Introduction:
Welcome to the Velocity Made Good Podcast. I am your host, Ted Grasela.
I am delighted to introduce today's guest, Dr Ian Hudson, OBE.
Biography:
Dr. Hudson trained as a pediatrician and practiced in several hospitals in the UK. Subsequently, he worked for SmithKline Beecham Pharmaceuticals in various clinical research and development roles. He eventually became the Director and Vice President of Worldwide Clinical Safety, responsible for monitoring and evaluating the safety profiles of all development compounds, licensed drugs, and product labels.
In 2001, he joined the UK regulatory authority, the MCA (now MHRA), as its Director of Licensing and subsequently became the UK's delegate to the CHMP. From 2013 to 2019, Dr. Hudson was chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA). He was responsible for the Agency, the National Institute for Biological Standards and Control, and the Clinical Practice Research Datalink. He was accountable to government ministers and health services organizations throughout the UK.
Ian developed extensive links with regulatory agencies worldwide and served as the Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) from 2016 to 2019. ICMRA brings together major medicine regulators worldwide to address common challenges, including support for innovation, supply chain integrity, pharmacovigilance, and crisis management.
In 2019, Ian became a senior adviser at the Bill and Melinda Gates Foundation. There, he worked on strengthening regulatory systems in low—and middle-income countries, strengthening the clinical trials funded by the Foundation, and providing regulatory support to those developing new medicines and vaccines for diseases predominantly affecting these countries. His work involved interacting with many stakeholders, including pharmaceutical companies, product development partners, academia, regulators, and policymakers.
He was appointed an OBE for services to healthcare in the 2020 New Year Honours.
Discussion Points & Timestamps:
How did you become interested in regulatory science? What experiences led to your role as chief executive of the MHRA? [3:00]
What accomplishments are you most proud of? [5:00]
What have been your most significant challenges? [8:00]
Can you talk about your approach to the risk-to-benefit assessment for a new drug? [9:50]
Can you discuss developing and refining the product label during regulatory review? [12:30]
What do you wish we could do better in developing product labeling? [15:30]
Most recently, you have been involved with the BMGF and its work to strengthen the networks of regulatory agencies in Africa. Can you talk about that project? [16:30]
What has been the most significant impact? [19:00]
What have been the biggest surprises of that work? [20:00]
What do you see going forward for them? [21:00]
What valuable activities could clinical pharmacologists pursue in low- and middle-income countries that would effectively contribute to the global ecosystem of regulatory review? [22:30]
Do you have any last thoughts about the topics we’ve discussed or topics we haven’t covered that are important? [24:30]
Summary:
Dr Hudson expressed his enthusiasm for collaboration among regulatory agencies and pointed to his work with the CHMP and EMA to develop a unified strategy for the international regulatory community.
He discusses the challenges of adequately assessing the benefits and risks of new drugs, keeping in mind the proposed context for their use and the uncertainty of knowledge about a drug. This risk-to-benefit assessment is key to ensuring an evidence-based product label reflecting the data in the dossier submitted for regulatory review.
Ian served as a senior adviser to the Gates Foundation. He was keen on its work supporting the regulatory agencies in individual countries and fostering their cooperative efforts as members of regional economic communities. He is rightly proud of his efforts to support the Foundation in establishing the African Medicines Agency.
Ian points to the key role of clinical pharmacologists from low- and middle-income countries in studying drug outcomes in diverse populations and conducting research to explain differences.
Ian is optimistic about the future and looks forward to advances in regulatory science stemming from the work to strengthen regulatory science in low- and middle-income countries and their future as members of the global regulatory community.
We trust you’ll find this episode of the Velocity Made Good podcast insightful. For more information, we encourage you to explore the suggested readings.
Supplemental Readings:
Mukonzo JK, Ndagije HB, Sabblah GT, Mathenge W, Price DA, Grasela TH. Expanding regulatory science: Regulatory complementarity and reliance. Clin Transl Sci. 2024; 17:e13683. doi:10.1111/cts.13683
Mashingia JH, Ahonkhai V, Aineplan N, Ambali A, Angole A, Arik M, et al. (2020) Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned. PLoS Med 17(8): e1003134. https://doi.org/10.1371/journal.pmed.1003134
Semete-Makokotlela B, Mahlangu GN, Mukanga D, et al. Needs-driven talent and competency development for the next generation of regulatory scientists in Africa. Br J Clin Pharmacol. 2022; 88(2): 579-586. doi:10.1111/bcp.15020
Centre for Innovation in Regulatory Science (CIRS)
The Centre for Innovation in Regulatory Science (CIRS) is a neutral, independent UK-based subsidiary of Clarivate plc. It aims to identify and apply scientific principles to advance regulatory and health technology assessment (HTA) policies and processes to develop and facilitate pharmaceutical product access.
Endnote:
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Finally, I would love your feedback and suggestions on the format of the Velocity Made Good podcast and thoughts on potential future guests – as together we chart a course toward better global health.
Acknowledgements:
We gratefully acknowledge Joe Brancato's generosity in allowing us to use his original composition, "Extraordinary People," as the soundtrack for the podcast.
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