TransCelerate calls out pharmacovigilance operational challenges
TransCelerate BioPharma has added Pharmacovigilance to its portfolio, establishing two new global initiatives: 1.) Interpretation of Pharmacovigilance Regulations and 2.) Value of Safety Information Data Sources. Both initiatives aim to create solutions that will reduce resource inefficiencies, enhance information exchange with global health authorities and improve patient safety to drive more value for patients.
“As part of our strategic planning process, there was overwhelming support among thought leaders for TransCelerate to leverage its highly collaborative approach to the escalating inefficiency in the pharmacovigilance space. We have an important and unique opportunity to collaborate with sponsors, regulators and others to ensure an absolute commitment to patient safety while substantially improving operational efficiency for all stakeholders,” said Dalvir Gill, Ph.D., chief executive officer, TransCelerate BioPharma.
The Interpretation of Pharmacovigilance Regulations Initiative will share expertise to more efficiently and effectively meet the intent of those requirements that seem ambiguous. The initial focus will be recent measures such as IND reporting requirements, but over time the initiative hopes to work proactively with regulators toward modernized and internationally harmonized pharmacovigilance.
The Value of Safety Information Data Sources Initiative will prioritize sources of safety information for single high-value valid cases and develop a plan to aggregate reporting of lower value cases. The Initiative will share a proposal with global health authorities.
“Improving the interpretation and implementation of global pharmacovigilance requirements across the industry will improve the collection, reporting, and assessment of adverse events so that we can better monitor the safety of marketed medicines,” said Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research (CDER) at the FDA.
Historically, pharmacovigilance has been viewed within the industry as a time-consuming challenge, suffering from misalignment on industry approaches regarding regulations and compliance issues, as well as synthesizing and prioritizing information. Sponsors collect and report on significant amounts of data, while regulators are inundated with the ever-growing volume of information collected and reported.
“TransCelerate’s commitment to the patient experience during and after a clinical trial is shared among the Member Companies and within the drug development ecosystem,” states José Vega, M.D., chief safety officer at Merck and executive sponsor of the new TransCelerate Pharmacovigilance Initiatives. “Through these global pharmacovigilance initiatives, we seek to identify solutions that can lead to the development of best practices for the collecting, triaging and reporting of high quality safety information to help further improve patient safety across the industry.”