A company committed to transforming cardiometabolic lipid disorders.
01/27/2016 Patient Voices: Dear FCS
|PRE-CLINICALPRECLINICAL||PHASE 1||PHASE 2||PHASE 3|
Calcific Aortic Stenosis with High Lp(a)
CVD with High Lp(a)
Severe High Triglycerides (SHTG)
High Triglycerides with Type 2 Diabetes
The Manager/Associate Director, Regulatory Operations is responsible for overseeing Regulatory Operations activities and strategic initiatives in support of Phase 3 clinical programs. The position requires participation in and supervision of formatting, publishing, compilation and submission of all regulatory documentation to domestic (FDA) and international regulatory agencies. This individual will be a key member of matrixed project teams, maintain submission-planning timelines for assigned submissions, and implement submission strategies. This position reports to the CMO.
Please visit here for more information. Reference Requisition #15-0104
Akcea has drugs in all phases of clinical development and is looking for an experienced Safety and Pharmacovigilance Physician to join us in our Cambridge, MA, offices and build and lead our drug safety programs.
Please visit here for more information. Reference Requisition #15-0107
A global strategic and operating management executive with over 25 years' success at building high-performance global teams, leading complex development programs from early stage through approval, and commercializing global products.
Experienced biotech program and brand leader with nearly 20 years of experience. Drove programs from discovery and pre-clinical through IND, clinical trials, NDA, and commercialization/marketing in multiple therapeutic areas, including oncology, neurology, renal, and other rare/orphan diseases.
Experienced commercial leader with over 15 years of experience in the life sciences, with expertise in pre-launch market development and commercial operations for biopharmaceuticals.
Board-certified physician and 22-year industry professional with a track record of successful global drug development and regulatory approvals. Dr. O’Dea has led 13 clinical NDAs, 4 orphans and 1 device approval and is experienced with proteins, peptides, small molecules and nucleotides, as well as with a broad range of devices and routes of administration.
Professor Kastelein is a recognized world leader in the studies focusing on the significance of lipoprotein metabolism in the development of atherosclerotic vascular disease. Prof. Kastelein's current research interests focus on the etiology, diagnosis, prevention, and treatment of hypertriglyceridemia, hypercholesterolemia, and low HDL cholesterol, all conditions associated with atherosclerosis and cardiovascular disease. He has published over 740 research papers in peer-reviewed journals, including Nature Genetics, Lancet, New England Journal of Medicine, JAMA, and Circulation. His Hirsch index is 82; and his total citations are more than 23,000.
Dr Witztum is a Distinguished Professor of Medicine in Endocrinology/Metabolism at UCSD in La Jolla, where he continues to see patients in his Lipid Research Clinic. He is internationally recognized for his research into the pathogenesis of atherosclerosis and directs a group of investigators studying both basic mechanisms, as well as novel approaches to diagnosis and therapy of atherosclerosis in humans. He pioneered the concept of the role of oxidized LDL (OxLDL) in the pathogenesis of atherosclerosis, studies that place OxLDL central to an understanding of atherogenesis. Besides his basic research studies, he has remained active in clinical lipidology and has been a member of national consensus panels. Dr Witztum has published more than 400 scientific manuscripts and papers and is an ISI Most Highly Cited Author. He has been an Associate Editor of multiple journals and is currently Editor-in-Chief of the Journal of Lipid Research.
Dr Tsimikas obtained his MD degree in 1988 from the University of Massachusetts Medical School and completed his Internal Medicine training at the University of Massachusetts Medical Center in 1991. He completed separate fellowships in Cardiovascular Disease, Atherosclerosis, and Interventional Cardiology at the University of California, San Diego, from 1992-1997. Dr Tsimikas' clinical interests are focused in his role as Director of the Vascular Medicine Program that encompasses treating a wide variety of patients in the continuum of high-risk primary prevention to endovascular intervention. Areas of interest include evaluating and treating patients with elevated Lp(a) levels and percutaneous coronary and peripheral interventions. This program also functions as a key teaching venue for general and interventional cardiology fellows. Dr Tsimikas has published over 195 articles and book chapters, including in NEJM, Cell, Nature, JACC, JCI, Circulation, Circ Res, ATVB, and EHJ. He is Fellow of the American College of Cardiology, the American Heart Association, and the Society for Cardiac Angiography and Interventions.
Under Dr Crooke's leadership, the CV/Metabolic research program has demonstrated that antisense technology can be used to create multiple drugs to treat CV and metabolic diseases. The vast pipeline of drugs created by this program include Kynamro, an antisense inhibitor to human apoB-100 that is approved for the treatment of HoFH and is completing registration studies in HoFH. Dr Crooke received her PhD at the University of Pennsylvania in 1986 and has progressed to steadily more senior positions at Ionis. She is an expert in RNA-targeted therapeutics and cardiovascular and metabolic drug discovery. She has authored more than 85 scientific publications and is an inventor on nearly 70 patents and patent applications.
References 1. Gaudet D, Brisson D, Tremblay K, et al. Targeting APOC3 in the familial chylomicronemia syndrome. N Engl J Med. 2014;371:2200-6. 2. Hung M-Y, Tsimikas S. What is the ultimate test that lowering lipoprotein(a) is beneficial for cardiovascular disease and aortic stenosis? Curr Opin Lipidol. 2014;25:1-8. 3. Handelsman Y, Bloomgarden ZT, Garber AJ, et al. The clinical approach to the detection of lipodystrophy–an AACE consensus statement. Endocr Pract. 2013;19:107-16. 4. Crooke RM, Graham MJ. Therapeutic potential of antisense oligonucleotides for the management of dyslipidemia. Clin Lipidol. 2011;6:675-692. 5. Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123:2292-2333. 6. Data on file. Akcea Pharmaceuticals Inc. 7. Minicocci I, Santini S, Cantisani V, et al. Clinical characteristics and plasma lipids in subjects with familial combined hypolipidemia: a pooled analysis. J Lipid Res. 2013;54:3481-90. 8. Ooi EMM, Barrett HG, Chan DC, Watts GF. Apolipoprotein C-III: understanding an emerging cardiovascular risk factor. Clin Sci. 2008;114:611-624.