Clinical Development

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

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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

Is It Time for “ERP for RandD?”

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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.

Thanks,

Jim

Fresh start in 2011

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By now everyone has gotten past their New Year’s resolutions and is picking up where they left off last year. So thinking about my

Fast start...

 first blog post for 2011 I would like to cover the following areas:

  • A look back at 2010
  • Maintaining momentum in 2011
  • The focus for the year

Reviewing 2010

The nice thing about blogging is that you can go back and see how you’ve progressed throughout the year. In last year’s blog post: Upgrading for 2010 I had worked on a business plan to startup a new Life Sciences practice for an IT services company. I covered the five focus areas last year by writing about the following topics:

  • Social Media – from the use of these tools to deriving ‘value’
  • Cloud Computing – producing a white paper for my employer
  • Drug Development
  • A three-part series on Aligning Life Sciences and IT – covering how to leverage information technology; Mobility and Innovation and the Business Process
  • Innovation and Outsourcing
  • A book review on ‘selling’
  • Patent Expiry

Unfortunately the business plan was not approved, and I moved to another opportunity to do business development for an IT services company. This challenging role now has me advising clients on the best use of IT within Life Sciences and Healthcare. This opportunity came by way of my network, and for that I can thank Robert.

Maintaining Momentum in 2011

I continue to focus on the use of social media tools. So I am thankful for my LinkedIn network and my followers on Twitter. I have come across lots of folks with the same interests and challenges for the Life Sciences and Healthcare industry. There are tons of creative people with new ideas for solving today’s business problems. In 2011 I want to carry the momentum started in 2010.

Karl Rove and Jim, 14Dec2010

 

I am also very grateful for my co-workers, coaches and mentors who have helped me transition into my new business development role. Towards the end of 2010 I started to see success in driving new opportunities for my company by aligning IT to improve businesses. Along the way I’ve met many interesting people. I had the chance to attend an industry meeting for Medical Devices and speak to Karl Rove the former aide to President Bush. Politics and Healthcare are very intertwined and for 2011 there continues to be changes.

 

The Focus for this year

I plan to enter 2011 by expanding on last year’s topics. How do I combine my interests with the tasks of being a business development executive? Here’s what I’ve come up with:

  1. Leveraging Twitter to cover the following areas:
    #pharma – how is clinical development, social media, and regulations impacting this segment of Life Sciences?
    #mHealth and #mobility – the use of mobile devices will impact healthcare throughout the world.
    #hcsm – how to best leverage healthcare social media?
    #healthit and #it – what is the impact of IT on the organization?
    #personalizedmedicine and #genomics – will genomics have an impact on healthcare in our lifetime? (I’m currently waiting on results of my own genomics that has to do with ancestry.)
  2. Business process improvements in the areas of Product Lifecycle Management (PLM); Customer Relationship Management (CRM) and Supply Chain Management (SCM).
  3. Clinical Development and Analytics
  4. Cloud computing
  5. Mobility
  6. Mergers & Acquisitions
  7. Globalization

In case I forget to add Marketing and the use of Social Media to further drive IT services opportunities. I will be more involved in our website and the use of the social media tools.

I continue to have a personal interest in the Life Sciences and Healthcare industry. Last year I saw the impact of ‘personal health records’ for my brother who is a kidney transplant survivor. I’ve have friends succumb to diabetes, and parents who are aging. How will technology help to improve the lives of these people? Will this be something I will see in my lifetime?

 

January Snowstorm for Newtown, Pennsylvania, USA

So like the snow storms on the East coast of the US. As of January 2011 there are more storms this year than last year. We are starting 2011 with a lot of momentum.

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/

Upgrading for 2010

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I’m not very good at keeping New Year’s resolutions. Yet what I intend to do this year is to align my interests with what I am currently doing. At present I am contracting with an IT service provide to ‘start-up’ a new Life Sciences practice. So in keeping with the title of my blog, how to ‘leverage IT for Life Sciences and Healthcare’ I hope to share what I’ve learned. I started blogging using Blogger and I hope you can see the change now that I have moved up to WordPress. This site has much more tools and allows for greater flexibility in terms of the ‘appearance’ of my blog. I would be interested in your comments on this……

In starting up a new business unit I’ve got to figure out how to be successful in a short period of time. I look forward to describing what I’ve learned through this blog. So the topics that I want to focus on are as follows:

  • “Design Thinking” – this is a new way to approach problem solving that combine both analytical and intuitive thinking. OK Jim, so how does this apply to IT and Life Sciences? Well if you consider that everyone seems to use some ERP package is there a way to make money in ‘improving’ IT processes? I think so and there are ways to promote ‘process innovation.’ What has been bothering me is how to go about this, in such a way as to develop a business around this……
  • How can IT improve areas such as Clinical Development? Unlike ERP where the business processes have been ‘integrated’ can the same be done in the area of R&D in Life Sciences? Is there a need to link Sales&Marketing applications back into R&D to help Life Sciences and clinical trials? I will talk about this under “Process Innovation.”
  • “Closing the loop” between the patient and Life Sciences companies. In the US, if we expect to achieve “Personalized Medicine” Life Sciences companies will need information from patients. The current ‘eco system’ in the industry prevents this from happening. So topics that I want to look into include: eHealth, Health 2.0, and ePatients.
  • We will also look into leveraging ‘cloud computing’ within Life Sciences.
  • The launch of this new business unit will let me try out new Social Media tools. This should be fun as there are new ways to ‘market’ new services and products. Yet choosing which tools to use is a challenge – especially given budget and scheduling constraints. Let’s face it – if I’m to be successful at launching this new business I’d better get the word out and create the attention needed in the market.

Word Press and the iPhone application – I like my Apple iPhone and so in the course of writing this I have had the chance to use the WordPress 2.0 application. Works great and saves me time when a new idea hits me. The application allows you to write-up a new idea and save it as a ‘draft.’ Make some tweaks and edits – chekc for grammar and spelling then hit the ‘publish’ button.