Q: What do you think the Internet of Things (IoT) means as applied to pharma?
A: The internet of things to me refers to everything being connected, and that can be an interesting opportunity in clinical trials. Researchers are increasingly exploring the concept of deep digital phenotyping and the ability to capture robust streaming data from patients. This is starting today with a range of wearables and sensors that are of increasing interest. It is extending into tomorrow to other devices in the home and around the lives of patients to passively capture data and extend the concept of patient-reported outcomes. From medication adherence to quality of life, from activity to physiologic parameters and environmental factors – IoT brings exciting new data. As with all new and large data sources, the ultimate challenge will be in extracting value. The next challenge will be identifying what new analytics capabilities are needed to fully use this new data.
Craig Lipset is head of clinical innovation within worldwide R&D at Pfizer. In this role, he works across units and stakeholders to define Pfizer’s vision for the future of clinical trials and enables the initiatives and investments to create that future.
Q: What is the most valuable lesson you have learned from the shortage of antibiotics in the pipeline, and what can executives and regulators learn and apply to other therapeutic areas?
A: Sustainable development requires a streamlined clinical trial path, better diagnostics, and pricing and reimbursement that value these assets. Gaining approval for new drugs typically requires that at least two large noninferiority clinical trials have been run. More feasible trial designs are crucial. Currently, no tests can tell physicians which drug may be most useful in treating an infection. We must ensure we have rapid point-of-care tests across therapeutic areas to help medical staff quickly select the right therapies for the right patients at the right time. For antibiotics, the reimbursement process needs to evolve. The model centered on a diagnosis-related group (DRG, or bundled payment system) assuming all patients will respond to the same medicine poses a significant barrier to capturing fair value for antibiotics.
Barry Eisenstein, MD, FACP, FIDSA, FAAM, is senior VP of scientific affairs at Cubist Pharmaceuticals and editor of Antimicrobial Agents and Chemotherapy.
Q: What best practices have you seen applied by life science executives when engaging with advocacy organizations, and what practices would you advise them to avoid?
A: I recommend assuring you are aligned with the mission of the advocacy organization. Also, do a “reputation check” to avoid pairing with a group in the center of a storm. Then, seek to find common ground where working together furthers the goals of both entities in a faster, stronger, and better fashion than going it alone. The biggest mistakes I have seen are not gaining sufficient clarity about your desired advocacy outcomes and what you’re agreeing to do. There will be a time commitment, so get clarity early on about what is expected of you. Ask for full details about events you need to attend, speeches you’re expected to deliver, media in which you may be quoted, and publications in which your writing may appear. This clarity will serve both sides well.
LAURIE P. COOKE
Laurie P. Cooke, BS, RPh, PGDip, CAE, is the CEO of the Healthcare Businesswomen’s Association (HBA), a global nonprofit professional association.