Regulatory Voices

In the next episode of Regulatory Voices , I speak with Bryce Whited, Ph. D. , Founder at WCI MedTech , a regulatory professional with 20 years of experience across FDA, medical devices, combination products and consulting. Bryce began his career as a Lead Scientific Reviewer within FDA’s Center for Devices before moving into industry, where his perspective on regulatory strategy became much broad...

Kicking off series 3, next week on Regulatory Voices , I sit down with Victor Paulus Ph. D, a senior regulatory leader with more than 30 years of experience across vaccines, women’s health, biologics and radiopharmaceuticals. Victor has had a fascinating route into Regulatory Affairs, beginning his career in the laboratory and vaccine manufacturing before making the move into Regulatory and eventu...

On the next episode of Regulatory Voices , I sit down with Beth Weinberg , Chief Regulatory and Safety Officer at Apnimed , who brings more than 30 years of experience across drug development and Regulatory Affairs, including over two decades at Eli Lilly before moving into biotech leadership. This was one of those conversations that moved well beyond regulations themselves and into careers, leade...

In this next episode of Regulatory Voices , I sit down with Jonathan Douek, PharmD, MS , Senior Director and Global Head of Regulatory Affairs at Oncolytics Biotech Inc. Jonathan’s career has taken him from an FDA externship and early regulatory roles at Amgen, through a rapid progression at Dynavax, to leading global regulatory strategy within a clinical-stage oncology biotech. This was a really...

In Episode 11 of Regulatory Voices , I speak with Jessica Duffy (Weckhorst) , a Regulatory Affairs Manager at Apogee Therapeutics with experience across small molecule oncology and monoclonal antibodies in inflammation and immunology. Jessica’s path into Regulatory Affairs began with a PhD in computational biosciences, before she made the transition from academia into industry. In this episode, we...

In today’s episode of Regulatory Voices , I speak with Bhargavi Pandit RPh, MS, RAC , a global Regulatory Affairs leader with 15 years of experience across oncology, immunology, and rare diseases. Bhargavi has worked across large pharma, biotech, and speciality organisations, with experience spanning early and late-stage development, global filings, accelerated pathways, labelling, paediatric stra...

In today’s episode of Special Episode of Regulatory Voices, I speak with Dr Robert Califf, former two-time Commissioner of the U.S. Food and Drug Administration. This conversation sits right at the centre of many of the questions being discussed across the regulatory community today. How does FDA function as an institution? What happens when experienced reviewers and leaders leave? How serious is...

In today’s episode of Regulatory Voices , I speak with Nataskia Lampe , a regulatory affairs leader with more than 20 years of experience across pharma, biotech, global regulatory strategy, Reg CMC, operations and asset strategy. This is a really open conversation about what a non-linear career in Regulatory Affairs can look like, and how each unexpected step can add something valuable over time....

In today’s episode of Regulatory Voices, I speak with Mark Charest, a senior regulatory leader with more than 25 years of experience across development stage biotech, commercial organisations. This is a very honest discussion and reflection about what a long term career in Regulatory Affairs actually looks like behind the scenes. What I found unique about my time getting to know Mark is how he sti...

In today’s episode of Regulatory Voices , I speak with Zak Huang , SVP Regulatory Affairs at Aditum Bio . Zak brings a really unique perspective on Regulatory Affairs, one shaped not just by technical expertise, but by how communication, influence, leadership, and storytelling all come together throughout drug development. A consistent theme throughout is Zak’s view that Regulatory is an Art. Not...

In today’s episode of Regulatory Voices , I speak with Ashley Preston , SVP Regulatory and Quality at BlossomHill Therapeutics, Inc. Ashley has built his career across both Regulatory and Quality leadership, giving him a broad perspective on how technical expertise, communication, and leadership all intersect as careers progress. In this episode, we explore something that does not get discussed en...

In today’s episode of Regulatory Voices , I speak with Sterling Chung . Sterling is Chief Regulatory Affairs and Quality Officer at Aurion Biotech and brings over 20 years of experience across big pharma and small biotech, spanning CMC, clinical, labelling, and beyond. Having worked across multiple functions and company sizes, he brings a grounded perspective on what regulatory actually is in prac...

In todays episode of Regulatory Voices , I speak with Andie Collier . Andie is a pharmacist by background and has spent over 30 years in regulatory affairs, building experience across big pharma, small biotech, and global leadership roles. Having worked across North America, Europe, and beyond, she brings a well rounded perspective on how regulatory actually operates in practice, and how much the...

Thank you for joining us for the next episode of Regulatory Voices featuring Nicolas James, PharmD, MBA . Nic began his career as a pharmacist, including time spent working in a psychiatric hospital, before transitioning into regulatory affairs. Since then, he has built experience across big pharma, small biotech, and been is an acquisition environment and kept on too, giving him a well rounded pe...

Happy to be sharing the first entry in Regulatory Voices where I am joined by Huong Huynh, Director of Regulatory Science at Critical Path Institute. In this first episode we talk about her time in the FDA and some of the mentality in Public Service vs Industry, we then dig deeper into what exactly is Regulatory Intelligence. We also take a deeper dive into the importance of Data Sharing, especial...