Sandra Gardiner on drug approval
From Sandra Garrett ConnectPreneur Presentation · · MediMergent LLC
“Each year approximately 77 new drugs are approved by the FDA and they are approved with a limited amount of data about the safety side effects and overall efficacy. We don't know anything about the real world effects until people in the community worldwide take that medication for a prolonged period of time.”
On , Sandra Gardiner, Chief Financial Officer and Principal Financial & Accounting Officer at NEKTAR THERAPEUTICS, spoke about drug approval during Sandra Garrett ConnectPreneur Presentation on MediMergent LLC.
About Sandra Gardiner
In a 2017 presentation to the CONNECTpreneur audience, Sandra Garrett, identified as the founder and CEO of MediMergent, described her company's digital platform as an "early warning system" designed to collect real-world data from patients about the side effects and efficacy of newly approved medications and medical devices. Garrett stated that the platform aims to address the limited safety data available at the time of FDA approval by tracking patient experiences over time. She noted that the company had raised $2.5 million from 35 physicians and was seeking an additional $5 million to scale its technology and build a national program. Garrett identified the company's stakeholders as pharmaceutical companies, health insurers, physicians, and patients. She said the business generates revenue by customizing data collection programs for clients and, once the database is large enough, by selling subscriptions for access to the information. Garrett also mentioned a partnership with the FDA, which she described as "both our carrot and our stick," and said the company was working with IBM and Watson to develop analytics using artificial intelligence.