Industry leaders will gather next week in Miami to network and share new advancements within our field at CHI’s Summit for Clinical Ops Executives (SCOPE). UBC is slated to present on a variety of topics spanning enrollment planning and patient recruitment, managing outsourced clinical trials, and leveraging real-world data in clinical and observational research.
Join us from 10 - 11 a.m. EST Thursday, November 17, for a complimentary webinar as our team shares their experience with selecting the right study design to address diverse evidence needs.
Biosimilar agents are similar but non-identical versions of existing biological drugs and may be authorized for use once the patent on the reference product has expired. Based on a recent market forecast of IMS, biosimilars are forecasted to deliver total savings of as much as $110 billion to health systems across Europe and the U.S. through 2020.
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 21st Annual International Meeting, conducted May 21-25, 2-16, in Washington, DC, industry professionals convened to delve into the topic “Value, Affordability, and Patient Centeredness: Can We Have it All?” UBC’s Value Demonstration experts joined the conversation with five abstracts highlighting some of their recentresearch.
A recent report from the Pharmacovigilance and Risk Assessment Committee (PRAC) found that in the 200+ study protocols reviewed, nearly half suffered from study design flaws. Don’t let methodological issues stall approval of your next Post-Authorisation Safety Study (PASS).
As the year winds down and planning for next year ramps up, PharmaVoice editors interviewed industry leaders about mega trends that will impact the life science industry over the next five to 10 years. The recent issue looks at trends ranging from disruptive technology to healthcare consumerism. Two UBC experts added their thought leadership to the mix.
Many sponsors utilize registries and observational studies when gathering real-world evidence in the post-marketing environment. When designing and implementing these effectively, the technological platforms supporting should not go unnoticed. There are a number of considerations that can help ensure success with your implementation. To help you navigate, we put together a two-part blog detailing what sponsors should keep in mind when designing platforms for their registries and observational studies.
Unlike controlled studies, observational studies have the potential to collect data on thousands – even millions – of patients. Increasingly, manufacturers are asked for information and data that only these kinds of studies can provide.
Observational studies can be used to help manufacturers and their stakeholders understand the clinical, patient-centered, and economic burden of disease, as well as the value of different treatments in reducing that burden.
Last week, more than 100 senior Late Phase pharmaceutical professionals and key opinion leaders representing Medical and Scientific Affairs, Health Economics and Outcomes Research, Safety and Risk Management, Regulatory, Market Access and Drug Reimbursement met in Berlin, Germany, at the Third Annual Medical Affairs Leaders Forum.
Dr. Annette Stemhagen, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, and Dr. Robert Sharrar, Executive Director, Safety, Epidemiology, Registries and Risk Management, led an informative tutorial on pharmacoepidemiology this week at the DIA Pharmacovigilance and Risk Management conference.