Start-up biotech company developing small molecules to treat neuropsychiatric disorders by enhancing neuroplasticity and reducing neuro-inflammation

Assisting biotech clients with assets ranging from pre-clinical development to life cycle management, in areas including neurology, oncology, endocrinology, and immunology

he EFL is a 9 month performance-driven program that aims to translate breakthrough science into successful business through mentorship, venture capital, and business development. As an EFL graduate, I worked with senior executives across various biotechnology companies, and more to scale the success of 4M Therapeutics.

Established capabilities for late stage pharmaceutical development, introducing new processes and systems, hiring new talent in clinical operations, regulatory affairs, program management, medical monitoring, biostatistics, medical affairs, and drug safety. Designed and executed successful phase 3 pivotal trial in oncology for telotristat etiprate, a new class of cancer treatment with orphan drug and fast track status. Developed innovated phase 2 program and achieved positive results for sotagliflozin, advancing this oral agent into phase 3 as treatment for type 1 diabetes.

Responsible for clinical development at Lexicon Pharmaceuticals: completed phase 2 studies in oncology, type 2 diabetes, ulcerative colitis, and irritable bowel syndrome. Provided oversight of phase 1 studies in clinical pharmacology and translational medicine. Additional areas of clinical development included immunology and ophthalmology.

Responsible for all development activities for a new drug intended to treat Alzheimer’s disease. •Led a broad, multidisciplinary team of over 30 people planning and executing worldwide development (preclinical, manufacturing, clinical, regulatory) and commercialization efforts.•Developed collaborations with diagnostic companies to support innovative use of biomarkers in Alzheimer’s Disease•Developed global registration strategy supported by interactions with regulatory authorities. Obtained positive EMA opinion for use of novel biomarkers to identify pre-dementia Alzheimer’s Disease•Oversaw planning and execution of phase 1 and phase 2 studies, including the first randomized trial in pre-dementia Alzheimer’s Disease

Responsible for all clinical, medical, and regulatory activities for CGT-2168, a novel formulated combination of clopidogrel and omeprazole:•Completed phase 1 study on pharmacokinetics and platelet aggregation with CGT-2168•Led successful end of phase II interactions with Cardiorenal division at FDA•Phase III international outcomes study (COGENT) was published in the New England Journal of Medicine.•CGT-2168 significantly reduced gastrointestinal bleeding in patients with cardiovascular disease

As development champion for irbesartan and irbesartan/HCTZ, held global responsibilities for all clinical and medical affairs activities. Also led medical affairs activities for all Bristol-Myers Squibb compounds in diabetes and obesity.

Led team conducting research in health economics, epidemiology, and health services research for all development products.

Held assignments in both US and Europe leading Outcomes Research teams.

Led Health Economics and Outcomes Research programs for cardiovascular, metabolic, and immunology products.

Health Economics and Outcomes Research

Conducted health services research, taught residents and medical students, and provided patient care.