DIA: Driving Insights to Action
Science:Life Sciences
“We're moving toward an era of truly personalized medicine where research is uncovering the genetic basis for disease as well as mutations and biomarkers that can be targeted with drug and biologic therapies. We need to continue to identify the right patients for these innovative therapies, and this is where companion diagnostics has a foothold,” explains Tiffany Levin (55th Parallel). “One of the key challenges for drug sponsors is the timing of the development and review of companion diagnostics when they're intended to accompany an accelerated therapeutic development program,” continues Megan Doyle (Amgen). “We know regulators have developed or are developing accelerated regulatory pathways for drugs that are intended to address areas of high unmet need. But we don't have a similar accelerated pathway in most jurisdictions for the companion diagnostic.”
Califf: Digitization Will Return Humanity to Medicine
New Sources Changing the Meaning of Evidence?
AI Research Can Optimize Clinical/Operational Effectiveness
Has Joining ICH Accelerated Innovation in China?
Pricing Pitfalls in Prescription Drug Advertising
MID-NET Among PMDA’s First Steps Into RWE
Regulatory Science 2019: Leading or Holding Back Innovation?
23andMe: Information Empowering Patient Action
The Patient’s Most Engaging Question: Why?
EUnetHTA: Post-Launch Critical for Comparative Data
HSA Harmonizing Culture and Science in Singapore
Promoting Patient-Centric Business: MedComm in Latin America
Separate but Equal: Regulatory & Pricing Assessments in EU
Genetics Leading Modern Revolution in Cancer Care
Automation No Substitute for Scientific Leadership
R2D2 & C-17 New Landmarks in Canada’s Collaborative Pathways
Advanced Therapies Moving Upon Combination Platforms
Challenges in Generic Drug Safety & Surveillance
Interview with a DIA 2018 Patient Scholar
Novel Approaches to PV Collaboration
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