Newsletter: Q1 2012

Message From Our President

Gilbert Lam, Ph.D.
President and Chief Scientific Officer

2011 Year in Review
2011 was a great year for MicroConstants. Although there are still challenges facing the CRO industry as a whole, last year we achieved a 15% growth over 2010 revenues. We also welcomed 27 new clients, developed 120 analytical methods, hosted 12 client QA audits, and distributed more than 1,500 specimen collection kits.

Some of the major accomplishments we achieved last year include completing the installation of our second Xevo® TQ-S tandem mass spectrometer from Waters Corporation (bringing our U.S. instrument count to 16 LC/MS/MS systems), welcoming Lilin Wang as the new Manager of our Immunology Department, and expanding our Drug Metabolism Group with the addition of Rishi Sharma, Ph.D. as our newest DMPK Research Scientist. Additionally, MicroConstants China received an endorsement of OECD GLP Compliance last May in the areas of analytical chemistry and pharmacokinetic studies from the Netherlands GLP Compliance Monitoring Programme.

MicroConstants exhibited at several industry meetings throughout the year and our scientists presented 4 scientific posters on the topics of pharmacokinetics, toxicokinetics, and LC/MS/MS analysis at the ASMS Conference and the AAPS Annual Meeting. We also had articles published in Next Generation Pharmaceutical Magazine and in Lab Manager Magazine on trends in outsourcing analytical support and the benefits of being proactive versus reactive in hiring and purchasing practices.

What's in store for 2012?
At MicroConstants, we remain committed to providing our pharmaceutical and biotech partners with the highest quality data and exceptional client services. In an effort to further solidify that commitment, some of our initiatives for 2012 include effectively utilizing our state-of-the-art instrumentation to push the limits of method development and encouraging our personnel to continue taking advantage of professional development opportunities.

Since the installation of our Xevo® TQ-S tandem mass spectrometer system in March, we’ve been able to achieve lower drug concentration levels than previously possible with other LC/MS/MS systems. One example is an assay we developed to determine the concentrations of Angiotensin I and II in human plasma to below endogenous levels. Previously published methods reported limits of quantitation around 26 pg/mL for Angiotensin I and 21 pg/mL for Angiotensin II; however, with the Xevo® TQ-S, we were able to determine concentrations to 10.0 pg/mL for Angiotensin I and 1.00 pg/mL for Angiotensin II. By detecting these low levels, we were able to determine the endogenous concentrations for nearly every sample tested. The vast majority of the samples would have been too low to determine the concentrations with existing published methods. We achieved similar results with an assay to determine the concentration of fluticasone propionate in human plasma samples with a lower limit of quantitation of 0.250 pg/mL. We look forward to expanding on our positive experiences and using these powerful LC/MS/MS systems to better support our clients that need to reach low to sub pg/mL concentration levels.

Next week, all of our supervisors will be attending an on-site management training program developed by The Ken Blanchard Companies. The workshop is on Situational Leadership and will focus on effectively managing and developing people, time, and resources. Attendance at these types of training programs is highly encouraged at MicroConstants. We believe that quality results can only be achieved through quality people. Therefore, professional development is essential to ensuring that we always have the most knowledgeable team supporting our clients.

2011 Client Satisfaction Survey Results

Each year, we send surveys to all of our clients to measure their level of satisfaction and request feedback on ways we can improve. 36% of our clients responded to the latest survey and here’s what they had to say…

• 100% were either satisfied or very satisfied with the quality of work produced by MicroConstants.
• 99% indicated that they were either confident or very confident in the quality of data and results provided.
• 97% said they would or already have recommended MicroConstants to a peer or industry colleague. The remaining 3% were undecided, commenting that it was still too early in their study to decide.
• The primary reasons given for recommending MicroConstants included excellent communication, high quality data and results, satisfaction with deliverables, and timely delivery of data and reports.

We are very pleased with these results and will continue to elevate the quality of our services to ensure we are consistently meeting our customers’ needs and exceeding their expectations.

Service Spotlight

Method Development and Validation
Our experienced method development team specializes in developing and validating robust methods for the analysis small molecules, proteins, and peptides using LC/MS/MS (HPLC or UPLC), HPLC/UV, and ELISA. Throughout the past decade, MicroConstants has developed over 1,400 methods, including more than 100 non-proprietary assay methods. We have solved difficult analytical problems including the detection of amino acids, peptides, steroids, cephalosporins, and chiral separation of various enantiomers using liquid chromatography / tandem mass spectrometry (LC/MS/MS).

We perform method validations, method transfers, method verifications, cross-matrix validations, full GLP validations, or any combination of them required to meet your analytical needs. All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation.

View our list of non-proprietary assay methods.
Contact us for more information, or to request a quote.

Employee Spotlight

Rishi Sharma, Ph.D., Research Scientist, DMPK
‘Fascination can be the seed for aspiration’. Since childhood, Rishi was always fascinated by the miracles of science and nature and curious to delve into the mysteries underlying. That fascination ultimately led him to pursue a career in scientific research, which is overwhelmed with mysteries.

Rishi’s interest in exploring the scientific field led to his first job as a pharmaceutical sales representative. The position provided him with deep insight into the impact medicines can have in curing deadly diseases and gave him the opportunity to learn about pharmaceutical business tactics. Those experiences eventually motivated him to pursue a business degree in Marketing and Operations. After graduating, Rishi spent six years working for pharmaceutical companies before returning to graduate school to pursue his Ph.D. in Medicinal Chemistry and Drug Development from Northeastern University, Boston. During his time at graduate school, Rishi realized what it actually takes to develop a drug from bench to market. His knowledge of synthetic and medicinal chemistry aspects of drug development and background in pharmacology are what led to securing his latest position as a DMPK scientist at MicroConstants.

Throughout his career, Rishi has had the opportunity to witness several facets of the pharmaceutical industry including sales, marketing, clinical research, regulatory affairs, and research. Now, as a Research Scientist at MicroConstants, he will be responsible for conducting drug metabolism research projects including, metabolite identification, drug-drug interaction, enzyme inhibition and induction, and small molecule impurity identification studies.

When away from the office, Rishi can usually be found at home, but more specifically, in the kitchen area. He loves to cook Punjabi Indian cuisines and hopes to share a special dish with everyone at MicroConstants someday soon. He also has a passion for paragliding and plans to take lessons at Torrey Pines gliding port and work towards obtaining his gliding license. Rishi made the move from Boston to San Diego less than a month ago, so right now he's missing his wife who is currently visiting India before joining him in their new hometown.

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