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




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.



Pharma 2.0 and the need for Process Innovation

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I read an article by Stephanie Sutton, PharmaTech Europe entitled The Pharma 2.0 Trend for 2010. The article summarizes how the industry will remain status quo for 2010 based on Ovum’s industry report. “The trend for slow growth will continue, and cutting costs and reducing time–to-market will remain a priority, particularly with the impending patent cliff in 2011.” If the Pharma industry remains the same how will personalized medicine come about? We know that the pending healthcare reform will influence the industry. How much of a change remains to be seen.

In a previous blog I expressed the need for ‘process innovation’ and in this article it describes how IT and technology solutions must connect knowledge between departments and global organizations if we are to achieve the new model for healthcare. The term Pharma 2.0 refers to the new business model when the industry moves to personalized medicine or some form of ‘targeted treatments.’ I like how Ovum describes Pharma 2.0 as “leaner, globalized entity whose increased scale is achieved ‘virtually’ rather than through accretion.” To me accretion seems to be an interesting word and according to “the growing together of separate parts into a single whole.”

There is ample data that indicates the current Pharma R&D model to bring new products to market is inefficient. Something we all know. Within these organizations the adoption of ERP has been an example (if done correctly) of how business processes can be streamlined and data collected in order to run a global business. This covers Manufacturing/Operations, Service, and Sales and Marketing. I see ‘process innovation’ being applied to the R&D side of Pharma. As new technology is introduced there must be an awareness of the role that IT plays in supporting the business process, and improving how data is collected and made available for decision making. Unlike ERP where there are vendors and service providers that have helped to put this in place on the business end of Pharma. There does not appear to be ‘one’ vendor for the R&D side. So the challenge is how to ‘connect’ these technologies together, when you have software-as-a service (SaaS) or ‘on demand’ applications alongside the traditional enterprise solutions or ‘on premise’ applications. This is the challenge we face as we go into 2010. I see this as an opportunity for IT to be the catalyst to help the industry transform into the Pharma 2.0 business model.