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.”
Future Science & Drug Review: FDA Closing the Gap
HHS Final Rule: Good Data Shared Well Leads to Great Science
Patient Partners: Power That Rests in Us All
Technology & Data Driving Europe’s ClinOps Forward
CFDA Joins ICH, Seeks Public Comment on Further Reforms
New DIA Forum to Align Regulatory & ClinOps Expectations
Different Roots, Shared Fruits: FDA-EMA Collaboration
RWE: Bridge Between Clinical Research & Practice?
Progress in Pediatric Therapeutics Bigger Than “Smaller Dose”
Is Drug Repurposing Really As Promising As It Seems?
More Than Socially Fair or Economically Just – It’s Better Science
New China-Denmark Food & Drug Regulatory Cooperation Centre
ABPI Sees Brexit as One Game of Two Halves
Europe’s IMI Helps Drive New R&D and Access Models
Lack of Access Can Lock Patients in “Disease of Despair”
Can We “Pay for Results” to Sustain Innovation?
Uncertainty is Certain: Pandemic Vaccine Preparedness
Where and How to Bridge the EU Biotech Funding Gap
Transparency Essential to Payers’ New Role in EU
EBE Plots Path from “Flawed Underfunded Biotech System”
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