FDA

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

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

What is your Strategy for Mobility?

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The driver for this new blog post came as a result of my recent trip to the SAP Sapphire conference in Orlando. I have an interest in technology and focus on the #mHealth (mobile health) aspects of Healthcare. It was during several discussions with key executives that you realize that few companies are prepared to handle the shift in the industry around ‘mobility’ more specifically the use of smart phones. Many IT organizations drive a strict policy around the use of smartphones. When I joined my company there was no strict policy. It is left up to the user to decide what his or her needs are and make their choice.

I previously wrote about a solution back on June 15th, 2010 entitled: Aligning Life Sciences and Healthcare IT. Part 2 A Practical Mobility Solution for Doctors and Nurses. We delivered a system that met the needs of a client for one specific problem using one form of technology. Last year this was a great example of the use of smartphones to improve the productivity and communications between nursed and doctors in providing ‘improved’ healthcare. When I reflect back on this if the client decided to change smartphone technology what would this do to the current process in place? One statistic that highlights the acceleration of smartphones is that by 2013 that there will be 6 billion devices!

In many organizations IT can be a deterrent in today’s rapidly changing world of mobility. There are a few things IT cannot change or control:

  • You have a ‘fixed’ budget
  • No control over changes in ‘compliance’
  • No way to expect your user’s increasing expectations

Evolving Technology versus your Fixed Budget

Users are looking to manage their time by finding ways to be more productive. As the pace of smartphones increases I believe there needs to a strategy that is ‘agnostic’ to the end device (whether you use an iPhone or an Android device). I recently ‘tweeted’ the following message: “David Mosher talks about how tablets are changing #medicine http://bit.ly/jsgDF0 RT @ONHealthcare: #mobility #healthit “ New apps are being released that can greatly improve various facets of healthcare. I am convinced technology is accelerating faster than IT policies.

Another example of how technology is changing the way IT provides support to their users. Google recently announced their “Chromebook.” In short these are laptops with no applications installed on the end-user device. Everything is running off of cloud services. So how can I lower my costs and allow for security, and at the same time give the users flexibility of using technology their most comfortable with….

  • There are several companies looking to offer their own “apps” store. This allows users to easily download company specific and widely used applications.
  • Deploy a mobility strategy… at the Sapphire conference I’ve seen solutions that allow IT to give access to key business processes

The SAP mobility strategy may be one choice that allows IT the ability to ‘connect’ key processes and make them on any device. This also includes the relevant data that can be used to make key business decisions. As more and more workers look to collaborate the mechanism to manage all this is ‘how fast can IT push this data out’ and into the hands of their workers to make key decisions.

IT groups must now see how they can balance the enterprise with mobility to create the ‘mobile enterprise.’ Over the next few months there is a concerted effort to prove this in the market. By providing a roadmap and tool kit to help organizations set up this mobile enterprise. Some of these components are here today and others are still being developed, and to reach this potential your mobile strategy should have the following attributes:

  • Device independent
  • Deliver and Enterprise – ready security solution
  • Provide integration to ERP/CRM

This strategy will eventually evolve to include Business Intelligence as well as governance, risk and compliance later in the year. What I will be focusing on is the ability to help Life Sciences companies fulfill this ‘mobile strategy’ through a series of investments and proof-of-concepts. As this proceeds I will offer a future blog post to cover this story.

I’ll conclude this blog post with a reference to an interesting article found in Computerworld May 23rd, 2011, Opinion: Halamka: Facing down VUCA, and doing the right thing.

The author, John Halamka, describes how IT leaders deal with ‘unpredictable demands; ever-changing technologies; and all on a fixed budget.’ These leaders must embrace VUCA and ultimately move from the left to the right. With the world exploding with data and businesses looking to compete in the new world the article pretty much sums up how to prepare yourself to meet this challenge and turn it into an opportunity for your business.

Volatility                      ->                                        Vision

Uncertainty                       ->                              Understanding

Complexity                ->                                       Clarity

Ambiguity                ->                                     Agility

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

Drug shortages will impact Healthcare…

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Supply chain

Most of us are excited about the changes occurring in healthcare around mobile applications, electronic health records and the advent of social media just to name a few examples. Yet there is a mounting concern with the rise of drug shortages now reported at “178 a 3x rise since 2005!” A look at the FDA web site for drug shortages shows a list of both generics and branded products with the reasons for the shortages (including manufacturing delays, increase in demand, etc.). We’ll look at the background of the industry, the traditional view of supply chain, current factors facing the industry, and what companies can do to ‘improve’ their operations. Recognizing the need to convert your improve your existing operations will be good business and the consequences will directly impact you and I.

Key facts about the industry

According to IMS Health pharmaceuticals sales in 2011 is expected to reach 880 to 890Billion USD, which is a growth of 5 to 7%, and is 1% higher than the 2010 expectations. The current view of the supply chain includes:

Today's supply chain

  • In the US market the top 10 pharmaceutical companies give some 60% of the total US sales.
  • As products come off patent Generics control the prices of these products.
  • The wholesalers may also negotiate prices between the manufacturers and the Pharmacies.

The traditional view of the supply chain

The driver for any supply chain is to offer:

  • Product at a ‘reduced’ cost
  • Faster to market
  • Delivered at a high quality

Apply this to the previous diagram and you can see the challenges that face healthcare. As the view of the patient and pricing for these products are disconnected. This diagram gives you the full view of the Healthcare supply chain:    

 
 
 

The Healthcare Supply Chain

 

Current factors influencing the industry and the Healthcare supply chain

The following factors have influenced the market:

  • Mergers and Acquisitions – have reduced the number of manufacturers as companies have consolidated to make up for the loss in patent expiry and look to increase market share (Merck and Shering Plough, Pfizer and Wyeth, and Teva and Barr Labs are just a few examples)
  • Regulatory issues – it is harder for manufacturing sites to recover from an FDA violation. This delay can lead to drug delivery delays.
  • Government control over pricing – as the cost of healthcare rises many governments are dictating the price of drugs (Spain, Canada, Turkey and Greece). This puts the supplier at a disadvantage to be able to deliver products at these ‘reduced’ prices given the cost for raw materials.
  • Globalization – in response to some of these factors many companies have already moved their operations to off-shore locations. India for API manufacturing.
  • Risk Management – having the ability to ‘view’ any of these problems can lead to drug shortages. Supply chain operations must therefore give this visibility so the right changes can be made.

Taking these factors into account and with a view of the ‘future’ of the healthcare supply chain from Gartner:

The Demand Driven Healthcare Supply chain

How can I ‘improve’ my operations?

I now work with a variety of companies that look for solutions to ‘improve’ their processes. We began his discussion trying to understand why there are so many drug shortages, and I would suggest the following as a means of enhancing your supply chain operations:

  • Refocus business growth and performance across the entire healthcare supply chain. This includes both the patient as providers of healthcare with a C level sponsor that understands that the aspects of healthcare lie outside of your companies boundaries.
  • Collaboration. Look to improve demand from both your suppliers as well as your customers. Provide visibility and metrics that you can mutually share.
  • Leverage IT as an enabler to meet the first two points. Make investments that promote organizational visibility. Specifically analytics solutions that provides management with a view the business as a result of this investment.
  • Governance. This process does not happen overnight. Change management is an ongoing process and you will need leadership and support to sustain these processes as they evolve over time.
  • Invest in skills and talent within your organization. I’m in the IT services business and you would think this takes away from my opportunities. There is a tendency to think that these processes can be solved through off-shore support capability. While this is true I am taking about the need to enhance your folk’s ability to understand the entire healthcare supply chain.

I am convinced healthcare can improve yet the threat of drug shortages can impact any course of treatment if the right products are not available. What I hope to do with this blog post is a summary of the problem and possible solution. I welcome your suggestions or comments to improving this blog post.

Thanks,

Jim

New Research Model to Accelerate Drug Development

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Online webinar was held on March 25, 2010.

As I was preparing to attend this call I remembered an article that appeared in Pharmaceutical Executive by Emmanuel Le Poul (November 18, 2009) entitled: “Rising to the Challenge in R&D.” So while the country was in the midst of discussing healthcare, the article started off by describing, that the pharmaceutical industry has not been able to improve the number of new molecule entities (NMEs) approved by the FDA. With the debate on healthcare focused solely on costs. The bigger issue is around productivity and innovation and why is it that we have not been able to improve the success rate for new NMEs? Many of you are well aware of the billions of dollars invested and countless clinical trials being performed each year. Is there a better model for drug development?

I had expected this webinar to focus on the ‘science’ aspects of drug development. Instead the focus was on improving the ‘process’ and for me that was truly enlightening. The presentation highlighted the growing ‘disconnect’ between academia and the pharmaceutical industry. We are well aware of the pending patent issues within the industry. The investment costs of $50 billion per year being spent on R&D, and the lack of ROI in terms of new products. The speakers covered the history for how we got to this point, and introduced the Accelerated Research Collaboration (ARC) model developed by the Myelin Repair Foundation (MRF). http://www.myelinrepair.org/research_model/

The ARC model is a holistic approach that spans the entire drug discovery and development value chain. This offers Pharma the means to make decisions when to license the discovery. I see it as improving the odds for success by closing the gap shown in the graphic on the right.

I’ll summarize the model as follows:

  • The first step is target discovery. This is the basic science conducted in university laboratories. For the most part, the NIH and other disease research organizations simply fund basic science that results in the publication of results in peer review journals. The result is hundreds of thousands of such articles published each year. The ARC model identifies the best scientists, requires them to share data in real time, manages the scientific process to a strategic research plan designed to discover therapeutically relevant targets, and then file patent applications on their discoveries.
  • The second link in the value chain is target validation. The ARC model establishes and manages a network of contract research organizations, better known as CROs, tasked with validating the basic science from the MRF labs to industry standards.
  • The third step in crossing “the valley of death” is drug discovery. The ARC model identifies and engages commercial partners to conduct drug discovery research. The MRF accomplishes this step in the process by entering into partnerships with multiple pharmaceutical partners, each established to move multiple targets through drug discovery and clinical trials.

The sports equivalent of the ARC model is to achieve as many shots on goal as possible, and thus overcome the high attrition rates inherent in getting a treatment approved and available to patients. An essential component of the ARC model is coordinating and being involved with all the players and participants in the value chain, from the academics, other non-profits, patients, physicians and various government agencies, like the NIH and the FDA. The MRF invests and is involved in every step of the process.

If better treatments can be found using this model then we will have achieved success. We have spent too much attention on the cost of healthcare rather than focusing on the patient and developing new treatments through process innovations like the ARC model. I would recommend visiting their site to learn more about this model and the success they have had so far.

For more information on the webinar including the transcripts and slides these can be found on: http://myelinrepair.org/myelincures/