MARGARETTA NYILAS

Pharmaceutical Executive

Independent Advisor & Board Member

Biopharmaceutical executive with over twenty years of diverse, global industry experience (CNS, oncology, analgesia, anti-infective, pediatric, orphan disease, formulation development, drug-device combination and digital health trials) with proven ability to deliver high value assets such as ABILIFY MYCITE® (aripiprazole tablets with sensors), ABILIFY MAINTENA® (aripiprazole), and REXULTI™  brexpiprazole), ABILIFY® (aripiprazole).

Transformational change leader in clinical and business operations overseeing quality and timely execution of large scale, global clinical development portfolios from early stage development through lifecycle management. Over the last five years, conducted approximately 91 studies at 3,000+ sites in 50+ countries with 30,000+ subjects resulting in 14 major global regulatory submissions and approvals. Hands-on development and regulatory submission experience in adult and pediatric CNS trials with different formulations in indications such as acute and maintenance treatment of schizophrenia, bipolar mania, major depressive disorder (MDD), agitation in Alzheimer’s Dementia, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disorder (ADHD), autism, and Tourette Syndrome (TS).

Strategic lead in establishing the Alliance Management function in support of an expansive due diligence initiative resulting in asset and corporate acquisitions (co-development and co-promotional agreement for five compounds with Lundbeck; acquisition of astex® and Avanir Pharmaceuticals).

Recognized as a clinical trial innovator by implementing the industry’s first end-to-end e-Trial with digital health technology. Successfully implemented a new business model designed to increase productivity and embrace the ePlatform leading to data base lock in less than 72 hours. Formed the R&D Innovation Team to provide research and management support with a key focus on business transformation through technology integration. Completed the first clinical development program and submission of an FDA-approved medication Abilify Mycite™ in combination with a sensor (the Proteus® ingestible sensor) within the medication tablet.

Currently serving as a Board Member of the Board of Directors Otsuka Europe Development & Commercialisation, Ltd.