We work in a customer service environment dealing with the in-vitro efficacy evaluation of many and varied antimicrobial products. One of the most important considerations in almost every study that we perform is proving effective neutralization/inactivation of the antimicrobial activity of the product(s) to be tested. In brief, proof of neutralization is necessary to ensure the validity of the test method. Without verification of neutralization, differentiation between –cidal (kill) or inhibitory activity is difficult, at best. And since most competitive marketing of products is based upon claims of “kills 99.9% of germs in 15 seconds” or “reduces bacteria by 99.99% in 10 minutes,” proof of neutralization is as important as the results of the bactericidal test itself.

Depending upon the active ingredient(s) of a test product, neutralization is accomplished chemically through the addition of neutralizing agents (i.e., lecithin, Tween 80, catalase, etc.), by dilution of the active ingredient to a sub-inhibitory or sub-lethal level, or by a combination of the two. One of the first questions asked of a potential customer is “what is the active ingredient of your product?” Without an accurate answer, the study design is a “best guess” – which neutralizing formula will work best to immediately inactivate a given product?

ASTM E 1054-08, Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents, provides excellent guidance on methodologies for demonstration of adequate neutralization. All neutralization verification procedures should, at minimum, include the following:

1) An arm/phase that provides data demonstrating that the neutralizing fluid immediately and completely neutralizes the product. If neutralization is not complete or immediate, residual “killing” activity may occur – a bacterial reduction reported for a 15 second exposure time may actually be a reduction for 30 seconds, 1 minute, or longer. If this happens, the danger is that a product may be reported as being more effective than it actually is.

2) An arm/phase demonstrating that the neutralizing fluid itself is not toxic to the organism(s) tested. If the neutralizer exhibits some antibacterial activity, it may actually “add to” the apparent antimicrobial activity of a product. Again, the danger is that a product may be reported as being more effective than it actually is.

3) An arm/phase providing data showing the starting bacterial challenge population. The data from this phase/arm are the basis of comparison for the previous phases – in general, neutralization procedures should employ a LOW population of bacteria, in terms of CFU/mL. If a challenge population is too high, a neutralizing system may appear to be effective, when in fact it is not.

4) REPLICATION – this allows for a statistical comparison of the data – PROOF that the neutralizing system is effective.

Verification of neutralization must be performed for all in-vitro efficacy evaluations of antimicrobial products to ensure the validity of the data; depending upon the type of evaluation and the familiarity with the active ingredient(s), this verification may be conducted in advance of a efficacy evaluation, or concurrent with the efficacy evaluation — as long as it is conducted using the same test formulation.

– Terri Eastman, Manager of the In Vitro Laboratory

 And no … I am not just saying this because upper management will read this. I am one of the fortunate people that have a job to say “I love”. If you can say, “I hate my job” … CONGRATULATIONS … you are still employed. 

As a clinical research manager conducting research on a vulnerable population particular attention must be given to the process of informed consent. This additional attention is required because vulnerable populations are populations who have limitations regarding their ability to provide informed consent and are more susceptible to coercion or undue influence. Because the decision to participate in clinical research must be made by a competent individual who has received the necessary information, and who has understood that information, special care must be taken to resolve language and comprehension barriers between the researchers and their potential subjects.

Therefore the researchers must set aside adequate time and resources to insure that the proper language, or languages, is used to inform the potential subjects of the requirements of informed consent. Not only should the language itself be presented at a comprehension level easily understood, but the content and concepts of the message must also be presented at a level that will allow their comprehension. Particular attention should be given to the concepts of clinical research, randomization, and inactive medications (placebo) due to complexity of the issues, their importance, and the relative inability of the normal population to completely comprehend them.

Each of these issues requires the attention of the Institutional Review Board (IRB). It is the responsibility of the IRB to determine that the minimal requirements of 45 CFR 46.111 are achieved, that additional safeguards for this vulnerable population are in place and that proper informed consent is obtained from each subject, prior to protocol approval.

Private, for-profit IRBs can function without ethical conflicts as long as their members are not directly involved in the research and the outcome of the review in no way benefits them as individuals.

John Dyba, Senior Account Executive

There has been a tremendous buzz in the first four months of 2009 about using social media to drive business.  For sales and marketing professionals, the question is “with so many social media recommendations, how does one know where to spend their time effectively?”  It seems like social media can easily overwhelm us.

After reading several articles on the topic, there does seem to be a collective opinion on how to develop a social media strategy.  First, start small and put your effort where it will get the most results.  Look at the social media sites where your customers are spending their time.  Is it Facebook, Linked-in, Twitter or something else?  Second, test one social media site/tool at a time and track results.  Just like conducting a scientific experiment, develop purpose, approach and key metrics.  Third, make the social media strategy compliment the search strategy.  Choose social media sites and tools that give search results for keywords related to your products or services.  This can be tested for each site as you add content to it.  Finally, position yourself as the “expert authority” in the market niche you serve.  Pass along helpful news and tips from industry organizations.  Create a question that is currently relevant, answer it, and encourage others to respond.

There is much to learn about the power of social media.  The strategies and tips undoubtedly go beyond these.   How are you using social media at your company?

Jim Verzuh, Director of Marketing.