JULY - 202119TECH OUTLOOKEffective Pharmacovigilance Driven by Infrastructure Integration, Cross-Functional Collaboration and Technological AdvancementBy Heather Stein, MD, MPH, Vice President, Drug Safety and Pharmacovigilance, Boston Biomedical, Inc., and Amie Goulbourne, MPH, MT(ASCP),Senior Director, Head of Pharmacovigilance Operations, Compliance and Training, Boston Biomedical, Inc.Pharmacovigilance (PV) is a critical component in ensuring that patient safety and well-being are maintained throughout the drug development and post-marketing life cycle. In addition, pharmaceutical companies must ensure compliance with all PV regulations while responding to the changing needs of their development pipeline. As programs advance through the phases of clinical development, or even as decisions are made to cease the development of a drug, PV departments must be able to respond rapidly to the shifting demands of its portfolio, including increased data complexity, additional regulatory requirements and a greater variety of patient populations. Boston Biomedical, Inc., a developer of novel cancer therapeutics to significantly improve patient outcomes, reached a pivotal point in 2018 with its clinical development program quickly expanding into various phases. After initiating multiple phase 1 studies, as well as continuing to progress a phase 3 clinical program, we recognized the need to rapidly scale up the company's PV capabilities to accommodate our growing pipeline, increased patient population, and a more complex global footprint.The expansion of this infrastructure at Boston Biomedical proved to be a challenging process, as our PV team works in collaboration across three companies: Sumitomo Dainippon Pharma Co., Ltd.--Boston Biomedical's parent company, Tolero Pharmaceuticals, Inc.--Boston Biomedical's affiliate and a wholly-owned subsidiary of Sumitomo Dainippon Pharma, and Boston Biomedical itself. We coordinate PV monitoring for investigational assets originating from all three companies and collaborate to share data and safety findings with them. Furthermore, we're committed to working with and supporting PV operational initiatives of a fourth group company, Sunovion Pharmaceuticals Inc., a wholly-owned subsidiary of Sumitomo Dainippon Pharma.The disease category of these assets--oncology--provided an added layer of complexity to our company's PV efforts. Compared to other therapeutic areas, intensive monitoring of oncology studies is complicated because of the severity of the disease and the potential toxicity of treatments. It can be Collaboration across pharmaceutical companies is becoming increasingly important due to the high number of agreements, mergers, and acquisitionsCXO INSIGHTS
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