Pharmaceuticals

This year’s focus

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January was an interesting month. Too many work projects that took time away from writing. Last month, WordPress provided a nice summary of last year’s topics. A look back at 2012 revealed that you were most interested in the healthcare value chain and supply chain.

2013

Looking ahead for this year I would like to focus on the following:

  1. Healthcare improvements
  2. Analytics and Mobility
    Analytics and Mobility
  3. Big data
    Big data
  4. Supply chain management (SCM)
  5. Customer relationship management (CRM)
  6. Business transformations for Pharmaceutical and Medical Devices
    Business Transformation
  7. Book reviews on relevant topics

Besides these topics I continue to see my activity on Twitter as a ‘service’ to those who are interested in the Life Sciences and Healthcare industry. Key hashtags include:

  • #pharma, #medicaldevices, and #lifesciences – how technology, social media, and regulations impact this industry segments.
  • #mHealth and #mobility – the use of mobile devices will impact healthcare.
  • #hcsm and #sm– how to best leverage healthcare social media.
  • #healthit, #it and #CIO – all topics related to IT.
  • #sales and #productivity – is a new focus for me since being active in sales

I hope to continue to blog and ‘tweet’ on topics that give help to others. I thank those of you that offered feedback on my blog posts.

Thanks,

Jim

Business Value and the CIO

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The question I keep hearing about is ‘how can Life Sciences CIOs help meet the needs of the business at the current pace of technology?’ Last month I wrote about Realizing a 360 degree view of your customer… and a focus on CRM. This described how IT technology can add value in helping the business keep and acquire customers. This month I want to summarize what is impacting today’s executives and what can be done to have IT be an enabler of value within Life Sciences.

The situation today

In the recent Gartner 2012 CIO Agenda “Re-Imaging IT” by Andrew Rowsell-Jones he presents a summary of the results from an extensive CIO survey, and a key question around the relevancy of IT departments when the business has a broader definition of technology.

Many of you reading this blog post experience the rapid pace of technology as you go about your business each day. Technology is reaching more people across the globe consider these points:

  • I’ve heard that in China over 70% of the population have never owned a laptop and went straight to handheld devices.
  • In India, mobile phones are more popular than toothbrushes
  • And other facts about the rapid pace of technology

In the Gartner survey CIOs ranked the following business strategies in order of importance:

  1. Growth
  2. New customers
  3. Reducing IT costs

Yet the Life Sciences industry executives have to deal with little or no growth in IT budget and increasing demands from the business for more technology (especially around analytics and mobility). CIOs are constrained from delivering IT innovation from budget to skilled IT resources to organization and culture plus alignment between IT and the business.

CIO as the Chief Innovation Officer

I had read this Forbes article by Perry Rotella entitled CIO = Chief INNOVATION Officer. The essence of the article was to lay out the case for CIOs to have their organizations adopt more of an ‘agile’ approach to the use of technology within IT. I recognize and experience that Life Sciences companies have to deal with Regulations, Compliance and Security. Yet I believe this to can be solved.

I do agree with Perry in this article that the CIOs “greatest responsibility is to create value” for the organization. You drive ‘growth’ via ‘innovation.’ IT enabled innovation can differentiate how you deliver service for medical devices, offer a great customer experience, and improve the productivity within the organization.

 

IT Service providers can aid and enable CIOs move to a more ‘agile’ approach to generate IT Innovation. I would suggest the following actions:

  • Embrace the fact that your current approach to delivering projects will have shortened lifecycles – full of frequent changes.
    • Find IT providers that add value from a solution/technology perspective. Think of them as extensions to your team. This reduces the need to up-skill or hires talent to your IT team.
    • Fill the gap within your IT team around new technology with IT service providers that can rapidly add value to key projects.
      • CIOs are asking for short ‘assessment’ projects that can diagnose the current process and offer solutions with costs and timelines. I’ve helped companies adjust their supply chain or enact benefits studies around specific business processes.
      • Focus on smaller and shorter (in terms of duration) IT projects.
        • Proof-of-concept projects in cloud computing. Balancing validation between on-premise and on-demand applications. Yes a ‘hybrid’ model is possible. Remember the previous points and align these projects with the business to meet the greatest value.

In the coming weeks I will address mobility and big data. These are some of the hot topics within Life Sciences and they can mean different things depending on if you’re a pharmaceutical or medical device company.

Thanks,

Jim

Social Media and Life Sciences

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While there has been a lot of discussion about the FDA’s view of Social Media I wrote last month about Gearing up IT for Future Growth. IT must become more relevant in supporting the business and this new way of ‘collaboration.’ In last month’s blog post I spoke of how IT can be a catalyst for the business. There is a conflict in all this since IT budgets are constrained between maintaining the current IT landscape and investing in these new areas.

To get a better view on this dilemma I suggest you read this blog post on The Next Wave of Technology Led Business Gains written by a colleague of mine. His blog post is entitled Sadagopan’s Weblog, January 8th, 2012. In this article he describes the issues that benefit the business and yet prove challenging for IT.

Being a ‘social enterprise’ to me is all about the connections between your end customers and the products you sell. Within Pharmaceuticals and Medical Devices investments have been made in the areas of customer relationship management (CRM) solutions to help business process improvements and adoption for example: sales reps taking orders and processing quotes. Technology is providing opportunities to improve the ways in which companies can rapidly gain insight into the use of a medication or device.

Integration is the key in all this since the business is using social media tools to quickly gather up this data and transforming this into relevant information. Today I am working with several companies that are looking to improve their business processes via upgrades and ‘smarter’ deployment of this technology. The challenge is to ‘connect’ the output of social media for improved clinical trials or insight into existing device performance (via call center data and complaint tracking).

We are not quite there yet in ‘integrating’ social media with back office systems. Tools are being introduced to ease the ‘listening’ and ‘gathering’ of this data. I believe that Life Sciences companies would benefit from a better ‘collaboration’ with their patients and consumers of their products. As I see this progressing in the market I will offer an update to this blog post.

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

Improving the Business of RandD

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A lot has been written about Cloud Computing. In “Tech Giants look forward to Cloudy Days” this speaks to the competition between Apple, Google and others that want you to store your files on their technology. In “Here’s Why Cloud Computing Is So Hot Right Now” talks about the shift from client-server to ‘shared’ hardware located away from the corporate offices. In a earlier blog I wrote called “Managing my data…”I detailed my experiences with my data after my laptop was damaged. Learning to use and apply cloud computing is the focus of this blog post with an emphasis on Pharmaceuticals and Medical Devices R&D.

Lately I’ve been working in the R&D area and specifically on the business processes that extend from Basic Research through New Drug Application (NDA). Most of you have heard about the impending loss of revenue due to patent expires of branded pharmaceuticals. The question is what can be done to “Improve the Business of R&D.” For starters most companies have realized that IT is not their core business. IT is just an enabler of the business processes within a company, and most executives I know want to focus on the core business of creating new medicines and treatments. Then there is the high amount of effort needed to make sure ‘compliance’ is maintained to the local regulations, when it comes to making these products. Add to this situation if IT develops a ‘homegrown’ solutions within R&D.

In the past information technology (IT) was used to serve the needs of the R&D. Today there is a need to see how IT can accelerate the business within R&D. The example that comes to mind is how kids use technology (cell phones, laptops, tablets, etc.). They just use it to do whatever it is they are looking to do. Make it simple and the user will consume more of this technology. Today we’ve come to the conclusion that IT is not keeping up with the demands of R&D. So how can we improve this?

Cloud computing offers the ability to expand IT capacity in an ‘on demand’ fashion. We’ve begun to take this concept one step further. What if IT services providers created an infrastructure or platform ‘on demand?’ Google Mail (Gmail) is an extreme example of this where users can get access to their email through cloud computing. As more users go to Gmail capacity expands to meet the needs of the users. I say this is an extreme because the cost model for Gmail is different from a R&D model.

Imagine a day when you can ‘rent’ a process – add database capacity – replicate existing IT landscapes in the cloud. We refer to this as process-as-a-service (PaaS) where you can use any given process via the cloud. Allowing you to add new users to a business process on an as needed basis. We can also provide infrastructure-as-a-service (IaaS). We’ve had clients ask if we can offer the servers organized in a specific fashion to support their business process. Companies can leverage these services and get out o the IT business of maintaining and supporting these systems.

Is this a novel idea? Not really – other industries have enacted similar PaaS and IaaS solutions. What makes this different is that within Life Sciences (especially Pharmaceuticals and Medical Devices) you have to discuss the regulatory aspects of your IT systems. And ‘yes’ we can support a cloud computing environment that is compliant to the FDA regulations. IT services providers would have to offer this in order for Life Sciences customers to use these solutions.

What is exciting to me is that we have the opportunity to apply cloud computing for the industry and create a fully ‘integrated’ process which, I believe, will improve the business of R&D.

Thanks,

Jim