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Reflections on World TB Day

3/24/2014

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My maternal grandfather died of tuberculosis. He contracted it while serving in the First World War. He returned from France to live a life of diminished quality, shortened by an early death.  I can also remember, when I was a small child, in the 1970’s going for rides through Los Angeles’ Elysian Park area and passing what was then the Barlow Sanatorium. I asked my dad what a sanatorium was and was introduced at a young age to, what was still then, the isolating treatment of tuberculosis.  The Barlow Sanatorium is now the Barlow Respiratory Hospital. Los Angeles, fortunately, no longer has the need for a facility dedicated to the treatment of TB.

My wife always tests positive with the Mantoux tuberculin skin test, the most common screening test for TB.  She grew up in Kenya and was most likely exposed when she was young sufficiently to produce an antibody response without being infected.   False positives in the Mantoux test are fairly common, leading to chest X-rays and sputum cultures being truly diagnostic. So I have had an unusually significant number of interactions with TB for a first world citizen.

TB has certainly been around since 9000 BC and probably became a human disease as a consequence of the domestication of cattle.  Evidence has been found in Egyptian mummies from circa 3000 BC.  TB has been a scourge of humanity for all this time.  The death toll peaked in the 18th century when accounted for ~25% of all fatalities.  The advent of the sanitarium movement followed by modern antibiotics with the discovery of streptomycin in 1946 made total eradication of TB seem like an obtainable goal.  Then in the 1980’s the first drug resistant isolates were found, and we returned to the old days of an untreatable TB.

Since 1980 reported cases of tuberculosis have been rising steadily from 1,000,000/year to over 5,000,000/ year .  Approximately 1/3 of the world’s population is infected, and 3.7% of new and 20% reinfections involve some form of drug resistance.  Total drug resistant TB has been found in Italy, India and Iran. It is unclear how extensive this strain is.  Only 9% of TB cases are drug tested worldwide, making the extent of the problem largely unknown. 


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The Five Biggest Mistakes of Start-Up or Early Stage Biotech/Pharmaceutical Companies

3/3/2014

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Starting a drug discovery endeavor is daunting task.  Without question, no one can know everything about a subject as vast as drug discovery.  There are resources out there to help, but often, scientists don’t know about them.  They are usually experts in their fields, but not in the many areas that are necessary to successfully navigate the difficult landscape of biotech-pharma start-up.  These are the five biggest mistakes I have encountered in my career:

1.       Not taking care of ones data.  Often a start-up or early stage company will have a bare minimum of personnel. The most common thing I have seen is storing biological and chemical data in flat files like spreadsheets or SDfiles. This makes them impossible to search, difficult to make sure everyone in your organization has access to the most current data, and prone to corruption and loss.  Start-up scientist from an academic background often don’t know about integrated cheminformatic and high throughput screening data management systems.  Scientists from a big pharma background usually associate these systems with expensive, cumbersome commercial systems, or even more cumbersome and expensive custom built systems.

The truth is flexible, easy to use, and cost effective systems exist that can solve all one data management issues.  I recommend CDD Vault™ to my clients. It is a private hosted solution, using a familiar web interface, removing all of the overhead in setting up a database.  Do yourself a favor, and check it out.  You will simplify your life and eliminate the hassles of managing your data.

2.       Doing without, when you can’t afford a full time hire.  Time and time again, I’ve seen: Companies founded by biologists do without chemistry support, Companies founded by chemists outsource their biology, and Companies with both do without specialist input like computational chemistry, chem- or bioinformatics, DMPK-Tox, or preclinical research.  It is easy to hire experts and affordable costs and keep them on call by negotiating a contract that guarantees them a minimum revenue to have them there when you need them.  Victrix provides these types of arrangements all the time.  I know other consultants do as well.  If you need any of this kind of support, but can’t afford to a full time hire, we can help you find the expert you need with our extensive range of contacts.

3.       Not having your outsourcing professionally managed.  I’ve had significant experience in locating, negotiating and managing chemical and biological service outsourcing.  I also make significant use of virtual assistants.  If you need a project outsourced, or are interested in making use of virtual assistants to streamline your operations, schedule a free evaluation.  We are running a 50% off special during the month of March. Our $10K outsourcing management fee is now $5K, and when your project is finished, you will be professionally trained to take over yourself on managing your project.

4.       Bringing your big pharma baggage with you to a start-up.  I’ve seen small companies saddled with the bureaucracy of a multinational company by well-meaning scientists who try to recreate the system they left behind at a large pharmaceutical company in their new smaller digs.  All this does is make, what should be a productive, nimble small company as unproductive as a sclerotic giant.  It’s natural to try to create the familiar in new circumstances, but often in creating a familiar cocoon we bring all the problems of the past with us.  Remember you aren’t at a mega-company where 100’s of people need to sign off on new or changed projects, don’t complicate the simple. Do what needs to be done, even if it violates some rule you were taught at your previous big company.

5.       Not keeping your eyes on the prize.  Despite the fact that we would all like to have infinite time and resource to find the perfect drug, the issue is no one is interested in you until you have de-risked your compound through Phase II.  This is the sad truth, but everyone should be focused on this goal and be working toward it. 


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    Adam Kallel Ph. D.

    Our CSO sounds off about drug discovery, computational chemistry and history

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