2018 Trends: The make or break moment for microbiome medicines?

Greg Dombal

Greg Dombal, COO of Halloran Consulting Group on how 2018 could be the year the research flood gates open for biologics and microbiome products reach their make or break moment.

Lessons learned from 2017

Something you wish you knew at the start of 2017?

That access to capital would stay strong and the investment conditions would be as positive as they have stayed all year.  We would have invested more heavily in the start of the year in talent to get ahead, rather than just keeping up with the demands from the industry.

A trend from 2017 that has changed the way you think/work?

The widespread lack of understanding of what real world evidence is and can tell us was surprising to me.  It was interesting to see our industry, which is normally very data driven, so easily jump on a buzzword without understanding real world evidence is and how it can reasonably be used to tell us about medicine and science.

Looking ahead

In what ways will predictive analytics better clinical trials going forward? 

Predictive analytics will help keep clinical trials in the world of actual data rather than succumbing to “alternative data.”  No longer will we be stuck estimating enrollment rates, trial costs or other simple outputs of multi-factorial processes.  In the past, such metrics were truly guesses, informed by experience, but limited by human recollection.  Our guesses can now be based on data and using predictive analytics, our estimates should be much more accurate.


How can sponsors look to reduce wastage in clinical trials 

Leverage data.  We have developed such sophisticated AI and data systems that we can deploy.  Specifically, using these tools to reduce the need to pound the pavement with CRA and other staff.  We can now predict issues and focus our human resources on the data points that help manage safety and point to efficacy faster and with greater consistency.  This will help change our clinical trial “norms” into a new reality.

What are you are excited to see take shape in 2018?

We should begin to see if microbiome products can deliver on therapeutic promise.  

The first few entries in the clinic, beyond human FMT, have seen limited success in clinical studies, yet many more clinical stage products will begin to show results.  

This is such an exciting and groundbreaking area, where the answers to many diseases could be literally already within us.

How will the biologics industry develop in 2018? 

Significant increases in development of cellular therapies.  CAR-T opened the door, and the flood gates of research will open.

Any challenge you think will become more widespread in pharma over 2018?

Integrated or mobile data collection methods.  App based data entry of patient and care giver self-reported outcomes. The percentage of non Case Report Form (CRF) data continues to go up year over year and this could be the year that more the 50% of data from clinical trials is not captured in traditional CRFs.