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Authors: Dr. Ayaskant Pany and Sorika Van Niekerk Read somewhere recently: “What is the biggest constraint for tuberculosis (TB) clinical trials? RESOURCES!” This is so true not only in the theoretical sense, but also in practice. From the microbiologic point of view, the TB organism itself is so challenging. Limited funding, manpower, technology, and outreach resources add to the challenge. The scarcity of accredited myco-bacteriological laboratories that are functionally efficient, technically competent, adherent to regulatory and biological safety requirements1 presents a practical constraint. Ideally such a laboratory needs to be within the same geographical location where the trials... Read More



My entire professional career, beginning from graduation from college, has been focused on fee-for-service analytical services supporting the pharmaceutical and drug development industry on a global basis. My first 13 years were focused on the Good Manufacturing Practice (GMP) analytical services realm supporting laboratory activities that enabled formulation development, finished product testing, manufacturing, and a multitude of regulatory compliant services in this area.  With this experience under my belt, I began to look for opportunities that allowed me to gain experience, expand my knowledge, and support drug development more broadly. My path to bioanalysis: Never afraid of... Read More


ADME , Bioanalytical Laboratories

Authors: Marc Edwards & Victor Weigman As we celebrate the efforts of so many researchers, providers, patients, and advocates on World Diabetes Day, we have much to be excited about today.  New discoveries are being made and new hope is being given to patients living with diabetes across the globe. However, this excitement is tempered by some very sobering statistics: Worldwide prevalence figures estimate that there were 415 million adults living with Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D) in 2015 and that by 2035, this number will have risen to 642 million, especially in middle and low income families.1  Diabetes affects 30 million children and adults in the US (1 in 11... Read More