In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. While it isn’t known whether 2024 might beat that record, it will surely be a busy year for the agency. Since January, the FDA has already signed off on more than a dozen novel drugs. Among these are Madrigal Pharmaceuticals’ resmetirom (branded Rezdiffra), which secured FDA approval in March for the treatment of nonalcoholic steatohepatitis (NASH) and sotatercept (commercial name Winrevair) for pulmonary hypertension (PAH). The agency is reviewing applications for several highly antici ..read more

Learn how to aggregate, integrate, standardize, manage and use clinical trial data from multiple sources. With seamless access to integrated data from different sources, you can provide your teams with a complete data management and quality experience. Understand how using AI to streamline workflows for multiple users to review real-time data can reduce timelines and risk and ensure safety. Key benefits: Increase speed to high-quality data, without increasing headcount Lower risk to the trial and help sites perform better Transform data for review/analysis in low/no-code experience Simplify d ..read more

In this episode, Ayesha spoke with Robert Barrow, CEO and Board Director at MindMed, a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The company is developing innovative psychedelic-based product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. Robert Barrow Chief Executive Officer and Board Director MindMed Mr. Barrow is an accomplished pharmaceutical executive and clinical pharmacologist with over a decade of experience leading drug develop ..read more

Heart failure, affecting over 64 million people worldwide, remains a formidable challenge in the medical community despite advancements in pharmacotherapy over the past decade. The prognosis for heart failure patients is disheartening, with a mere half surviving beyond five years post-diagnosis. This stark reality highlights the urgent need for novel heart failure management options, particularly for advanced stages of the disease. The economic impact is also staggering, with heart failure leading as the top cardiac diagnosis among Medicare patients, reinforcing the demand for innovative care ..read more

April marks not only the blossoming of spring and the onslaught of my allergies but also a pivotal moment for raising awareness and advocating for equitable healthcare access. National Minority Health Month, observed annually throughout April, serves to emphasize the recognition of the unique health challenges faced by minority communities. This month-long observance is not just a symbolic gesture; it’s a critical opportunity to take a deeper dive to open up dialogue and cast our focus on disparities, promote health equity and catalyze meaningful change. In 1914, Booker T. Washington, an Ameri ..read more

John K. Celebi, MBA President and Chief Executive Officer Sensei Biotherapeutics In this episode, Ayesha spoke with John K. Celebi, MBA, President & Chief Executive Officer, Sensei Biotherapeutics, a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients. Sensei Biotherapeutics specializes in creating conditionally active antibodies engineered to operate specifically within the acidic tumor microenvironment, enhancing the immune system’s ability to combat cancer. John Celebi, MBA, has over 25 years of experience ..read more

In this episode, Ayesha spoke with Howard Berman, PhD, Founder and CEO of Coya Therapeutics, a clinical-stage biotech company developing regulatory T cell (Treg) therapies targeting neurodegenerative, autoimmune and metabolic diseases. Dr. Berman founded Coya Therapeutics in 2021. Howard Berman, PhD Founder and CEO Coya Therapeutics Dr. Berman has over 18 years of entrepreneurial and industry experience working at the interplay of science and business. His experience offers him a unique combination of business acumen and scientific credibility with the ability to assess, quantify and bridge b ..read more

Approaches to help better understand the complexities of brain function are key to advancing the development of novel treatments for Alzheimer’s disease. In recent years, researchers have increasingly recognized the value of biomarkers in Alzheimer’s disease in several areas, including offering biological insights into the disease’s pathophysiology, developing diagnostic tools for earlier disease detection, monitoring disease progression and evaluating the efficacy of new treatments. The use of EEG (electroencephalography) biomarkers in Alzheimer’s disease represents a promising approach to un ..read more

In this episode, Ayesha spoke with Margaret Froh, President of the Métis Nation of Ontario (MNO), and a lawyer by training, about the importance of improving cancer screening among Métis communities in North America. Margaret Froh President Métis Nation of Ontario (MNO) The Métis are a distinct Indigenous people recognized in s.35 of Canada’s Constitution. Métis communities have their own shared customs, traditions and collective identities that are rooted in kinship, their special aboriginal relationship to the land and a distinctive Indigenous culture and way of life that persists to the pr ..read more

This episode features an interview with Bruce Culleton, MD, CEO, ProKidney, a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for chronic kidney disease. Prior to joining ProKidney in 2023, Dr. Culleton served as Vice President and General Manager at CVS Kidney Care and also worked in leadership roles at Becton Dickinson and Baxter healthcare. Before beginning his career in industry in 2007, Dr. Culleton was a Clinical Associate Professor in the Department of Medicine at the University of Calga ..read more