Thoughts over breakfast on product development for emerging infectious diseases
I had the pleasure of attending the Biomelbourne breakfast this morning where the issue of Australia’s readiness to tackle emerging infectious diseases was ably discussed by the panel of speakers. The presentations and subsequent Q&A raised a number of issues and highlighted for me the challenges that are faced in the drug development, regulatory and legal disciplines when time is of the essence and innovative methods of translating research into products are required.
Professor Doherty captured the sense of urgency around this issue, opining that the world had dropped the ball on the curent Ebola crisis being faced in West Africa (and, increasingly, around the world) and that we need to be ready to proactively face the next challenge presented by an emerging infectious disease.
Dr Marc Pellegrini set out an example of a potential development solution, noting his research and subsequent translation to the clinic of a method of promoting the death of infected cells in a number of chronic human infections, notably Hepatitis B. Could perhaps a broad spectrum approach be an answer to the development of a drug to treat the as yet unknown threats presented by emerging infectious diseases?
Fascinating also was the discussion of medical countermeasures to infectious diseases presented by Drs Leigh Farrell and Craig Rayner of Medical Countermeasure Products Australia. They set out a groundbreaking alternative to single entity drug development, which would eschew the traditional lengthy pipeline in favour of creating a functional nexus to join up different competencies (from different entities) to efficiently take R&D through to products for patients. To paraphrase Dr Rayner, all the components are in place but the wiring between them needs to be fixed. To me, this raises interesting issues from a lawyerly perspective: what would the relationship between the components be and how would it be governed? How would intellectual property be shared/protected and how would newly created intellectual property be dealt with? How would regulatory responsibilities be borne by the different components?
A proactive and innovative approach to expedited drug development also calls for an innovative and creative legal structure; exciting challenges lie ahead!