Synopsis: 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. Bio: Dr. Gerardo Gomez has more than 25 years of experience in the Pharmaceutical and Biotechnology...

Synopsis: 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 Larcier is Senior Director at...

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. Involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided Quality,...

Synopsis: 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. Bio: Olena Chervonenko is...

Bio: Michael Braun-Boghos 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. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle with the Relsys acquisition in 2009. As a senior director in the safety strategy team, he helps drive the product roadmap of the Oracle...

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...

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. Guests’ bio: John Lockwood is Senior...

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. An expert in global drug development, Alex Klein has over 15...

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. Bio: Dr. Jürgen Hönig is Senior Director, Regulatory...

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. Bios: Monica Buchberger is senior director of pharmacovigilance at...

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.  Bio: Jim Horstmann is Product Manager of Clinical Products at Phlexglobal where he draws on his extensive experience in document management solutions...

Summary: 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. Speaker: Keely So is Manager, Medical Devices / IVD at PharmaLex, leveraging her extensive knowledge of the regulatory requirements in Australia, Europe, New Zealand, the USA, Canada and Asia to help clients with new...

Summary: A lot of statistical work within pharmaceutical companies is repetitive and this costs money and resources, especially if it’s done within GxP environments where there is often a need for double programming, extensive data quality control and meticulous follow-up of procedures. The podcast explores requirements and ways  to  develop fully automated solutions and processes to address this repetition and improve overall business efficiency. Speaker: Davor Josipovic is senior manager...

A strong quality culture in the biopharmaceutical industry is one in which all participants in the organization understand patient safety and how their roles impact patient safety risks. It is one where decisions are prioritized based on patient safety first. From a GMP perspective, that means not only abiding by the formal law but knowing the applicable current best practices, understanding the risks a company’s processes and products pose to patients and implementing effective quality risk...

There are unique considerations and nuances to the US Food and Drug Administration’s (FDA) pre-submission process for medical devices that companies need to consider. Known as the Q-submission (Q-sub) program, these pathways are a way of communicating with the regulator to obtain their feedback on particular topics that are germane to both the manufacturer and the regulator. About the speaker: Mohammad Asad is the Regional Sales Manager – Asia Pacific at PharmaLex, where he draws on his...

With pharmaceutical companies increasingly turning to outsourcing partners to support maintenance of marketed products, efficiency and reliability are imperative. Digitalization, in particular automation and AI, plays an integral role in streamlining processes and enhancing that outsourcing relationship. Timm Pauli is Vice President and head of R&D informatics at PharmaLex, where he combines his informatics and systems expertise with his experience in the pharmaceutical industry. Timm...

This podcast introduces the concept of strategic product development as part of an integrated strategy to bring new drugs to the patients that need them. This holistic approach helps to save time, reduce overall development costs, and identify and mitigate risk throughout the product lifecycle. 

Introduction: The ICH-Q2 and ICH-Q14 together describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products. But what is it that defines the quality of a reportable value? The podcast explores how Bayesian statistics makes it possible to take an observation made during the validation of the analytical procedure and predict the uncertainty around any future result, and in so doing bridge the gaps that exist...

Brad Carlin is a statistical researcher, methodologist, consultant, and instructor.  He currently serves as Senior Advisor for Data Science and Statistics at PharmaLex, an international pharmaceutical consulting firm.  Prior to this, he spent 27 years on the faculty of the Division of Biostatistics at the University of Minnesota School of Public Health, serving as division head for 7 of those years.  He has also held visiting positions at Carnegie Mellon University, Medical Research Council...

Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these responsibilities existed under the Medical Devices Directive, workload will be impacted. From requirements around Eudamed, to having a person responsible for regulatory compliance, to ensuring certain obligations are properly followed through to complaint management, the roles of all economic...

The next frontier in outsourcing is the management of established marketed products, which provide the opportunity to sustain revenue, keep maintenance costs low and ensure compliance of mature products.

A recent survey of senior pharmaceutical and biotech executives explores why IPD programs are becoming an increasingly important strategy to successfully bring a new drug to market.  To find out more, we speak with Frédéric Pailloux, Senior Director, Head of Integrated Product Development & Consulting, at PharmaLex.

Classification and regulation around medical device software has become more complex, and in recent years most regulatory authorities have tightened the regulatory pathways. The podcast explores software differences and how these impact regulator classifications in various markets. It also looks at key considerations for managing the oversight of these products, in particular with regards to a quality management system. Yervant Chijian, Director, Team Lead Medical Devices / IVD,...

Some major changes have been outlined in the EU Annex 1 Revision. Listen to PharmaLex expert Patrick Nieuwenhuizen on how the industry can implement the new Annex 1.