Heather Stein, MD, MPH, Vice President, Drug Safety and Pharmacovigilance, Boston Biomedical, Inc., and 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 challenging to distinguish drug-related events from the effects of the underlying disease, prior treatments, or concomitant therapies, especially given the widespread use of combination regimens in oncology.

To address these challenges, the PV team at Boston Biomedical identified and implemented three strategic priorities to augment our PV processes.

Integrate infrastructure across companies

To address the complexities of monitoring patient safety of assets originating from multiple companies and to enhance their global safety data platform, we took a collaborative approach by migrating our safety data into Sumitomo Dainippon Pharma’s global safety database. The utilization of this advanced, integrated platform enabled Boston Biomedical to simplify the steps in the information-sharing process and improve data exchange between the two entities. The operational integration of safety data in this shared reporting system removed procedural barriers between companies, bringing efficiencies to the processing, analysis, and interpretation ofthe data. Additionally, the utilization of this shared platform has enabled the companies to meet regulatory requirements in a more streamlined fashion.

With the integration of Boston Biomedical into the global safety database, we joined Sumitomo Dainippon Pharma and affiliate company Sunovion as part of the system support team. This arrangement has allowed the companies to maximize the utilization of shared capabilities, resources, and cost savings with vendors. It has also brought together the subject matter expertise from three companies, leading to innovative solutions as to how the database can be structured and managed to meet the needs of each organization.

Ensure close collaboration across departments

One of the critical elements to Boston Biomedical’s success is open communication between the PV department and other departments across the company. The PV team closely collaborates with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Data Management, Information Technology (IT), and other departments to ensure patient safety is interwoven into all the company’s efforts.

As part of Boston Biomedical’s safety governance, our PV team members lead cross-functional program-based meetings allowing for open dialogue with other departments to facilitate transparency and communication, keeping patient safety at the forefront. The PV team has also held company-wide meetings to educate those outsides of the function about the structure of the organization, the processes followed to ensure compliance, and the benefit/risk assessments performed on the company compounds. Finally, all employees routinely participate in training to ensure adherence to regulations and reporting requirements.

Prioritize exploration of technological innovation to yield new efficiencies

Innovation in technology holds the key to the future of PV. Our PV and IT teams work closely together with colleagues from Sumitomo Dainippon Pharma and Sunovion in assessing how to integrate new technologies such as automation, artificial intelligence, and machine learning into patient safety data processing and reporting. Additionally, Boston Biomedical PV is exploring ways to bring efficiencies to signal detection processes and the analysis/visualization of safety data.

Conclusions

Collaboration across pharmaceutical companies is becoming increasingly important due to the high number of agreements, mergers, and acquisitions. Boston Biomedical, its parent company, and group companies are examples of how relationships created through these types of arrangements can be utilized in the field of pharmacovigilance to streamline processes, improve compliance, and share knowledge.

The future is expected to bring new platforms that will accelerate drug development and bring innovative treatments to patients more quickly—and the PV department at Boston Biomedicalmust be prepared to adapt to these new technologies. As Boston Biomedical’s portfolio advances and the company moves toward commercialization, it is critical to be at the forefront of embracing innovative technologies. The PV team’s expertise and proven track record of scaling up capabilities demonstrate that the company is well-positioned to apply new tools to ensure patient safety, including in the post-marketing environment.