This workshop is the core component of the sixth and final module in the Going Global program. It will provide a deep dive into the commercial development of cell and gene therapies through global regulatory pathways.
About the workshop
The workshop will provide a deep-dive into the commercial development of cell & gene therapies through global regulatory pathways. In particular, it will highlight commonalities and differences in major regulatory requirements in key markets and provide guidance on how to accommodate or incorporate these to build a more efficient global development program.
Duncan Mackay (Director, Regulatory Affairs, ERA Consulting Ltd UK) will discuss utilising a classic “what, where, why, when, who and how” approach to engage with regulatory agencies to validate and adjust plans in a dynamic environment. He will also explore accelerated pathways and incentives and how to prepare for success in attaining these.
The workshop will be interactive with each session beginning by drawing upon experience, ideas and issues faced by the participants before moving into more formal presentations and finishing with a summary of key learning points. Sessions will be designed to address often overlooked or poorly planned issues such as sourcing, distribution and final product delivery (how to get the therapy to and into the patient).
In addition to attendance at the workshop for one company representative, registration includes:
- up to three attendees at the module BioBriefing (Tuesday 21 May)
- a 30-minute advisory session with the module leader for up to four representatives from your organisation (Thursday 23 or Friday 24 May at BioMelbourne Network premises – we will be in touch to advise your meeting time.)
- an invitation to attend the exclusive BioMelbourne Network Entrepreneur Roundtable Lunches with local business leaders who have succeeded in taking products to global markets.
The fee is $550 (incl. GST) if this is your first Going Global module, or $440 (incl. GST) if you have participated in earlier modules.
Registration confirmation: Please note that places are strictly limited and registration is subject to confirmation by BioMelbourne Network.
Cancellation policy: A full refund is given up to 14 days prior to the module. No refunds within 14 days of the module.
About our speaker
Duncan Mackay, Director Regulatory Affairs, ERA Consulting Ltd (UK)
Duncan Mackay is currently working as the Director of Regulatory Affairs for ERA Consulting, located 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.