As cell and gene therapies continue to advance, so too do the regulatory frameworks that surround these products. Researchers and industry organisations can find navigating the regulatory guidelines a challenge as they endeavour to interpret legal and safety protocols, and seek to understand the geographical variations and unique challenges that exist in different regions, while facilitating product development.
In this BioBriefing, Duncan Mackay (Director, Regulatory Affairs, ERA Consulting) will take both seasoned tourists and novices alike on a guided tour of the established concepts, current regulatory landscapes, and more recent destinations being explored by product development teams in the cell and gene therapy space. Duncan will provide attendees with an insight into some of the trending hot topics in cell & gene therapies and will explore the opportunities and challenges that lie ahead for organisations in the industry.
Who should attend:
R&D scientists, biotech entrepreneurs, industry related professionals, doctoral students and post-doctoral scientists.
For a more in-depth look at this topic, you may be interested in participating in Module 6 of our Going Global Program – Navigating cell and gene therapies through global regulatory pathways.
Date: Tuesday 21 May
Time: 3.45 pm registration, presentation & discussion 4.00 pm – 5.00 pm, followed by networking until 6.00 pm
Venue: CBD location – TBA
BioMelbourne Network Members: $65
Non Members: $130
(Prices include GST.)
Note: Participants registered for the Going Global program will receive three registrations for this event.
A full refund is given up to 7 days prior to the event. No refunds within 7 days of the event.
Duncan Mackay is currently working as the Director of Regulatory Affairs for ERA Consulting in Cambridge, UK, and has been with them since October 2016. Duncan has over 30 years’ experience in pharmaceutical product development including 30 years in Regulatory Affairs covering cell & gene therapies; biologics; medical devices (including combination products) and small molecules.
With experience gained throughout the life cycle from discovery/acquisition to post-market life cycle management, Duncan has very broad experience at senior levels in both blue-chip and start-up businesses. Since 1995 Duncan has worked at both strategic and practical levels in the emergent field of cell therapy including autologous, allogeneic, stem-cell and combination products. Duncan has extensive experience in agency interactions and negotiations: as an elected representative of Industry (BiA EBE) he was a leading figure in the drafting and implementation of the ATMP regulations in Europe and beyond. At Genzyme/Sanofi Duncan led the regulatory and multi-disciplinary teams of several projects and collaborations including conceiving and executing the regulatory strategy for the first combination tissue-engineered cell therapy product to be licensed by EMA in Europe. Prior to joining ERA Duncan has held a number of positions of increasing seniority at GSK; BMS; Boston Scientific; Biogen and Genzyme and more recently as an independent consultant on Regulatory Affairs and Quality.