Explaining REST

I ran across a great post from Ryan Tomayko the other day and had to link it here. He goes into how he explained REST to his wife and it is actually very solid - better then I would have managed. Check it out here. I was laughing and appreciating the great description at the same time.

Blackberry tether mode

I have the Blackberry 8330 and it is generally a good device. Yes, it occasionally looses it's mind and has to be given a hard reset, but otherwise, I can get online, check email, view (tiny) presentations and so on. The best is the function I rarely have to use, but LOVE when I do.

Tether mode is something every business person should have. (at least those without a dedicated air card!) I have used it on vacation at the beach, in airports and other remote locations. Yes, I know I should not have to check email on vacation, but what do you think pays for the vacation? You have to earn the cabbage some how so occasionally taking a meeting from vacation is a minor annoyance made easier with this capability.

I installed the connection manager from Verizon and all I have to do now is plug in the phone and go. Of course, if you are using this feature, make sure you are on an unlimited plan for data or you will be hurting at billing time!

Lab Data Standards

The primary challenge with implementing instrumentation in the lab environments (beyond the obvious cost issue) is making it work with what you already have in a timely manner, with limited IT involvement. Of course, when working in a regulated environment, this is only amplified by the amount of validation testing required to prove things work as advertised.

In a meeting comprised chiefly of senior scientists, this came up as a discussion point and one of the scientists asked the obvious question –

why can I plug almost anything into my computer at home and it just works, or it downloads whatever it needs and then works, but it takes an IT team and an integration project to get an instrument working in my lab?

Of course, the answer is a little more complicated then just plug and play hardware drivers, but that is one issue. The other is data format and communication. A nice start would be a universal data standard for instrument data that all vendors can agree on and the regulatory agencies support. I have worked in the clinical space on many standards, chiefly around CDISC, but I have not seen the same enthusiasm to date in the labs. Side initiative… figure this out! I am working with a group of folks to identify areas of focus, and corresponding standards that may be emerging. Where there are none, I will try to see what we can get started. I have a couple of notes into the FDA to see what they have in this space and am currently waiting on a reply from a guy in the instrument area...

More to come in this space to be sure...

The joys of air travel

As I type this, I sit in the airport in Philly waiting for the aircraft that is supposed to get me to Burlington at 5:30 to arrive. It is now 5:38 and they say we are not leaving until 6:30 earliest so unless US Scare-ways has a time travel capability that I am not aware of, I am getting in a couple of hours late. No big deal, it just means dinner later and driving later... and I hope the ferry is open later. Come to think of it, that's a detail I should verify. I suppose on landing I can find that out assuming they know at the car rental agency. (stream of consciousness [eof] )

Travel gets interesting every time weather gets a little weird and that seems to happen with surprising regularity! Watching the reaction of fellow travelers is mildly entertaining, with the resignation displayed by some and the freak out mode from others. (I'm not sure how that really helps anything). Now the debate is to eat in the airport or hold off for a late dinner in Vermont or NY... I suppose a little more time on the keyboard and a check on the departure time will drive that decision.

The delay has allowed me to try out the e-Book reader I brought along and I am pleased with the device. It is easy to read and pages nicely. The button placement could be better but I am able to hold it one handed and page so I suppose it was a design compromise for functionality. I did accidentally flip to the beginning once while getting used to it, but that was easily corrected and I am sold on the concept. I think I will be picking up a kindle at the end of the year. I am looking for the whisper net feature, larger screen and keyboard features but this is a great bridge device and thanks to my wife for sharing.

Update on the flight - still in the airport at 8. Original flight canceled. New flight delayed until 11 or so at this point. It's looking like a long night. My first meeting is at 8 in NY. I could have driven there at this point, but who knew. If this gets cancelled, I will have to skip this leg and drive straight to Andover, missing NY this pass. Here's to hoping I make this flight.

Travel Time...

I'm packing for this coming week, and cramming in a bit of work on my slides for upcoming integration work. We are nearing that long awaited deal close and I think we are all so very ready for the final papers to be signed and begin working as one company, even if layoffs are imminent for at least some of us. The news reports have been predicting large numbers will loose jobs due to synergy targets, which makes sense even if it is a tough process. (Been there before)

For now, I am heading up to Chazy, NY by way of Burlington, VT (closest airport I can get a direct flight to) to meet with my Drug Safety team and clients, then on to Andover, MA the following day to meet with clients in that location as well as my associate in the AAPS, Sheldon. That day is divided between AAPS and Bioanalytical client work. The final leg is on to Groton, CT to meet with Pfizer associates and others on the Wyeth team, then a quick flight home from Providence, RI.

For the trip, I am going through the usual list of electronics and gadgets to take along, with a new addition. My wife recently brought home a Sony e-Book reader, the PRS-300 in pink. While I am not thrilled with the pink color as I am more of a basic black kind of guy, I am taking it along with a couple of books, some slides and pdf documents to review and also my itinerary. I am looking forward to seeing how well it works and how I like the eBook approach. Of course, the Zune, GPS and other goodies come too. Ok - off to pick up my daughter and resume preparations for the week.

Generics and the impact

I have had a number of discussions in the past over the topic of Generics in the marketplace, and one recently with my wife that caused me to feel the need to write my opinion out for comment and clarification.

Generics are generally safe alternatives to brand name prescription drugs. There, it's out in the open! That being said, are they always the same product? The answer is an unequivocal NO. While there are generics that are close enough, and work the same, they are not the same formulation and therefore, are not exactly the same. The real metric is efficacy in the patient against the target indication, and there as well, there is variation. The testing for generics is generally by blood level comparison, not full trials matching efficacy. See the comments from the FDA on this topic here.

The FDA backs up this position with a series of "Fact Statements", including this one:

Generic manufacturers are able to sell their products for lower prices, not because the products are of lesser quality, but because generic manufacturers generally do not engage in costly advertising, marketing and promotion, or significant research and development.

As can be seen, leeway is granted a generic manufacturer, though theoretically it is "close enough".

We can accept that the generics are generally safe alternatives to name brand, and in most cases will be sufficient for use. The cost is also compelling. This is the next and as or more significant piece of the discussion. Reading the FDA comments, you can see the highlight about the lack of R&D that goes into the process for generics. This allows the price to be low. The inverse is also true. Drug development and manufacturing is a hugely risky business, with an extremely high failure rate. Who wants to invest in that? As we increase regulatory hurdles, we increase the burden on the drug companies engaged in actual R&D bringing products to market. While the generic manufacturers do not feel this, it dramatically impacts the source of their products, the original manufacturers.

As the risks increase and the costs increase, if there is not a corresponding increase in profit, the investment in new drug research becomes less and less appealing. As investment dries up, research also decreases until we are left with a marketplace comprised of products that are "has beens". Not to diminish the value of what we have, but drug resistant strains of virtually all major indications are becoming the norm. without innovation, we will be unable to continue to effectively treat even the common illnesses, let alone the novel work being done around the big ones like Alzheimers, Aids, Cancer and the like.

The answer I believe, lies in the balance of regulation, patent protection and risk management. We cannot crush or eliminate innovation in the name of short term cost. This is an investment that pays over time, and we need to keep the future of our grandchildren and their future generations in mind on this argument.

FDA accepted, shared validation foundation

Over the years, I have worked in both regulated and non regulated environments in the health care / life sciences area. The predominate difference in the two areas is the amount of rigor required for development or implementation of IT solutions. While I am very much in favor of good process, I also am a big fan of eliminating redundant, or non value add process. Looking at the current situation, there is a blend of both.

We need to keep the rigor imposed by the regulatory agency compliance directives, good process is after all, what they are after. We also need to work with the regulatory bodies to optimize these processes across areas.

A first target for this effort is the validation exercise for commercial applications. As a part of all implementations of COTS or customized applications in a regulated area, the application must be validated and the vendor audited. For a large, frequently used application / vendor combo, this results in duplicate work happening at every customer implementing the application.

If we can eliminate the duplicate work with a standard for vendor audit and foundational application certification for use, recognized by the FDA and other regulatory agencies, we would save millions of dollars across the industry every year.

To this end, I am working with some folks from across the industry to begin the effort needed to get to an acceptable standard. If you have interest or thoughts on this, contact me, let me know your feedback and how you can help.

New blog

I am starting the new blog on digital vision consulting, integrating it with this site and publishing from blogger.com.

I am moving back to a hosted, hand rolled environment, having gotten tired of the lack of flexibility offered by the generic service packages. The site has been rebuilt from the beginning on the .NET platform with C# and also a bit of PHP thrown in just because it's interesting. Since I do little to no development in my day job and I miss the work a bit, I get my outlet through my free time or consulting.