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.”
DIAmond Session 203: “Innovation is Clearly Happening”: Next Generation Collaboration: Transforming the Industry
DIAmond Session 201: International Regulatory Convergence, Collaboration & Cooperation
Executive FDA Leadership Reviews & Previews PDUFA Reauthorization
“Biosimilars have at last come of age in the United States”
Mission, History & Opportunity Attracts New DIA Americas Leadership
Clinical & Real-World Data: Is AI the Missing Link?
TransCelerate Moves Clinical QMS from Vision to Conceptual Framework
Executive Director Shares New CTTI Strategic Plan to Improve Clinical Trials
Who Determines the Price of Medicines – and How?
“An Urgent Imperative Now to Learn Quickly”: DIA 2016 Co-Chair Dr. Gigi Hirsch
Industry-Patient Relations: Culture Change or Culture Shock?
Every Journey Begins with a First Step: DIA Patient Engagement
“Outbreaks are inevitable. Pandemics are preventable.” – DIA 2016 Keynote Speaker Dr. Larry Brilliant
Growing Irrelevancy of Pre- versus Post-Market Divide for EU Medical Devices
Crossroads in Europe: Access from a Market and HTA Perspective
A Visionary Takes the Helm at DIA Europe, Middle East & Africa (DIA EMEA)
Steps to Meet the “Big Quality” Challenge of “Big Data”
Innovation: Can it Span the “Efficacy versus Effectiveness Gap”?
Dr. Kemal Malik Ponders “Is Innovation Always the Answer?”
EMA Senior Medical Officer Explains “Access versus Evidence Tradeoff”
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