In recent years, cardiovascular drugs have experienced spectacular and expensive failures during late-stage development. But could these failures have been avoided?

This audio conference will address “if and how” some of these failures could have been prevented. The conference will review:

• Using predictive rather than standard pre-clinical models
• Innovative PoC-designs in Phase IIa
• Close cooperation between all relevant departments within the sponsor company as well as regular authority interactions
• Less complex protocols with similar endpoints throughout Phases II and III

This audio conference covers:

• Innovative proof of concept designs in Phase II can help with decision making
• Careful planning of Phase III will help reduce failure rate
• Work with regulatory authorities early and often
• Preclinical models should reflect clinical realities
• Not to sacrifice approval for speed

About the speaker:

Dr. Michael Kirchengast is PRA’s cardiovascular specialist and has 29 years of experience in global cardiovascular drug development. After several years in academia he joined Knoll AG, Ludwigshafen, Germany (now part of Abbott) in 1984 and held various positions in cardiovascular R&D and global strategic marketing. Dr. Kirchengast has been significantly involved in the successful global development of several cardiovascular compounds, including an ACE inhibitor, an ACE inhibitor/calcium antagonist combination and several endothelin receptor antagonists. Of note, he was involved in programs in left ventricular dysfunction post-MI (e.g. TRACE) and congestive heart failure (e.g. EARTH) as well as pulmonary hypertension (e.g. ARIES). He continues to maintain personal relationships with many of the key thought leaders in cardiovascular research. His experience is reflected in a number of invited presentations and about 90 peer reviewed articles. In recognition of his work, he was appointed Associate Professor of Pharmacology, Faculty of Clinical Medicine, at Heidelberg University, Germany in 2001. Since early 2003, Dr. Kirchengast has played a lead role in PRA’s cardiovascular initiatives.

Who should attend?

• Heads of Research & Development
• VPs of Clinical Development
• Directors of Clinical Operations
• Therapeutic Area Leaders
• Program & Clinical Study Managers
• Directors of Outsourcing and Procurement