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.”
DIA 2016 Co-Chair: "A Market for Ideas" in a Global Forum
Advances and Best Practices in Communications with Consumers and Health Care Professionals
Challenges in Deploying a Global Pharmacovigilance System
Challenges in Adverse Event Reporting and the Role of Specialty Pharmacies
Access & Attitude to Clinical Trial Technology: The Global Investigator Perspective
What Precision Medicine Means Today and Will Mean Tomorrow for Patient Care
FDA Director of Division of Online Communications, CDER, Discusses FDA's First Mobile App
Pediatric Drug Development & Therapeutics in September TIRS
TransCelerate BioPharma Clinical Quality Management System Conceptual Framework
Patient Engagement and Rare Diseases at DIA
Ethical Considerations in Policies on Drug, Device, and Companion Diagnostics Development
Medical Communications Transformation and Impact on Health Care Community
Challenging the Value of Source Data Verification
The Impact of Collaborative and Risk Sharing Innovation Approaches on Clinical and Regulatory Cycle Times
How to Get Published with DIA
Perspectives on Statistics
An Expanded Role for Patients in Clinical Trial Design
Women and Children First—Time for a Coalition to Address a Substantial Patient Need
PhactMI Strives to Bring Medical Information Transparency to the Health Care Community
Clinical Safety and Pharmacovigilance
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