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.”
Innovative Partnering Models and Outsourcing Strategies
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP)
Trends in Pharmaceutical Quality
Innovative Technology in Clinical Development
Interview with DIA Annual Meeting Co-Chair Dr. Michael Rosenblatt
Innovation in Vaccine Development
Implementing Innovation- Globally Conducive Regulatory Policies
Availability of Medicinal Products: Drug Shortages
Medical Devices and Combination Products
Pharmacovigilance in 2015- Poised for convergence of innovation
Spiros Vamvakas on Early Dialogue with Regulators
Detlef Niese on Translational Medicine
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