How Small Pharma, Working Within a Global Pharma, Can Benefit From One Pharmacovigilance System

Mai Huang, M.D., Executive Director, Drug Safety and Pharmacovigilance, Avanir Pharmaceuticals (NASDAQ : AVNR)

At Avanir Pharmaceuticals, safety is our number one priority. We are committed to delivering innovative Central Nervous System (CNS) solutions that help improve the lives of patients and their care communities. To achieve our mission, it’s vital to maintain a diligent, robust, and resourceful pharmacovigilance system. As a subsidiary of global healthcare company Otsuka Pharmaceutical Co., Ltd., we are able to draw upon global resources and expertise to enhance drug safety. While many pharmaceutical companies choose to outsource the development of their pharmacovigilance systems, Avanir's position in the Otsuka family of companies enables us to leverage shared knowledge and resources that can help enhance our drug[1]safety vigilance system.

Whether small or large, drug development companies should always utilize every resource at their disposal to bring safe drugs to market. If your company happens to be part of a larger organization, you may find that you have more tools, resources, and expertise available to you than initially thought. I’d like to share a few ways we’ve been able to take advantage of the global resources and tools to better ensure the safety of the patients we serve.

SHARED DATABASE

Pharmacovigilance is more than a functional area—it’s a system that enables the pharmaceutical company to draw safety data from a variety of channels, both internal and external to the organization. These channels include patients, physicians, manufacturers, and service providers, among others. To ensure a robust pharmacovigilance system, companies must maintain a solid pharmacovigilance master file (PSMF) and adhere to their responsibilities. Avanir's position within the Otsuka family enables Avanir’s PSMF to synchronize with Otsuka’s pharmacovigilance master file.

Because of its relationship with Otsuka, Avanir has access to a well-established pharmacovigilance database as well as a number of health agencies’ safety monitoring databases. This allows Avanir to apply statistical methodology, in addition to Individual Case Safety Report (ICSR) review, for “signal detection,” which helps develop more accurate and complete assessments of the product safety profile.

SHARED TECHNOLOGIES

I can’t leave out mentioning the abundance of shared technologies across our global network. Avanir also has access to Otsuka’s innovative technologies and safety intelligence tools. These technologies and tools include automated data reconciliation, automated aggregate report generation, literature screening, advanced safety data analytical solutions, state-of-the-art data mining algorithms and statistical techniques for detecting, and analyzing and managing safety signals.

“Whether small or large, drug development companies should always utilize every resource at their disposal to bring safe drugs to market”

SHARED EXPERIENCE

While the availability of databases and analytical tools helps develop more efficient pharmacovigilance functionality for both clinical investigations and post-market commercialization, collective medical judgment must always be the core driver of decision making when it comes to safety. Being part of a global pharmaceutical family also grants Avanir access to the wealth of experience our sister companies have to offer. Companies like Otsuka U.S. are able to offer both their pharmacovigilance expertise as well as their global intelligence. At Avanir, we’re also proud to bring our own central nervous system experience and expertise to Otsuka. Sometimes we learn, and sometimes we teach, but together we grow and learn from our shared experiences.

DRUG SAFETY REMAINS NUMBER ONE

Pharmacovigilance is essential both to bringing a safe drug to market and for maintaining an effective safety compliance program. As a small pharmaceutical company working within a larger global pharmaceutical organization, Avanir is able to operate under one harmonized pharmacovigilance system by sharing resources and experience, all in focus on our number one priority–drug safety.