Time to Use a Blog Tool (Blogger)

Until recently I've managed this site with a simple HTML Editor. It's time that I took the easy path, so this a a test posting from Blogger.com


Wither Document Management? Part 1

I work for Open Text. Livelink is Open Text’s flagship platform. At its core it has a comprehensive feature set for document management, but as with everything there is always room for improvement.
In looking at how people share files, it seems to me that there are two diverging paths, or more accurately, there is the established 1990’s model where people navigate through a repository to deposit a document or other file in the ‘right’ place, where version control and other docman features can be applied; this is the model Livelink was designed to support, although it was the first docman system to support navigation by a browser. However, as e-mail has become pervasive in the last ten years (it’s hard to remember that in the 1980’s and early 90’s only academics and geeks had e-mail) companies have started to struggle with the uncontrolled proliferation of documents by e-mail. Big players like Microsoft and Adobe are starting to add 'control' features, and there are a host of startup companies with approaches to address what I consider to be parts of the problem. In future entries to this blog I’ll discuss this further…


Are We at War or What?

Recently the company that I work for declared that unused vacations were growing out of control. The Company has to carry unused vacations as a fiscal liability, and the vacation balance is starting to become a sizeable obligation. So a couple of decisions were announced: First, there will be no vacation carry-forward after this fiscal year (which ends in June). Second, all staff must take all of their accrued vacation before the end of June, and furthermore, should take at least half of their accrued vacation in this calendar year. I have 20 days unused at the moment, so I’ve been FORCED to take 10 working days vacation this month on top of the statuary holidays!
You should hear the complaining: “They’re making me take vacation!!” On this face of it this might seem surprising, but I think it is a case of not letting the team down.
It’s a bit like Iraq. It is amazing to hear volunteer soldiers who are injured can’t wait to get back to what is truly an awful situation. They don’t want to let their comrades face danger without them. It’s very noble to be sure, but I think it is also a quite primitive and fundamental tribal instinct.
My colleagues and I are all working hard – much more than the 37.5 required hours per week (or whatever it is). Making money may be part of the motive, but in fact extra work can only influence bonuses in the near term. Mostly I think we are ‘in it together’ as a team. I work long hours because they work long hours, and they expect that I will work long hours because they are, and since I know they expect it…
It’s hardly the same as being under hostile fire, but there is arguably a health dimension. The Company has certainly taken that tack: “We don’t want you to burn out. Your performance will be better after you have had a real break. This is an important health issue.”
I’m actually looking forward to having more than two weeks off, and my guilt is lessened by the knowledge that many of my colleagues are being forced to take the same time off. Mind you, since most of us work from home, working often just means looking at our e-mail in-boxes… Some have already declared that they will book out the vacation time and work as usual – I'm pretending not to have heard that.


What is an Original Document in the Electronic World?

An editorial I authored was just posted on the eyeforpharma website:http://www.eyeforpharma.com/index.asp?news=43996
The article starts:
"Electronic technologies have had a profound influence on the ways people work; even in the life sciences almost everyone uses e-mail and voice mail in their daily jobs, and many use web conferencing, document authoring, websites, etc. Usually these e-technologies were implemented by companies to promote process efficiencies, or even just to ‘keep up’ with other companies. But just as Napster and other file-swapping technologies have challenged standard business models, so are electronic technologies forcing process changes within companies, not necessarily only to achieve benefits, but also to maintain or achieve compliance. (11/10/2004)
As an example, consider the concept of an ‘original document’ which is very common to many structured processes in life sciences companies: in the electronic world there is no such thing as an ‘original’ – there can be any number of exactly equivalent versions that cannot be distinguished by special paper or blue ink signatures as paper originals have traditionally been. Nevertheless, for compliance reasons we need to confidently point to a specific document as being ‘authoritative’; with tightly implemented controls this can be achieved within a company (a “closed system” under 21 CFR Part 11), but then how do we do the same as we exchange documents with partners, regulators and even the public? This article briefly surveys some alternate approaches, including the industry SAFE initiative..."



Oh what a lot has gone on since I last posted. And oh what a lot of blog postings I thought about in that time. But now they will never see the light of the web, but no great loss. Onwards…

A Tale of Two Knights - Part X?

I’ve had a few people ask me when I was going to post Part 2 of 'A Tale of Two Knights'. I guess I wasn't clear enough. The Tale is a poorly disguised allegory to a battle that I am currently engaged in, along with many colleagues. We work for one company, and we are fighting in the marketplace against another. And while I described the other company as having "... put on a few pounds and become complacent..." they are indeed fighting back now – which makes it even more interesting. But the next phase of the Tale will probably take a few years to develop, so if I don't make up the happy ending that I hope for, I won't be telling the next Part for some time.

Karina's Next Milestone

The proud Father refers you to: http://www.yorku.ca/yfile/archive/index.asp?Article=3449


A Tale of Two Knights – Part 1

I haven’t written about this before and it is still an ongoing story, but it may be of interest. I’ll weakly disguise the names of the parties to protect the innocent … and to make a pretense of keeping proprietary information.
“Once upon a time, there was a Land of Pharmaceutical Regulatory Compliance where the good Citizens labored to meet the demands of the Federal Directorate Administration. The FDA had decreed to those good Citizens of the Land that they should document all matters of importance in great detail – which they did. But to ensure that the Citizens did as they were bade, the FDA required of the citizens that they should send their document for review, or at least keep them very carefully until an FDA Sheriff should come and perform an on-site inspection and ask to see some manner of obscure but nonetheless required document.
Although the good citizens labored hard, their lives became increasingly difficult as more and more documents were penned, and as the Sheriffs demanded ever more detailed evidence that a given document was the very latest, authoritative version and not some copy or horrors, even an outdated or altered copy.
And so it was, that one day, into the fair Land came two heroes, one being the newly knighted Sir D’dumb and the other gallant Sir O’desta. Each of these good knights promised to help the faithful Citizens of the Land – not as you might think by slaying the FDA as if it was a dragon, for though it was demanding, the FDA had the ultimate good in mind. Rather the knights offered to provide to the citizens some mighty software tools and other devices for the management of documents. But each knight offered something different and the Citizens had need of only one. So after much debate and discussion among them, it was resolved to hold a Tournament to determine which knight’s offering would be selected.
The two knights strove mightily, but at the end it was decided by the closest of margins that Sir D’dumb had carried the day. And so it was that Sir O’desta quit the field and rode off to seek his fortunes elsewhere and Sir D’dumb was hailed by all.
Over time, while Sir D’dumb’s offering was used by many, it was found to be quite demanding, requiring much honing before first use, and frequent polishing to keep its shine. These efforts required that many of the Citizens apprentice in Maintenance and Administration, and yet still there was much work for traveling craftsmen of the Consultancy Guild. But the Citizens did not much complain since their lot in life was improved and there was naught else to be had.
But what of the good knight Sir O’desta you ask? Well, he traveled near and far, and over time was befriended by Sir O’Text. And so it was when Sir O’desta decided it was time to retire, he bequeathed all his worldly goods to Sir O’Text who was enriched thereby – which was fortunate indeed for Sir O’Text had many tournaments with the likes of Sir Scrapernet and Sir Whistlingbird.
Beside his great strength in arms, Sir O’Text was also adept in the study of Arts and various Magicks, becoming knowledgeable in the Ways of the Wise Web and the ceremonies of Collaboration.
As time passed, disturbing tales began to reach Sir O’Text’s ears of the increasing labors of the good Citizens of the Land so he rode forth to see if these tales were true. On reaching the Land, some Citizens came forth and told him that though they still used Sir D’dumb’s offering, it pained them and they sought relief. But many other Citizens would hear naught said against Sir D’dumb, for they claimed he had helped them much and indeed still ensured that they had good and steady employ. But as with the way of children all over, the young Citizens sought something new and better and they were much heartened to hear what Sir O’Text had to offer and many subsequently started to use it.
At first Sir D’dumb did little, for in truth over the years he had put on a few pounds and become complacent, saying: “My offering is the one and only true document management offering, and all else fails in comparison.” But after a while he began to become concerned and soon resolved to become wise in the ways of collaboration, purchasing at great expense a special Room of Ease, but alas this did little to help because when he was in the Room he had little connection with the doings of document management. So after a while he resolved to form a powerful alliance and soon pledged his allegiance to the Earl of McVault who had made his wealth in vaults and other stores.
Meanwhile Sir O’Text continued to find followers in the Land and was joined in his efforts Sir Xos."

…to be continued


Technology Saved the Day – I Hope

This week I’ve been at the Drug Information Association (DIA) Annual General Meeting in Washington, DC. The meeting ran from Sunday evening to Thursday lunch. Besides attending some of the sessions, helping to answer questions at the Open Text booth, and talking to reporters about the SAFE initiative, I also chaired and presented at a session. There was one little problem: while that session was originally scheduled for Tuesday it was moved to Monday from 1:30 to 3:00pm. And the reason that was a problem was because York University decided to schedule Karina’s Honours B.A. graduation at 7:00pm on the same Monday. Try as I might I could not find a way to travel from Washington to Toronto and then on to York in the intervening four hours – the airline schedules just didn’t jive. Lindy felt that I should cancel my DIA session to attend; I considered it, but since I had invited Ruedi Blattmann from Switzerland to present I wasn’t too comfortable doing that.
Fortunately technology came to the rescue. Coincidentally Karina sent me a link to an article about a honourary degree being presented by York University to Dr. Tak Mak – someone I worked with about a decade ago. In the article it mentioned that the variousw Spring convocation ceremonies would be broadcast live by streaming video!! Yeah!
I watched part of an archived convocation – it wasn’t bad. I was to stay at a Marriott-Courtyard in Washington and they usually have free high-speed Internet access in their rooms. I talked to Karina to see if she was OK with me attending virtually – and bless her, she said she was. I arranged that she should have her cell phone on so that I could call her right after the convocation. It sounded like a plan.
On Monday, while the rest of the Open Text staff went out to dinner, I went back to my room and connected to the Internet. Precisely at 7:00pm the video stream started. The picture was fairly good and the sound excellent. I listened to the opening speeches and the awarding of a honourary degree. Then they started on the graduate students… disaster. There was a problem with the sound – it appeared that the wrong microphone was connected – I could barely hear the people names as they came to the stage. And with their big, floppy red hats I couldn’t see their faces. But after about ten minutes the sound was fixed and clear. Then when the undergraduates started to come onstage, it was clear that they weren’t wearing the same hats and their faces would be visible. Phew!
But one problem remained: as an almost endless procession of undergraduates came forward in the different programs, occasionally the director decided to switch to a camera giving a panoramic view of the hall, so you couldn’t see one or two candidates before the view switched back. Fingers crossed it wouldn’t happen when Karina came up!
Finally we got to the Honours Humanities graduates, and right at the end Karina’s name was called, together wit the fact she was receiving the degree Summa Cum Laude, and she came up to receive her degree; I could clearly see her face – but then the camera view switched to the panoramic view. But I had seen her and I yelled, “Yeah Karina” in my hotel room.
Right after the ceremonies I was able congratulate her by phone; at that point she hadn’t even met up with Marc, Lindy and Lindy’s parents, so I go the first word in.
When I talked to Lindy later it turned out that she had sat near the back of the Hall with Marc and that the best view they had was via a large monitor that was showing exactly what I saw!
So with a few close calls it worked out. It’s not the same as being there, but its much, much better than missing everything.


Of Wheelchairs and Geese

Driving back from the airport on Monday night, I heard a repeated splatter sound as bugs hit the windshield of my car in the dark; I reflected on how long it had taken these insects to grow and metamorphose, only to be smashed in an instant as I headed home in two tons of steel, glass and plastic. Fortunately the Canada geese that suddenly appeared in my headlights decided to stay where they were as I flashed by. It made me think back to the morning when a man in an electric wheelchair came racing down the hotel hallway to enter the same elevator as me. On the ground floor he neatly reversed out of the elevator, using the back wall mirror to see behind him, raced through the hallway and came to a fast halt at the restaurant. And also to the shuttle bus driver whipping around to pick up passengers, but when he climbed out of the bus he had trouble walking because he was grossly obese.


Fairy Lights

I’m lucky – not too much keeps me awake at night and I usually fall asleep within about five minutes of going to bed. While psychologists say that is a sign of sleep deprivation, I also wake up in the morning automatically and feel refreshed, so I don’t agree.
Nevertheless, there are times when I do wake in the middle of the night and walk through the darkened house as others sleep. Nowadays it’s pretty easy to do so without risk – besides having a large (18’ x18’) skylight over our central courtyard in New House, there are literally dozens of little lights on in the house.
Warning: This is one of those musings when I remember the past and compare it to the present.
I remember when there were only a few lights in a darkened house at night. Televisions and radios used to glow because there was always some current going through the vacuum tubes/valves to keep them warm; the glow came from the vents at the back. And some clocks had subtle lighting. Interestingly the shade of light was warm, and the devices hummed and were themselves warm. Even night lights, which had to be turned on manually and used a white Christmas light bulbs were warm-ish. Then there were gas appliances which had a permanent dancing pilot flame – almost invisible in the day but one of the few beacons in the dark
Fast forward to today: tiny points of coloured light and ghost writings in the air. Little green diodes announce whether we plan to have toast or bagel, and if we like our ice crushed or cubed. A red diode to say sound is set to surround – is there any other way? Innumerable things have power – I’m not sure where they got it from – me perhaps when I decided that we need more than more than two of every breed: phones, VCRs, DVDs, stereos, printers, computers, etc. And all over the house clocks in shades of green, white and amber argue about the exact time. Little red numbers tell you which window is open – if you can match number to window. Several computers and hubs flicker to announce they are talking on the Internet – probably about me – even though they are supposed to be off. Even the mice glow red from below – but they never scamper or dash to hide as I appear.
I must admit though, that for a gadget-rich house we are a little behind the times: we don’t seem to have anything in the latest blue and indigo shades. Perhaps I’m slipping? The first cheap commercial diodes were red, and then it became possible to make cheap green, now it is the turn of blue. A gadget shows its age by its night colour. But since you can make all colours from RGB soon we’ll have hybrids – pink, violet or yellow anyone?
Speaking of cost, diodes and electroluminescent displays use minute amounts of power, so most are permanently on. We did switch to night lights that turn themselves off in the day to save energy – the trouble is that they seem to have a half-life of two months so the set that I bought at Home Depot on sale are mostly shot. I think the net cost is probably an order of magnitude greater than if I’d bought ones that stay on all the time.
But what of the house of the future? It’ll probably turn on lights as I enter a room to my preferred level, provided no one is sleeping in that room and that the light will not enter the room where someone is sleeping, i.e. lights on only after I’ve closed a dividing door (i.e. IF THEN). Perhaps that’s the key to predicting the near term – things that could be done today, but with more logical controls than are currently cost-effective. The windows may be opaqued, but frankly I find those ugly, so I’ll wait for ones that display a scene or design. On the other hand maybe there will be fewer lights at night – already I’m bombarded with information I don’t need at a given time (like the toaster selection). Perhaps a kindler, gentler, darker house?


Decision Units (DUs) – Independent and Dependent

Karina and Marc (my two children) have their birthday on the same day in May, although they were born four years apart. My Father’s birthday is five days before. Family members wanted to know when we were having the 3-way birthday party this weekend, but it was hard to pick a day and time. Lindy (my wife) and I usually have no trouble agreeing so in the past we would make a single decision for the whole family – in essence we are a single decision unit (DU). But now that Karina and Marc have grown up, they make their own decisions – in essence they have become Independent Decision Units (IDU) – which means our former single family DU is now three DUs. And my parents-in-law live in an adjacent part of New House – so that was another IDU, for a total 4 IDUs. My Sister-in-law and her family planned to come, as did my Mother, and of course my Father – three more DUs. But in this case I would say that these three DUs were dependent DUs (DDU) for this decision – they had little ability to set a date, but could give input and after the primary decision was made could then decide whether they were going to come or not.
Finally a decision was made, but with 4 IDUs and 3 DDUs involved it took time; the party was on Sunday. But at the last minute one of my nephews became sick and my Sister-in-law’s family could not come – an example of an unplanned decision breaking event (DBE). Sometimes I don’t think business decisions are any harder than family decisions…


Who's Byline is it Anyway?

This Wednesday I received an e-mail with attached article just before noon from our PR firm, the gist of which was: “We’ve authored an article with your byline and could you review it quickly because it has to be submitted to the editor by 5:00pm today.” Talk about a different world!
When I was a practicing scientist, ‘it’ was all about authoring scientific papers and the rules were and are still very strict: only say what you have data to backup; if you speculate make it clear that you are doing so and restrict speculation to the Discussion section; and most importantly, make sure you fully reference and attribute any work of others.
When I used to manage public relations for Allelix Biopharmaceuticals, I learned to write news releases; the style is very different than scientific papers of course. Interestingly there are always included quotations from some senior executive: “We are extremely pleased about blah, blah, blah.” Now if you’ve ever thought that was what the executive said, think again. It is what the release author thinks the executive should say if anyone asked them. And many times in an early draft one person, such as the CEO is supposed to have said it, but in the final release a VP or someone else gets the attribution.
None of this really matters since most of the time the beautiful release becomes a two- or three-line filler in a magazine or newspaper, and the quotation goes unused. As an aside, that’s why the title of a news release has to make the key point, and the first paragraph has to say everything that is really important. Then subsequent paragraphs say it again in a bit more detail, and then finally there is a quotation or two. Sometimes reporters will actually use a quotation from a release. Apparently it is OK to write a column which makes it sound like you actually interviewed the person by using that quotation even if you never did.
A few weeks ago I heard a radio show discussing how the quality of journalism is declining because under deadline pressure journalists are more often using material from company releases almost verbatim. Well I guess over the years I’ve done my little bit to grease the skids…
Not to say that is true of all journalists – I’ve given interviews over the years where they actually used something I said in the interview in the final article; not always correctly mind you, but hey…
So what did I do with that story with a 5:00 deadline? I dropped what I was doing, rewrote a good chunk of it and sent it back to our PR firm. By the way, much of the article was taken from other articles that I had written, so it was mostly my stuff. But then we get into another issue, I was trained never to publish the same thing in two different journals. But apparently that doesn’t apply in the world I’m in now…

Bricklayer's Song

There a song based on the Bricklayer's Story that I talked about before! It's funny too in a very un-Hoffnung way. Many thanks to Karina, who found it for me. Here's the link: http://www.captainscience.com/code/bricklayer.mp3


Irreverent Moment

One of the interesting things about my job is the chance to meet the staff of many different company in the pharmaceutical and life sciences sector. Just sitting in a meeting you can sense the culture of the company, and dare I say it, even the quality/skills/smarts of the company staff – there are tremendous variations. Some companies would be interesting to work for, and some would be very painful. In chatting about one such latter company with a colleague, it occurred to me that if they ever offered me a job I’d be tempted to say something like, “I’m sorry, stupid companies hire stupid people, so I’m not qualified!” Like I said, its irreverent and perhaps a lot of other things, but…

My How Things Have Changed

I first joined the commercial world in 1984 when I joined the biotechnology company Allelix in Mississauga, Canada. By 1985 I had moved from the lab to the business side in the company, getting involved in business development, marketing and sales support. In the early 90’s I went back to the lab, but that’s another story.

Anyway, in going from an office to a lab I gained the part-time support of a secretary (as assistants were more commonly referred to in those days). That was the first time I had a secretary, except when I had a thesis to be typed – as an interesting aside the secretary who typed my Masters thesis is now the mayor of our town!

I’ve been reflecting on the work process in those days. While the company had a few word processors they were only used by the secretaries – they used 8” floppy disks and printed out on a daisy wheel printer that was kept in a somewhat soundproof cabinet. When I wanted to send a letter I first typically wrote it out by hand and gave the draft to the secretary. She did her best to decipher my scrawl and produced a first ‘typed’ draft, with blank areas where she couldn’t figure out words. I’d then correct that and she’d produce another draft; after a few more possible iterations the letter was finished and was mailed. After a couple of weeks I would typically receive a reply.

If a faster mode of communication was required, we usually used the phone – yes they existed way back then J, but phone rates were much higher and one used them somewhat selectively. If I was out of the office, the secretary would answer my phone and record the message on a special piece of paper. At various periods we also allowed paging via the company intercom if a call was on hold, but as other people found paging to be irritating this approach was sometimes banned for a while, only to be resurrected with a management change.

We also had a teletype, but mostly used this for communication with Japan.

My how things have changed! I work remotely for a software company now, although I do have an office I try to visit once a week to keep it from feeling abandoned. Since we sell a collaborative content management system (Livelink) I think we are probably on the leading edge of new practices, but not that far out. I still run into dinosaurs in the pharma industry that have secretaries to print out their e-mails, but they are in the minority.

I do all my own typing – which I am profoundly bad at – but with a rich, personal auto-correction library in MS Word I don’t have to fix many words. I’d guess that I mistype perhaps one word in four – it’s fun to watch Word fixing as I go. You can tell how bad I am if you communicate with me by instant messaging (IM) – so far the IM clients don’t have auto-correction, but I’m waiting... Probably at least a third of my day is spent with e-mails and much of the rest preparing documents. I’m bemused by people who complain how long it takes to do their e-mail before they can get to their job – in my case it IS a large part of my job. I can’t remember the last time I send a printed letter by mail.

IM has its place – mostly we use it typing people for a quick question or to see if they are free to talk by phone as the majority of my colleagues are also remote workers. There are different camps in the company – I’m in the Yahoo IM camp. But recently Open Text introduced an integrated IM function in Livelink so we are starting to move to that as the company standard.

Then we get to phones and telephony… I have a phone in my office, but it uses our FirstClass product. If you phone me and leave a voice message, that message is forwarded by e-mail to me wherever I am. It is always fun to reply to someone’s v-mail by e-mail and attach the sound file and hear their response. People tend to feel that voice mails are somehow trapped in limited phone system so only you can hear them and will then destroy them. If you choose not to leave a voice mail, you can select from a menu and have the call forwarded to my cell phone or home office. And when I remember, I may have one of these auto-forwarding to the other – each has voice mail too.

I also have access to a standing conferencing facility where I can have up to 16 people dial in toll-free to a teleconference at any time.

We also sell a meeting support tool called MeetingZone, which I use almost once a day to support virtual web meetings; it can also support physical meetings and the dynamics there are very interesting (perhaps the subject of a future posting).

No secretary, no written voice mail messages, no teletype… Big changes, much faster, and in the end I think more efficient.


I was at a conference in Philadelphia yesterday on the eCTD and CTD – these are new standards for the submission of drug and other life sciences applications to regulatory authorities. Pharmaceutical and other life sciences companies cannot test new candidate drugs on humans or market tested drugs without the permission of government regulatory authorities such as the Food and Drug Administration (FDA) in the United States, or Health Canada’s Therapeutic Products Directorate (TPD). The Common Technical Document (CTD) and its electronic equivalent (eCTD) is a global quasi-standard format for such submissions. Maybe in a future posting I’ll describe this more, but for the moment I thought I’d focus on an element of the talk that I gave – I can’t remember the last time I went to a conference as an attendee – either I’m a speaker or I man a company booth.
Most of the speakers were from pharmaceutical companies and so talked about aspects of implementing the CTD or eCTD. As a member of a software company that sells a solution to help such companies prepare eCTD submissions (i.e. Livelink for Collaborative Submissions), I wanted to talk about software. Now no one at these conferences wants to hear a commercial from a software company, so I decided to give a talk entitled, “Applying the eCTD Standard to Internal Business Processes.” The talk was well received and I was asked by a number of people for copies. One aspect of the talk was how people confound the potential benefits of an electronic system.
As a first example, I talked about the steps involved in the review of a document:


In the paper world, a request for an action (e.g. a draft report for review) by a user takes time to arrive by internal mail. When that user has completed their review, then it takes time to hand-off or mail to the originator or next person required to act. In theory, with electronic content, distribution at the beginning and end is essentially instantaneous. But in the real world, the expected time savings are often not achieved. While the worker may have been notified that they have to perform an action, they may not be ready to do so. Consider the scenario were the worker has decided that on Fridays he/she will perform all their reviews for that week. A request that arrives electronically on Monday will be addressed on Friday, just like a request that took until Wednesday to arrive by internal mail. So the actual time involved is longer:


But it gets worse. Very often people prefer to review on paper – if they receive a request for review of a paper document, they can begin work immediately. If the request is electronic, they have to ‘find time’ to print it out, before beginning their review, and then at the end they have an extra step transferring their comments back to electronic form:


Another potential benefit of electronic systems is that they can allow multiple workers to perform tasks on the same material at the same time (i.e. in parallel). Technologies exist for people to be adding comments to a document and in real-time see the comments added by their colleagues – each worker is seeing the latest version of a document. In the paper world, serial processes are much more common – only one copy circulates and one person at time makes comments:


But frequently, as electronic systems are adopted, a pre-existing paper process is mapped unchanged to the electronic system, reducing the potential time saving benefits. And then ‘people factors’ enter the equation again – we may find that a final manager is less motivated to perform the his task because he got the request sooner – he doesn’t think it is so urgent!:


Simple examples from personal experience, but I’ve found they resonate well


The Past Marches On

Many years ago (about a decade…), when I was at the biotechnology company Allelix Biopharmaceuticals (acquired by NPS), I worked with Dr. Dan Drucker at Toronto General Hospital (TGH; now part of The Toronto Hospital) to develop derivatives of the hormone GLP-2. Dan had discovered that GLP-2 has a powerful effect in stimulating the development of intestinal epithelium cells, i.e. the lining of the gut. I remember being there when he ‘opened up’ some experimental mice – you didn’t even need to take a measurement to see the marked difference in the bowels of the experimental mice versus the controls as the differences were so significant.

Dan had indications from earlier experiments that one of the glucagon family of hormones had this effect, and he had tried various elegant engineering experiments to determine which one. As the Allelix research director I had sponsored a collaboration with Dan and provided him with synthetic samples of these hormones. Near the end of the collaborative period, with little success, Dan decided to take the simple, direct approach – he simply gave series of injections to mice with each of the hormones – which is when GLP-2 ‘jumped’ out.

That period was one of the most exciting in my professional career. Dan had new results almost every day that he e-mailed to me and I kept designing and sending him new samples to test. I’d e-mail him at 1:00am and he’d respond at 1:30am! We were having fun and were driven. In drug development you want to find a new approach to treating disease. Here we had a powerful effect by a natural hormone. We wanted to know if there was any disease that we could effectively treat and if we could make a more effective version of the hormone.

I made literally dozens of derivatives of GLP-2 and passed them on to Dan. Experiments looked at the minimal size of the hormone and the critical regions. We were also very interested in improving the activity of the hormone. That family of hormones are quickly inactivated by an enzyme (DPP-IV) that chops-off one end. By testing different ends we were able to make versions of GLP-2 that resisted that degradation and were therefore several times more potent, i.e. you could get the same effect with less hormone. Besides improving the economics of the drug it gave Allelix a proprietary product – a key requirement in commercial drug development. Of the dozen of so patent applications in my name that were made over the years, the only issued patent that I bothered to frame and hang on my office wall was one for those derivatives of GLP-2.

There are lots of diseases involving the intestinal lining. But the most obvious one to look at was Small Bowel Syndrome (SBS) – a condition where patients have had to have large portion of their intestines surgically removed and must be maintained on intravenous feeding, often for the balance of their lives, which may be significantly shortened.

Why these reminiscences? While NPS has been testing one of my derivatives (ALX-0600), which they subsequently called Teduglutide, over many years, they just announced that they have initiated pivotal Phase 3 clinical studies on patients with SBS. If these studies are successful they will be a giant step closer to getting approval for the drug and being able to make a meaningful difference in peoples’ lives.

It’s been years since I worked on the project, and literally dozens of other people have contributed, but it’s still something I recall fondly and am especially proud of.


A Hoffnung Moment

My family moved into what Karina call New House last August (2003). At the time New House was new, but hardly finished. It wasn't until late November or early December that most things were done, as in the there weren't workmen somewhere in the house at least once or twice a week. Of course, as anyone who has moved into a new house knows, that simply means that there are lots of things that are left for you to do yourself. One such little thing I have to do is to put up a shelf in our shower stall; for the moment the various shower accessories are piled in a corner on the floor - and so is set the scene for our little tale...My wife and I usually shower together. Last weekend as I started to straighten up after bending over, she started to bend down - the inevitable happened. I was reminded later of Gerard Hoffnung famous address to the Oxford Union in 1958, where he presented the Bricklayers Story, but in this case, "Halfway up, Martin met Lindy coming down; she received a severe blow to her nose." I felt a rather unpleasant crunch against my skull, but of course no pain. The same cannot be said for Lindy. While I didn't actually break her nose, I certainly came close to doing so. She can still hardly touch it without pain several days later.Hardly funny at the time, but then neither would the events described by Hoffnung have been, and yet it is one of the funniest comedy monologues I've heard. Reading the words alone does not convey Hoffnung's superb comedy timing which really make the piece. He gives enough of each sentence so that you could anticipate what is coming before he actually says it - it engages you in a way that makes you picture the events clearly in your mind while you almost feel like you are telling the story from personal experience. There are audio copies of the talk on the Internet - enjoy if it is your taste. Interestingly the story is not original, versions going back to as early as 1918 have been tracked. But I doubt anyone else has ever told it as well as Hoffnung.

Dead Parrot

Yesterday the FirstClass Division of Open Text held a Monty Python's Tea Party. I have an office there which I use occasionally, but I didn't want to miss the party being a longtime Python fan - after all I was growing up when they were current. There wasn't time for a fancy costume so I decided to wear my oldest suit, my old British school tie and a Norwegian Blue shagged out after a long squawk:




New Daughter Look

After years and years (at least a large percentage of her life) Karina has had her hair cut - it looks great to the unbiased father...

Time and Time Again

It must be mid-life crisis but I've detected a recurring theme of time in all of my postings to date:
New Daughter Look = "After years and years..."
Buggy Customers = Time zone offset in software
The Past Marches On = Time-themed title, even though the post had to do with drug development
Watery Strings = How electronic systems can fail to save time
It Starts, Parts 1 & 2


Buggy Customers

Yesterday was one of those crazy days which start out with too much to do and end with you having done none of it despite being furiously busy. I participated in two web meetings (one in Italy and one in Boston) and a conference call and produced two documents – most of which were not on the plan as the day started. One of those documents was a quick position paper that essentially said, "No, there's nothing wrong with our software – you just have to think..."
There are strict requirements in the pharmaceutical industry to ensure that crucial events performed with software managing electronic records are captured and time stamped. An inspector from the FDA or other regulatory agency may want to know exactly what happened, who did it and when it occurred. Open Text Livelink runs a comprehensive audit trail and timestamps all of the events.
But in the process of validating their Livelink system according to regulatory requirements a customer discovered that when they viewed the same audit trail using two different computers as web clients the recorded times differed, and not even by an exact number of hours --> Big red flag waving, major problem, slam on brakes, system can’t be validated, panic, it is the software vendor’s problem, make them fix it yesterday, call Martin, fix it or make it go away…
Martin looks at problem, takes deep breath, answer simple = client hasn’t thought this through.
So what was the problem you ask Dear Reader (if there even be one!)? Well Livelink gets its time from the server(s) on which it runs (both application and database server(s)). Typically systems are configured to get their time from a time-server – this may be internal or external, in either case an atomic clock available on the Internet (e.g. at NIST) is usually the final authoritative source of information (good overview). As long as the servers from which Livelink gets time information have accurate and synchronized clocks, then the timestamps are fine.
So where’s the problem? Well users get confused – that old ‘human factor’ thing I keep running into. Livelink has an option to either represent time to users exactly as ‘known’ to Livelink (i.e. ‘server time’) or to reinterpret this time to each user’s local time – this feature is called the “Timezone Offset” and is a configured by a Livelink Administrator and applies to any client computer accessing a given Livelink system. The aim of this function is to enable users to conveniently understand events according to their local time.
To illustrate the usability benefits (i.e. trying to address the human factor) of the Timezone Offset feature consider the following example:
A Livelink server is configured to record and display times according to Eastern Standard Time but does not have Timezone Offset enabled.
A user working in Pacific Time adds a document as 10:00am.
If that user subsequently refers to the audit log they will see that their document was added at 1:00pm, not 10:00am.
However, if Timezone Offset is enabled, then whenever Livelink sends time and date information to the user in the Pacific Time zone it reinterprets the time to their local setting, so the user would see that they added the document at 10:00am as expected, not 1:00pm. This reinterpretation of time applies to all time events, not just those related to a particular user.While the Timezone Offset feature can aid users, it presents particular challenges in a validated system. In order for Livelink to reinterpret server time to a user’s local time, it has to determine the user’s current time. It does this by querying the time as known to the user’s client computer and compares this to the Livelink server time, calculating the difference between these two. This calculated time difference is then applied to all time references provided to a given user. The times in the authoritative Livelink record are not being changed, only their representation to users to keep them happy. If a given user’s computer clock is accurate then the times shown to the user correspond exactly to the times in the Livelink record, although they are adjusted to the corresponding local time equivalent.
In the real world unless adequate controls are enforced this can lead to unexpected variations. It is of course essential that the clock of any computer accessing Livelink be correct – not only must the ‘displayed time’ be correct (e.g. 05:13:12pm), but also the correct time zone must be set. In general the clocks employed in PCs are not accurate. Also, when users travel they often fail to reset their computer clocks or reset the displayed time but not the time zone. As a simple example, in a Livelink system when the Timezone Offset feature is activated and two computers differ by 2 minutes and 12 seconds, then all time events shown by Livelink will differ by this amount when compared between the two computers.
So how to address this? 1.) Ensure that the clocks of client computers are correctly set or, 2.) Establish procedures to deal with apparent time variations. If neither of these can be achieved, then the Timezone Offset feature should not be used. Is simple is it not?
So Martin writes this all out in more formal form (i.e. passive voice, qualified sentences, using official corporate template, converts to secure PDF, etc.), e-mails to sales and technical people on account, and then gets back to serious work on the next unscheduled task. Sigh…


It Starts - Part 2

This just in (based on my earlier comment):

To: Karina Sumner-Smith
Subject: Please Forward to your Dad
Dear Mr. Karinasdad: Yes, other online journalers do get a little freaked out when their parents start talking to them about their journal. Really. We just get over it.Hmmm...


Watery Strings

I was involved in a customer demonstration today showing the regulatory affairs group of a small pharmaceutical company our new software offering to support the preparation of electronic submissions to regulatory agencies. There is a classic paradigm shift underway in this space – that’s a well worn cliché, but in this case quite true. In a future entry I’ll expound on this a bit, or even a lot, more. But the point here is that the staff of the potential customer neither understands what technology can do for them nor do they realize how much that technology will change the way they do things. And it’s not like they will have choice – the regulatory authorities are moving inexorably to require electronic submissions in a new format called the eCTD from the ICH that incorporates XML.
After a two hour web demo I felt like I’d been through a wringer. How do you sell something to someone who doesn’t even know enough to know what they don’t know, or to understand the issue and how they will have to address it at some time? Obviously the answer is you don’t. Clearly this company is not one of the early adopters ready to ‘cross the chasm’, they aren’t even a member of the mainstream – they are clearly a laggard – so onto the next prospect for me.
I felt like we were trying to, “Push water up a slope” or “Push on a string” as the sayings go.
Today’s experience leaves a number of half formed questions in my mind, mostly related to the ‘human factor’. At times I’ve watched how electronic systems have failed to yield the expected benefits because human behaviour works to confound them. As an example, in many companies it can take a month or two to collect the required signatures on a formal document such as a standard operating procedure (SOP). If you analyze the time involved, something like 30-40% of that time is taken by the process of moving the document around in internal mail. So you’d think that if the document was circulated electronically you could immediately get a 30-40% time saving; but no such luck. People notice that they get the document quicker so they feel a lower sense of urgency to sign it – they procrastinate. Or they have structured their work week to only sign procedures on Friday, so whether they get a document on Monday electronically, or on Wednesday by internal mail, there is no time saving by the time they sign.
Most people know that saving time will benefit their company, but in today’s experience, we couldn’t even talk about benefits when the people on the call didn’t understand the issue or the problems associated with it. One day they will, but not until I’ve moved onto another career – and I don’t have any current plans to do so…


It Starts

I've had fun reading my daughter's weblog, Spontaneous Things, but whenever I mention that I've just read something or comment on what I read she feels uncomfortable. Hmmm.... Lots of anonymous people on the Internet can read it, but when Karina's father reads it she's uncomfortable. And she says that other web bloggers understand how she feels. There's nothing like personal experience, so here goes...While that’s certainly one of the reasons I thought I give this online journal ‘thing’ a try, there are others that may emerge on these pages in the future…
What to talk about he muses… Well, being half-a-century old (“But only just,” he feels compelled to add) certainly gives plenty of historical fodder: things I’ve done, professions I’ve had (more than one), things I’ve seen, relationships, and so on. Not to mention thoughts of the Future, of which I personally will undoubtedly have less of than I've already had of the Past.
So who is this guy (or bloke - note subtle reference to English birth)? I could be lazy and simply say “Google me’” by clicking this link. In looking at the results right now there are 129 hits – what a grab bag of my Past and a little of my Present. None of my Future though of course; what a scary thought that is: Imagine going to www.futuregoogle.com, searching on your name and seeing things that you will do that will make it on the web. But I digress. I’m very happily married, have two great children (including the aforementioned Karina), and live in Palgrave, Ontario, Canada. I’m a molecular biologist by training (Ph.D. University of Toronto, 1982, Postdoc Yale to 1984), spent many years in biotechnology with a company called Allelix (subsequently acquired by NPS). In 1996 I founded a bioinformatics company called Base4, which was ultimately acquired by Open Text, my current employer.
But enough for now; let’s see where this goes over time…