Highlights from the LifeSciences Collaborative Conference

JeanMarie Markham–CEO, Clinlogix | Greg Ambra–CEO, DZS Clinical Services | Jason Monteleone–CEO, Clinipace Worldwide | Sina Adibi (Moderator)–CEO, Adaptive Clinical Systems | With Robert Fesnak and Steve Kantor, Co-founders, Life sciences Collaborative.

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Adaptive Clinical’s CEO, Sina Adibi, had the privilege of participating in a panel at the LifeSciences collaborative Conference March 5, 2019. The topic of this year’s conference was Opportunities in a changing Life Sciences Landscape. We had the pleasure of being among entrepreneurs and investors primarily from the Philadelphia area and focused in Bio-tech and Life Sciences. The specific panel moderated by Adaptive Clinical was focused on the role that CRO’s play in this transformation. Here are some highlights:

Patient Recruitment

Patient recruitment remains top priority even as the breadth of testing required narrows significantly with personalized medicine and advances in genomics research.

The overriding theme of the discussion was that patient recruitment is not working now and will be even more difficult in the future. For example at Cancer Treatment Centers of America (CTCA), only 3% of eligible patients participate in trials. Considering the significant access to cancer patients, increasing this by 5% will be a major leap.

In addition to needing to raise participation, the panelists identified an increasing need to target specific patients to the point of N = 1. With genomic testing, personalized medicine, AI and big data, there will be more precise ability to develop targeted drugs, and hence, narrow pools of subjects. Due to their inherent complexity of such studies and the fact that many different data points need be collected and carefully scrutinized, a challenge will be to modernize information flow and revise study the data structures to enable clarity of analysis. And as all necessary data does not reside in a single container, interoperability among disparate systems will be essential. Failure to achieve this level of specificity will slow the advance of the biotech industry; they can’t commercialize what they cannot test.

To increase participation, new recruitment models that reach out directly to providers will need to be developed. This will require culture change, new business models and technology enablement.

Technology will be a key to enabling this and needs to include contemporaneous data collection, immediacy and security protections. It is expected that Block Chain could play a significant role subject to overcoming all the fear, doubt, and uncertainty that comes with new platform adoption.

Advances in Technology

Technology investments are now treated as strategic investments and not just overhead. CRO’s are becoming tech players, helping lead the “information flow modernization,” by allowing transformation of raw healthcare data to decisions. Examples of this range from tactical improvements in workflow such as risk based monitoring or innovative study designs using real-world evidence.

Now every business now is a digital business, and digital innovation and disruption is impacting the industry in unprecedented ways. Innovative CRO’s understand that technology has moved from overhead to enabler to strategic differentiator. This touches on every aspect of emerging trends from genomics and personalized medicine to big data to AI, none of which work without secure, clean and reliable data, and of course, robust security.

Another challenge is the rapid and unprecedented pace of newly emerging systems and data sources. The traditional “plan your work; work your plan” doesn’t work when the plan needs to change in real time. This impacts culture, systems and technology and places new demands on relationships between CROs and sponsors. When it comes to tech, the pharma industry has traditionally been one that more preferred to build rather than buy. That model is not sustainable and requires a change. Those that do are much more likely to succeed.

Data Quality and Integrity

Data integrity is cornerstone of a CRO’s role as velocity and volume of data being generated is increasing — as in wearables. This coupled with prevalence of analytics and AI and has elevated the importance for data quality and data integrity. Data quality and Integrity are already a center piece of FDA regulations but rooted in an era of paper based data collection. In that context, here are some questions that came up:

• Do we see the FDA getting stricter or more trusting of new types of data collection sources?
• Will we ever get to true virtual, patientless trials? How to validate the data in these cases?
• Will giant leaps in maintaining data take a long time to implement?
• Is block chain going to make a difference?

These topics were weaved through all of the discussion. In listening to the panelists, it is clear than this touches on data access, data integrity, and finally, interoperability across systems.

Access speaks to the issue identified by the CTCA speaker, that only 3% of patients are enrolled in clinical trials. There is no way, easy or otherwise, to access the 97% who are likely not even aware that trial participation is an option. If the data (assuming it even exists) is “locked away” for example in an EHR, it is not useful. Technology coupled with data standards can help liberate this data, but there more far reaching implications that will require change in relationships and culture between sites, CROs and sponsors through to demands for new business models as well.

Interoperability will be what ties it all together and allows the data to become information to translate to more patients, better targeted, in more trials. There is a lot of effort around data standards, but these solutions are still a long way away, and typically may not apply to markets outside the US. Technology in the form of interoperability platforms and software will fill the gap. When EHR’s can (with permission of course) be queried, run through Algorithms powered by AI etc.,  the universe of possible study patients will expand.

As interoperability comes to fruition, we will likely see the development of virtual and siteless trials. With data accessibility, interoperability, security, wearable devices and the like, the need for expensive, brick-and-mortar facilities should lessen. This should be a more patient-friendly model as well, lessening if not eliminating the need to go to a special facility outside of the subjects normal routine.

International Trials and Regulatory Trends

Initiating and managing clinical trials is a daunting task even for the most experienced sponsors let alone small biotech startups. Questions raised and discussed where:

• Is it easier to work in the US?
• A lot is happening internationally, so is BREXIT a factor for Europe and why?
• A/P expansions maturing and country specific regulations affecting studies?
• International expansion will grow such as China, with 4% of trials but 20% of the world’s population as well as emerging regions like the Middle East and Africa.

Regardless of where the trial takes place, partnering with an experiences CRO significantly increases the chance of success. Experienced CROs will help a young innovative company navigate regulatory as well as cultural issues in a fast changing international geo-political landscape.