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SAP for Life Sciences

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The Life sciences industry is at an inflexion point. The sector is facing challenges such as:

 

  • Eroding margin due to intense competition, increased regulatory requirements and reduced reimbursements resulting from health care reforms.
  • Faster Time to markets is a necessity. Companies should find new ways to get innovative drugs, devices, and services to market that reduce the cost of care while improving patient outcomes.
  • Higher operation excellence ensuring patient safety and product quality.

 

Life sciences companies are building competitive advantages by entering new markets, standardizing global processes, leveraging their global buying power, and innovating with customers, partners, physicians, and patients.

 

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New Technologies to Solve Today’s Challenges

 

With over 42 years of experience in working with life sciences companies, SAP has developed innovative technologies and platform to turn these challenges into competitive advantages. SAP helps the companies to stay innovative, enable compliance efficiently, and improve product efficacy.

 

  • SAP HANA in-memory technology enables the real-time enterprise to improve profits through higher responsiveness, better strategic decision-making, faster analysis of genomic and proteomic data, more insights into supply and demand, more precise assessments of operational and compliance risk – and the list is not complete here. The possibilities are vast.

 

  • Cloud solutions simplify deployments, boost collaboration, deliver agility, lower total cost of ownership and provide best practices. Some examples: With Ariba, life sciences companies can find, on-board, and audit suppliers including CxOs flexibly and stay compliant. Hybris enables to engage with patients, caregivers, and providers meaningfully. SuccessFactors helps to Acquire and retain specialized talent and scientists.

 

  • Our industry knowledge, combined with new technologies, helps improve life sciences-specific processes in areas like R&D, serialization, compliant manufacturing, and sales, marketing and services.

 

 


Let’s see these SAP innovations for Life Sciences in action:

 

Use Case 1

A medical device manufacturer needed a complaint handling and a global sales reporting tool. The company serves patients every 4 seconds,and 7 million patients per year – so the amount of structured and unstructured data they have to deal with is huge. With SAP HANA, unstructured text as large as 15,000 characters can now be managed and analyzed in near real time. In addition, global sales reportsformerly took minutes – today, they can be done in seconds.


Use Case 2

A pharmaceuticals company had limited leverage over their global supply base. During transactions, compliance was inconsistent, invoicing was paper based and almost 1/3 of all payments were late. After transitioning 1,900 suppliers onto the Ariba Network, the organization enabled a comprehensive supplier on- and off boarding process and real time suppliers and contracts compliance. They also increased touch-less invoicing into SAP by 60% and on time payments to vendors and partners to 98%.


Use Case 3

 

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A medical device company lacked a unified view across their wholesaler, physician and patient channels. Sales contracting was complex, and visibility was not sufficient to up- and cross-sell across channels. With SAP hybris B2B Commerce, product content was consistently positioned and viewed, customer experience was harmonized, and organizations understood which channels originated the orders. Improved insights made increased cross- and up-selling possible.

 


Conclusion


There are many more stories from our unmatched customer base – 97% of the life sciences companies in the Forbes Global 2000 are SAP customers. In total, more than 3,200 life sciences companies, from the small private-equity-funded organizations to large multi-national enterprises, who all derive competitive advantage using innovative SAP solutions and technologies.


Watch Joe Miles, Global Vice President for SAP Life Sciences Industry Business Solutions, talk about SAP innovations in more detail here.


Come find out more on our website at sap.com/life-sciences and follow us on @saplifesciences for the latest news in the industry.

This blog was written jointly by Chuck Pharris and me. I would like to express to Chuck my appreciation for his inputs, research, and contribution and thank him for his fantastic engagement!

 

 

 

The life sciences industry has long been associated with innovation. This innovation is not only the perceived heart of success in this industry, it is the life-blood of a vibrant economy creating jobs, increasing productivity and resulting standards of living.


Organic growth through innovation has not been the only key for success of life sciences companies. The industry also went through a period of high profile M&A activity in the 90s already with a resurgence in the last year and an especially high degree of activity in Q1 this year with 49 deals vs 35 in the same period of 2013. News catching headlines have included Pfizers record setting $119B bid for AstraZeneca, Valeants attempted hostile takeover of Botox maker Allergen, Novartis and GlaxoSmithKline asset swap, Mercks divestiture of its consumer care business to Bayer.

 

In spite of the skepticism of achieving success in these large megamergers given the challenges of large scale integration, McKinsey and Company report analyzed the success of the top 20 pharmaceutical companies by revenue in 1995 andtheir subsequently M&A history showing they created shareholder value, generated greater economic profit, and even changed long term performance expectations.

 

The challenges these former mega-mergers faced and the recent M&A activity all face success challenges more core to traditional business operations than new single drugs or technologies. In particular, some drivers of mergers this year have centered around:

  • Margin Improvement: Novartis established an internal business services unit targeting $6 billion worth of expenses it oversees. Teva is seeking to reduce half of its 75 manufacturing facilities it acquired through acquisitions.
  • Business Focus: Novartis is swapping assets with Glaxo Smith Kline in a series of transactions worth $25 billion to better focus their mutual core competencies. Novartis expects this to improve its core operating profit by 2.5%. The Harvard Business Review highlights a variant of this M&A frenzy in life sciences “David-Goliath partnerships” described as an alternative to the all or nothing disrupt or acquire view of startup competitors. Abbott spun off Abbvie and with it all of its big name drugs, including Tricor, Niaspan, and Humira, the blockbuster anti-inflammatory with greater than $10 billion in sales. Baxter plans to spin-off its biotech business in 2015 enabling it to focus on its core medical technology business.
  • Tax and Cash Incentives: Another growing trend is the pursuit of US companies of reverse acquisitions where a larger company buys a smaller foreign player and relinquishes the headquarters to this smaller company location seeking more favorable tax treatment or enabling them to utilize foreign cash reserves without repatriating the cash into the US tax structure.  Medtronics recent $42 billion takeover of Covidien, which is operated from Massachusetts but is incorporated in Ireland, is reported by Bloomberg as the “biggest yet to renounce its US tax citizenship”. Covidien gets the majority of its sales from the US where 19 of its 41 factories are located.  Its headquarters location originally shifted with its parent Tyco to Bermuda in 1997 and then spun off as a Bermuda company before switching to Ireland. This will also give Medtronic access to its $20.5 billion in cash held overseas without the 35% US corporate income tax it would have to pay if brought into the US.


The performance bar is growing given the maturity and market consolidation. The financial and operational challenges of these increasingly complex global enterprises grows on all aspects of finance, accounting, trade, R&D coordination, manufacturing and supply chain management, and overall ovation oriented collaboration. 

 

How can SAP help bring margin improvement, better research and collaboration to achieve greater business focus, and manage the complex financial and operational requirements of these global enterprises? Just a few illustrative examples:

  • Faster analytics for better strategic decision-making: Our solutions help getting the insights companies need to understand their performance as well as the root causes for it. The ability to run future scenarios quickly enables companies to make fact-based decisions ranging from decisions on M&A, product portfolios, global manufacturing plants, HR, customer-related questions, finance and tax – there are no limits.
  • Improved R&D processes: SAP HANA helps analyze genomic and proteomic data, and with solutions for R&D from SAP and our partners, companies can increase efficiency of Clinical Trial Supply Management and streamline project management.
  • Margin improvement through increased operational efficiencies: With an integrated solution that SAP offers, companies can standardize and consolidate operational processes globally across plants, such as Manufacturing, Supply Chain Management and Serialization, as well as Procurement and Management of CxOs. All this can be especially beneficial for achieving quick RoI after M&A.
  • Flawless post merger integration processes: Flexible and robust HR solutions by SAP allow companies to manage change, maximize employee loyalty, to identify and retain best talents, and to boost productivity.

 

To learn more about we can help you with your business challenges please have a look at the Life Sciences web pages on sap.com!


What do you think about the issues discussed here? Continue the conversation in the comments below and on Twitter @SAPlifesciences!

No matter if it’s about strategy, innovation, regulatory compliance, quality standards, or responding to requests from physicians and other customers – all the different parts within a life sciences company have one thing in common: the race for the highest precision.

 

Speed and precision may not always go hand in hand, but enterprises who champion in both disciplines will lead the game. It’s the deep insight on small pieces and single processes as well as the ability to extract the essence of the big picture in real time that makes the difference.

 

It’s the ability to find out specific scientific breakthroughs and on market trends earlier than competitors as well as to simulate the future to be able to identify the right decisions resulting in competitive differentiators. It’s the power to analyze terabytes of data on genomes and proteomes quicker and to launch new drugs and medical devices faster that turns companies into first movers. It is the capacity to analyze each plant and each batch in real time to be able to detect risk of non-compliance and to define the right preventive actions early on that delivers the highest quality and cost advantages. It is the competency to respond to requests of thousands of patients quickly but forward-looking that eventually builds trust and customer loyalty.

 

Many life sciences companies ask us how SAP can support both, achieving precision in detail and utilizing exactly these little details as a sound basis for a clear view on the complete Life Sciences universe without losing time just crunching data. SAPPHIRE NOW offers the opportunity to get the answers through discussions, live demos, and best practices.

 

Are there other aspects you would like to discuss with us to win the race for the highest precision? We very much look forward to welcoming you at our Life Sciences Expert Table IN 113!

Yes, quality has its price, and yes, the global demand for drugs and medical devices is high. For these reasons, Life Sciences is an attractive area for some market participants to play a different and dangerous game offering falsified products.


The drivers for this behavior are sometimes lower price; sometimes higher margin. Either way, for patients and the concerned companies, this is more than just unpleasant. The recent scandal of PIP breast implants in Europe and an open letter of John J. Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America illustrate how severely counterfeit drugs and medical devices can impact health – and unfortunately, there are many more cases out there.

 

In order to combat counterfeiting of drugs and medical devices and to increase security, new serialization regulations in life sciences around the world are being established. The unique device identifier and the Drug Safety Quality Act are prominent examples, but they are not the only ones. Complying with all existing and upcoming local regulations in the rapidly changing world of serialization is complex.

 

Preparing for the new set of regulations in a timely manner for each region is challenging. Should life sciences companies start now and try to interpret the rough guidelines that are already available? Or should they wait until more details are clear and implement very fast at a later point of time? This won’t be easy, as they need to integrate with suppliers, contract manufacturing organizations, warehouses, plant shop floors, wholesale distributors and other third parties. How will life sciences companies validate and monitor all serialization activities? And how can they efficiently manage the massive data volumes associated to all this?

 

We would like to discuss with you different approaches on how to secure patient safety and how to put serialization into practice. Meet us at SAPPHIRE NOW at the open microforum discussion “Maximize the Quality of Drugs and Medical Devices Efficiently in Real Time”, June 4, 2014 at 3 p.m. at IN137 and at our Life Sciences Expert Table IN 113! We look forward to seeing you.

Life sciences companies need to be wide-awake to keep up with the fast pace of market changes. Scientific and technology progresses, healthcare reforms in mature markets, and globalization are just a few factors that drive competition on the one hand, but that also offer new opportunities for innovation in areas like  personalized medicine. M&A keep on growing, new strategic directions and collaboration models in the health sciences sector are on the horizon, and at the same time the focus on operational excellence to ensure efficiency, compliance, and quality is here to stay.

 

Art or science?

 

Where should pharmaceuticals, biotech and medical devices companies start to stay ahead of the curve? Some part of the answer may sound like pure science: control and optimize your processes continuously, hire and develop the best talents, and analyze market trends to underline your strategic decisions. Practitioners know that this not only requires analysis, focus and discipline, but also whole lot creativity. They may say that mastering all this is even an art – especially because rivals never rest.

 

Get inspired and check facts with other front-runners!

 

Sharing best practices has been a proven recipe for reality checks and for inspirations for brand new ideas. SAPPHIRE NOW and ASUG offer you the opportunity to do right that.

 

Start with a deeper look into strategies in the life sciences industry and on innovating drugs and medical devices. Learn how CareFusion simulates strategic planning with greater speed and precision, how Endo’s approach on analytics looks like and how Medtronic is using data-driven innovation to create a holistic view of care. Discuss about the opportunities of data modeling in life sciences, and learn why Varian moved to SAP HANA, how Animal Health explains the RoI of SAP HANA, and don’t miss how SAP HANA enables new discoveries in genetic research. Talk with peers and SAP experts about improving clinical productivity and patient outcomes while respecting patient privacy, overcoming complexities in clinical supply chain management, and see how life sciences companies can benefit from in-memory technology in R&D.

 

Customer-centricity in sales, marketing and services is key to stand out. See how patients, care providers and the life sciences industry can collaborate to improve treatments, learn how Medtronic gets deep customer insights and optimizes the patient experience, how Animal Health improves pricing performance and how Novartis Animal Health generates metrics on customer-360, segmentation, market-opportunity, and brand-effectiveness. Round up this chapter with a discussion about how to offer outstanding services for medical device customers.

 

Cost-efficiency, compliance and quality build the core of your operations – so find out how you can get even better. Join the session with Medtronic on how to benefit from real-time analysis in quality management and IT, hear what Varian Medical, Larsen & Toubro and GE have to say on responsive manufacturing, how Varian Medical optimized Manufacturing Execution and share best practices on serialization and innovations in manufacturing drugs and medical devices including predictive analytics. Get to know how you can improve supply chain management in Life Sciences, how you can calibrate and maintain assets on the go, and how to best perform signal detection and maximize quality in life sciences.


In the end, it’s your people who make all this happen. Explore how to encourage learning in regulated industries, how Eli Lilly effectively runs Employee Self Services, how Johnson and Johnson boosts payroll processes with SAP HANA and how Hospira changes the face of SAP with their new UI strategy.

 

Are you missing anything that should be covered at SAPPHIRE NOW and ASUG? The programs are packed – so I’d love to help you find the right sessions! Share your feedback and thoughts in the chat box below, on contact us on twitter @saplifesciences, or meet us at the life sciences expert table.


We very much look forward to welcoming you there, very soon!

Life Sciences companies have reached a tipping point with a recent sequence of external events forcing the industry to re-evaluate their strategies and rethink their goals. On one hand the drug patents for some of the most blockbuster drugs started to end from 2011. This phenomenon referred to as ‘patent cliff’ is expected to continue for the next five years.  It means that medicines that currently generate $133 billion in U.S. sales alone will face generic competition, according to Evaluate Pharma.  On the other hand there is a growing decline in US prescription sales to the lowest in decades. The projection from data firm IMS Health shows the global prescription drug market growing by 3 to 6 percent over the next four years to $1.2 trillion by 2017 compared to a growth rate of 5.4 percent in the last four-year period. These coupled with the ever-increasing R&D costs have mandated the companies to find new ways to save costs to counter diluting revenues and redirect money back into R&D.


The Outsourcing Conundrum for pharmaceuticals

 

Outsourcing is one of the major trends in pharmaceutical business, motivated in part by efforts to reduce costs and increase ready access to specialized capabilities and services. This is a natural evolution beyond back office outsourcing like finance and accounting and information technology, of which pharmaceutical firms have been strong adopters. Companies are increasingly outsourcing activities previously considered core internal processes ranging from formulation, lab services (assay testing, toxicity testing), validation processes, clinical trials, downstream production and regulatory advice.

 

Supplier Management: A strategic imperative

 

There are, however, challenges associated with outsourcing especially in an industry like life Sciences. Companies now have to manage a large number of fragmented outsourced processes, which in itself may result in unintentional inefficiencies. Thus, there is a need to consolidate, streamline and manage suppliers consistently and efficiently to mitigate related risks.  Supply risk is typically associated with single source suppliers – API, specialty components. Supplier risk management is needed to identify potential new suppliers, analyze these new suppliers, and score them on key performance indicators of price, quality, reputation and service.  Companies generally communicate the score back to suppliers and allow them to act on the feedback and continually measure the improvements. Once a supplier is finalized, they need a host of services to help simplify and streamline the commerce process for both buyers and suppliers – from automating key purchase, invoice, and payment transactions; to accessing community-based insights and services  like dynamic discounting, receivables financing, and community-based ratings and market data.

 

From supply chain to a supply network

 

The industry also needs to have a re-look at the supply chain. In fact, it needs to think not about supply chains — with their sequential orientation — and more about supplier networks with multiple points for obtaining information and taking action. Companies should have access to supply chain insights enabling faster and more informed decisions aligned with direct and indirect spend, supply, inventory, and fulfillment goals. They should support serialized item traceability to allow monitoring of condition of goods and provide authentication service/ pedigree information and enable faster recalls.

 

Outsourcing and offshoring of the pharma and life sciences industry in its many forms has resulted in significant benefits — revenue growth opportunities and lower costs for companies, lower costs for patients and greater access globally to life-saving and life-enhancing products. Yes, it is fraught with insidious challenges and invidious risks companies have not seen before. To counter them a well-orchestrated and thoughtful outsourcing strategy is needed to achieve multiple benefits that many are not currently achieving. The best practices are here and you don’t need a weather man to know which the way the wind blows!

 

You can read the full blogs along with the infographic at http://blogs.sap.com/innovation/industries/manage-strategic-sourcing-and-procurement-complexity-in-life-sciences-0125083…

As the Life Sciences industry finished the first decade of the 21st century, the focus was and has been on restructuring the portfolios to reduce costs, grow revenue and transform their business models to align with reduced margins given the end of the blockbuster drug model.  Examples of this trend included:

 

  • Pfizer divested their animal health and nutritional divisions as they focused their organization the pharmaceutical segment.

 

  • Abbott Labs spin off their branded pharmaceutical business, now known as Abbvie, that now focused them on the remaining consumer products, generic pharmaceutical and  medical device & equipment divisions.  

 

  • GlaxoSmithKline spun off a number of consumer divisions as they focused on their higher selling and higher margin brands.

Recently, it appears we are seeing the end of this phase and the start of a new period of mergers & acquisitions that has begun to accelerate at a very rapid pace.   Amgen’s acquisition of Onxy Pharmaceuticals highlighted the increasing value of drug pipelines powered by continued lost revenue from patent expiries and continued challenges of getting new drugs & devices to market but this was merely a signal of things to come.  

 

In my previous blog, Life Science Paradox: Creating Opportunities During Times of Tremendous Change,  I highlighted how companies needed to transform their organizations to enable globalization, profitable growth, operational excellence and increased employee engagement but the acquisition strategies that have emerged in the last few weeks will accelerate and complicate those efforts.   Pfizer’s $105B+ acquisition of Astrazeneca, GlaxoSmithKline and Novartis’ oncology and
vaccine exchanges combined with a consumer products joint venture  and Valeant’s acquisition of Allergan highlight how organizations are willing to go to any length to ensure the growth, margin and shareholder value of their portfolios and, ultimately, their companies.      

 

Finally, the coming weeks will continue to see additional activity as companies respond to the new market dynamics and competitive landscape.   An organizations ability to manage the increasingly vast holding companies on a global level will be essential to maintaining profitability and avoid the loss of scale across their global operations.    Driving top line revenue only, without a focus on globalization, profitable growth, operational excellence and employee engagement, will fail to achieve the competitive advantages intended by the global categories, segments and brands created through the acquisitions. 

 

To learn more about we can help you with your business challenges please have a look at SAP's Solution Explorer for the Life Sciences Industry.

 

What do you think about the issues discussed here? Continue the conversation in the comments below and on Twitter @SAPlifesciences

Track and trace (also referred to as serialization) is one of the most important topics for pharmaceutical manufacturers at the moment. How can businesses not only suffer but profit from these new regulations? SAP solution extensions by Vistex provide additional value for pharmaceutical manufacturers regarding serialization.

 

The track and trace regulation was introduced to combat drug frauds. The serialization is not only a matter of registering the serial numbers of medicaments, it also results in a complete transformation of the supply chain of pharmaceutical manufacturers. The reason for this is that it implies the way businesses manage their stock and register their goods. Furthermore, it also influences the reporting of authorities that sell the products. Some countries like China (with some limitations), Turkey, India (with some limitations on exported products) and Argentina (with some limitations) already require a serialization of medicaments. In some other countries the serialization will be mandatory soon like for example in Korea starting 2015, in Brazil starting 2016, in Saudi Arabia starting 2016 or in the EU starting 2017. As pharmaceutical manufacturers (also referred to as laboratories) are distributing globally, these worldwide legislations impact them highly.

 

Pharmaceutical manufacturers can use the requirement of serialization for improving their business processes. How that? As serialization will bring better quality of data, businesses can improve the controlling of their finances. Let´s take chargebacks as an example. The chargeback process can be very labor intensive especially in reconciliation and revenue losses. By incorporating the serialization into the chargeback process, businesses can get a better control of the process. This is where SAP solution extensions by Vistex can provide additional value. The SAP Paybacks and Chargebacks (PBCB) by Vistex solution incorporates the serial number in the chargeback process resulting in laboratories being able to extend the control of their paybacks and chargebacks processes.  Additionally they can ask their distributors to include the serial number in their claim which simplifies the whole process. This gives the manufacturers full control of their inventory benefitting them in getting accurate claim reconciliations.

 

Main benefits for pharmaceutical manufacturers using SAP solution extensions by Vistex are:

  • Reduction of chargeback discrepancies: As the price of a medicament is saved by the serial number as well, the distributor’s claim can be automated based on the serial number of the product. Additionally, manufacturers can control if distributors claim for serial numbers they have not received.
  • Avoidance of duplications: In case a product is returned to the manufacturer it is not possible to claim the product again as with the help of the serial number, the manufacturer can record the interactions and sees that the product has already been returned resulting in avoidance of duplication of claims.
  • Omitting reverse chargebacks: Reverse chargebacks occur when a product is sold or a chargeback failed. As a result the product is returned to the manufacturer which generates a refund of the chargeback from the distributor to the manufacturer.
  • Reporting to government: Reporting of every single serial number to the government due to claim serial numbers supplied and received via claim.

 

Pharmaceutical manufacturers can benefit and take advantage of the legislation requirement that at first glance looks like it only impacts the distribution of products. By using the SAP Paybacks and Chargebacks by Vistex solution, pharmaceutical manufacturers have a better control of their chargebacks and can be more accurate.

 

SAP Paybacks and Chargebacks by Vistex also has the functionality to incorporate the serial number in the commercial aspects giving the possibility to determine rebates and other sales incentives.

Fools ignore complexity. Pragmatists suffer it.  Geniuses remove it.”      Author unknown

 

The last five years have seen the evolution and, in some instances, revolution across the Life Sciences and Healthcare industries.    Increasing regulations, policy reform & patent expiries continue to transform the industry with one of the bi-products being a move from on-premise to cloud technologies.   Note the following:    

 

 

  • Europe, also a mature market, has been moving, albeit at a somewhat slower pace, to the cloud but concerns over patient & corporate privacy have them responding more cautiously given the investigations over widespread corporate spying like he NSA scandal in the US. 

 

  • In emerging markets, Life Science companies are leveraging cloud applications to quickly adopt the process standardization to support their processes which, in many cases, do not include “GXP” areas like manufacturing, sourcing or quality but, rather are primarily finance and sales focused facilities.    

 

Companies must embrace the need to move to the cloud for commodity areas like Procurement, Sales, HR and IT but must do so in a way that doesn’t increase complexity and cost, in the long run, as a result.   Without a solid cloud integration strategy, organizations will simply transfer the IT costs from one area to another but now with limited or no visibility due to the siloed nature of the cloud applications.

 

Further, cloud applications typically have a rapid enhancement & patch methodology that will create significant challenges for “GXP” areas regulated by agencies like FDA.   Without a thoughtful approach that addresses oversight, governance and documentation, organizations will be overwhelmed by complexity and frequency of the revalidation efforts and will, ultimately, fall out of compliance.   Companies need to have a “hybrid” cloud strategy that allows them to pick and choose where to leverage the cloud in order to reduce cost, improve adoption and minimize risk while still maintaining the visibility and compliance that are pervasive in their on-premise environments.

     

To learn more about we can help you with your business challenges please have a look at SAP's Solution Explorer for the Life Sciences Industry.

 

What do you think about the issues discussed here? Continue the conversation in the comments below and on Twitter @SAPlifesciences

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Pharma has been a high value goods business in the last century. Most of the exports were by air. As pharmaceutical margins have decreased and low cost generic volume has increased, some companies have shifted their mode of exports to sea.  This shipping alternative to traditional air freight can save companies millions of dollars if planned and executed well.

 

 

A recent customer interaction was with a multibillion dollar pharmaceutical company, under an operational cost reduction mandate. We were in discussion with the transportation function to understand the profile of operations. Then a certain number struck us – about four-fifths of the company’s export was by air. The mode optimization appeared as an unexplored goldmine as shipment by sea costs about five to seven times lesser than air. If you are a generics pharma manufacturer exporting a billion dollar worth a year, just consider the magnitude of savings - for every 3% points increase in proportion of exports by sea, you save a million dollars every year.

 

There are many reasons a company would transport certain products by air – for high value products, Make to Order products with stiff lead times, inventory shortage in destination markets for Make To Stock products, products in the beginning or the end of their lifecycle.  However most of the shipments for generic pharma companies do not have the above constraints. The temperature control is far superior in sea shipments with products in controlled temperature in containers. Also reduced emissions by sea will in turn help companies meet their sustainability targets.

 

The biggest challenge against sea is the smack from sales in case of any loss of sales opportunity. An agreed list of rules for exigencies based on wide parameters and alert system running on an integrated supply chain solution is a must.

 

With the present crop of integrated supply chain execution solutions with wide real-time visibility, transportation mode optimization has become easier. Sales order integration enables a longer planning horizon, hence enabling mode selection at an order level. An alert for expedition based on multiple parameters through the supply chain, changes the mode to air to avoid any sales loss.

 

Load forecasting and consolidation planning plays a pivotal role in enabling higher sea shipments. Planned container level load consolidation will enable timely dispatch of containers. Orders where shipments cannot be consolidated to a container level for certain markets due to lack of volume would be marked for air-shipment at planning stage.  As per out studies, only 23%* organizations have product forecast translated into transportation requirement forecast broken down by mode and lane.

 

Exception alerts would ensure timely corrective actions to avoid loss of sales opportunity. As per our studies, only 15%* organizations have alerts captured and routed along a pre-defined workflow and resolution options dynamically proposed to the decision-maker.

 

The pharma industry as a whole seems to be utilizing sea cargo to move more product.  As per IATA, the proportion of air cargo has fallen gradually from 17% in 2000 to 11% in 2013. We may see continuation of this trend with companies pressed for margins in these times of stagnant growth.

 

*Figures based on overall SAP Benchmarking database, 2013

 

If you liked this blog, please also read my previous blog “Electronic Tendering is the Future for Logistics Providers"

Albert Einstein once said, “We cannot solve our problems with the same thinking we used when we created them.   This is an interesting point of view given the magnitude of the changes that are underway across the health sciences industry in 2014.

 

In the “go, go” days of the ‘90s and early 2000s, life in the life sciences industry was great given the healthy pipelines and high margins that could obscure the need to improve efficiencies, reduce costs or focus on anything other than producing the next blockbuster drug or product.    

 

Of course, today’s reality is a very different place.   Life science manufacturers must not only focus on developing innovative drugs and devices but they do it with smaller R&D budgets with a focus on operational excellence that was never required in the past.    Organizations must reduce costs, improve productivity and increase revenues by getting products to market faster through new and more innovative ways.  

 

More specifically, the new paradox in the life science industry requires companies to transform their organizational operations & processes and ensure that they are, at a minimum, focusing on the following:  

 

  • Enabling Globalization:   life sciences companies must leverage their global buying power, standardize global processes, leverage common master data and think globally to avoid the redundancies & inefficiencies of the regional operating model.   This provides a huge competitive advantage from a profitability perspective and has become a must have strategy in 2014 and beyond.  

 

  • Creating Profitable Growth:  organizations must open new and innovative channels to get their products to market in the “digital age”.    This would include traditional channels such as wholesalers but also innovate with new channels such as direct to patient as organizations seek to drive top line revenue but though effective channels that can do so with low transaction costs.

 

  • Enable Operational Excellence:  as the generic and branded markets begin to converge, enabling operational excellence is becoming a baseline requirement whose goal is to increase productivity, reduce inefficiencies and eliminate costs wherever possible.   Further, as I highlighted in my previous
    blog “Leveraging Technology to Improve Therapeutic Outcomes & Reduce the Cost of Care”, organizations must adapt to leverage the breakthrough technologies that can transform processes and markets to create tremendous competitive advantages.   Without flawless operational execution,
    organizations will be unable to compete. 

 

  • Increasing Employee Engagement:   as process efficiencies continue to improve organizations must leverage their vast enterprise, operational and performance data to transform the employee experience by providing real time, predictive analytics that anticipate problems & identify opportunities before they are apparent to the “siloed” employee.   In my previous blog “Finding the Therapeutic Needle in the Healthcare Data Haystack”, organizations must utilize the operational data to create the analytics for the “millennial” employee of today who is more digitally astute than previous generations to empower them to make the real time decisions.

 

In short, organizations need to seize the moment to capitalize onthe opportunities that are presented during times of tremendous change.    Focusing on execution with an eye on innovation of business models that provide allow partners, physicians and patients to easily interact with your organization will, ultimately, win the day.

 

 

To learn more about we can help you with your business challenges please have a look at SAP's Solution Explorer for the Life Sciences Industry.

 

What do you think about the issues discussed here? Continue the conversation in the comments below and on Twitter @SAPlifesciences

US Drug supply chain and security act has provided definition for Transaction history, information and statement. I kept reading about these definitions and tried to create a tentative formats which can be used post 1st January 2015.

 

According to DSCSA, "Transaction means the transfer of product between persons in which change of ownership occurs". I felt instead of persons it should have been organizations or business entities.

There are few exemptions to this term "Transaction". This means that below transaction are not considered as change of ownership. Few are

 

1. Intracompany distribution of any product between members of an affiliate or within a manufacturer.

If a manufacturer hires a 3PL to distribute his products, 3PL do not have liability of owning the product and these interactions between 3PL and manufacturers are not part of a transaction. If this thought of mine is right then, i feel that there would be good potential for drug counterfeiting.

 

2. Distribution of intravenous products.etc..

 

Check this document for complete details..

 

 

Transaction History is a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Every Manufacturer,Wholesale distributor,Dispenser and Re-packager must maintain transaction information history and statement for not less than six years after the date of the transaction.

 

Transaction Information should provide below details

 

1. The proprietary or established name or names of the product

2. The strength and dosage form of the product

3. The National Drug Code number of the product

4. The container size

5. The number of containers

6. The lot number of the product

7. The date of the transaction

8. The date of the shipment, if more than 24 hours after the date of the transaction

9. The business name and address of the person from whom ownership is being transferred

10. The business name and address of the person to whom ownership is being transferred.

 

Every Manufacturer,Wholesale distributor,Dispenser and Re-packager, whenever there is a change of ownership, should provide the subsequent owner with transaction history containing transaction information and transaction statement.

 

Transaction Statement

 

The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

          (A) is authorized as required under the Drug Supply Chain Security Act

          (B) received the product from a person that is authorized as required under the Drug Supply Chain Security Act

          (C) received transaction information and a transaction statement from the prior owner of the product, as required under section 582

          (D) did not knowingly ship a suspect or illegitimate product

          (E) had systems and processes in place to comply with verification requirements under section 582

          (F) did not knowingly provide false transaction information and

          (G) did not knowingly alter the transaction history

 

So after 1st January 2015, whenever there is change of ownership of product, the owner of the product should provide the above transaction information and transaction statement to subsequent owner of the product. And also all owners should provide transaction history of the product for not less than 6 years after the date of the transaction.

 

Hypothetical example,

 

Manufacturer to Wholesale Distributor




image 01.jpg

 

Manufacturer called A Pharmaceutical Ltd produces Botulinum toxin under brand name iBotox. Its national drug code is 023-3921-02.

A Pharmaceutical received a sale order from Datson Pharma – A Whole sale distributor, for 1 carton of iBOTOX. A Pharma suggested delivery date as 17/01/2015 which was acceptable for Datson pharma.

A pharma started packing of 1 carton of iBotox with mandatory product identifiers and data, imprinted on every saleable unit in 2D barcode form.

 

A pharma procured services of a 3PL service provider to distribute this 1 carton of iBotox to its customer. So according to its delivery schedule A pharma called 3PL to pick the consignment and executed order delivery. Along with the necessary documentation, like sales invoice, packing list (optional), excise documents, this time A pharma provided 3PL with two new more documents called Transaction Statement and Transaction information. These documents along with the product have to be delivered to customer on or before 17/01/2015.

 

When product received at Datson pharma, warehouse executive and quality assurance officer will perform necessary checks along with scrutinizing Transaction information history document and perform goods receipt acceptance.

Later that rest of the payment process will get initiated.


Transaction Statement


image 03.jpg




 

Transaction Information History


image 04.jpg


Wholesale Distributor to Dispenser


image 02.jpg

Datson Pharma receives an order from Jupiter pharmacy to supply a carton of iBotox. Delivery requested date is 23.02.2015. Both parties agree for deal and Datson pharma initiates delivery process on 19.02.2015.

Along with necessary documents Datson pharma will staple transaction statement and transaction information history document to be sent to Jupiter pharmacy.

When product received at Jupiter Pharmacy, Pharmacist will perform necessary checks along with scrutinizing Transaction information history document and perform goods receipt acceptance.


Transaction Statement

image 05.jpg

Transaction Information History


image 06.jpg

All these entities, Manufacturer, wholesale distributor and dispenser will have to retain these documents at least for 6 years from the date of transaction.

Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, a manufacturer/Distributor/Dispenser shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request, or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction history, and transaction statement for the product.

 

I have cited above example for bringing more clarity on the mentioned subject. Names of products and companies are mere fictitious and should not be referred to any of those existing ones.

Not only pharmaceutical products are subject to counterfeiting, also counterfeit medical devices are being sold world wide. Therefore the FDA has put in place regulations for the US market to ensure safety and to prevent counterfeiting of medical devices. The key of the new regulation is the unique identification of medical devices, namely by adding the unique device identifier (UDI) to the label of the medical device. The uniqueness is achieved by making the batch/lot, serial number or expiration date part of the UDI. In addition the manufacturer has to report certain parameters which are assigned to the specific device version or model into a central government database. By 09/2014 the regulation will become effective for the most strictly controlled class of medical devices, (Class III, e.g. implants, HIV diagnostic tests, …). Other classes follow until 2018.

UDI_Timeline.png

1. Establish a UDI

The UDI is a unique numeric or alphanumeric code that includes a device identifier (DI - Device / Product Identifier - GTIN) which is specific to a device model, and a production identifier (PI) which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

 

2. Print UDI on Label

The UDI must appear on the label in a human readable format, as well as in a manner that can be read by automatic identification and data capture (AIDC) technology, such as a linear or 2D Data Matrix barcode. The label with the unique UDI must be applied to the “base package” and higher levels of packaging. In addition devices must bear the unique UDI as a permanent marking when the device is intended to be used more than once.

 

3. Submit device version data to a central government database

FDA Global UDI Database (GUDID) serves as the repository of key device identification infor-mation. The GUDID contains ONLY the DI, which serves as the primary key to obtain device information in the database. PIs are not submitted to or stored in the GUDID; the GUDID will contain only production identifier flags to indicate which PI attribute(s) are on the device label.

 

 

SAP's proposal to approach this topic is via Master Data Governance. SAP's MDG capabilities allow to

  • extend the data model according to the requirements of different regulatory bodies (e.g. US FDA, EU, China, ...),
  • govern the creation and approval process for product data across different systems,
  • manage the submission processinto the GUDID,
  • maintain one version of the truth!

The FDA defines Personalized Medicine as  “… the tailoring of medical treatment to the individual characteristics,needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.”   These “characteristics, needs and preferences” of a patient are not easily obtained given the definition is typically at the scientific, biologic or genomic level but once physiological parameters are available to define a specific patient population, for example genetic markers for diabetes or cardiovascular disease, the ability to increase the effectiveness of drugs or products can be dramatically increased.   

 

Further, we are currently seeing an explosion of devices that are used for a multitude of scenarios, both inside and outside of healthcare that will have a dramatic impact on the quality and outcome of a patient.   Whether it’s a “Fitbit” wristband that is transmitting personal health metrics such as blood pressure and heart rate or a consumer gaming device like Xbox that is leveraging its virtual reality capabilities to help measure the coordination of multiple sclerosis patients, the ability of these devices to provide therapeutically relevant data, in real time, is unprecedented.    CNBC’s recent documentary “Rise of the Machines” highlights the tremendous impact that society is already seeing with the proliferation of devices across health sciences, industrial, automotive and
other industries while discussing the tremendous potential that lies ahead. 

 

In my previous blog Leveraging Technology to Improve Therapeutic Outcomes & Reduce the Cost of Care I discussed how devices are becoming an integral part of the current and future treatment protocols as life sciences manufacturers integrate devices into their treatment regimens in order to leverage real time data that empower the patient to take more ownership of their health while also allowing physicians and care providers to monitor a patient’s real time status.    The combination of these two emerging sciences continues to create tremendous synergies for patients as well as physicians, providers and payers as we continue to seek improved patient outcomes at the lowest cost of care.

 

 

To learn more about we can help you with your business challenges please have a look at SAP's Solution Explorer for the Life Sciences Industry.

 

What do you think about the issues discussed here? Continue the conversation in the comments below and on Twitter @SAPlifesciences.  


The Event has happened...

Track 1 - Executive Focus

  • Session 1 - What does the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204, mean to you? Presenter: Bill Fletcher (View the session: http://bit.ly/1iWl4PU)
  • Session 2 - What strategies and solutions should you be considering for Supply Chain efficiencies and regulatory compliance? Presenter: Bill Fletcher (View the session: http://bit.ly/1g38eSh)
  • Session 3 - Solutions to help with Supply Chain efficiencies for serialized items. Presenter: Stephen Cloughley (View the session: http://bit.ly/1iWlGVK)
  • Session 4 - Implementation considerations for global serialization. Presenter: James Tucker (View the session: http://bit.ly/1eczjAe)

Track 2 - Solution Focus

  • Session 1 - An overview of SAP's Track and Trace Solution with a focus on SAP EM. Presenter: Kevin Wilson (View the session: http://bit.ly/1qMcyIz)
  • Session 2 - Looking in depth at SAP OER and SAP AII. Presenter: Kevin Wilson (View the session: http://bit.ly/1mdC4WH)
  • Session 3 - Extending SAP's Serialized Track and Trace solution with Verifier Suite . Presenter: Guido Rijcken (View the session: http://bit.ly/1kCGHGM)
  • Session 4 - A detailed look at SAP Global Batch Traceability. Presenter: Stephen Cloughley (View the session: http://bit.ly/1gFZzjE)

 

Q Data USA is hosting a seminar on 12th March to cover the important topic of how SAP solutions play a role in providing answers to the serialization issue that faces the pharma industry today. We have 8 sessions by 6 thought leaders giving their thoughts on DQSA, OER / AII, GBT, Implementation and Integration on the production line...

Download Seminar Flyer | Abstracts

Eventbrite - 1st Annual Serialized Track and Trace Seminar

Date: 12th March – 8 sessions starting 8am PST and ending at 3pm PST

 

Congress enacted the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204, in November 2013 and it starts to take effect in a significant way in January 2015. You should be planning to attend the 1st annual Serialized Track-and-Trace Seminar on 12th March, 2014. It’s a virtual seminar that allows you to attend the sessions from the comfort of your own home or office, yet you still have access to all the content and experts that you would expect from a live event. It’s a truly unique and valuable opportunity for those focused on these latest changes in legislation for the Pharma industry.

Pills

With this latest passing of legislation, it’s more critical than ever for you to gain a true understanding of the implications to your business understanding the time-frames for compliance and working through the intersection of the law with SAP based solutions.

Listen to the industry experts providing for an information-packed seminar. Presenters will explore DQSA and what it means to the Pharmaceutical Supply Chain players. Hear what solutions SAP and partners are providing to distributors and manufacturers to successfully implement serialized track-and-trace technology to further secure the safety and security of the healthcare supply chain.

This seminar also offers a unique opportunity to hear from leading solution providers and solution implementers.

This year’s seminar topics are split in to 2 tracks:

TRACK 1: An executive focus

Understanding the business impact and overall solutions available to you

  • What does the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204 mean to you?
  • What strategies and solutions should you be considering for Supply Chain efficiencies and regulatory compliance?
  • Solutions to help with Supply Chain efficiencies for serialized items
  • Implementation considerations for global serialization

TRACK 2: A Solution focus

This track focuses on serialized Track and Trace solutions provided by SAP and Inxites

  • On overview of SAP’s Track and Trace Solution with a focus on SAP EM
  • Looking in depth at SAP OER and SAP AII
  • Extending SAP’s Serialized Track and Trace solution with Verifier Suite
  • A detailed look at SAP Global Batch Traceability

 

Target Audience

This seminar is a must-attend for pharmaceutical distributors, manufacturers and retailers seeking to explore implementation strategies, understand the DQSA legislation and its impact on the healthcare supply chain. If serialization, batch traceability and regulatory compliance is of importance to you then don’t miss out on this great opportunity.

 

Presented by Q Data USA

Q Data USA

Supported by TBMG, Inxites, SAP, Pharma Logic Solutions and Auto-ID Consulting LLC

Pharma Logic Solutions
Inxites


Agenda

Download Seminar Flyer | Abstracts

Track 1 – Executive Focus

Session

Time (PST)

Session TitleSpeaker
1

8am
to
9am

What does the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204 mean to you? On November 27, 2013 H.R. 3204 was signed into US Federal law as the Drug Quality and Security Act of 2013 (DQSA). Among other things, the new law will impact the way prescription drug trades are documented in the United States and preempt state laws for drug traceability, including California’s e-pedigree law.  This one hour session outlines the requirements of the DQSA, Title II, referred to as the Drug Supply Chain Security Act (DSCSA).Bill Fletcher
2

9:30am
to
10:30am

What strategies and solutions should you be considering for Supply Chain efficiencies and regulatory compliance? Many countries around the world either have existing or pending laws and regulations to track the movement of prescription drugs in an effort to improve the integrity of their drug supply chain.  Life sciences companies are preparing new systems to comply with serialization and traceability. This one hour session will outline the requirements and suggest methods to comply and to gain efficiencies and benefits from traceability.Bill Fletcher
3

12pm
to
1pm

Solutions to help with Supply Chain efficiencies for serialized items SAP has been actively leading the drive towards providing comprehensive serialization solutions dating back to 1999 when they were the first software company to join and collaborate with industry visionaries at MIT’s Auto-ID Center.In recent years, as counterfeit detection and supply chain integrity have climbed to the top of the agenda, SAP is once again leading the way in integrating serialization for track & trace with traditional “back end” ERP processes, evidenced by the fact that the majority of the world’s major pharmaceutical companies are deploying or planning to deploy SAP Auto-ID Infrastructure (AII) and SAP Object Event Repository (OER).This session will outline the business drivers for serialization and cover the SAP solution functionality and the standards that they support. It will also touch on Batch traceability in addition to serial number traceability.Stephen Cloughley and Kevin Wilson
4

1:30pm
to
2:30pm

Implementation considerations for global serialization Implementation of a serialization solution requires a holistic approach and broad view on how the data will be provisioned, captured, managed and disseminated. A phased-based, multidisciplinary and cross functional approach is required to deliver successful results. Building in adaptability and extensibility is key to meeting evolving requirements.This one hour session will explore the many challenges facing serialization projects and key issues and approaches to consider.James Tucker

2:30pm
to
3:00pm

Wrap-Up / open forum – What are your next steps? In this quick wrap-up session we will pull together any open questions and also give an outline of a typical road-map that TBMG follows towards helping interested companies make an informed decision around if and how to implement a serialization solution.Martin Rowan

Track 2 System Focus

Session

Time (PST)

Session TitleSpeaker
1

8am
to
9am

An overview of SAP’s Track and Trace Solution with a focus on SAP EM SAP’s Track and Trace solution comprises of the following components:
  • SAP Object Event Repository (OER)
  • SAP Auto-ID Infrastructure (AII)
  • SAP Event Management (EM)
  • SAP Global Batch Traceability (GBT)

In this session we will cover an overview of each of the components and do a deep dive in to SAP Event Management functionality showing how it can be applied to your business process. We will also dive in to a demo system to show some hands on views of SAP Event Management screens

Kevin Wilson
2

9:30am
to
10:30am

Looking in depth at SAP OER and SAP AII These are the 2 main SAP modules providing Track and Trace functionality for serialized items. In this session we will run through the standards that are applicable when talking serialization and in particular Pharma speak. We will also cover the needed architecture together with the scope and functionality covered by each module. After attending this session you’ll have a clear understanding as to what the intended use and scope is for SAP OER and AII.Kevin Wilson
3

12pm
to
1pm

Extending SAP’s Serialized Track and Trace solution with Verifier Suite A serialization project has many nuances to it making it an extremely tricky and complex implementation to handle. In this session we will highlight these complexities and share details on common roadblocks that are encountered. We will also introduce the Verifier Suite of components, developed by Inxites and certified by SAP, that helps bridge the gap for Pharma companies between what is required to gain supply chain efficiencies in your serialized process and what is provided standard within SAP. A typical serialization project approach will be outlined showing what components are needed to be addressed.Guido Rijcken
4

1:30pm
to
2:30pm

A detailed look at SAP Global Batch Traceability The need is out there to be able to understand the reach of a bad batch that is discovered in your supply chain. How can we quickly search the batch genealogy top-down and bottom-up? Can we take those results and see the distribution record and report it to authorities? Can we use that information to affect a targeted recall and limit our exposure?In this session we’ll take an in-depth look at SAP’s solution that covers these questions. You’ll get a detailed look in to what SAP GBT is and what is needed to implement the solution.Stephen Cloughley and Kevin Wilson

2:30pm
to
3:00pm

Wrap-Up / open forum – What are your next steps? In this quick wrap-up session we will pull together any open questions and also give an outline of a typical road-map that Q Data follows towards helping interested companies make an informed decision around if and how to implement a serialization solution.Kevin Wilson


Speaker Bios

Download Seminar Flyer | Abstracts

Bill Fletcher1 - Bill FletcherManaging Partner
PHARMA LOGIC SOLUTIONS, LLC
Email:
bfletcher@pharma-logic.com Mr. William (Bill) Fletcher’s background spans over 30 years in pharmaceutical, enterprise software and healthcare systems.  In December 2013, he completed his 21st commercial serialization and traceability project for global life sciences companies, including design, strategy and requirements.  He has been recently helping companies implement projects to comply with serialization and tracking regulations around the world, including the recent US Federal Drug Quality and Security Act of 2013 (DQSA), China, EU, Turkey, South Korea, Brazil and others. Mr. Fletcher has received various industry certifications, including SAP Auto identification infrastructure (Aii) version 7.1 and the GS1 Certified Professional (certifying a detailed understanding of barcoding and serialization standards).
Download Bill’s full bio here.
Stephen Cloughley2 - Stephen CloughleySenior Director
SAP Labs LLC
Email:
stephen.cloughley@sap.com Mr. Cloughley is a Senior Director at SAP Labs LLC, responsible for Supply Network Traceability.  Stephen has responsibility for SAP’s supply network traceability solution as part of its sustainability program, which has SAP Event Management as a key technical component.He came to SAP through the acquisition in 2005 of Lighthammer, where he was part of the leadership team responsible for business development.  Prior to Lighthammer, Stephen was President and CEO of Base Ten Systems, Inc., a leader in Manufacturing Execution Systems (MES) for the FDA-regulated industries.  Stephen is a chemical engineer from University College Dublin and has over 20 years’ experience in the software industry in Europe, South Africa and the United States.
Kevin Wilson3 - Kevin WilsonES+ Practice Lead and SAP Solution Engineer
Q Data USA, Inc.
Email:
kwilson@qdatausa.comMr. Wilson has more than 24 years’ experience in business analysis, solution architecture, project management, solution development & implementation. 18 years of SAP experience covering supply chain, retail, utilities & manufacturing, amongst others. Business case and value engineering expertise covering multiple, integrated SAP solutions with a strategic focus on Supply Chain Management. Author and thought leader in SAP supply chain execution processes. Download Kevin’s full bio here.
James Tucker4 - James TuckerSAP Serialization and Traceability Expert
Auto-ID Consulting LLC
Email:
jt@aieguru.com Mr. Tucker has been referred to as the AIE Guru for his expertise with SAP serialization and traceability solutions, He has seen serialization evolve from its roots in early RFID pilots to today leading global full life cycle implementations leveraging the latest in SAP solutions and best practices.Over the past several years, Mr. Tucker has led major pharmaceutical clients from initial strategic planning through blueprinting and onwards to production implementations. Through this experience, James provides a holistic view to the challenges faced when implementing a serialization program. His broad background in IT strategy and operations, client delivery as well as developing solutions leveraging emerging technologies enables him to provide a cross functional understanding of the obstacles faced when trying to adapt to an ever changing landscape of regulations and requirements.
Martin Rowan5 - Martin RowanManaging Partner
The Business Maturity Group
Email:
mrowan@tbmginc.com Mr. Rowan’s primary focus is to facilitate solutions that help companies optimize their Integrated Supply Chains to achieve a level of Business Maturity and increase profitability.  He is actively involved with local and international ERP markets and has been for over 20 years.  His experience covers a wide variety of industries across multiple countries.  Some clients he has represented across the globe are BMW, Toyota, General Motors, Mittal Steel, Sanyo, Insight and Asics.  Martin holds a Bachelor’s Degree in Engineering and a Master’s degree in Commerce.
Guido Rijcken6 - Guido RijckenManaging Director
Inxites Americas, Inc.
Email:
guido.rijcken@InXites.be Mr. Rijcken is one of the “early days serialization” consultants and has been involved in many serialization projects in many different industries. He has 30 years of ICT/ERP experience focusing on Functional Consultancy, Project Management, Solution architecture, Shop Floor Integration and Execution for Mass Serialization projects.

Download Seminar Flyer | Abstracts

Eventbrite - 1st Annual Serialized Track and Trace Seminar

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