Genomic medicine's future means solving people problems, not 'just' science problems

Danaher's Genomic Medicine Summit at Boston's Harvard Club last week was an eye-opener, even for those steeped in the field.

I hosted a panel discussion focused on how the future of genomic medicine could become more accessible and affordable. We discussed the need for collaboration among those involved in driving the science, engineering, clinical practice, and regulatory frameworks in order to advance the field. We highlighted the challenges of driving down the cost of manufacturing and speeding up approvals, which we considered as much of a people problem as a technology problem. In some cases the science is well-baked and we are slow because we are pushing through "human systems" problems.

Here's what I learned and re-learned (yes that is a thing):

1. Training and education: There is a crisis of talent. There are not enough trained people in the multi-disciplinary approaches that are required (cell biology, engineering, genomics, computational biology, analytics etc), and not enough knowledge in the regulators to enable the rapid and smooth acceleration of therapies to the clinic. There is not enough understanding among the general public as to what these new therapies can enable, and what opportunities for better health outcomes exist with potentially controversial, if poorly communicated, technologies such as full population genome sequencing for risk stratification. Science communications needs to step up its game.?Insight: China will overtake the US & Europe – it is training and educating enough people in the critical skills
2. Clinical trial architectures and regulatory systems are adapting and there is great willingness to do so. While they were built for small molecules, they are not always fit for regulating curative therapies where speed-to-human trials is critical: animal models do not advance the science conclusively enough. Good article on this in FT>> Science will always move faster than the regulations: this is good for patient safety, until it slows progress.
3. These therapies are so much more likely to succeed than small molecule and mAb therapies, so we need to adjust our forward planning and expectations: Planning manufacturing at much earlier stages and standardizing to reference processes could help speed regulatory approval
4. Reducing costs and financing health outcomes. Many see technology as a major cost driver, despite a tacit understanding that a majority of the cost currently lies in expensive, highly-trained and educated labour. Automation, and complete health economics of curative therapies is important. Full cost-benefit analyses and exhaustive economic models (esp. for curative therapies, and in the argument for full-population genetic screening) need to be compelling if they are to make progress. A platform approach is critical in almost all areas, from assays, analytics, QA, manufacturing, diagnostics to clinical practice, etc – this could also reduce costs and help accelerate approvals.

Catch all the talks here>>