What is it all about?

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.

Meet Our Speakers

Michael Lambell

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.

Wayne Howell

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.

Ester Brown

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.