The Laszlo Letter

Roche to implement Google Apps for 90,000 employees

You are probably aware by now that Roche has made a deal to roll out Google Apps on a global basis. This was reported by many news organizations and bloggers. One that is quite interesting, however, is on ZDNet since it generated quite a bit of heated discussion.

The rationale for this important move has to do with interoperability issues, or lack thereof, between the two solutions used previously by Roche and Genentech. This is stated by Roche CIO, Alan Hippe, on Google's Official Enterprise blog.

Reactions to the announcement focused on three issues:

1. Data Security

2. Data Privacy

3. Usability

In particular, comments pointed out security flaws in Google Apps, the probability that Google would inappropriately mine the Roche data/documents for their own purposes, and that users would get a much weaker set of email and MS Office-like functions.

These concerns may be real but also show that the commentators do not know how Roche operates. First, nothing at Roche is done in haste or without due diligence. The type of questions raised by those reacting to a press release would have already been studied to death by Roche staff and made available to senior management including risk, QA, procurement and legal staff. The decision would not have been made without Google agreeing to a detailed set of system requirements and the contract no doubt contains an equally strong Service Level Agreement (SLA). There would also be strict controls on privacy and security including what Google could or could not do with the data. Indeed, it is likely that the only thing Google will be able to do with Roche data is to provide appropriate technical support. And yes, it is also likely that an agreement is in place to govern how data moves (or not) between borders.

Then there is the rollout. Although I have worked quite closely with Roche IT on application implementations in the past, I am not privy to the way Google Apps will be rolled out. What I can predict is that it won't be done on a one-shot basis. One probable scenario (given what Dr. Hippe has stated) is for the email and calendaring functions to be rolled out first and even that in a phased manner to the 140 countries where Roche operates. It will probably start with the USA and Switzerland, then the UK, followed by the rest of Europe. Other regions would follow with double-bite countries like Japan going last.

You can then expect word processing, presentation and spreadsheet functions to follow. However, I would be willing to bet that other collaboration features (e.g. blogging, social networking) may come out before or in parallel with the more traditional office functions.

Although Roche and Google maintained radio silence on the current systems, it does not take a genious to see that Microsoft is in jeopardy at Roche. Given that this industry tends to follow the leader, Microsoft may suffer the fate of Blackberry in the biopharma sector. You may be elated or deflated by the prospect.

IT Trends for 2012 by SAFE-BioPharma

The following was recently released by the SAFE-BioPharma Association. Although the IT trends they cite may be on the adoption curve, it is not clear how long the adoption will take. As with almost anything in our industry, don't expect it to happen overnight.

THREE MAJOR IT TRENDS WILL SHAPE LIFE SCIENCES IN 2012

Fort Lee, NJ (January 19, 2012) -- Three trends will shape the life sciences in 2012, according to an analysis by SAFE-BioPharma Association. They are the expanded use of standards-based interoperable digital identities, cloud computing in clinical trials, and the use of electronic trial master files for clinical trial management.

1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES

Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies [broken sentence]

2. CLOUD COMPUTING IN CLINICAL TRIALS

As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures.

3. ELECTRONIC TRIAL MASTER FILES

“Trial Master Files – the central record containing the files associated with clinical trials – are one of the last areas where clinical development records are primarily paper-based,” explains Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association, Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org.

Electronic Health Records (EHR) coverage at HIMSS

The annual meeting of the Healthcare Information and Management Systems Society (HIMSS) took place last week in Chicago. While there are many publications out there covering this meeting, ChannelWeb had an especially good series of articles on it.

Those of you who are not yet familiar with ChannelWeb, it is a web site focusing on companies that sell computer and communication based solutions (i.e. hardware and software.) In other words, the sellers ARE the channel.

As you will see from these articles, the most popular topic at HIMSS was the Obama stimulus package and its implications for health care. As you can imagine, vendors had a Pavlovian reaction about the potential to make a lot of money.

How well the money will be spent remains an open item. Once thing is certain. A lot of it will be wasted.

Read on...

HIMSS: Moving From Stimulus Hope To Real Health-Care IT Projects
ChannelWeb , April 10, 2009
At HIMSS, VARs, CIOs and vendors look past the initial round of stimulus excitement to gauge what's coming next.

20 Scenes From HIMSS 2009
ChannelWeb , April 09, 2009
The annual HIMSS conference brought more than 27,000 attendees to McCormick Place in Chicago, to hear from each other and from the likes of Dennis Quaid and Alan Greenspan as they place their bets on the future of health care IT. A strong pulse? You bet--and Channelweb was there to check it.

HIMSS: Greenspan Says Economy 'Will Turn, But Not Yet'
ChannelWeb , April 08, 2009
At HIMSS, Alan Greenspan addresses technology's role in health care and the broader economy.

HIMSS: Dell, Perot Systems Unleash Health Care IT Salvo
ChannelWeb , April 06, 2009
Dell announces partnerships with Perot Systems and others and virtualization and social networking solutions for health care

HIMSS: Dennis Quaid Calls On Health-Care Modernization To Eliminate Errors
ChannelWeb , April 05, 2009
Actor Dennis Quaid said at HIMSS keynote that health-care IT technology is the only way to reduce medical errors.

HIMSS Preview: Health Care Tech Revs Up As Stimulus Begins
ChannelWeb , April 03, 2009
Electronic medical records and health care IT funding from the federal stimulus package are on everyone's minds as HIMSS gets under way in Chicago.

Health Care IT: 25 Solutions To Check Out At HIMSS
ChannelWeb , April 02, 2009
A sampling of products and solutions to see at the 2009 HIMSS Conference in Chicago.

Sharing Clinical Data through Application Integration

Notes from the 23^rd DIA CDM conference

While I’m not enamored of attending conference sessions that start at 8:30 in the morning, I was glad that I made it to the Tuesday morning session on “Accessing Clinical Trial Management Information from eClinical Systems and Capabilities” chaired by Paul Bleicher of Phase Forward.

Before I jump into the details, I want to warn you that the words “clinical trial management information” in the title of the session can be misleading. This is because of a key learning that I took away from this session. In short, when we begin to effectively extract and use data and metadata from all of the transactional systems at our disposal, they become (in aggregate) a comprehensive clinical trial management environment. In other words, we no longer need a CTMS because we have achieved a CTME(nvironment).

DIA Euromeeting: Impressions and Recommendations

I’m writing this on the plane to New York from Barcelona having just attended the 2008 DIA Euromeeting. As a veteran of many DIA annual meetings in the USA, I must admit that this year’s Euromeeting was like a breath of fresh air. A key reason for this may be the calculated risk that the meeting planners took by redesigning the program around themes and sessions.

Suggestion: Click here to see a phenomenal set of Barcelona photos!

Virtual Software Testing with StackSafe

It's not too often that I run into something innovative that leads to the thought: "Why didn't I think of that?"

This is exactly what happened the other day on reading the following passage in the February 4th issue of Information Week:

"Two-year-old StackSafe showed how its first product, Test Center, captures snapshots of the IT production environment, stores them, and then assembles virtualized production environments in which to test software changes."

I then found a somewhat longer article on this product here. In that article you can also learn about a competing product called StageManager from VMWare.

What's intriguing about this product is the possibility of replacing the physical hardware and software instance that we currently use to validate software. Instead of continuously maintaining a development, test and production environment, you keep the development and production environments and create virtual test environments as necessary.

Note: If you are new to the concept of virtualization, read this prior post.

By dropping out the physical test environment, you save both hardware and maintenance costs. More importantly, creating a virtual test environment will assure that the tests you run correctly represent the impact of changes on the "real" production environment. Let's face it, the production environment is never exactly the same as the current physical test environment.

A move to such an environment has regulatory implications that must be addressed. First, the validation program itself will need to change and include the validation of the virtual test environment from creation to use to deletion. In other words, you will need to prove that using a product like StackSafe Test Center for validation can be done reliably and consistently. Second, you will need to have some assurance from regulators (e.g. FDA or EMEA) that using virtualization in this manner is acceptable to them. It never hurts to ask!

The unacceptable alternative would simply be to ignore this method and assume that the regulators wouldn't approve.

FDA Information Technology Plan (Draft)

Your chance to comment!

If you or your company is in any way affected by the way the FDA handles your pre- or post-approval activities, then you should be interested in the information technology plan that it plans to use over the next five years.

The draft plan was released on December 27th, 2007. Comments are due to the FDA by Friday, February 22, 2008. The Docket number for this plan is 2007D-0481.

Having read this 37 page document, I can tell you that it will be no easy task to either understand what they want or to collect your thoughts. Never the less, submitting your comments should be a priority. With this post, it is my intention to make it a bit easier to get through the comment process.

Read on...

2008: IT budgets to fall?

If the pundits are right, IT budgets will be smaller next year. Or, to put it more correctly, the percent increase for 2008 over 2007 will be less than the percent increase for 2007 over 2006. Are you still with me?

As an example, take the recent article by John Soat of Information Week, who cites two separate surveys involving CIOs. Both predict smaller budget increases for 2008. Mind you, this is across all industries and it's not clear what will happen in the Biopharma sector.

We can guess, however, that based on the somewhat dismal performance of most pharma and some biotech companies, CEOs will be looking for savings wherever they can be found. And that includes IT.

From my perspective, this is quite unfortunate since I am convinced that our industry has squandered countless opportunities to leverage information technologies to improve both day-to-day operations and improve the R&D pipeline. If you want examples, I'll give you several:

• document management and electronic publishing
• data management and exploration
• electronic data collection (EDC)
• clinical trial management
• master data management

Now, you may be saying: "Is this guy nuts? These are the areas where we have made the most progress!"

And no, I'm not nuts. These are great examples where lots of time and money have been wasted or investments underperformed. Despite glowing reports at DIA meetings and other venues, the reality is that we still don't know how to properly leverage IT.

I'll offer just a few reasons why our IT dollars/euros don't get us the returns we need:

1. Lack of resolve and leadership to change course;
2. Continued disconnect between the business community and the IT organization;
3. Missing or half-baked strategy for improving productivity;
4. Cowardly management disguised as management by consensus;
5. Focus on regulatory compliance rather than operating efficiency;
6. Failure to create a learning and innovative organization;
7. Over-reliance on selecting technology rather than setting strategy that drives technology.

So, it's possible that we don't actually need to increase the IT budget. Maybe it would be enough to just stop wasting it.

Bedside Portable Computer

Motion Computing has announced the availability of their Motion C5 Mobile Clinical Assistant (MCA) tablet computer. This flash demo gives a good overview of the device.

The device was created in collaboration with Intel Digital Health Group. While currently intended for hopital use, the tablet could be used for other purposes such as EDC.

It should be noted that the device is primarily a hardware solution and does not come with healthcare application software. A good example of the way the device can be adapted for bedside use is described in this field study by Intel. In this case, the tablet was integrated with the Eclipsys Sunrise Clinical Manager platform.

The unit uses the Intel Centrino processor, runs on either MS Vista or XP and includes a bar code reader, RFID reader and digital camera. It also supports wireless and bluetooth connectivity.

Biopharm IT Leaders - The Infoweek 500

The 19th Annual Information Week 500 list has been published.

Here, we will only concentrate on the Biotechnology and Pharmaceutical companies that made the list.

As the publication states, "to be ranked, companies with at least $500 million in annual revenue are asked to complete a qualifying application that examines business technology strategies. The application contains a quantitative section on technology initiatives and priorities, and a qualitative section of essay questions. The responses to these two sections are evaluated, weighted, and combined into a total score to rank the companies."

The following Biotech and Pharma companies made the list:

• BD Biosciences
• Beckman Coulter
• Eli Lilly
• Genzyme
• GSK
• Merck
• Pfizer
• Roche Diagnostics
• Schering Plough
• Solvay
• Thermo Fisher Scientific
• Wyeth

Of these, only three made it into the top 250 list. These are:

• Eli Lilly - #50
• Wyeth - #59
• Roche Diagnostics - #231

Read on to learn a bit more...