In this podcast, Gerardo Gomez talks about the interactions between validation and technology transfer, considering the views and expectations of the regulators. As Gerardo explains, technology transfer is really a very sophisticated and complex project management activity and therefore needs to be carefully planned to avoid discrepancies or deviations from the regulations.
Early access programs are designed to allow patients suffering from a life-threatening unmet medical need or disease to be given promising treatments that have not yet received marketing approval. Examples of these types of programs include named patient programs, which are for a specific patient suffering from a rare, ultra-rare or life-threatening disease, and cohort programs, where patients with the same disease have been identified.
Bio Patrick Nieuwenhuizen: Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Fill Finish and Solid Oral Dose.
Technology transfer involves two main types: scale-up and transfer to a different site. Scale-up technology transfer involves moving a technology or process from a laboratory or pilot-scale environment to a larger production scale. Transfer to a different site involves relocating a technology or process from one location or organization to another. Listen to the podcast to learn more about technology transfer and important considerations for success.
Michael has been working in medicinal product safety for the last three decades. He spent 13 years at the European PV headquarters of Fujisawa, which later became Astellas, ultimately leading the Safety Data and Quality Management group.
Cheryl James has worked at a senior level within the pharmaceutical industry for over 15 years, building extensive business knowledge and implementation experience with the Oracle Life Sciences suite, specifically AERS and now Argus Safety.
Market access can be a big hurdle for companies to overcome and might require a different approach to the process of gathering evidence to support reimbursement discussions. Early phase modeling can help to inform feasibility of future adoption, the product development program, support investor communication, and sometimes even to inform decisions on whether to pursue product development or not. The podcast explores early phase modeling, what it is and why it’s becoming a key component in reimbursement and patient access.
Combination products offer unique advantages in terms of delivering improved therapeutic outcomes or enhanced patient convenience. Typically, combination products are understood to be a drug-device or biologic-device combination. The regulatory strategy as to which center at the FDA has jurisdiction over product approval depends on their primary mode of action. Listen to the podcast to learn more about combination products and how they are regulated.
Companies often fall into common traps in early-stage product development. These range from interactions with the regulators to their ability to manufacture their product. Forward planning is crucial, but all too often smaller companies lack the regulatory, business development or marketing expertise needed to support this way of thinking. The podcast explores some of the pitfalls companies can fall into and ways to avoid them.
The pharmaceutical industry has been globalizing for many years as demand for medicinal products grows and as companies look to expand into the large and increasingly prosperous emerging markets. The impact of rapid globalization is that the industry is dealing with complex and ever-changing regulations and government policies that can vary across jurisdictions. The podcast explores the opportunities and challenges of globalization.
For US-based companies seeking to market their product in the EU, it can be a struggle to navigate a different market, and, in particular, to manage requirements from a safety reporting perspective. The podcast explores the challenges faced managing not only the European pharmacovigilance legislation but also dealing with each EU Member State, which can implement these requirements in their own way at the national level.
Artificial intelligence is playing an increasingly important role in document management in the life sciences industry and in particular in improving management and oversight of the Trial Master File (TMF). The podcast explores why and how AI is a gamechanger for the TMF and what it means for pharmaceutical companies now and in the future.
IVD manufacturers must perform two types of performance studies, clinical performance and analytical performance, in order to provide evidence that the device is safe and performs as intended. While both have always been required, IVDR is a lot more prescriptive.