This post is sponsored by DIA.
It Starts with Pregnancy Registries and a Look at the Data
Women around the world ask themselves every day whether the risk of taking their medications during pregnancy is worth it. Unfortunately, there is not a lot of information available to help them make informed decisions. Many rely on the knowledge of their health care practitioners, but even they are in need of more and better data to make decisions about the relative benefit vs. risk of medications taken during pregnancy.
“Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women, ” a panel discussion taking place at the DIA 2015 51st Annual Meeting, will explore the challenges of conducting postmarketing studies in pregnant women and offer perspective from industry and regulatory experts from the United States and Europe.
DIA has long focused on the issue of drug safety in pregnancy. In fact, the organization began in the 1960s, as the world was horrified by findings in multiple countries that a morning sickness drug, Thalidomide, was found to cause birth defects. In response, the U.S. Congress passed sweeping legislation that set the threshold for safety and efficacy requirements for drug product approval. This set 30 driven pharmaceutical and research professionals on a mission, and DIA was born out of this desire to protect the safety of patients while also working to improve health through the advancement of lifesaving medicines and technologies.
Today, pharmaceutical companies engage in extensive postmarketing research to determine the safety of their drugs in pregnancy. Pregnancy registries offer some of the best opportunities to track and study the use of prescriptions during pregnancy; however, getting the relevant information can be challenging.
Other study designs may complement data collected in pregnancy registries.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The panel at DIA 2015 51st Annual Meeting will explore innovative approaches to collecting pregnancy safety data in the postmarketing setting. Key messages from FDA’s 2014 public meeting on “Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting” will be reviewed. Regulatory experts from the United States and Europe and industry will participate in a panel discussion about the current thinking and experience on the approaches to postmarketing data collection in pregnant women.
Leyla Sahin, MD, Medical Officer, Division of Pediatric and Maternal Health, OND, CDER, FDA, will chair the session. Panelists include Catherine Sigler, DVM, PhD, MPH, Senior Director, Safety, Epidemiology, Registries and Risk Management, UBC: An Express Scripts Company; Melissa S. Tassinari, PhD, Senior Clinical Advisor, Division of Pediatric and Maternal Health, OND, CDER, FDA; and, Kevin Blake, PhD, National Expert on Secondment Pharmacovigilance and Risk Management, European Medicines Agency.
The session, “Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women,” will take place on June 17 from 3:30-5:00 pm ET. The DIA 2015 51st Annual Meeting brings together a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies. This year’s event offers more than 245 educational offerings over 20 tracks, 450+ exhibiting companies, and more than 125 representatives from global regulatory agencies. The meeting provides participants with a valuable opportunity to network with professionals from around the world, share knowledge, and build new relationships.
Register for DIA 2015 51st Annual Meeting and join the conversation on Twitter @DrugInfoAssn using #DIA2015.
