As we begin the New Year we’ve gone through our resolutions. Now the focus for us is to gain a fast start and the aim of this first blog post around the idea of the Life Sciences Industry Cloud. I’ll provide the background and challenges you will face, and what you could consider that will put IT in a position to help meet your business goals.
Background: The Enterprise in 2015
Cloud computing has been often discussed as the innovation option for Life Sciences companies. Back on September 7th, 2014 I wrote about an initial way of getting into cloud via Testing in Planning your Move to the Cloud? as an option to get the organization used to using cloud applications.
I read an interesting article from Alison Wagonfeld (@awagonfeld) The Enterprise in 2015. Which takes an investor’s perspective on technology trends for the Enterprise, and the focus on “industry cloud” applications. The article points our examples from Salesforce and Veeva of applications that can be rapidly deployed and consumed by business users. This puts Enterprise software vendors in a place to play catch-up with two distinct reactions/approaches. One is to buy up point solutions, and leave the integrations to the systems integrators (SIs) or the end-user. Cloud applications are easy to deploy the key here is to make sure you plan out the business process. The second being a hybrid approach where part of the solution is deployed as ‘on-demand’ (in the cloud) and integrated with the rest of the back office application (on-premise). This forces the end-user to rely on their SI to have the right resources and plan for every interface and data point.
There is a nice summary on the software challenges we will face as we seek to improve the business with technology. Lora Cercere’s (@lcecere) article “Undeniable Truths of Software” provides some very good perspectives on the challenges that Enterprise Software vendors face. She describes a variety of challenges with software companies.
Because the cloud vendors come at the problem from the user side it is easier to create a solution with no back-end integration. The challenge for the Enterprise Software vendors is do they re-write the application or develop only a portion of the business process. There are some Life Sciences clients that are waiting to see how the enterprise software vendors respond to the challenge from cloud applications. There are other considerations from a business user perspective that is driving these discussions*.
[*I will look at the issues with Big Data and Mobility in another blog post.]
Best practices that allows you to leverage cloud applications
Prior to cloud applications the focus was on ‘best practices’ for each industry. I contend that we have to resurrect these processes as a guide to reaching the Life Sciences Industry Cloud.
The focus should be on the business process and the integration points needed to offer the complete process for the end-user. This allows for an easier time to ‘validate’ the process. In 2015 we are at a point where business users are clamoring for IT to improve the business. The benefits are as follows:
- Enterprise software vendors can pick which part of the business process to move into the cloud or stay on-premise. Timing for all this is inevitable as the users of the solutions prioritize business process that give the highest benefits and can rank them so.
- System Integrators (SIs) will have to live with the fact that deploying cloud applications are more about the experienced resources used in faster and quicker projects than long program deployments. Done well repeat business will help drive net new opportunities.
- Clients need to become more aware of the users and how they work to give the right business process. Change should be the motive in all this – failure to recognize this will lead IT to fall out of favor with the business.
For many customers the move into cloud applications can be daunting given the investment in on-premise software applications. Today’s users want to work more efficiently and have already personal experience with cloud applications. The goal for 2015 is how well you can adopt the Life Sciences Industry Cloud into your organizations.
Let me know what you think?
For most IT departments supporting the business with new functionality
means planning a move to the ‘cloud.’ With most of the Enterprise software vendors are now offering their solutions via the cloud. In this blog post, I will present some the most commons myths against the use of ‘cloud computing’ and offer a common Testing application to help you and your organization get experience with ‘cloud computing.’
What is holding you back from moving to the cloud…?
Today as you read this blog post you most likely have your personal data in the cloud. Costs for storage have been dropping, and recently my Dropbox account went from 100GB to 1TB for the same monthly fee! So what is holding organizations back from moving to the ‘cloud?’
- Compliance – Life Sciences companies have the need to perform computer system validation (CSV). Very often the push back is around how to define the systems and processes.
- Drawing a line around the components and defining the connections between the applications helps to focus on what needs to be validated. Once you define this as part of your process – the validation and documentation that you used with your legacy systems remain the same. Just because you have a part or all of your process in the cloud should not hold you back from performing CSV on your process.
- Data security – there is still a ‘fear’ that going to the cloud means a less secure IT environment.
- Overcoming this fear is to look at how you currently access your data. I work closely with Amazon Web Services (AWS). Where the concept of a ‘private cloud’ is certainly an option in protecting access to your data. In short, this is a direct connection between your IT landscape and the cloud servers.
- Another way of overcoming this fear is via industry examples, and thanks to Andy Waroma and the folks at Cloud Comrade here is a link to an article “Amazon Web Services becomes first cloud provider to handle sensitive US defense data” So if the US Defense industry can use cloud services it most certainly can be leveraged for your application data.
- Cost – what are the savings from moving to the cloud?
- We have been accustomed to a cycle of Capital requests for software and hardware on an annual basis, and support costs is an on-going expense.
- In working with my clients comparing the overall costs – moving to the cloud can bring down the overall support costs by 2X!
- The added benefit from a move to the cloud is the flexibility it can bring to your current IT landscape. This is where you need to get some experience with cloud computing to gain further insight in this area. We will discuss this next.
Typical IT Landscape
For purposes of this discussion we will focus on an SAP landscape. The situation is where you want to add additional users to an existing landscape of ERP, Business Warehouse (BW) and NetWeaver. What you would do is to test the performance of your applications with the increased user count.
For my client we provide Testing services and invariably we have to request additional hardware to ‘simulate’ this environment. The solution is to provide….
Performance Testing in the Cloud
Consider the use of cloud computing services for “Performance Testing” to achieve the following experience:
- Requires a discussion on connecting your IT landscape to Amazon Web Services or similar provider. This will ensure and test the security around your data. Direct Connection versus Virtual Private Network (VPN)
- Server sizing and set-up that is similar to your landscape. Please note: the hardware will not be exactly what you currently have in your landscape.
- Have your IT department provide Basis support for performing client copies and any software application changes you need to simulate in the cloud. If you don’t have the resources available you can ask your systems integrator to provide this service for you.
- Costs – include a one-time setup – an operating cost and cost for when you don’t run you’re ‘performance testing.’ Your costs will vary based on your needs.
In summary, moving to the cloud should be part of your annual IT project planning. You can work through your Compliance and Data Security needs. The goal should be a move to shift your overall support cost from maintaining your hardware to an operating cost that will allow for expansion of your IT landscape to meet the increasing needs of the business.
In discussing this with clients that have the ‘traditional’ server centers there is a hesitance to move to the cloud. I would recommend you look to do your ‘performance testing’ in the cloud to give you and your IT team the experience in working with cloud computing services. The benefits can be realized very quickly.
I am open to your feedback, so tell me what you think?
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:
- 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.
- Companies need to give supply chain ‘visibility’ so that the organization can make faster and better decisions.
- 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.
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
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:
- 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
- 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.”
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.
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.
Admittedly this is not a new concept. When enterprise resource planning (ERP) was first introduced the focus was on integrating finance/accounting, manufacturing, sales and service. ERP provided the means for ‘integrating; the business processes within an organization. So why raise the topic of “ERP for R&D?” Pharmaceuticals and Medical Devices develop new products in an environment that is driven more by science than a ‘business process.’ Scientists will suggest that forcing a business process into R&D limits their creativity. Today we are well aware of the problems facing R&D: lack of new products, reduced productivity, significant capital cost with diminishing results in terms of new products.
In my last blog post “Improving the Business of RandD” the focus was on the impact that cloud computing could have on R&D. Platform as a service (PaaS) and Infrastructure as a Service (IaaS) are alternatives that can help IT supplement their existing business process. Today contract / clinical research organizations (CRO) are being used to supplement R&D in the area of clinical development. Basic research and clinical manufacturing (in some organizations) are also being ‘outsourced.’ Given this quilt of organizations and separate business processes I’ve concluded the need for “ERP for R&D.”
Ultimately change will occur. I read an interesting article “Pharmaceutical Innovation Hits the Wall: How Open Innovation Can Help” by Henry Chesbrough. He writes about the need for changes to the industry’s innovation process. You may already know about the industry’s focus on ‘blockbuster’ drugs where the business is using science to find that next billion dollar product. Which comes at the price of research in seeking medications for smaller patient populations, so I contend that the business processes with R&D need to be ‘integrated’ with visibility to the data across the organization. I do agree with the point that Henry makes in his blog post that ‘there needs to a change in the innovation process.’
I have begun this journey to offer ERP for R&D as several of my customers have asked our company to give end-to-end services. I would like to see the industry focus more on new treatment and medication innovation and leave the IT to systems integrators (SI). Unlike software development companies SIs is pretty much agnostic to the software solution and more about how to drive out cost and improve IT performance.