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Interest in Real-World Evidence (RWE) took off after the 21st Century Cures Act of 2016 required FDA to explore use of RWE in certain drug approval submissions. FDA has since utilized RWE in multiple regulatory approvals, including a drug treatment for male breast cancer, a label expansion for a device for minimally invasive heart valve surgery and expansion of use for an injectable to treat schizoaffective disorder. As an alternative or complement to traditional drug approvals, RWE can accelerate and reduce the cost of drug approvals and make possible more sophisticated evaluations of drugs and medical devices. Most drug approval applications now include at least some RWE data, and recent surveys have shown that more than 90% of pharmaceutical companies either already are or plan in the near future to prioritize RWE programs.
Speaker:
Neil Belson, Law Offices of Neil Belson
This summer has been hot in climate change legal and technological developments. The European Parliament has passed the European Climate Law, a “law of laws” to drive reductions in greenhouse gas emissions to climate neutral levels, the US has upped its effort on climate initiatives through a series of executive orders earlier this year and states across the country are deliberating and passing legislation, like the Act for the Next Generation Roadmap for Massachusetts Climate Policy to ensure safety, security from cyberattacks and physical sabotage, equity, and reductions in greenhouse gas emissions. Join SciTech’s Cleantech and Climate Change Committee members for the latest legal and technological updates in the effort to stave off climate change.
Speakers:
Elizabeth Dawson, Crowell & Moring
Robert Brammer, Brammer Technology, LLC
Before proving the case with scientific evidence, know that not all science is created equal. Join panelists to discuss whether to defend or debunk science in the courtroom.
Speakers:
Hon. Roderick T. Kennedy, Retired Chief Judge, New Mexico Court of Appeals
Robert Knaier, Fitzgerald Knaier
