Advanced therapies such as cell and gene therapies and regenerative medicine offer ground-breaking treatment for many diseases that could not be adequately treated previously. In the European Union, for example, advanced therapies for conditions such as prostate cancer and cartilage regeneration have been recently approved. Regulations governing these products, however, vary greatly by health authorities across the globe. Gopalan Narayanan, MD, Biologics and Advanced Therapies Expert at UK-based NDA Group, is chairing a session related to this topic at DIA’s upcoming 51st Annual Meeting in Washington, where speakers will examine the regulatory requirements and classification issues specific to advanced therapy products.
Narayanan recently shared his thoughts with Pharm Exec on the regulatory environment today in Europe and elsewhere for advanced therapies, the progress in advancing regulatory science for these products, and the struggle, at the same time, in translating that to more approved treatments in this area. He also comments on the conditional marketing approval experiment underway in one country and its potential implications.
Trends to Watch in Patient-first Pharma Marketing
May 10th 2022As healthcare increasingly shifts to digital, new pharma marketing and patient engagement trends are emerging at the forefront of care. In this podcast, Phreesia Life Sciences and Pharmaceutical Executive discuss how technology is changing healthcare consumers’ expectations and helping to create more personalized experiences focused on connecting the right patients to the right content, care and resources.
Patients Outcomes Impact (POI™): The Evolution of Measuring Patient-Centered Investment
January 17th 2024Michael Shaw, JD, and Sharon Suchotliff, MPH, from ZS, discuss why measuring impact through a patient-centric lens is a business imperative for life sciences companies. They explore key considerations for a key challenge when thinking about impact for patients in the real world- the compliant measurement of non-promotional activities, results from an early ZS proof of concept to determine Patient Outcomes Impact (POI™) metrics, and discuss what you can do today to advance POI™ at your organization.
Balancing Costs and Data Integrity: Maximizing ROI with Lab Software Solutions
December 21st 2023Explore the implementation of enterprise laboratory software and the start of a digital transformation in your lab with an industry expert who discusses maximizing returns on investment, upholding data integrity while managing cost containment, and adopting digital best practices. This podcast addresses critical topics such as cybersecurity, regulatory compliance and fiscal strategy for pharmaceutical labs and offers valuable insights for professionals at the crossroads of technology, finance, and pharmaceutical regulations. Discover how laboratories can use software solutions to surpass industry standards while managing costs with Bob Voelkner, Vice President, Sales and Marketing, LabVantage Solutions, Inc.
Thought Leader Engagement Planning
October 29th 2021Understand the value of involving thought leaders in engagement planning and learn why it is important to the strategy of a product’s lifecycle. IQVIA offers a customizable cloud-based platform to facilitate Thought Leader Engagement Planning & Tracking with coordinated next-generation customer engagement across all channels.