Philadelphia, PA, June 29, 2016 – The future of Big Data, while promising, will depend on the ability of stakeholders to come together and collaborate to develop quality standards for use of big data in drug development and medical decision making. This was one of the key themes that emerged during a wide-ranging panel discussion on Big Data moderated by Catalyst during the Drug Information Association’s 52nd annual meeting in Philadelphia.
Panelists represented a wide range of stakeholders, including companies that are either generating or using Big Data:
- Luciana Borio, FDA Acting Chief Scientist
- Sally Howard, Human Longevity, Head of Regulatory Affairs and former FDA Chief of Staff
- Mike Doherty, Roche, Chief Innovation Strategy Officer and Strategic Advisor, Foundation Medicine
- Kara Dennis, Medidata Solutions, Managing Director of Mobile Health
- Brad Hirsch, Senior Medical Director, Flatiron Health
- Moderator: Nancy Bradish Myers, President, Catalyst Healthcare Consulting
Discussion focused in part on the challenges involved in determining quality data, and knowing what will be relevant for both innovators and regulators. Despite all of the excitement and promise of big data, “it’s still early days,” Mike Doherty, Roche and Foundation Medicine, said.
For example, with the use of wearable sensors, “we’re looking at sleep, we have hypotheses; actually often it’s hypothesis-free, we’re just looking.” So “this is quite a long journey,” getting to the “right level of quality and understanding what’s relevant,” Doherty said.
Kara Dennis, Medidata Solutions, said that when considering use of technology such as wearables, in-home tools, mobile apps and machine learning to improve clinical trial data, companies want to know: What is the quality of the data, and does this tell me anything clinically meaningful about these patients?
“I think the role of collaboration is going to be huge” in evaluating quality and relevance of data “as our understanding of how the data will be used evolves,” Catalyst President Nancy Bradish Myers noted.
Brad Hirsch of Flatiron Health, a company that is leveraging Big Data to improve oncology drug development and clinical care, agreed: “It’s very hard to know what is quality data.” Recognizing that we “can’t do this in a vacuum,” Flatiron recently began working with FDA in this area; “I don’t think anybody really has the answer of what this [quality] looks like, so we really have to work together to get there.”
FDA Acting Chief Scientist Lu Borio said collaboration among different types of stakeholders is “a requirement; we need to work together in the PPP [public/private partnership] realm.” Several panelists agreed that forming a consortium may be the most useful way of achieving this kind of collaboration.
Building on Mr. Doherty’s vision of the world of data shifting from being “milestone-based to continuous,” Ms. Myers asked how FDA will respond when there are continuously updated streams of data, including real world data, available to regulators.
“We have to realize it’s a fact that clinical trials that lead to registration are a small snapshot of what the real use of the product is going to be,” FDA’s Ms. Borio said. “And that how patients and physicians use products after registration can be very different, and it’s incumbent on the system to be able to learn from that and be able to adapt.”
Many aspects of Big Data will “challenge the regulatory framework,” Sally Howard, Human Longevity, said. FDA traditionally looks at data in a binary way – a product is either approved, or it’s not, she noted. We need to “free them up to really use big data”– perhaps through a legislative fix – particularly given the “exponential learning happening now in terms of genetic variants.”
Summarizing her take on Big Data and the panel discussion, Ms. Borio said: “I see the day where every encounter” between a physician and a patient “is an opportunity to add to the body of knowledge.” This dynamic “blurs the lines” between research and patient care, “and that’s very, very exciting.”
About Catalyst Healthcare Consulting, Inc.
Catalyst Healthcare Consulting is a boutique regulatory affairs advisory firm.
We work closely with our clients to anticipate and shape complex health care issues that can affect their business, and to address the FDA regulatory hurdles that can arise during the product development and approval process. We create engagement strategies to find win-win solutions that benefit the patient, client and regulators.
Serving as a Catalyst is what we do best. With strategic vision, expertise, and energy, we help clients generate and advance meaningful opportunities and solutions while side-stepping unnecessary challenges.
Our clients include biopharma, medical device, combination product, digital health and genomics companies, as well as patient advocacy organizations, venture capitalists launching new companies, and nonprofits. We specialize in helping cutting-edge companies identify the best pathways forward and helping clients advance their regulatory policy agendas.