Having a validated drug discovery platform is the first and most important criterion for defining a good platform company. The platform is typically comprised of a combination of technology, experienced personnel and intellectual property that can generate a stream of drug candidates. Most importantly, investing should be done only after a product of the platform demonstrates activity in clinical trials. Having a clinically validated product is not a guarantee for future success of the platform nor does it mean that the specific agent will reach the market, but it does imply that one or more of the platform’s products stand a reasonable chance of becoming a commercial drug. A validated platform may increase overall success rates, yet the odds of a particular drug candidate to make it all the way to approval are still low.

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Exelixis is active in the ever growing market of kinase inhibitors (KIs) for the treatment of cancer, that is, drugs that block the activity of kinases in cancer cells. Cancer cells are often described as cells that are out of control: They proliferate quickly, ignore death signals, invade nearby tissues and eventually metastasize to distant organs. These disease onset and advancement are associated with processes such as cell growth, motility and blood-vessel formation, which are governed by a complex network made of kinases. Thus, blocking these processes by inhibiting the relevant kinases has emerged as one of the most attractive approaches to fighting cancer.

Together with monoclonal antibodies, kinase inhibitors represent a paradigm shift in cancer treatment from cytotoxic agents to targeted therapies, a trend that is constantly growing. Like antibodies for cancer, kinase inhibitors target tumors while sparing healthy cells and consequently lead to better activity with fewer side effects. Kinase inhibitors, however, possess several advantages over antibodies. The most evident advantage is that KIs can hit targets inside the cell while antibodies can only bind targets presented on the cell surface, so internal targets are approachable only by KIs. Another advantage is the fact that KIs can be given orally, which is a major factor in terms of patient convenience, especially given the typical long treatment duration associated with targeted therapies. Another advantage, which will be later discussed in the article, is the ability to produce KIs that hit several targets at once.

“PCI Risk Management”

Now usually when I see a term like this, I can only imagine that such things are the byproduct of rapidly decaying brain cells.  In my mind I imagine there’s a conference room somewhere with some marketing types all hopped up on the vapors from industrial solvents spewing terms like “protectivity” or “advanced adaptive deep packet inspection” into the ether with all the acumen of an intoxicated long-horned bovine.

BUT

I thought about this, and it’s really not a bad idea - depending on how you define it.  Now I just couldn’t make the effort to read how the author used the term (I have a short pain threshold), but here’s my thoughts on what PCI Risk Management should be.  If we define Risk as the probable frequency and probable magnitude of future loss.

Then managing the risk inherent in PCI DSS compliance could mean:

1.)  The expected frequency of being out of compliance and how much that will cost us.

Because let’s face it - being in or out of PCI compliance is still a subjective judgment.  First, we have what our ever-qualified assessor says.  But in the case of an incident, it’s really someone else who has the final say in whether or not we were “compliant” at the time of incident.  So we can only know for certain if we’re in compliance after the fact - i.e. after there’s an incident.  So if we cannot really “know” if we’re compliant - we have a probability problem to solve!  Sounds like “risk” or “secure” doesn’t it?

So we could view the PCI as a threat community to deal with.  This gives us the first angle of what we could call PCIRM (this sort of term begs to be it’s own acronym, doesn’t it?) - the simple creation of a probability statement that says there is some belief that we could be found out of compliance - regardless of our efforts - and the calculation of what the impact would be to our organization (like defending frivolous 90 bajillion $ law suits from tiny financial institutions whose lawyers smell blood in the water).  Note that you may or may not want to add the value of the money and time spent on PCI compliance into your loss magnitude calculations.  It’s a sunk cost at that point.

However, there’s another side of the coin.  We can find out the risk of being out of compliance, but is there risk in being *in* compliance?  I think there is.  So our second aspect of PCI Risk Management might be:

2.)  The expected frequency of being in compliance and how much that will cost us.

An alternate view of how we could view the Payment Card Industry as a threat community would involve trying to figure out the probable frequency with which they will make onerous demands of our security budget, and the impact of those demands.

Now note that we would have a “secondary risk” to measure here.  I’m thinking that it’s not improbable that our PCI efforts may not be the most efficient use of or time and money.  So if we’re spending money on what PCI says we must, and neglecting areas of our IRM landscape that would actually reduce organizational risk more than those PCI efforts - then PCI compliance is costing us some real value by reducing our capability to manage real risk.  However,  and it’s quite a long tail event but, imagine that we’re unlucky and an incident happens!  This incident may become, in no small probability, the byproduct of PCI requirements.  Being diligent in risk management, we might want to study this likelihood, too.

So there you have it.  In both cases PCI Risk Management involves looking at the Payment Card Industry as a threat community, and determining the probable impact of having to deal with PCI DSS.

Now if you’ll excuse me, I have a white paper to write and I’m fresh out of acetone-based paint remover.

POST SCRIPT

I should make it clear that Risk Management should (and is) obviously being performed by those with PCI concerns.  PCI, if you will, is simply a sort of ISMS.  And the development of an ISMS can assist IT management with the process of developing metrics and analysis concerning the organizations capability to manage risk.  There’s nothing wrong with PCI in this regard.

But I figured I should make the effort to read what the author was advocating, and the document this “PCI Risk Management” term was drawn from was really a set of “best practices” for PCI and “best practices” above and beyond what PCI requires.  This is not risk management (and no, adding “risk assessment” - in quotes because the author is really referring to vulnerability management - to the list of best practices doesn’t make it risk management, either).  It is more witch-doctory.

Forgive me for going totally off topic (hey its my blog I write what I want) but it is Sunday and not much news on security.  I wanted to write about an article I saw in the NY Times today called "Even the Insured Feel the Strain of Health Costs". The article details that with the hard economic times even people who have health insurance are being bitten by the ever rising costs of health care.  Rising premiums, covering less procedures and care and charging more for prescriptions and medical care combine to put the bite on everyone.  From my own experience here are 4 examples of how even with health insurance, medical care costs are taking a bite:

1. My wife had minor surgery in September.  It was ambulatory surgery where she went in the morning and went home that afternoon/evening.  Even though we have full PPO coverage and it was participating doctors, hospital, etc. my out-of-pocket costs after insurance were almost $3000! The surgeon received a whopping $472 from the insurance company for the operation and the hospital billed like 17k!  When I called the hospital they said they did not expect to get paid that much, but had to bill it so they could get as much as they could.  I than had to negotiate what I would pay out of pocket beyond that. I also had to pay the anesthesia, the prescriptions, etc.

2. Here at StillSecure we had to switch providers again this year because United Health Care wanted another 15 to 20% raise in premiums. In fact that is about normal for health insurance, way above the cost of living and inflation.  We pay a good chunk of our employees insurance premiums, but even so the 20% or so that we have the employee pick up gets bigger and bigger.  Plus the insurance company covers less and less.  This squeeze is frankly baffling. How can you pay more and get less.

3. I had a dental implant a few months back.  Though we pay for dental coverage, our insurance would cover a bridge or cap, but they don't consider implants necessary and would not cover any of it. I had to lay 2k out of pocket. On top of this the panoramic x-ray the oral surgeon took (which again was not covered, another 100 bucks) showed I had an impacted wisdom tooth with a cyst around it.  My dental insurance covered the wisdom tooth, but the cyst removal would be considered under my regular insurance and my dentist was not participating. In fact I could not find a participating oral surgeon in the area.  So I had to an extra $600 dollars out of pocket and of course my out-of-network deductible was $750, so I ate it again.

4. The orthodontist.  This one is perhaps the worst of all and really gets my goat.  My oldest son went for an orthodontic exam. The doctor told my wife that he would probably need braces when he gets older and that current best practices in orthodontics is to put braces on now in a phase 1 and than if necessary they put other braces on later when more of his adult teeth come in. Putting braces on now would lesson the severity of what he would need later.  OK, great lets do it, right?  Wrong!  Our insurance covers a one time payment of $1200. The dentist said if we use it now, the cost for phase 1 would be $3600.  That leaves a balance of $2400 that I have to pay.  However, if I do it without insurance he would charge me $2400 and than I could use the $1200 towards the phase 2 braces my son may need which could be up to 10k. So if we went through insurance the cost was $3600 with $2400 out of pocket or no insurance $2400 out of pocket.  What is wrong with that picture. Whether I have insurance or not, it still costs me $2400!  This is fundamentally what is wrong with our health care system.  The dentist is willing to accept $2400.  He should take the $1200 from my insurance and I should pay him another $1200.  Anything else is ludicrous and in my mind borders on criminal insurance fraud.

We need to restore sanity to the whole system. It is not just the 48 million people in this country that don't have insurance, it is also the costs of the people who do have insurance. Don't tell me that giving us greater limits to put in tax deferred health savings plan are the answer either.  Fundamentally we need the insurance companies to stop sucking the blood of the premium payers. We need the health industry to bill for what the do and what it is worth, not how to maximize what the insurance company pays and most of all we need to make sure that people can afford and receive decent health care!

BTW, if you want to read an excellent blog on this subject, Dr. Stanley Feld, Brad's dad writes a great blog on it.

Took the kids to see Iron Man tonight with our cousins Jeri and Danny.  I generally like Robert Downey, Jr and he acted very hard in this movie. However, I just didn't get the story. I remember watching Iron Man cartoons when I was little and reading the comic books, there was some special thing about Iron Man's blood the way I remember it that gave him super hero powers.

In the movie incarnation, Tony Starks is the son of a weapons designer and a brilliant weapons designer himself.  However, he has some serious character flaws. He is kidnapped by some sort of mid-eastern terrorists and take some shrapnel in his chest.  A doctor attaches an electromagnet to a car battery on his chest to keep the shrapnel from going into his heart. Downey then designs some sort of mini-power source to power the electromagnet,  He uses the power source to power a metal suit he builds (long story) and escapes from the terrorists.  From there the movie is fairly predictable and frankly in my opinion not very good.  I didn't understand how he got the superpower, it was just a powered suit and how it worked was pretty silly. 

The ultimate thumbs up or down for me was that both of my sons fell asleep in the movie theater.  The good news is that this is the start of the summer movie season. I am really looking forward to Indiana Jones and the kids want to see Speed Racer!