight diabetes. Through a smart wrist band and a sensor in their glucose reader, patients can automatically track their health data in a mobile app and connect with their doctors more quickly. Vice versa, doctors can analyze the health status of their patients more precisely and quickly and react accordingly to improve outcomes.

 

 

Hot Topic #2: Supply Chain Integrity – More than “Just” Compliance

 

 

Supply chain integrity is about patient safety. It’s about us, our children, our neighbors. Any kind of copied drugs or medical devices can bring risks to people’s health – either because there are cheaper hazardous substances contained than in the original, the active ingredient is not contained, faked implants don’t meet safety standards, or because drugs are distributed without complying with Good Distribution Practices – the list can be continued. Legislation and regulation across the globe have been implemented to mitigate this health risk. Not only in order to not only fulfill these requirements, but also in order to save their reputation and public health, Life Sciences companies continue to prioritize supply chain integrity.

 

 

Hot Topic #3: Contingent Workforce – It’s Not About Efficiency Only

 

 

There was one interesting conversation I would like to share. The question was how contingent workforce can be enables and motivated to work as productively as possible. The advantages of higher flexibility don’t pay off if the contingent workforce is not properly on-boarded, and not continuously trained enough to achieve the top quality levels. Cloud solutions can intensify collaboration between external workers and the hiring company resulting in a win-win situation for both parties: higher performance on the one hand with more identification with the brand and satisfaction for the contingent worker at the same time on the other.

 

There were many more best practices and discussion points included in the event – this is just a short snapshot. What are your key priorities for LS this year? Please join the conversation in the chat below, or through @SAP_Healthcare on twitter!

 

 

Photo credit: “Direction” by Ram Karthik on flickr

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”.

 

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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.

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