Oracle

Time to ‘Tune-up’ your Supply Chain

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This month my focus is on Supply Chain in Life Sciences. As we head towards the end of the year budgets are being planned and IT projects are being prioritized for next year. Many companies are reviewing their current IT investments in light of mergers and acquisitions and projects that will add to the company’s business ability. My discussions have been around how best to improve your operations at a minimal cost. No one seems to want to buy new IT systems and they want to extract ‘value’ from their current IT systems.

Time to ‘Tune-up’ your Supply Chain

Ask yourself if you are getting the most from your current Supply Chain? Do you feel you’re gotten significant return from your SAP or Oracle investment? It seems everyone had one of these IT solutions. I believe the reason most companies should be looking at their Supply Chain is as follows:

  1. Most firms have invested in IT solutions to help react quickly and expect demand. We now are moving to ‘collaborative’ business processes as a means for extracting added value from your partners.
  2. Companies need to give supply chain ‘visibility’ so that the organization can make faster and better decisions.
  3. Business process improvements need re-training for your people.

I get this now how do I get there?

The answer is to create a ‘road-map’ for your supply chain that includes opportunities (projects) specific to your business systems. The key is how to develop this road-map. You need to have the following:

  • Supply Chain experts that can analyze your data and processes.
  • IT ability to look at how your SAP or Oracle solutions have been installed.
  • Our company has developed a unique set of tools that can analyze your Demand, Supply and Inventory.

We’ve created a project approach to this kind of analysis. Over the next few months I plan to promote this approach for Life Sciences and yet this approach is not just for this industry. I know this can be applied for any industry that is looking to get more value out of their IT investment in supply chain. As we gain traction in the market I hope to offer some proof points to this approach.

I would be interested in your comments and suggestions on this topic.

Thanks,

Jim

Change is inevitable…

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Last month I spoke about the ‘model’ for integrating clinical operations. In this blog post we’ll review the solution that was presented at the Oracle “OpenWorld” conference held earlier this month. There is also two links to collateral that you can use to help understand how the solution works at the end of this blog post. I welcome your reaction and comments.

I’ve written about ways to improve R&D from the idea of “ERP for R&D” through “Integration” of key business processes. In summary the background issues that I think drive this solution are:

  • Access to relevant data
  • Getting out of the IT business within R&D
  • A solution that is scalable to meet tomorrow’s business needs

How does this solution solve these issues?

Data integration

Starting with ‘Access to relevant data’ – there have been many attempts to create an IT landscape for R&D. This best-of-breed approach favors decisions that support the best solutions to meet a specific need. Yet if you take a step back and ask how I can get access to facts to make ‘key’ decisions this approach falters. The solution approach being offered starts with the premise that the user needs access to key data. Based on an individual’s role you get access to key data and permission to upload new data. This removes the user from having to make the required ‘conversions’ between solutions to create the information needed. The benefits include:

  • Adaptive trials can now be easily facilitated
  • Financial decisions tied to key outcomes of clinical trials can be reviewed and decided upon
  • Users get to focus on the science of creating new medications and treatments and not the nuances of the technology

Getting out of the IT business – the biggest advantage to this solution is that Pharmaceutical companies can focus on their core business goals of producing new products to complex diseases.

Global access to data

You now have a scalable approach to R&D. This solution not only accommodates your scientists and statisticians you can also invite clinical research organization (CROs). Data security is also key to this solution since you may be adding other teams to help in the development of new clinical products. The solution also takes globalization into consideration as a result of today’s clinical trials.

HCL Unified Clinical Operations Platform

HCL Innovation through Integration

Thanks,

Jim

Integration for RandD

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The purpose of this blog post is to summarize a model for ‘integrating’ clinical operations. I’ll summarize the goals for this model and describe the background and next steps around such an offering. Over the past few months I’ve been engaged with several clients in discussing how our IT Services Company could create such a platform. This new platform should meet the following:

  • Lower Operating Costs
  • Increase Productivity
  • While maintaining Quality and Compliance

There are several very good software solutions yet we know that there is a lack of an ‘integrated’ process that can ‘unify’ the R&D clinical data landscape of IT solutions. The key here is a focus on ‘transformation’ rather than ‘yet another technology implementation.’

In a earlier blog post titled “Improving the Business of RandD” (31Mar2011) the focus was on cloud computing and how this technology could lead to an ‘integrated’ business process. Since companies would be relying on IT Service providers to host these applications. In another blog post “Is It Time for “ERP for RandD?”” (30Apr2011) I spoke to the need for integrated business processes. Now I’ll look to pull these to thoughts together for a more complete view across clinical operations.

Let’s start with the Users

This integrated approach would address users that include Pharmaceutical companies, Clinical Research Organizations (CROs), and any Healthcare entity. We would leverage cloud computing solutions to offer the users with a portal that supports:

  • Single point of information capture
  • With access to data by role, study and function
  • Single sign-on

Content Layer

Here there is a dedicated source of content by pharmaceutical company. Various databases would be organized with content ranging from electronic data capture (EDC) to clinical and scientific data warehouse (CSDW).
Key to the content layer:

  • Standards
  • Dedicated source by pharmaceutical company
  • Providing flexibility to support variety of data sources

Business Shared Services

Supporting the users and the content is layer of business services ranging from:

  • Component user support
  • Compliance
  • Change management
  • Staging and data migrations services
  • Data reconciliation

Our team will be presenting this approach at the upcoming Oracle OpenWorld conference in October. In addition to this we will also be presenting on the topic I wrote about last month – Serialization. I am very appreciative of my colleagues – specialists in a variety of topics. What I find satisfying is in ‘stitching’ all this together. We now have several interested clients and the possible next steps are to deploy this solution and that will take some time. I would be interested in hearing from you – and your comments on “Integration for RandD.”

Thanks,

Jim

Gearing up for Serialization…

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I recently attended an Oracle product training session for ‘serialization.’ The Life Sciences industries, and especially pharmaceutical and medical device companies, are gearing up for the need to offer product traceability. This blog post will be the basis for a possible industry presentation later this year.

Oracle product/training

There are several solutions that address pedigree and serialization. A recent article by Carla Reed provides a great background to this topic. (Reed, Carla. “Beyond the mandates: Finding business value in mass serialization and supply chain visibility.” Pharmaceutical Manufacturing June 2011: 34-36.) I can recall as early as 2006 when radio frequency identification (RFID) tags were introduced as the solution for the industry. We know that for various reasons this never panned out due to price for the tags and adoption within the industry. Today a good example of this technology is the use of RFID with the devices that help automate toll collection on the various US highways.

Alternative technologies to RFID tags include 2D barcodes. Printers can create these unique tags at a fraction of the cost of RFID tags. The Oracle solution allows you the ability to attach these tags and their associated numbering at any level within your product hierarchy. This data can then be organized into a ‘pedigree’ document for your product. This would be analogous to ‘shipping’ papers that you would normally prepare once you prepare to send your product off to a distribution center or local warehouse.

Implications for supply chain

Now doubt that technology alternatives exist to help solve the problem of product traceability and authentication. Companies today are being forced by local and global regulations for the need to provide traceability solutions. The questions for many companies is just how to go about solving this problem. Let’s first decide what you want to ‘track’ within your product and your business process. I often describe the application of technology with the use of a ‘babushka’ doll (or Russian nesting doll). Where do you want to apply a tracking solution within your product? How do you want your supply chain to track your product?

Why IT services?

An interesting comment came out of the training session when one of the attendees asked “when would I use an IT services company?” Some manufacturers have looked to their packaging and labeling suppliers to provide the ability to ‘serialize’ and track their products. This would be a great idea were it not for the fact that these suppliers lack the resources and ability to discuss the need for traceability within a ‘business process.’ This became very clear when the discussion turned to when do you apply serialized information? You see no two products are manufactured in the same way.

Some manufacturers use production order with routing to make their products and some use process orders and recipes for their products. That was a tough conversation and when I raised the fact that production and process orders can often be mixed – well let’s say that the value of IT services providers that can navigate a client’s business process answered this question.

Some next steps

In my opinion IT service providers need to offer:

  • The ability to understand a client’s business process and offer cost-effective solutions to the application of serialization and product traceability.
  • Provide the ability to organize a series of steps within a project to deliver a solution. You need good project management – deliverables that includes documentation (yes it is a validated environment) – with skilled resources. Ask your IT service providers if they have any ‘accelerators’ for this type of work?
  • Have the technical ability to apply Oracle and SAP solutions. This is a mixed technology environment and there is no one solution to solve this problem.

I will let you know if this turns into an industry presentation later this year.

Thanks,

Jim

Aligning Life Sciences and Healthcare IT. Can IT bridge the gap? Part1

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What lessons can Healthcare Information Technology (IT) take from the Life Sciences IT? My background has been in Life Sciences and looking into Healthcare I can’t help but notice the similarities and differences in the use of technology. Over the past few weeks I’ve been engaged with rolling out a new business unit to cover the full value chain for Healthcare. Like most of us we are well aware of the cost for healthcare and the promise of “personalized medicine.” So how do we ‘evolve’ from our current position to fulfill this new ‘model’ of healthcare? In this posting I will focus on the Life Sciences portion of the value chain.

Technology choices and Life Sciences IT

Last week I was in Orlando, Florida to attend the SAP conference @SapphireNOW. I came away with the following key points:

  • Acquisition of Sybase brings mobile computing into a ‘strategic’ offering for SAP.
  • In-memory resident database will help solve customer issues with legacy systems.
  • SAP is making an effort to enter into cloud computing for key applications.

My perspective includes both being a user of technology – providing technology to solve business problems – and now adding value via IT services. IT executives within Life Sciences are under pressure to add value by leveraging IT to support the business. Unlike other industries that are more ‘customer centric,’ Life Sciences suffers as a result of being ‘disconnected’ from the end-user, the patient. The change in moving to a ‘patient centric’ model is part of the challenge. Yet their hands are tied because a large portion of their budget is spent on maintenance and internal IT operations. So when recent articles highlighting messages about Oracle by Bob Evans, Global CIO: Oracle’s Phillips Says Standardizing On Oracle Is The IT Cure, Information Week, April 23, 2010, and most recently on SAP by Bob Evans, Global CIO: Oracle Hammered By SAP For Stifling Customer Choice, Information Week, May 20, 2010 where does this leave you? How to solve this dilemma of minimal funding and yet provide unique “value-added” solutions that can bring the organization closer to the end consumer?

Providing IT Services for Life Sciences IT

Service providers offer “integration” and an increase use of IT. Since the challenge for Pharmaceuticals and Medical Device companies has been to leverage their existing technology. Here is the graphic that I use to convey what we mean by this, and I have several a very real customers who are looking for support across this ‘value chain.’ In a perfect world we would look across each department and leverage one common IT solution, yet within Life Sciences this is not the case. There a few companies that can standardize on one IT solution for the whole organization. (Some Generic companies have opted for one vendor solution since there is a limited R&D requirement for clinical trials.) IT must be the enabler for an organization’s ability to change in today’s market. To me this means looking into advances in technology that can improve agility.

Life Sciences and Healthcare value chain

Let’s see how the available solutions have an impact on Life Sciences IT and where IT services companies can add value:

  • R&D to Operations – Oracle’s Agile solution is widely used for product development and with their recent acquisition of Phase Forward and Relsys they now have solutions for clinical trials and drug safety. SAP ERP and Supply Chain are de-facto solutions within Operations. Effectively connecting these solutions can accelerate products to market.
  • Operations, Services to Sales & Marketing – Within Life Sciences the ability to gather pertinent customer information (more than just sales orders) is relevant to supply chain, and to new product development. Oracle and Salesforce.com are key solutions for Sales and Marketing. There is value in understanding how ‘patients’ are using your products.
  • Analytics – Underlying all of these solutions is a workforce that utilizes IT applications and Microsoft Office products for their daily work. Databases that gather application data across the value chain must be made available to the workforce and ‘served up’ so that data can be transformed into information for business decisions. There are Business Intelligence (data ‘cubes’) applications installed across the organization. Documentum is widely used for storing ‘compliance’ documents while Microsoft SharePoint is used to process data across a variety of sources. Users do not want complicated systems and most of all they want their data fast.

Next Steps in achieving alignment

The economy has impacted Life Sciences in terms of:

  • The high cost of healthcare which is driving need for ‘efficiency’ (from new product development to supply chain). Life Sciences now see the relevance of ‘patient’ feedback.
  • Lack of new products (either from R&D or enhancements to existing products) have forced the industry into M&A, realignment of existing resources, and IT investments to fuel new business.

IT services can connect the ‘dots’ within Life Sciences. Customers need to ask their service providers:

After alignment
  1. What can they offer to resolve the problem between applications within the value chain? Look for vendors with multiple technology expertise and a delivery model that is a mix of off-shore and near-shore resources. Low cost does not guarantee success if you’re not able to diagnose the problem area.
  2. Are we leveraging our IT to the ‘maximum’ within our organization? I speak to customers who tell me they have multiple IT vendors for application support. Again while this may curb costs you may miss out on a ‘strategy’ that improves your business processes.
  3. Are you within ‘compliance’ to the regional regulations? Can you improve operations and still be in compliance? When was the last time you had your regulatory group and IT processes reviewed?

Healthcare IT can learn from Life Sciences IT since there is no ‘one’ solution for the industry. SAP and Oracle are the dominant players in the market for Life Sciences. There are ‘excellent’ smaller niche players are likely to pose a problem for IT from an ‘integration’ perspective. Within Life Sciences IT we hear about the 80/20 budget crisis (80% is spent on maintenance and IT operations, and 20% for new projects) and with the advent of ‘cloud computing’ IT will need to see how they can leverage this technology. What I heard at the SAP conference that was quite interesting is that ‘in-memory’ databases could be applied to legacy systems. Given the current need for fast access to data this is very encouraging. I’m sure when I head to the Oracle conference we’ll hear of even more technology improvements.

In the next blog post I will share my perspective (that of an IT service provider) for Healthcare. There are some new business processes that can add value as Life Sciences and Healthcare IT move closer to each other.

While at the same time continuing to learn and strategize more about Healthcare IT solutions.

Thanks,

Jim