Safety Signals

When Drugs and Devices Come Together, Safety Considerations Get More Complex. Dr. Khaudeja Bano, Vice President Combination Product Quality at Amgen, joined the Safety Signals Podcast to discuss the unique safety challenges posed by products that include both drugs and devices. In this episode of Safety Signals, Dr. Bano talks about: The different safety approaches in the drug and device worlds Supporting women in clinical research Why safety and quality organizations need to speak the same language   “The word ‘signal' means nothing to my quality peers and the word ‘trend' means nothing to my safety peers,” Dr. Bano says. “So some of our growing pains are around truly bringing the cross-functional team together to start speaking the same language.” To hear more from Safety Signals, check us out on Apple Podcasts, Spotify, or on our website.  Listening on a desktop and can't see the links? Just search for Safety Signals on your favorite podcast player. The views of the hosts and guests featured on Safety Signals are their own and do not necessarily reflect the views of Saama or the individual companies for which the guests may work.

More than Just Paper Shuffling and Regulations Dr. Yvonne Nanciu, Country Head Pharmacovigilance Germany at Bayer Pharmaceuticals, joined the Safety Signals Podcast to explain how pharmacovigilance can be a rich and rewarding field. The lively discussion covered a far-reaching variety of topics, including: The importance of having practitioners with diverse backgrounds The need for predictive analytics Ways to improve patient centricity    Dr. Nanciu, who also lectures on pharmacovigilance at universities throughout Germany, tells her students that “pharmacovigilance is like medicine on paper. So you have your patients, you have their adverse event reports, you have their entire history, diagnostic, lab values, disease, evolution, and you can see their evolution through a disease.” To hear more from Safety Signals, check us out on Apple Podcasts, Spotify, or on our website. Listening on a desktop and can't see the links? Just search for Safety Signals on your favorite podcast player. The views of the hosts and guests featured on Safety Signals are their own and do not necessarily reflect the views of Saama or the individual companies for which the guests may work.

Small Patient Populations Pose Unique Challenges for Safety Scientists “These are diseases that are not often taught in medical school,” said Peter Hawkins, Senior Director, Head of Rare Genetic Disease Risk Management at Agios Pharmaceuticals, about the types of diseases he and his team are working to cure. Mr. Hawkins joined the Safety Signals Podcast for a discussion on the specific safety challenges faced by sponsors developing medicines for very small patient populations. The episode covered a wide variety of topics, including: The importance of real-world data in understanding rare disease patients The need to look at quality of life metrics Reasons why safety scientists should actively participate in clinical trial design    With limited data available, Hawkins acknowledged that he and his team look at any information they can get to understand what patients are going through, and whether or not new safety signals are from a drug they're studying, from the disease, or something else, such as comorbidities. “Understanding the whole world this patient lives in is essential to making sure that the patient makes the right decision,” he said. The views of the hosts and guests featured on Safety Signals are their own and do not necessarily reflect the views of Saama or the individual companies for which the guests may work.

Emerging Professionals Must Understand Data Science and AI “The number one priority that I have at the moment is thinking about the PV professional of the future,” said Richard Wolf, Head of Pv Operations at CSL Behring. He joined the Safety Signals podcast for a lively discussion about improving pharmacovigilance operations through technological innovation. In this episode of Safety Signals, we discuss: Why adverse event awareness is pushing PV operations to run more efficiently How pharmacovigilance will change in the next five years The importance of collaboration among regulators and sponsors    Focusing on a three-to-five-year time horizon, Mr. Wolf is optimistic about the future. “I'm expecting good things because I've seen a lot more collaboration…on the challenges that need to be overcome,” he said.

Today's data explosion is forcing pharmacovigilance professionals to use artificial intelligence technologies to get answers in a more proactive way. “Just putting 100 more people in a room and trying to look at documents and bounce ideas off of each other's head isn't going to work anymore,” says Bruce Donzanti, former Senior Group Director, Global Regulatory Pharmacovigilance Innovation Policy at Genentech. Donzanti joins the podcast for a lively discussion about the evolution of pharmacovigilance and how pharma companies and health authorities are working together to advance the future of safety science. In this episode of Safety Signals, we discuss: How AI has become a necessity, not just a nice-to-have How human biases have plagued the industry for decades The quest for rapid access to quality data

What Does Drug Safety Mean from the Patient's Perspective? Rakesh Raman, M.D., Senior Director, Head of Medical Safety at REVOLUTION Medicines, joined the Safety Signals Podcast when he was in a similar position at Mirum Pharmaceuticals for a lively discussion about the importance of knowing everything possible about how a drug impacts a patient's lifestyle. In this episode of Safety Signals, we cover a variety of topics, such as: How focusing on improved signal detection, drug class comparisons, and natural disease history can provide a fuller picture of drug safety Why it's important to analyze data in terms of how it impacts a patient's life and provide patients with management guidelines for dealing with potential side effects Techniques for working with regulators as partners, not police  According to Dr. Raman, “if the motivation is always on doing what's right and best for your patients, it sort of triggers that level of creativity and ambition to go and find the best possible sources and tools to be able to do our jobs the best that we can.”

While individual case reports will always have an important role to play in ensuring drug safety, pharmacovigilance professionals are moving towards an aggregate analysis of real-world data in their effort to understand how drugs and vaccines affect patients. This “is a huge shift for pharmacovigilance,” asserts Stewart Geary, MD, Chief Medical Officer at Eisai Co., Ltd. Dr. Geary joins the podcast for a dynamic discussion about gaining a more holistic view of drug safety in both the clinical development and post marketing environments. In this episode of Safety Signals, we discuss: New requirements and techniques for looking at the complete data picture How media can influence adverse event reporting Why scientists need to know what they want from their data before they analyze it Why pharmacovigilance professionals must work with technologists to understand what new tools can really do

Introducing Safety Signals, the show for pharmacovigilance professionals, benefit risk managers, epidemiologists, and other patient safety stakeholders. From pharma leaders to academics and scientists, we provide expert perspectives on the challenges, opportunities, and technologies that are shaping the future of the safety sciences. Get ready to be inspired and energized as you work to reduce the risk of life-changing--and life SAVING--medical treatments.