Date: 2017-01-04
Type of information: Nomination
Compound: head of clinical development, head of regulatory affairs
Company: Akari Therapeutics (USA - NY - UK)
Therapeutic area: Rare diseases - Inflammatory diseases
Type agreement: nomination
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- • On January 4, 2017, Akari Therapeutics announced that it has expanded its clinical and regulatory teams. In December 2016, Dr. Brihad Abhyankar joined as head of clinical development and Justine Lees joined as European head of regulatory affairs. In January 2017, Nigel A.S. Hernandez, PhD, joined as Vice President of Worldwide Regulatory Affairs.
Dr. Brihad Abhyankar has 14 years of experience in the pharmaceutical industry working in clinical development and medical affairs for many mid- to large-size pharmaceutical companies. Prior to joining the pharmaceutical industry, he originally trained and worked as a surgeon. Most recently, he was executive director of global R&D at Takeda Pharmaceuticals and global clinical lead for an innovative monoclonal antibody developed for treatment of Crohn’s disease and ulcerative colitis that has now been registered in more than 50 countries.
Justine Lees has more than 25 years of biopharmaceutical experience, including 20 years in regulatory affairs. Ms. Lees has worked for both large and small pharmaceutical companies and for clinical research organizations at a variety of levels covering a number of different territories and her responsibilities have included global oversight of various projects both in development and in already-marketed drugs. Her experience encompasses novel chemical entities and biotechnology compounds in a variety of different therapeutic areas, including oncology, anti-infectives, CV, CNS, rare diseases, generics and biosimilars. She has extensive experience of early phase development, agency scientific advice, orphan drug designations, pediatric development plans and clinical trials. She is a member of TOPRA and an active participant of TOPRA clinical development and global development CRED courses. She is also a member of the DIA pediatric scientific interest group.
Nigel Hernandez joined Akari as vice president of worldwide regulatory affairs. Nigel has more than 20 years of global regulatory experience (nonclinical through commercial) in the pharmaceutical industry. He began his regulatory career at Biopure, then worked at LeukoSite (acquired by Millennium), Millennium Pharmaceuticals, GMP Regulatory, Archemix Corp, Ariad Pharmaceuticals and Tarsa Therapeutics, where he held roles of increasing responsibility. At Actelion Pharmaceuticals, he was responsible for global regulatory leadership and strategy for Veletri® (epoprostenol) and Zavesca® (miglustat), including several early and late-stage developmental products in the cardiovascular, oncology and neurology therapeutic areas. He was most recently at Esperion Therapeutics where he led the global regulatory development of bempedoic acid to lower elevated levels of low-density lipoprotein cholesterol (LDL-C).
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