Amir Shojaei

Chief Scientific Officer, & EVP, Clinical Development at AsclepiX Therapeutics

Amir has built a career in life sciences as a leader with over two and a half decades of drug development experience, focused on the clinical development, registration and commercialization of biopharmaceuticals and biologics in multiple therapeutic areas. Most recently, Amir served as the Chief Executive Officer for TherOptix, where he was responsible for the business and clinical/medical strategy advancing the novel drug eluting contact lens technology platform of the company to bring innovative products to address unmet medical needs for anterior and posterior segment diseases. While at Theroptix, Amir implemented strategic development on two lead programs, with successfully gaining Orphan Drug Designation (ODD) for one program for prevention of proliferative vitreoretinopathy (PVR) and completing a pre-series A debt financing round for a total of $3.5M. Prior to TherOptix, Amir served as the Chief Development Officer for TearClear leading clinical development and regulatory strategy of all pipeline and late-stage assets. Before joining TearClear, Amir spent just under 20 years at Shire until it was acquired by Takeda in Jan 2019. At Shire, he helped create the ophthalmology franchise as the Global Therapeutic Area Head in Ophthalmology and was later able to successfully divest the key asset in that franchise, Xiidra, to Novartis for $5.3 Billion. While at Shire, Amir oversaw all aspects of clinical stage ophthalmic pipeline assets. His team brought Xiidra® (lifitegrast) from development through to U.S. FDA filing and approval. Amir’s active engagement in the clinical development around design and implementation of OPUS-3 as well as the analysis of totality of evidence were pivotal in the negotiations with the FDA leading to a US approval in July 2016. Amir is also an independent Board member at iVeena Inc., ForwardVue Inc., and a member of the Scientific Advisory Board of Ophthalmology for HTL Biotechnology, France. Prior to the start of his industry career, Amir was in academia, Texas Tech University and University of Alberta, as tenure track assistant professor teaching and training graduate students as well as post-doctoral fellows in pharmaceutical sciences and transmucosal drug delivery. He earned his Doctor of Philosophy degree and his Doctor of Pharmacy degree (magna cum laude) from the University of the Pacific, Stockton, California and holds a Bachelor of Science from the University of Alberta, Edmonton, AB, Canada.

Timeline

  • Chief Scientific Officer, & EVP, Clinical Development

    Current role

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