Comments – Part of the EMA’s continued commitment to RWE in support of medicinal product utilisation. When you see regulators investing in infrastructure like this, you know they are serious Continue Reading
COMMENTS: Part of the growing trend for big pharma to secure bid data sources for their own use. IMPACT: A move in the right direction towards ‘regulatory grade’ RWE, READ Continue Reading
IMPACT: Taking insulin and a GLP-1 agonist significantly increases the ability of achievement stable blood sugar levels READ TIME: 2 mins * 1. “Sanofi’s Soliqua combines an insulin with a Continue Reading
Quick Notes: CONTEXT: RWD, RWE, Pfizer, Isaeli Government, Data Transparency, Real-World Epidemiological Evidence Collaboration Agreement IMPACT: Sharing of Real-World Epidemiological Evidence to improve understanding of impact of COVID-19 vaccination Time Continue Reading
Quick Notes: CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs) IMPACT: step forward in providing the valuable information that IVD manufacturers and others Continue Reading
EXPERT NOTES: CONTEXT: EU, Commercial RWD Data Source IMPACT: Access to EU RWD, drive cutting edge improvements in patient outcome Time Taken = 3 mins QUOTES FROM SOURCE: 1. “NEW Continue Reading
EXPERT NOTES: CONTEXT: Peer Reviewed Data, RWE of Effectiveness of Cabozantinib IMPACT: In the largest real-world study to date, cabozantinib was effective in unselected, heavily pretreated patients with mRCC. Initiation Continue Reading
EXPERT NOTES: CONTEXT: Decentralized Clinical Trials IMPACT: Enabling technology for ‘Decentralized Clinical Trials’ a.k.a ‘Virtual Trials’ Time Taken = 2 mins QUOTES FROM SOURCE: 1. “As mentioned earlier, COVID-19 has Continue Reading
EXPERT NOTES: “To solve this inferential problem”. It’s only a problem in their heads, but no matter. Would not have stopped to read this without the ML primer. However. Continue Reading
EXPERT NOTES: CONTEXT: Cool Shit REACTIONS: Expert 1: “We are all doomed…someone turned on SkyNet and the AIs became self aware.”Expert 2: “Nice human interest story”Expert 3: “Centaurs guys, … Continue Reading
