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Dpharm 2015: Challenging the Status Quo of Drug Development

by Dan McDonald
dpharm 2015

 

Forward Thinkers Gather to Challenge the Status Quo in Drug Development
A Dpharm 2015 recap


I had the honor of representing DAC Patient Recruitment Services and speaking at the “Disruptive Innovations – US” conference, which took place in Boston on September 10th and 11th. The event, now in its 5th year, brings together forward thinkers from across the drug development industry. The goal is to provide a platform for the sharing of initiatives, products and companies which are helping to change the notoriously slow moving and stodgy world of drug development. DAC was an Associate Sponsor of the event and participated as an exhibitor as well.

My presentation was part of an “American Idol” style session where representatives from various companies presented some of the unique and differentiated (if not disruptive) solutions they are bringing to the industry in order to drive progress. Titled “Leveraging Today’s Big 3 Recruitment Channels“, my talk focused on the shift we’re seeing in patient recruitment projects towards the use of three channels that – because of a variety of reasons – are now becoming far more prominent and effective.

These include:

1. Direct to Patient Digital Marketing
2. The Physician and Medical Community
3. Advocacy and Health Associations

(Stay tuned for my upcoming blog post on this topic. I’ll share the reasons why these channels have become so important and how our team is leveraging them to drive results for our clients.)

Overview of the Disruptive Innovations Conference

[pullquote]No doubt, technology is the driver of these changes”[/pullquote]

In general, most of the innovations discussed were in the technology realm, and aimed to improve the drug development process in order to make it more efficient and less costly. A lot of discussion took place around decentralizing research and moving participation away from the study site, to the patient’s home, place of work or primary care – through the use of technology. Many of the initiatives and products are newer, so adoption rates seem low and many are truly in a proof of concept phase. Nonetheless, these ideas are helping to change the way the industry looks at drug development. No doubt, technology is the driver of these changes and as the methods for interacting with patients remotely, both physically and mentally, evolves, so will the ability to decentralize research.

CRO Panel

Jeffrey Kasher (Founder, Patients Like Me) led an interesting panel discussion with members of executive leadership from Covance, PPD, INC and Quintiles. A good portion of the discussion came back to driving down costs by using digital solutions – things like big data, streamlined monitoring approaches, virtual trials and more.

Wearables/Remote-Mobile-Sensing

Nirav “Rav” Sheth from MC10 was part of a panel on Thursday morning and he talked a lot about how sensors can be used to remotely track all sorts of different data points for patients in trials and how that would ultimately allow for less site visits, better patient satisfaction, lower costs, etc.  These “label-like / patch-like” sensors are flexible and can be placed in a variety of different locations. They send data to the iPhone or Apple ResearchKit and that gets transmitted back to sites.

Along similar lines, the mSToPs study discussion was very interesting. Here is another example of using big data and remote monitoring capabilities for diagnosing and following patients – in this case asymptomatic atrial fibrillation. The speaker was from Scripps, but collaborators include Janssen and Aetna. In this study, they used Aetna’s insurance claims data to first identify where patients were located and who was treating them. It then involved the use of a fit band/wristband device in collaboration with a patch-type device for the remote monitoring of activities.

The Cloud

[pullquote]…sort of like a CTMS on steroids”[/pullquote]

Andreas Koester of Janssen led a series of interviews. One that I found particularly interesting was with Ibraheem Mahmood, President and CEO of DrugDev. DrugDev is small, well-funded and growing rapidly. They are buying up companies left and right and are in the process of completing several such transactions. They use cloud-based solutions to drive efficiencies and eliminate pain-points in the trial process. For example, they have the largest database of opted-in investigators globally and are matching them with trial sponsors. They bought up CFS Clinical and are streamlining the site financials and payments process in a number of ways. They bought TrialNetworks and are doing all sorts of cloud-based clinical trial optimization through a centralized platform – sort of like a CTMS on steroids.

Science37 presented as part of the Idol competition as well; they are doing something similar to what others have done, but with a twist.  Their system helps to connect the best researchers to potentially eligible trial participants, but through their mobile devices using a home-grown system they call NORA. The “matchmaking” capability is only the tip of the iceberg though. Essentially, they are trying to create a decentralized trial platform where patients don’t need to go to the study site to participate – including secure video chat with the CRC and Investigator, virtual consent, reminders and alerts, surveys and forms entry. The digital capabilities are paired with home-health-care / mobile nurses to allow for a 360 degree decentralized conduct of the trial.

Advocacy

Lori Abrams of BMS lead an interesting discussion with Mary Stober Murray – Advocacy Director at BMS and Gerald Matczak, Community Manager at Lilly. They described working with advocacy groups for an Oncology study and also a rare disease study. They used digital and social media based campaigns, as well as traditional media and sort of compared the two. The big takeaway for me though, was that these groups are becoming savvy on their own and they are expecting more of a partnership in order to use them as a channel and advocate for a study.

Patient Satisfaction

Abbe Steel, formerly of UCB has started a new business called HealthiVibe; essentially, post-trial satisfaction surveying of patients. This type of service has been needed for a long time and I applaud Abbe for taking the reins and making a go at it as a business. The goal is to develop benchmarks with regards to the patient experience in clinical trials through conduct of validated-post trial surveys. They are capturing all sorts of data which can be used to help reshape the trials process, improve outcomes and much more. HealthiVibe was a finalist for the American Idol type competition that they have at Dpharm.

Those are just a few of the interesting topics and ideas presented at the conference. I would highly recommend executive leadership from across the industry to attend this event going forward. While the presentations are terrific, they should strongly consider expanding the conference to include a lot of breakout group style discussions. I think this would help attendees not only walk away with some big picture ideas, but some tactical and actionable ones as well.

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