Rob Wright, Chief Editor of Life Science Leader Magazine, interviews Larry Stambaugh, President and CEO of Cryoport, a life sciences global frozen logistics provider. Stambaugh discusses regulatory challenges facing the cold chain shipping, sample degradation, improper storage, and transportation. The increased emphasis on regulating the cold chain is being driven by the trend of companies moving their clinical trials to emerging market countries. Stambaugh lists a variety of agencies involved in setting cold chain standards, including the FDA, FAA, USP, FCC, DOT, PDA, and IATA. Because of the wide variety of organizations and associations involved in setting cold chain shipping standards, it can be very difficult to stay abreast of regulatory changes.
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Length: 10 min, 24 sec
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