Tenured Drug Safety Team Reflects on Industry Changes

UBC's drug safety team shares experience and insights

Tenured Drug Safety Team Reflects on Industry Changes

At UBC, we believe experience matters, and the combined experience of leaders in our Safety, Epidemiology, Registries and Risk Management (SERRM) team adds up to an impressive collection of knowledge and hard-earned expertise.  Under the leadership of Annette Stemhagen, DrPH, FISPE, Senior Vice President, SERRM, the team specializes in the design, implementation, and analysis of epidemiologic studies, registries, large streamlined safety studies, and observational studies of real-world use for products.

Based on years of education, research and study design and management, this team has become proficient in creating and guiding safety programs for medicine and medical devices. We asked the team to take a look back at what has changed in their work over the past 15 years.  By recognizing important changes taking place, the team is helping to provide our clients with key solutions for the challenges ahead in the pharmaceutical industry.


It’s all about technology! One of the biggest changes in the biopharmaceutical industry in the past 15 years has been the increased availability of automated tools and data accessibility that allow for more efficient signal detection and risk assessment.  These changes have allowed pharma to become more proactive in identifying and evaluating safety issues, in refining signals, in comparing risks across different populations and regions, and in some instances in evaluating whether safety measures that have been implemented have resulted in reduced risk.

Gretchen Dieck, PhD, Vice President, SERRM

 


Looking back over the last several years, there have been significant changes to European regulations. In the EU, the Pharmacovigilance legislation, which came into effect in July 2012, included the requirement to submit a Risk Management Plan (RMP) for all new products in order to define the risk profile of the product, to proactively plan safety data collection and proactively plan risk minimisation. The legislation also strengthened the legal basis for regulators to request the Market Authorisation Holder to conduct a post authorisation safety study (PASS).  As a result, more PASS studies are being performed, more risk minimisation tools are being developed. And, I believe changes will continue to occur as methodologies to assess the effectiveness of the risk minimisation activities are evolving.

Janine Collins, MBBS, LLM, Sr. Director, EU Risk Management


The most transformational change over my career as an epidemiologist in the pharmaceutical and biotech industry has been the increased focus by regulatory agencies on drug safety and the management of risks associated with medicines.

In the early years of our industry, the role of epidemiology was primarily focused on safety.  However, there came a time when it was recognized that epidemiology could add value to other areas of the organization, e.g. clinical development, health economics/outcomes, medical affairs, and marketing. The regulatory focus is now turning to risk management. The role of the epidemiologist is once again key to drug safety but its value across many disciplines is now fully established. 

Haley Kaplowitz, PhD, Executive Director, SERRM


Data gained from post-marketing studies have moved from a “nice to know” to “must have.” Clinical development and product safety have greatly expanded beyond Phase III. New regulatory authority requires studies to assess known risks or signals of serious risks in the marketplace, resulting in an increased volume of studies and data as well as in a greatly improved understanding of the health effects of products in real world settings.  This public health orientation acknowledges the truth that benefit-risk is best assessed not solely in Phases I-III, but through studies of use and effects in larger patient populations.

Catherine Sigler, PhD, Executive Director, SERRM

 


The major change in the pharmaceutical world in the past 15 years has been in pharmacovigilance with new regulations requiring risk management.  Regulatory agencies expect pharmaceutical companies to be increasingly transparent and proactive in monitoring product safety, and focused on important identified risks, potential risks and missing information.  Many companies are choosing to monitor the safety profile of their products by doing signal detection in large databases containing spontaneous post marketing safety reports and by doing signal detection and evaluation in large electronic claims or medical record databases.

Robert Sharrar, MD, Executive Director, SERRM

 


Interested in learning more how our team can provide safety solutions for your product and patients?  Please contact us.

You also can learn more from our experts who have contributed to the webinars and whitepapers linked below:

Webinar: Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women – Catherine Sigler, PhD, Executive Director, SERRM

Whitepaper: Post-Authorisation Non-interventional Prospective Observational Safety Studies: Protocol Considerations – Janine Collins, MBBS, LLM, Sr. Director, EU Risk Management

Webinar: Evaluating the Effectiveness of Risk Management Plans in Europe – Janine Collins, MBBS, LLM, Sr. Director, EU Risk Management

100 REMS Programs and Counting – Lessons Learned – Annette Stemhagen, DrPH, FISPE, Senior  Vice President, SERRM