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SAP for Life Sciences

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The life sciences industry is poised for massive changes as Joe Miles pointed out in his recent blog. Technology will enable making the change real. For example, the IoT alone can change the way life sciences companies run their R&D, manufacture, and interact with customers and patients.

 

IoT in Life Sciences R&D: Higher patient-centricity


Take R&D: Health wearables, smart pills, smart refrigerators, smart scales – every product a patient uses could be equipped with sensors to monitor health traits of a person. This information could provide signals on early indicators of potential diseases, at a much sooner point in time than possible today, or help monitor if a treatment works well in real time. Of course the realistic use of smart devices depends on what the patient or consumer is willing to measure and share. This means, the end user needs to achieve a tangible added value from this. Classic perceived benefits could be prevention or improved patient-doctor interactions during therapies, as these smart devices can also trigger further actions instantly, e.g. alert doctors and patients if any limits are exceeded. Adding sensors and intelligence to a medical device can further improve maintenance of this medical device as it can send signals to the technician early on, so that he or she can plan and conduct maintenance activities before the worst case of a failure happens.


Smarter Production and Supply Chain Management through the IoT


Switching scenes, the IoT can also drive changes in manufacturing. Smart sensors can automatically capture the state of a machine, e.g. its temperature or pressure. With this information, the precision of this machine can be predicted much more precisely, and in case of any risk, maintenance steps can be conducted early on. If the workers wear a smart device, the machines could identify the person and interact with him or her directly, e.g. check authorizations or provide instructions what to do next. In supply chain management and logistics, the ways of batches could be tracked automatically to avoid theft or detect risk of potential delays, or the IoT could help keep up the cold chain.


…Beyond IoT: Other IT Technologies Disrupting Life Sciences


This of course is not a comprehensive description on how the IoT may influence the life sciences industry. What is more, the IoT is not the only technology driving changes. Big Data analytics will massively impact R&D and enable huge advances in precision medicine. In-memory technology will allow life sciences companies interact with wholesalers, payers, providers, and other customer segments in real time across channels. Cloud solutions will simplify collaboration with scientists, hospitals and care providers.


Overall, technology will drive the industry rethink their business models. Outcome-based pricing and offering medical devices as a service are just a few of many models that will come up. This implies that professionals in life sciences across the board will not only need to consider scientific, regulatory and customer-centric factors, but also focus on aspects such as new delivery models, value-added services and potential revenue streams. Successful talents will need to have a much more entrepreneurial mind-set than today – and the tools that allow them to have a holistic view on the entire business.


Want to learn more about IoT in Life Sciences and latest trends in R&D, SCM, manufacturing, and sales and marketing? Meet experts from the life sciences, consumer products, high tech and other manufacturing industries to discuss further at the SAP Manufacturing Industries Forum 2016 on June 14-15 in Lombard, IL. For details, please visit the forum’s website.

The need: Providing life-saving, high quality products from production to service efficiently

 

Physicians, hospitals and care providers across the world rely on high quality drugs and medical devices to deliver exceptional care. With growing amount of patient needs and increasing global regulations to fulfill, manufacturers of life sciences products need to improve operational efficiency levels, and they also need to increase agility to stay compliant with ever-changing and upcoming new legal requirements.

 

In order to achieve operational excellence, flexibility and compliance, collaboration between R&D, supply chain planning, production, quality management, maintenance, distribution, marketing, field services and regulatory affairs has to be tightened. Further, real-time visibility into operational processes, asset status and risk indicators can improve performance significantly.

 

The strategy: Using technology innovations to change the game

 

With business networks, in-memory technology and the Internet of Things (IoT), medical device companies can not only streamline processes within R&D, supply chain management, manufacturing and field services. They can also improve global collaboration between these departments internally and with external partners. This leads to improved productivity and product quality while legal and regulatory requirements can be fulfilled more easily, including Good Manufacturing Practices (GMP), the Drug Quality and Safety Act (DQSA), and Unique Device Identification (UDI).

 

What would be the right technical approach to start with? The first step would be to build a foundation by replacing a large number of legacy applications with one single platform that spans from R&D to services. It should enable real-time analytics, include predictive scenario capabilities, and support collaboration through the integration of different Cloud solutions. Other requirements the platform should fulfill is reliability, flexibility and scalability.

 

With that, optimized operations can be achieved from R&D to services through real-time analysis and transactions, productivity can be increased through decreased documentation efforts, compliance cost can be reduced through harmonization and collaboration can be simplified.

 

An Example: First successes in manufacturing by a medical device manufacturer

 

A large medical device company streamlined their IT landscape and implemented a solution for real-time analytics and reporting. Positive results could be measured pretty quickly: they reduced manufacturing quality reviews from 30 minutes to 10 minutes per batch, and 99.9% of at least 100,000 shipments per month are compliant with DQSA regulations without any manual corrections. They gained the visibility, control, agility and scalability needed to serve growing demand from patients globally. They also could deliver the highest quality products much more efficiently, leaving more time to focus on customers and on innovation.

 

More process innovations to be expected

 

The digital transformation will impact all life sciences processes, not only in R&D, supply chain management, manufacturing, but also in the way life sciences manufacturers interact with wholesalers, payers, physicians, and patients. The possibilities are larger than we might imagine today. New ideas on how to run life sciences businesses in a smarter way will also be inspired by other industries, such as consumer products, high tech and chemicals. Therefore, SAP hosts a yearly event where all these industries meet to share best practices and latest innovations. Want to learn more? Attend the SAP Manufacturing Industries Forum 2016 on June 14-15 in Lombard, IL. For details, please visit the forum’s website.

The world is changing and improving due to technological advancements - even in some unexpected ways. Here are four tools that increase insight, efficiency and safety in your supply chain. All of which benefits patients.

A solid base

It all starts with a solid base. By automating all core processes, including finance, manufacturing, warehousing and quality control, you optimize your entire business. It enables you to become more efficiently and more transparent. An ERP system helps you to mitigate risk while maximizing productivity.

Quality is key

While ERP is valuable for automating processes, patient safety mostly improves with increased quality of the pharmaceutical product. Generally, improvements in patient safety are associated with innovations in lab systems or the development of new production methods. Optimizing your business software, however, can have a surprisingly great impact on the quality of your products and, with that, on patient safety.

 

An integrated quality management system (QMS), consisting of several tools, ensures the highest quality of the produced product. It does so by tackling three problem areas: issue management (Corrective Action/Preventive Action or CAPA), Governance, Risk & Compliance and supply chain traceability.

 

With an integrated issue management tool, you can act upon and investigate any internal and external issues more effectively because you can eliminate paper flows and create a single point of truth. This eventually leads to improved safety and quality and prevents additional cost due to regulatory non-compliance.

The importance of compliance 

Patient safety is not just an essential element of your business plan. It is also increasingly regulated by national and international law. Compliancy is therefore no longer something to strive for; it is a non-negotiable requirement to stay in business. From experience I see that regulatory bodies are becoming more and more keen on critical systems and how you manage these.

 

You can monitor risks and check for incorrect or unauthorized use of your systems with a governance risk & compliance tool. The advantage is that you can quickly act upon possible wrong doings, or even prevent them. This results in a positive outcome on the integrity of your system and users.

 

Finally, a traceability tool offers insight into your entire supply chain. This allows you to see of which batch of materials your product is made up and which route each of these materials have taken. This type of tool guarantees a fully transparent supply chain, data integrity and, with that, patient safety. This way, you can be compliant with strict rules and regulations.

 

Technological developments improve patient safety in many ways. Next to 'classic' supply chain optimizations, an integrated QMS system can significantly increase data integrity, product quality and patient safety.

The digital economy is alive and growing in a market near you. Leading companies in all industries are using digital technologies to change their processes and disrupt their value chains. Why? Because they want to create competitive barriers through exceptional experiences. Think Uber, a company that has transformed the taxi and limousine industries. Or take Apple, which has changed the way consumers access and listen to music. These companies have used disruptive digital technologies to transform their respective sectors.

But how can life sciences companies do this when they operate in a regulated market? What can they do to transform when approving a drug or product can take more than a decade and billions of dollars?

To answer these questions, let’s take a step back. What are some of the key trends driving the digital transformation?

  • Empowered patients:  This is one of the biggest drivers of change in the life sciences industry. Patients are more accountable, informed and connected than ever before. 75 percent of patients expect to use digital services to help make decisions about their health. By sharing data and experiences with other patients through social apps, they are able to get the best results at the lowest cost.


  • Scientific advances:   Technology companies continue to make advances in science, increasing the pace of innovation across the industry. By adapting these technologies to life sciences, firms are creating new, innovative drugs and devices, especially in the area of personalized medicine. Continued advancements in the study of genomes, proteomes and metabolisms, combined with the huge processing power of today’s information technology, are driving a great many innovations.


  • Healthcare reforms. Healthcare reforms have made it critical to focus on cost-effective therapies, higher efficacy and improved patient outcomes. We’re seeing a huge push for value-based care and outcome-based payment models. These are fundamentally different from traditional fee-for-service models.


  • New competitors. We’re also seeing new competitors emerge from across the technology landscape. Companies such as GE, Apple and Google are disrupting traditional health markets as industry boundaries begin to blur.


Clearly, these trends suggest a major change from today’s blockbuster drug and fee-for-service health market. But are you prepared to adapt your business models and processes to compete and thrive? To do so, you’ll need to be ready to leverage a digital health sciences network using the latest digital innovations. For example, patients are more connected than ever, as sensors and devices capture data and provide new insights. When this data flows through the network, it enables unprecedented collaboration between patients, physicians, providers and producers, which can dramatically improve outcomes.

At the same time, digitization makes it possible to drive insights across value chains. For example, using sophisticated analysis techniques on large amounts of data makes many things possible, including:

  • Predictive health alerts and notifications.


  • Detection of adverse reactions.


  • Remote device or patient monitoring.


This type of analysis can also provide new therapeutic insights, which are essential in an outcome-based economy. Meanwhile, the rapid growth of personalized medicine creates a “segment of one” therapeutic focus as opposed to traditional mass-marketed products.

Interactions among research and development, manufacturing, and clinical care are moving to new, cloud-based platforms, where numerous organizations, physicians and patients can connect for faster, easier, and more cost-effective collaborations. New security technologies are making it much safer for digital organizations to operate — which is key for life sciences firms that must protect sensitive patient, clinical and product data.

Forward-looking companies are using these digital innovations to reimagine new, holistic business models where patients, physicians, providers and producers work together to achieve improved patient outcomes. Some of these new business models include:

  • Outcome-based healthcare solutions:    Life sciences companies are marketing health outcomes by using their products and services in more holistic and innovative ways. The focuses is now on patient outcomes rather than cost. For example:

 

    • Amgen recently announced an outcome-based payment for its new cholesterol-lowering drug Repatha.


    • Merck recently agreed with Cigna to create diabetes drug pricing based in part on whether health-outcome data shows that patients can better control their blood sugar levels.


  • Medical information solutions:   Manufacturers are now providing medical devices and equipment as a service instead of using the more traditional unit-cost model. The service model includes infrastructure to allow devices or equipment to operate more effectively. Manufactures are able to integrate the product and market knowledge into the solution that helps differentiate it from the competitors who may only focus on cost.   


  • Personalized medicine solutions. Companies are developing holistic therapies that provide highly effective treatments for specific patient populations based on biomarkers. This allows manufacturers to create personalized treatments that are likely to have much higher success rates than previous protocols while also becoming the framework for many outcome based reimbursement models.


It is truly a remarkable time in life sciences. For more detail on the digital transformation taking place across the industry, please read the white paper, “The Digital Health Sciences Network: Collaborating in a Digital World to Improve Outcomes” and have a look at Life sciences: Collaborating in a digital world.

Please let me know where we need to assign transaction to WEB UI data in SAP OER.

Hi Team,

 

When I queried a delivery document in Aii Cockpit got an message at the item details Tab as"Tab Hidden by Personalization", Please do you know what would be the root cause.

 

Regards

NTG

After SAP launched SAP Advanced Track and Trace for Pharmaceuticals (or "ATTP" as it is now called in the market) in September, we always got the same question from our customers: "Can you integrate to my packaging line vendor?" While we could answer this question easily with a big "Yes, of course!", this was still all theory. Even though we put a lot of effort into understanding the detailed requirements from our co-innovation customers, and defining open web-services to integrate with packaging line systems, we were still waiting for a real line system to be physically connected in a real project.

 

Now two of our partners did that step and integrated ATTP with an Optel Vision line system. Together, Movilitas and Optel Vision demoed this integration during their opening of their new joined demo facility in Frankfurt ( Press Release ). In a nice demo both the automated serialization unit as well as the manual case packing station were connected to Advanced Track & Trace, requesting serial numbers and reporting commissioned data back. Consumption of raw serial numbers as well as the hierarchy of the case could be reviewed and the messages were monitored.

 

So, congratulations for the first partners to be "ATTP ready"....And there are more to come!

Part 1     Part 2

 

Since we released SAP Advanced Track and Trace for Pharmaceuticals on September 15th, I had numerous discussions with customers about how to get there, what would come next and especially how to derive value out of the current track and trace efforts. Even though the main target is compliance right now, at the end everybody tries to understand where additional value can be derived which is understandable given the enormous cost of packaging line equipment, changes in warehouse operations and IT infrastructure. So what did you actually get for your Dollars (or Euros, Swiss Francs, Danish Krona or British Pounds for that matter). Did your company already realize any additional value beyond compliance and is there more to achieve?


Packaging lines under control

One interesting aspect that customer shared at last year’s Movilitas “We track” Conference was the fact that their final overall equipment effectiveness (OEE) for a pure-serialization line (i.e.no aggregation in that line) was up from the values before serialization. That customer reported a dramatic dip in OEE initially but once all the little (and larger) issues have been solved, OEE was higher than before. This may be a result of the intensive work on the packaging line, where a lot of the small issues that were not transparent before became visible and had to be tackled for printing and scanning to work properly on the line.. Now, once all those have been solved, the machine could run at higher OEE. However, no customer reported a higher OEE for a line that covers aggregation steps. So as a result we can assume that OEE can stay at current levels or may even slightly increase for serialization only but will go down if aggregation is added. So no additional value to be harvested here!


Internal traceability

Even though the different national legislations have been put in place to enable track & trace throughout the supply chain to increase drug safety in the first place, they may also positively impact your ability to track products within the company. With serialized barcodes printed and aggregations stored in a central repository, companies can monitor internal product movements much easier on a much more granular level. And those product movements can span the world very much like external shipments. The ability to uniquely identify a single unit of finished product together with the exact information where this unit is at any point in time may allow much better cold-chain monitoring and provide ad-hoc visibility into the critical supply chain of narcotics as well as extremely expensive products. These benefits may lead to the decision to include aggregation even for products where this is not legally required. However that has to be evaluated against the dip in OEE as discussed above.


Better understand your supply chain

Even if pharmaceuticals world-wide were tracked and traced without gap (which is not the case in most markets anyhow), this would not necessarily increase your external supply chain visibility. To a large extend this is due to the fact that you don’t own the data and / or have no right to use them. In today’s pharma supply chains, the dispensers have the most granular level of data. This is the place where demand becomes visible and that’s why companies like IMS made it a business to crunch these data, mask them and sell them to the Pharma companies. This even has been cemented in some markets through the setup e.g. of the national databases in Europe where the pharmacy view is physically separated from the manufacturers database. The same holds true for the US market where data are sent along the supply chain. As a manufacturer you gain no visibility in the supply chain at all. Even in the final stage of the US legislation with full track and trace being mandated by 2023, manufacturers will not have an unobstructed view on their downstream supply chain. Manufacturers may gain some insights from returns, but the vast volumes will not be traceable for the manufacturer for the same reason: no access to data unless the wholesalers share them.


Targeted recalls

One monetary benefit that companies may be able to realize would result from the ability to selectively recall products. Imagine a pallet of a finished product that wasn’t cooled properly at some point in the supply chain and therefore the product was severely damaged. You would expect returns that would come in once the product reaches the point-of-dispense and even consumers. Today manufactures have no choice other than to recall the entire batch. In a world where products are serialized and aggregations are known, you can pinpoint the pallet where all returned products were shipped on and therefore could recall all units from this pallet. However, most national systems currently do not support this. This would require some changes, e.g. in the definition of messages for the European Hub which currently supports batch recalls only.


Chargebacks and rebates

One more process that may see a change is that of chargeback claims which is especially important in the US market. Wholesalers request chargebacks from their suppliers as they are forced to sell below their purchase price due to contracts between marketing authorization holders (MAHs) and group purchasing organizations (GPOs) representing the various dispensers. The validation of the chargeback claims at the wholesaler poses a significant effort and duplicates cannot always be avoided at the wholesaler and may not be detected at the manufacturer. In addition it is hard to pinpoint the exact price at which a certain unit was sold to the wholesaler as prices may vary over time. In the future manufacturers may require wholesalers to send the serial numbers with the chargeback request, thus avoiding duplicates altogether and allowing determining the exact price at which the product was sold.

 

 

It is still very much a mystery how to retrieve real value from the investements made into serialization and track & trace. Maybe the scenarios mentioned above materialize, maybe not. I wold be interested to hear your comments.


To always stay on top of latest developments and best practices on track and tracea 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!

Dear Fellow Industry Friends,

 

Just want to share a thought and trying to see if we can spread the word.

 

Looking at how SAP is positioning HANA within the Life Science industry, it is mainly focusing on R&D and possibilities to speed up the Clinical Trial process.

 

Very important topics, but I haven't seen a lot about faster and precise recall with the help of SAP GBT with or without HANA. This functionality, in combination with SAP ERP can really provide a safer place for patients/ consumers.

 

We are working with SAP GBT for some time now and I honestly think we can make a huge difference in the market for trace-ability and precise recall.

 

Any thoughts on how we can spread the gospel of SAP GBT for the Life Science market as a life saver?

 

With the kindest regards,

 

Ruud

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, read the blog by accenture which summarizes the SAP Digital Life Sciences Enterprise event which took place on September 22, 2015 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?

 

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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!

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