David Kallend,
Vice President, Global Medical Director,
The Medicines Company
Following graduation from Kings College Hospital School of Medicine in London, Dr David Kallend worked in various hospital departments in the UK, predominantly at the Royal Postgraduate Medical School Hammersmith Hospital, London, where his final post was Research Fellow in the Department of Surgery. In 1995 he joined the pharmaceutical industry. He initially worked as an International Clinical Research Physician on imaging studies for Schering AG in Berlin, predominantly in the area of magnetic resonance contrast media for abdominal and joint imaging. Following this he joined AstraZeneca, based in the UK, working mainly on the development of rosuvastatin from Phase II to Phase IV and the post-approval phase. He was also involved as an advisor to other cardiovascular programs and collaborations. From 2005 to 2012 he was the Global Clinical Leader and a Group Medical Director for dalcetrapib at Roche. In this role he was responsible for the clinical development plan during Phase II and Phase III. He was also an advisor for other lipid programmes and various due diligence procedures. His current role is Vice President and Global Medical Director for the early development lipid programs, Apo A-1 Milano and aPCSK9, at The Medicines Company. During these last 18 years he has been involved with many clinical studies in the cardiovascular area and several regulatory approvals.
The Use of Biomarkers and Imaging in Early Phase Cardiovascular Studies Prior to Large Outcomes Trials
Thursday, 15 January 2015 at 11:00
Add to Calendar ▼2015-01-15 11:00:002015-01-15 12:00:00Europe/LondonThe Use of Biomarkers and Imaging in Early Phase Cardiovascular Studies Prior to Large Outcomes TrialsPrognostic, Predictive, and POC: Biomarkers from Research to Clinic in San Diego, California, USASan Diego, California, USASELECTBIOenquiries@selectbiosciences.com
New targets for the treatment of cardiovascular disease have been assessed with pharmacotherapy for several decades. The most successful have undoubtedly been the HMG-CoA reductase inhibitors or statins which lower total cholesterol, LDL-cholesterol and triglyceride and raise HDL-cholesterol. These changes in biomarkers have been associated with significant improvements in cardiovascular mortality and morbidity. Other lipid targets have been less successful in terms of improvements in cardiovascular outcomes despite significant changes in these biomarkers. Unless a new therapy is a statin, approval is usually dependent on outcomes data which involves a lengthy and costly development. Retrospectively, once outcome benefit is shown for a new therapy then the biomarker may be validated, and may even help other therapies in the class gain a more rapid approval. Imaging modalities have also been used to assess new therapies and these may eventually prove to be a better surrogate than plasma biomarkers, although LDL-C is still the gold standard and may be as reliable as any other biomarker. Currently, these biomarkers can only be used prospectively when making decisions regarding the conduct of large Phase III outcomes trials. Until these surrogate biomarkers are clearly linked to improvements in outcomes and therefore validated by the regulatory authorities globally as a route to approval of new lipid modifying therapies, the development of new therapies for the majority of lipid targets will remain a lengthy and costly process.
Add to Calendar ▼2015-01-15 00:00:002015-01-16 00:00:00Europe/LondonPrognostic, Predictive, and POC: Biomarkers from Research to ClinicPrognostic, Predictive, and POC: Biomarkers from Research to Clinic in San Diego, California, USASan Diego, California, USASELECTBIOenquiries@selectbiosciences.com
Add to Calendar ▼2015-01-15 11:00:002015-01-15 12:00:00Europe/LondonThe Use of Biomarkers and Imaging in Early Phase Cardiovascular Studies Prior to Large Outcomes TrialsPrognostic, Predictive, and POC: Biomarkers from Research to Clinic in San Diego, California, USASan Diego, California, USASELECTBIOenquiries@selectbiosciences.com
