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.”
New MD and IVD Regulations: Implications of Implementation
DIA EMEA: Research in Europe “Disconnected from Business”
Blockchain, AI and Other Radical Drivers of Biopharmaceutical Innovation
FDA Overviews New EU-US MRA on GMP
Networking 101: Extrovert or Introvert? In Person or Online?
DIA Forum Acts on Statistical Impact of 21st Century Cures
Q12 Aims to Align CMC with Accelerated Development & Approval
EuroMeeting Preview: Real-World Data + AI = Clinical Evidence?
Cures Within Reach at DIA 2017: Good Therapies at Reasonable Cost
EuroMeeting Co-Chair Envisions “Continuous Loop” from Bench to Bedside and Back
BfArM President: Real-World Data & Randomized Trials “Compatible, Complementary Tools”
PatientsLikeMe: Patient Value Should Drive Market Value
Value & Access Experts Explain Price for Progress at EuroMeeting 2017
MHRA Chief Executive: Today’s Learning Will Inform Next Gen Products
Can Our Future Afford Today’s Model of Innovation?
Chair of DIA Council of Regulators Previews Risk Management & Drug Safety Updates
Bringing Regulators & the Regulated Together: DIAmond Session 412: CDER Town Hall
DIAmond Session 303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
DIAmond Session 302: Europe and the US: Making Outcomes-Based Health Care Possible
DIAmond Session 203: “Innovation is Clearly Happening”: Next Generation Collaboration: Transforming the Industry
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