Welcome to Freyr’s Regulatory Radio - a series of podcasts for all things related to Life Sciences Regulatory. Our one-of-a-kind podcast series strives to simplify the complex positioning of pharmaceutical regulations through candid conversations with our experts.
In the upcoming season, we will discuss how a pharma organization anticipating the launch of their biological products in the Europe market can gain insights into the Regulatory requirements. This season’s episodes will further throw light on the international norms, CMC challenges, and key considerations for biosimilar development in the EU.
Introduction to Biologics and Biosimilars is the core of this episode. Our Regulatory experts will give an overview of the different Regulatory approval pathways for Biologics and Biosimilars in the EU. Additionally, they will discuss the significance and requirements of Regulatory submissions and scientific advice during the Regulatory processes.
Episode 2 will detail the various guidelines for biological product development and approval in the market. The reference guidelines discussed in the podcast will include the following:
Our Regulatory experts will share more details about the subsidiary guidelines to be referred by a pharma company for streamlining Biologics development.
Biological product development involves proper planning and experimentation. Comprehending the biological CMC requirements is one such critical aspect during its development. This episode will detail the specifications required during biologics/biosimilar development.
Our experts will also share insights on the steps involved in the characterization of biological products, expression systems, and related details.
Streamlined biologic product development involves proper Regulatory assessment and overcoming challenges encountered during the CMC development phase. This episode will discuss the challenges faced during complex biological product development.
Our experts will also share insights on the steps involved in the characterization of biological products, expression systems, and related details.
In the last episode of Freyr Regulatory Radio, Season 4, our experts discuss key considerations for Comparative Quality Studies for a proposed biosimilar product in the EU.
Furthermore, this episode throws light upon the criteria for the reference biological product and its evaluation.
Senior Vice President, Freyr
Michael has forty (40) years of experience in the industry. He has worked predominantly in CMC Regulatory functions for twenty-nine (29) years and another eleven (11) years in other scientific development roles (formulation development, analytical method development, and clinical trials supply) at Eli Lilly and Johnson & Johnson. His experience includes managing collaborations with Regulatory partner companies. With extensive experience, he is currently leading a range of Regulatory programs at Freyr.
Vice President, Staffing Leadership, Freyr
Wayne possesses over thirty (30) years of experience in the Talent Acquisition field. For the past decade, he has focused primarily on the Regulatory space. Additionally, Wayne has supported several external clients in the pharmaceutical and healthcare arena. He has worked closely with Michael for the past few years, supporting Freyr's growth in the CMC domain. He is currently leading the staffing team at Freyr.
Director, Americas Business Development
Ester is a Director at Freyr with over twenty (20) years of work experience. She is a skilled collaborator with more than six (06) years of expertise supporting the Life Sciences industry as a commercial business partner. She has experience across multiple focus areas (Pharma, Medical Devices, Biotech, etc.) with clients ranging from global companies to start-ups. She assists customers to help navigating their Regulatory requirements and addressing challenges from pre-submission to post-market across the entire Regulatory value chain. Ester is well-positioned to leverage Freyr's global Regulatory solutions, services, and technology innovations toward achieving client goals and requirements.
