Drug Manufacturers Seek Remote Control

As facilities of the future become more far-flung and distant from drug manufacturers’ home bases, and as outsourcing continues to increase, the challenge of monitoring varied and vast activities around the globe becomes greater. One obvious solution for this dilemma is to make use of remote videoconferencing capabilities. Videoconferencing has long been used in boardrooms and amongst researchers, and is gaining traction as a means of ensuring manufacturing consistency and quality worldwide.FDASmart Inc. is one solution provider banking on manufacturers’ need for greater, faster global oversight. Its SmartInspect system enables live, secure, Internet-based, mobile video transmissions between two locales. In other words, says founder and CEO Ram Balani, “complete global visibility without travel and without a boatload of money.” SmartInspect has garnered interest from Pfizer, which is testing the system for various purposes—assisting technology transfer, performing quality audits remotely, and for remote training. The company has experimented with using the system for API screening at sites in China, for instance, notes Balani. Whereas Pfizer might typically send three people abroad for a lengthy trip to perform such screening, it could potentially do the entire task via videoconference, Balani notes.Bristol-Myers Squibb is also doing Proof of Concept testing of SmartInspect to facilitate tech transfer for biologics—for knowledge transfer of complex information between Syracuse, New York, and, for example, a contract manufacturer such as Celltrion in South Korea.“Having a direct link to our plants and subject matter experts around the world is obviously advantageous,” says Kirk Leister, director of new technology for BMS. Leister’s job is to go out and find technological innovations that can facilitate development and manufacturing.Leister uses the example of having spent two months trying to troubleshoot a peptide map in a Korean facility, eventually sending an expert to the site, only to find out that the problem was related to a fairly simple setting. Being able to set up and operate instrumentation via mobile video would have made a significant difference, he says.SmartInspect users pay a $24,000 fee upfront for the equipment and software, and may sign up for a maintenance contract as well. While BMS and Pfizer have shown interest, Balani envisions his technology being used more by small and mid-size companies with limited resources, and by clinical trial teams.