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.”
Risk Inherent in Benefits of Drug/Device Products?
EU Business and Data Needs Converge Through Telematics
RIM Accelerating Efficiencies in Regulatory Pathways
Translating Clinical Trials into Clinical Benefit
More Tools & Data Sources: More Insights for RBM?
Landmark AMA to Rely on Regulatory Reliance
Healthy Population Key to Economic Success
Defining Rational Medicine and Research at DIA Japan 2019
How Do You Put Your Disease on the Agenda?
Participatory Medicine Changing Information Exchange
New Ethics and Consent Guidelines Pillars for Safety in India
Real World Data Expanding into Label Expansion
Educating Persons Critical in Personalized Medicine
FDA Payer Communication Guidance Steps Toward Sustainability
Genetic Engineering Transforming Research Ethics
Only Big Trust Propels Big Data into Big Discoveries
Empowering Today’s Patients to Help Tomorrow’s
Imaging Data Plus AI “One of the Best Combinations”
Clinical Trial Diversity Begins (and Ends) with Patients First
Califf: Digitization Will Return Humanity to Medicine
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