A Message from the Chief Scientific Officer Stephen Dueker

January 2011

This is the second message from management and while perhaps overdue, marks a number of changes for Vitalea and the industry as a whole. Our message from 2009 was characterized by excitement over our new facility, expanded scientific team, and growing the recognition for Vitalea's scientific and technical expertise.

The intervening period saw Vitalea's team direct intense efforts towards elucidating and expanding the role of our AMS technology in the pharmaceutical development paradigm. It has not been easy for Vitalea or the industry, in the face of patent expirations, a paucity of new products and deep layoffs across the board. While the fallout continues, I cannot help but be optimistic over the role of Vitalea's services in addressing some of the major weaknesses in the products development pipeline: the ability to select the proper candidate and once selected, to move that product efficiently across the various goalposts or, recognizing an intractable weakness and abandoning that product before consuming more resources on a losing bet.

I firmly believe that Vitalea's services can in part address both those areas: Human microdosing as the final arbiter in candidate selection and lead optimization, and MIST (Metabolites in Safety Testing) readouts in Phase 1 to evaluate potential metabolite-mediated toxicity. We have seen an explosion in the later and a nice uptake in the former as human microdosing is being surgically used for specific problems solving and problem resolution if not a routine checkbox study.

The one unexpected surprise was the facile acceptance of absolute bioavailability in a single test using an I.V. microdose. This design has found immediate traction in the Phase 1 area where formulation development is taking place. It has further been requested for labeling purposes for approved products, particularly by authorities outside the U.S. This elegant and powerful design bypasses all the traditional barriers to I.V. development of oral drugs and is useful on many levels for evaluating the product. It truly brings speed and efficiency at a reduced cost.

For 2011 I see the application of AMS 'universal and equal detection' to biologics, be they polymers, proteins, antibodies or RNA drugs. Here AMS delivers quantification to attomole levels without method development or in most cases any sample preparation. The non-specificity of ELISA assays and the confounding influence of matrix ion suppression in MS are not present with AMS therefore providing early decision-making with full confidence in the bioanalytical results.

2010 marked many firsts for Vitalea in several study designs. We pioneered the first multidose radiolabeled study with one of our sponsors and led the way for AMS validation concepts that came to a discussion at the CPSA workshop we hosted in Langhorne PA in October, 2010. Vitalea is committed to engaging thought leaders around the globe — we realize that as AMS becomes routine, scientists will expect us to provide guidance for what realistic expectations are for accuracy and precision. We have started that work with three publications in Bioanalysis this year. All papers centered on validation topics. The year ended with a requested contribution to Advanced Drug Delivery Reviews on approaches using microdoses and other low dose tests. This paper builds upon the years of low dose work in vitamin, phytochemcials, gene toxins, environmental chemicals, and cancer drugs by many of the active researchers at institutions and companies.

As 2011 approaches, there are some new developments with the Vitalea infrastructure. Realizing that while AMS is a great tool, it is only a tool, and industry standard operations from study set up to final reporting are always paramount concerns for any sponsor. In response to that need, Vitalea's board of directors has recruited Robert Bethem as CEO and Director of Laboratory operations. Bob comes from a CRO background, most immediately recognized as a founder of Alta Analytical Laboratories. Here Bob earned a loyal industry following for emphasis on customer service, responsiveness, open communication, problem solving and the best science. Bob's addition marks the next natural evolution in Vitalea's growth as we move from a technology driven company to a trusted CRO partner. As evidence of Bob's insight, his first act as CEO was to recruit two of the industry's leading business development agents in Ann Hoffman and Gaye Martin. These individuals have outstanding reputations for communication and responsiveness and are capable of speaking to the science with as much alacrity as the contract management. Their contributions have been immediate and substantial.

The team is set. We will continue to strive to be our very best and seek to develop new assays and ideas that can help the drug development process, with a keen appreciation of the needs for those in regulated bioanalysis. I am pleased to now be serving as Chief Scientific Officer. You are in good hands with Vitalea and we look forward to 2011 as our best year ever.

Keep innovating!

Stephen Dueker