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October 31, 2006

QD Information Services Now Offering Podcast Consulting Services

by @ 4:10 pm.  Filed under Asides, Technology

QD Information Services is pleased to announce they now offer podcast consulting services. If you want to learn what podcasting can do for your company and you want to start a podcast QDIS can help. QD Information Services has been involved with podcasting since its inception in August 2004 and now produces the podcast “Searching the Internet“.

Podcasting is not jut a fad but is an efficient method, unique, low-cost method to communicate with your costumers or just anyone with access to the Internet.

Feel free to contact me if you’d like to further discuss how podcasting can help your company.

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    Your Vote on Nov 7 is Important

    by @ 3:24 pm.  Filed under Asides, Search Tips, Technology

    Voting is an important duty for everyone in the US. I also think people should spend time going over the issues and candidates in order to make an informed choice. With that in mind, I wanted to let you know about what is easily the most important episode of “Searching the Internet” that I have done to date. Episode 12 covers information for voters and I review sites to help you make intelligent decisions in the upcoming election. All the sites reviewed are non-partisan and give unbiased information about the candidates and issues. I’m hopeful that people will find this review of election and voter information related sites useful and helpful.

    I feel voting is very important and wanted to contribute something to the podcasting community. I went through many sites before settling on the ones I decided to include. Episode 012 covers election information sites. These include:

    I feel voting is the most important duty of any American and I hope this episode helps people make informed decision at the polls on Nov 7.

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    New Bird Flu Strain Found

    by @ 1:12 pm.  Filed under Health News

    Well, I think it was just a matter for time but it seems to have occurred much sooner than I thought it might. A new strain of bird flu called H5N1 Fujian-like has been discovered at the University of Hong Kong. This new strain is resistant to the vaccines that are currently in development for bird flu.

    Scientists Uncover New Bird Flu Strain - Los Angeles Times

    It will be interesting to see how this plays out. Unfortunately it looks like the virus is drifting but there is no way to know if the drift will make the virus more easily spread.

    Other Resources

    Emergence and predominance of an H5N1 influenza variant in China — Smith et al., 10.1073/pnas.0608157103 — Proceedings of the National Academy of Sciences (abstract)

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    Merck Buys Sirna Biotech

    by @ 12:57 pm.  Filed under Pharma News

    Wow! Merck is paying a 100% premium in cash for the tiny company Sirna. The merger activity is really picking up steam and is almost a mania now in my opinion.

    Inside Merck’s Biotech Buy - Forbes.com

    Merck Buys Maker of Gene-Silencing Drugs - New York Times

    Sirna is developing a technology for silencing genes that Merck seems to want very badly. This is the technology that was the basis of the Nobel prize in medicine announced last month. The deal is all cash at double the Sirna stock price as of Oct 30. While RNAi is interesting, it seems to be a large price to pay for a promising but not yet proven technology. It may pay off, but the risks seem high for a technology this early in its development cycle.

    To be fair, Sirna does have some other products in development including one for hepatitis C and for macular degeneration. And thy do have deals with a GlaxoSmithKline and Allergan. It will be interesting to see how those deals are dealt with after the acquisition.

    I want to comment on the whole merger mania as a whole. By this point, I’m starting to believe that it is moving beyond finding a good deal with a good chance of a return and moved into “jumping on the bandwagon” because everyone else is doing it. When this sort of attitude starts prevailing I think it can lead to some very bad deals. It allows downtrodden beaten up companies that aren’t performing well to be picked up at a premium. Overpaying for an acquisition is never a good thing. I have been involved in some M&A activity where it seems the acquiring party has already made up their mind before even doing the required due diligence. This sort of mentality leads to very poor decisions from my perspective. I can only hope that any further M&A activity is done with an open mind and by looking at the facts and data before coming to a decision. Otherwise, the pharmaceutical industry could be looking at a future of continued lack of drug candidates due to poorly chosen merger activities.

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    October 27, 2006

    Recent Science Graduates Unprepared for the Real World

    by @ 12:57 pm.  Filed under Science, Pharma News

    A recent article in Business Week caught my eye. It talks specifically about the biotech industry complaining that too many recent college graduates have little understanding of what was required of them in the real world.

    Biotech’s Beef

    The main complaint is that they lack some technical skills and have no understanding of the concepts of quality control and regulatory issues. I personally think there are several reasons for this and I’ll discuss each of them below.

    Let’s first talk about colleges. There are two major reasons that colleges and universities don’t do a better job at preparing students for jobs in technical fields such as biotech. In regard to technical skills, many colleges do not have the sophisticated equipment needed to train their students. Money is a constant problem and my personal experience is that the equipment in colleges and universities is sometimes decades out of date. This is especially true for expensive equipment. When I was studying as an undergraduate in the early 1980’s, we didn’t even have a working mass spectrometer to use in the advanced analytical lab. We barely had an NMR (60 MHz continuous wave). When I went to graduate studies at a large state university known for its chemistry program, the situation was much better, but still many of the day-to-day instruments such as the gas chromatography equipment was from the 1970’s, although we did have access to high filed FT-NMR.

    The second reason that colleges and universities don’t do a better job has to do with make up of those teaching, i.e. the professors. My experience is that many of them have never spent anytime in industry so how can they teach what they don’t know or understand themselves? My personal experience was that in tens years of college, none of the science professors I took a class from or who I knew had ever held a job in industry. They all had graduated, gone on to a post-doc position, and eventually worked in a college or university. It is practically impossible to talk about topics such as the regulatory environment or quality control without any experience in those areas.

    In some cases it goes beyond jut not knowing; there are some who seem to have an attitude of contempt for those in industry who may express a desire to teach. Many professors have a certain disdain for industry and those outside their small cliche. As an example, a small community college in my area had an opening for a chemistry professor. I applied and was told that I they had “grave concerns” about my teaching abilities since I hadn’t “taught” for over 14 years. I replied that although I had not taught in a college or university since my graduate school days, I did a lot of teaching in my community, my church, my corporate life and even taught paid training courses in my own consulting business. This didn’t count according to them. They seemed to feel that the lack of teaching experience in the exact environment of a college outweighed the practical, real world experiences I could bring from industry. After several months of not hearing form them, I called and was told they had forgotten about my application and would send me a notice in the mail soon. A couple of days later, I received a very short rejection notice.

    All though universities and colleges are to blame for much, some of that blame also lies with biotechs themselves. In many cases, they seem to want fully trained robots that they employ without difficulty. One of the first things cut in down times at companies are the training budgets. Also, there is much talk about employee loyalty and that if they train someone, they will leave for another job before they benefit from the training. This may be true, but, when this is brought up to me, I always ask when was the last time they had a lay-off due to a temporary set back. Invariably within the last 16 months or so they have had some sort of major “restructuring” which included people losing their jobs. Today, companies that complain about employee loyalty but then have lay-offs every time there is a down turn, have no room to complain. To make matters those who have to find other jobs,find upper management at their former company gets rewarded for getting rid of employees?!

    Then end result of the short-term short-sightedness of many companies is that the employees are over-worked and pay doesn’t keep up with the increased responsibilities. The motto of corporations today seems to be” do more with less for less”. This means that those workers don’t have the chance to work as an adjunct professor at their local college or university (see my ideas for improving this situation below).

    Here are a few of my ideas for improving the situation.

    1. Allow industry folks to have a sabbatical to teach in a local college. This could be for just a portion of a semester or quarter; maybe three or four weeks.
    2. Industry should encourage colleges to hire adjunct industry faculty (see #1 above). They could earmark money for equipment and then set up a schedule for them to have access to that equipment. At a former university I attended this was done successfully. The company helped purchase a new high-field NMR and in return, they were given one day a week full access to the machine. Then they also did not have to worry about routine maintenance. That was taken care of by the university.
    3. Industry needs to set up and effectively run programs to give students industrial experience. This is more than just allowing an intern to flounder for 6 weeks in one of their labs. THere needs to be a culture of showing students what the industry is about if industry is serious about solving this problem.
    4. Expose college faculty to industrial positions. Encourage industry to accept professors during their sabbatical to learn about the industry and the various roles needed. This also means industry has to be willing to give this sort of experience to professors.

    I am hopeful that the situation can be improved, but it requires more than just talking from both sides. There is a need to implement these sorts of programs in order to keep America competitive in an increasing technological society.

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    October 26, 2006

    Aptuit to Acquire SSCI

    by @ 10:59 am.  Filed under Pharma News

    More mergers, this time in the contract services area. Seems Aptuit will acquire SSCI.

    RedOrbit - Health - Aptuit to Acquire SSCI

    I have done work in the past with SSCI and find them to be an excellent company to do business with. They specialize in polymorph issues and have an great background in solid state characterization. Aptuit has reported they will keep all ~100 employees of SSCI there in West Lafayette, IN. I truly hope this doesn’t change the culture and work ethic of SSCI. I am always hesitant though having been through several mergers and knowing the problems and confusion that can result . Invariably the larger companies culture inculcates the smaller company and in my opinion, this stifles the advantages that the smaller company usually brings to the market. These include responsive customer service, as well as being able to change and adapt to changing circumstances quickly.

    Maybe my fears are unfounded, but if my experience is any indication, it may mark the end of another innovative and adaptive company which was a pleasure to work with.

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    October 25, 2006

    Outsourcing Drug Manufacturing

    by @ 11:36 am.  Filed under Drug Development, Pharma News

    The third part of a recent series from in-Pharma got me to thinking.

    A world of outsourcing awaits – part III drug manufacturing:

    The article basically states that there is over-capacity in the active pharmaceutical ingredients (API) mainly due to increasing capacity in India and China as well as a reduction in drug pipelines as well. I would add that there seems to be s shift from classical small molecules to either more involved new chemical entities (NCE’s) or biologics. Since biologics have much higher prices and better profit margins, more and more major pharmaceutical companies are expanding into biotech manly by acquisitions.

    However, the area of final product (FP) or finish fill operations, seems to be going well with continued growth. Another area seeing growth are the so-called contract biomanunufacturing organizations (CMBOs). This area will be interesting to watch in the coming years and it may end up that these operations are more about growing to the point of being an attractive acquisition than in long term survival. I could be wrong, but that is what is currently looks like to me.

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    October 24, 2006

    India Sets Drug Pricing

    by @ 11:55 am.  Filed under Pharma News

    There is a lot of talk drug prices and pricing in the news today. China and India and often mentioned as sources for cheap generic bulk active ingredients. It was interesting then to find that India is setting pricing regulations for 324 generic drugs.

    India Sets Risky Drug Price Rules - Forbes.com

    This is an interesting situation and is creating divisions within the India government. Since the pharmaceutical industry is one of the fastest growing industries in India, the fear is that it will slow grow in this area. There is also concern over the affordability of drugs in India for the poor.

    Drug pricing is a controversial issue and is made worse by those who claim that “free markets” will set the price. This ignores the fact the the majority of developed countries in the worlds governments control prices. There is NO free market when it comes to drugs.

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    FDA to Review Electronic Signature Regulation

    by @ 11:18 am.  Filed under FDA

    The Third annual FDA Information Management conference is coming up next month and it will be interesting to see what comes out of it. For a long time 210 CFR Part !! has been controversial and created a lot of confusion and talk concerning implementation and exactly what was required.

    FDA to review electronic signature regulation

    I remember when these regulation came out and the amount of confusion it caused. Also, many companies were hesitant or refused to go with an electronic system mainly because at the time, none of the commercial software for analytical instruments had the capability to track users and lacked password protection. The main problem was that the regulations were requiring systems that involved many parties and not just the pharmaceutical manufacturers. It wasn’t until the systems software developers were broung into the fol and it explained what was desired and

    As the technical person responsible for choosing a contract manufacturer back in the lately 1990’s and early 2000’s, I remember touring contract manufacturers’ analytical labs and one of the first things I always tried was to see if the computers connected to the instruments had password protection. Sadly, many did not and allowed access to the system for anyone who stepped up to them.

    The requirements also set up the situation where companies preferred older paper systems and did not investment in modern technology mainly because of fears and misunderstandings of what was required. The result was the law of unintended consequences; the policy for supposedly encouraging adoption of electronic systems actually had the opposite effect.

    This is a topic I’ve kept an eye on for years and find fascinating as to how the pendulum has swung in this regard from overly harsh and almost draconian to a more adaptive system. It will be interesting to see what the consensus is after this meeting.

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    October 21, 2006

    Novartis Does Right on Recalling and Replacing Flu Vaccinne for Children

    by @ 3:44 pm.  Filed under Pharma News

    Today the Washington Post had an article on Novartis recalling over 500,000 doses of flu vaccine intended for use in children.

    500,000 Flu-Shot Doses Recalled - washingtonpost.com

    The first thing to point out is the vaccines are not dangerous but had been frozen while under the control of Cardinal Health, so the problem was not with Novartis. Freezing will deactivate the vaccine so it isn’t dangerous but it would likely not protect against the seasonal flu. However, Novartis recalled all vaccine to be absolutely safe and will be replacing it. The new vaccines should be available by early November and will be handled by another distributor obviously.

    I find this to be the kind of reaction that is admirable on behalf of Novartis and is to be applauded. It should also be noted that the product is labeled as from Chiron who was acquired by Novartis earlier this year.

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