Major Cardiotoxicity Biomarkers During Oncology Development
Cardiotoxicity is now recognized as a common adverse effect of many antineoplastic agents. Targeted anti-tumor therapies and cytotoxic, chemotherapeutic agents have an effect on both the cardiovascular system and the tumor.

New Challenges in Early Clinical Development
With many new challenges in early clinical development there is pressure to change how early phase clinical trials are conducted. It is increasingly important to consider and be creative about new designs and flexible implementation of new techniques. Case studies illustrated in this paper show how trial design and execution can successfully overcome these challenges.

LIVE WEBCAST: February 22, 2012 at 10:00 AM EST; 4:00 CET
Regulatory Challenges in Global Biosimilars Drug Development
Regulations for biosimilars are currently evolving in Europe, the United States and many emerging countries. Europe has been in the forefront of biosimilar regulation since 2001 when the EU created a pathway for the approval of biosimilars. Companies seeking to establish a point of entry to or maintain a position within the biosimilar marketplace must first identify the requisite regulatory requirements for every intended market. As guidelines and pathways around the world continue to mature, the complexity of this exercise cannot be understated. This process needs to follow a logical step-wise progression to ensure that, where possible, a global development plan can be developed to satisfy regulators in each potential market. The regulatory and commercial considerations are the primary drivers for successful biosimilar development, because speed-to-market is critical.

Live Webcast: Monday, March 26, 2012 at 11:00 AM EDT
New Drug Approvals Lacking in Lupus Clinical Research: Is The Accurate Design of an Appropriate Efficacy End Point to Blame?
The focus on SLE Clinical Research has surged over the past ten years, particularly with the development of Standardized Efficacy Indices capable of measuring disease activity and patient response during clinical trials. RPS welcomes you to join them for an Interactive discussion with Lupus Industry KOLs while deconstructing past and current clinical trials, inclusive of study design and the application of the current tools available to today’s clinicians to assist in the successful development of investigational products that provide an improved quality of life for those affected by this devastating disease.