Robert Califf weighs in on FDA, Big Data and Public Health at CLSA Program

Former FDA director keynotes CLSA’s Evening With Thought Leaders Event
Sept. 22, 2017

By Sara Radcliffe
President & CEO
California Life Sciences Association (CLSA)

CLSA was greatly honored to welcome Dr. Robert Califf as the keynote speaker at our recent Evening with Thought Leaders in Los Angeles. Dr. Califf has had an extraordinarily impressive career as a cardiologist, Commissioner of the Food & Drug Administration (FDA), and now as a researcher with Duke University and adviser at Verily, an Alphabet company.

Dr. Califf began with an overview of FDA, stating that the Agency regulates 20 percent of the economy, half of that through its oversight of the nation’s food. He described the gradual expansion of the FDA’s role over time, and some of the public health crises which sparked that expansion, such the birth defects which resulted from the use of thalidomide during pregnancy in the late 1950s and early 1960s. He noted that FDA is asked to do tremendous amount with a relatively thin budget, and CLSA agrees; our association has been a strong advocate for increased FDA funding for many years.

Dr. Califf also remarked on the Agency’s recent focus on patient-centered drug development.  In particular, he mentioned the Agency’s efforts to incorporate patient and caregiver perspectives into its decision-making. He credited patient advocacy groups – such as the Cystic Fibrosis Foundation — for funding research that will lead to new treatments and collaborating closely with the FDA to move these treatments through the pipeline.

In addition, he observed that manufacturers are increasingly engaging with patient communities to design better products and therapies that meet the needs of the communities they are intended to serve.

“Even the smartest engineering does not always generate usable products. It makes a lot of sense to ask people who have a problem what they need.” 

Dr. Califf also expressed his concern that many clinical trials are conducted in an “unreal world.” In other words, the demographic profile of the trial participants sometimes does not represent the real-world population that will use the drug. He pointed to personal devices, electronic health records and other big data sources as possible ways to expand clinical trial recruitment and improve care.

“We are in a revolution in our evidence-generating systems,” said Dr. Califf. 

Dr. Califf then segued to his new roles with Duke and Verily, which are giving him a unique opportunity to use Big Data to find solutions to pressing health problems. He expressed a particular interest in ameliorating economic, race- and geography-based health disparities.

“Look at the university towns in North Carolina,” he said, “tremendous health, people are … running, they look good. You go two counties away, and you have an enormous opioid epidemic, depression, cardiometabolic disease – it’s going the wrong direction.”

Dr. Califf spoke at length about how technology can be a force for good. For example, he highlighted a new feature recently launched by Google, that provides a referral to the National Suicide Prevention Lifeline at the top of the search page any time a user searches for information that might indicate an intent to commit suicide.

He also referenced Verily’s Debug Project, a program to scale the sterile insect technique to reduce the number of invasive, disease-carrying mosquitoes in target areas. The project focuses on Aedes aegypti which can transmit dengue, Zika, and chikungunya. Dr. Califf also spoke about the promise of machine learning, noting that that because every procedure in robotic surgery is recorded, there is a tremendous potential to mine the recorded information to improve outcomes.

“The ability to compile everything from genes to social behavior – and everything in between – and analyze it is going to be revolutionary,” said Dr. Califf. “Both for healthcare and medical product development.”

To learn more about upcoming CLSA events and thought leadership, click here.

About Evening with Thought Leaders

CLSA members & non-members alike have come to rely on this program as a way to stay current on trends in the biomedical industry and get fresh insights from key opinion leaders on policy, economics, business and society. Past speakers have included Former Secretary of State and Distinguished Fellow at the Hoover Institution, Stanford University, George P. Schultz, the Dean of Scripps School of Medicine and author of The Creative Destruction of Medicine, Dr. Eric Topol, and the Distinguished Professor, from the UC San Diego Stem Cell program, Dr. Larry Goldstein.

About California Life Sciences Association (CLSA)

California Life Sciences Association (CLSA) is the state’s largest and most influential life sciences advocacy and business leadership organization. With offices in Sacramento, San Diego, South San Francisco, Los Angeles and Washington DC, CLSA works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow California’s life sciences economy. CLSA serves biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers throughout the Golden State. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged. Visit CLSA at, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.